Surgery for Breast Cancer

October 1981

NTIS order #PB82-124181
CASE STUDY #17

THE IMPLICATIONS OF

COST-EFFECTIVENESS

ANALYSIS OF

MEDICAL TECHNOLOGY

OCTOBER 1981

BACKGROUND PAPER #2: CASE STUDIES OF

MEDICAL TECHNOLOGIES

CASE STUDY #17: SURGERY FOR BREAST CANCER

Karen Schachter, M.A.

Formerly, Research Assistant

Harvard School of Public Health, Boston, Mass.

Duncan Neuhauser, Ph. D.

Professor of Epidemiology and Community Health, Professor of Medicine

Case Western Reserve University, School of Medicine, Cleveland, Ohio

OTA Background Papers are documents that contain information believed to be

useful to various parties. The information under-girds formal OTA assessments or is

an outcome of internal exploratory planning and evaluation. The material is usually

not of immediate policy interest such as is contained in an OTA Report or Technical

Memorandum, nor does it present options for Congress to consider.
Library of Congress Catalog Card Number 80-600161

For sale by the Superintendent of Documents,

U.S. Government Printing Office, Washington, D.C. 20402
Foreword

This case study is one of 17 studies comprising Background Paper #2 for OTA’s

assessment, The Implications of Cost-Effectiveness Analysis of Medical Technology.

That assessment analyzes the feasibility, implications, and value of using cost-effectiveness and cost-benefit analysis (CEA/CBA) in health care decisionmaking. The major, policy-oriented report of the assessment was published in August 1980. In addition

to Background Paper #2, there are four other background papers being published in

conjunction with the assessment: 1) a document which addresses methodological

issues and reviews the CEA/CBA literature, published in September 1980; 2) a case

study of the efficacy and cost-effectiveness of psychotherapy, published in October

1980; 3) a case study of four common diagnostic X-ray procedures, to be published in

summer 1981; and 4) a review of international experience in managing medical technology, published in October 1980. Another related report was published in

September of 1979: A Review of Selected Federal Vaccine and Immunization Policies.

The case studies in Background Paper #2: Case Studies of Medical Technologies

are being published individually. They were commissioned by OTA both to provide

information the specific technologies and to gain lessons that

the broader policy aspects of the use of CEA/CBA. Several of the

cally requested by the Senate Committee on Finance.

Drafts of each case study were reviewed by OTA staff; by

could be applied to

studies were specifimembers of the advisory panel to the overall assessment, chaired by Dr. John Hogness; by members of

the Health Program Advisory Committee, chaired by Dr. Frederick Robbins; and by

numerous other experts in clinical medicine, health policy, Government, and economics. We are grateful for their assistance. However, responsibility for the case studies remains with the authors.

JOHN H. GIBBONS

Director

tfi
Advisory Panel on The Implications of

Cost= Effectiveness Analysis of Medical Technology

John R. Hogness, Panel Chairman

President, Association of Academic Health Centers

Stuart H. Altman Sheldon Leonard

Dean Manager

Florence Heller School Regulatory Affairs

Brandeis University General Electric Co.

James L. Bennington

Chairman

Department of Anatomic Pathology and

Clinical Laboratories

Children’s Hospital of San Francisco

John D. Chase

Associate Dean for Clinical Affairs

University of Washington School of Medicine

Joseph Fletcher

Visiting Scholar

Medical Ethics

School of Medicine

University of Virginia

Clark C. Havighurst

Professor of Law

School of Law

Duke University

Barbara J. McNeil

Department of Radiology

Peter Bent Brigham Hospital

Robert H. Moser

Executive Vice President

American College of Physicians

Frederick Mosteller

Chairman

Department of Biostatistics

Harvard University

Robert M. Sigmond

Advisor on Hospital Affairs

Blue Cross and Blue Shield Associations

Jane Sisk Willems

VA Scholar

Veterans Administration
OTA Staff for Background Paper #2

Joyce C. Lashof, Assistant Director, OTA

Health and Life Sciences Division

H. David Banta, Health Program Manager

Clyde J. Behney, Project Director

Kerry Britten Kemp, * Editor

Virginia Cwalina, Research Assistant

Shirley Ann Gayheart, Secretary

Nancy L. Kenney, Secretary

Martha Finney, * Assistant Editor

Other Contributing Staff

Bryan R. Luce Lawrence Miike Michael A

Leonard Saxe Chester Strobel*

Riddiough

OTA Publishing Staff

John C. Holmes, Publishing Officer

John Bergling Kathie S. Boss Debra M. Datcher Joe Henson

● OTA contract personnel.
Preface

This case study is one of 17 that comprise

Background Paper #2 to the OTA project on the

Implications of Cost-Effectiveness Analysis of

Medical Technology. * The overall project was

requested by the Senate Committee on Labor

and Human Resources. In all, 19 case studies of

technological applications were commissioned

as part of that project. Three of the 19 were specifically requested by the Senate Committee on

Finance: psychotherapy, which was issued separately as Background Paper #3; diagnostic Xray, which will be issued as Background Paper

#5; and respiratory therapies, which will be included as part of this series. The other 16 case

studies were selected by OTA staff.

In order to select those 16 case studies, OTA,

in consultation with the advisory panel to the

overall project, developed a set of selection

criteria. Those criteria were designed to ensure

that as a group the case studies would provide:

●

●

●

●

●

●

●

examples of types of technologies by function (preventive, diagnostic, therapeutic,

and rehabilitative);

examples of types of technologies by physical nature (drugs, devices, and procedures);

examples of technologies in different stages

of development and diffusion (new, emerging, and established);

examples from different areas of medicine

(such as general medical practice, pediatrics, radiology, and surgery);

examples addressing medical problems that

are important because of their high frequency or significant impacts (such as

cost );

examples of technologies with associated

high costs either because of high volume

(for low-cost technologies) or high individual costs;

examples that could provide informative

material relating to the broader policy and

methodological issues of cost-effectiveness

or cost-benefit analysis (CEA/CBA); and

● Office of Technology Assessment, U.S. Congress, The lmplications of Cost-Effectiveness Analysis of Medical Technology, GPO

stock No. 052-003 -00765-7 (Washington, D. C.: U.S. Government

Printing Office, August 1980).

● examples with sufficient evaluabIe literature.

On the basis of these criteria and recommendations by panel members and other experts,

OTA staff selected the other case studies. These

16 plus the respiratory therapy case study requested by the Finance Committee make up the

17 studies in this background paper.

All case studies were commissioned by OTA

and performed under contract by experts in academia. They are authored studies. OTA subjected each case study to an extensive review

process. Initial drafts of cases were reviewed by

OTA staff and by members of the advisory

panel to the project. Comments were provided

to authors, along with OTA’s suggestions for

revisions. Subsequent drafts were sent by OTA

to numerous experts for review and comment.

Each case was seen by at least 20, and some by

40 or more, outside reviewers. These reviewers

were from relevant Government agencies, professional societies, consumer and public interest

groups, medical practice, and academic medicine. Academicians such as economists and decision analysts also reviewed the cases. In all,

over 400 separate individuals or organizations

reviewed one or more case studies. Although all

these reviewers cannot be acknowledged individually, OTA is very grateful for their comments and advice. In addition, the authors of

the case studies themselves often sent drafts to

reviewers and incorporated their comments.

These case studies are authored works

commissioned by OTA. The authors are responsible for the conclusions of their specific case study. These cases are not statements of official OTA position. OTA does

not make recommendations or endorse particular technologies. During the various

stages of the review and revision process,

therefore, OTA encouraged the authors to

present balanced information and to recognize divergent points of view. In two cases,

OTA decided that in order to more fully

present divergent views on particular technologies a commentary should be added to

the case study. Thus, following the case

1’11
The case studies were selected and designed to

fulfill two functions. The first, and primary,

purpose was to provide OTA with specific information that could be used in formulating

general conclusions regarding the feasibility and

implications of applying CEA/CBA in health

care. By examining the 19 cases as a group and

looking for common problems or strengths in

the techniques of CEA/CBA, OTA was able to

better analyze the potential contribution that

these techniques might make to the management

of medical technologies and health care costs

and quality. The second function of the cases

was to provide useful information on the specific technologies covered. However, this was

not the major intent of the cases, and they

should not be regarded as complete and definitive studies of the individual technologies. In

many instances, the case studies do represent excellent reviews of the literature pertaining to the

specific technologies and as such can stand on

their own as a usedful contribution to the field. In

general, though, the design and the funding

levels of these case studies were such that they

should be read primarily in the context of the

overall OTA ‘project on CEA/CBA in health

care*

Some of the case studies are formal CEAS or

CBAS; most are not. Some are primarily concerned with analysis of costs; others are more

concerned with analysis of efficacy or effectiveness. Some, such as the study on end-stage

renal disease, examine the role that formal

analysis of costs and benefits can play in policy

formulation. Others, such as the one on breast

cancer surgery, illustrate how influences other

than costs can determine the patterns of use of a

technology. In other words, each looks at evaluation of the costs and the benefits of medical

technologies from a slightly different perspective. The reader is encouraged to read this study

in the context of the overall assessment’s objectives in order to gain a feeling for the potential

role that CEA/CBA can or cannot play in health

care and to better understand the difficulties and

complexities involved in applying CEA/CBA to

specific medical technologies.

The 17 case studies comprising Background

Paper #2 (short titles) and their authors are:

Artificial Heart: Deborah P. Lubeck and John P.

Bunker

Automated Multichannel Chemistry Analyzers:

Milton C. Weinstein and Laurie A. Pearlman

Bone Marrow Transplants: Stuart O. Schweitzer and C. C. Scalzi

Breast Cancer Surgery: Karen Schachter and

Duncan Neuhauser

Cardiac Radionuclide Imaging: William B.

Stason and Eric Fortess

Cervical Cancer Screening: Bryan R. Luce

Cimetidine and Peptic Ulcer Disease: Harvey V.

Fineberg and Laurie A. Pearlman

Colon Cancer Screening: David M. Eddy

CT Scanning: Judith L. Wagner

Elective Hysterectomy: Carol Korenbrot, Ann

B. Flood, Michael Higgins, Noralou Roos,

and John P. Bunker

End-Stage Renal Disease: Richard A. Rettig

Gastrointestinal Endoscopy: Jonathan A. Showstack and Steven A. Schroeder

Neonatal Intensive Care: Peter Budetti, Peggy

McManus, Nancy Barrand, and Lu Ann

Heinen

Nurse Practitioners: Lauren LeRoy and Sharon

Solkowitz

Orthopedic Joint Prosthetic Imp’ nts: Judith D.

Bentkover and Philip G. Drew

Periodontal Disease Interventions: Richard M.

Scheffler and Sheldon Rovin

Selected Respiratory Therapies: Richard M.

Scheffler and Morgan Delaney

These studies will be available for sale by the

Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

Call OTA’s Publishing Office (224-8996) for

availability and ordering information.

. 1)111
Case Study #17

Surgery for Breast Cancer

Karen Schachter

Formerly, Research Assistant

Harvard School of Public Health

Boston, Mass.

Duncan Neuhauser

Professor of Community Health

Case Western Reserve University

School of Medicine

Cleveland, Ohio
—

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..***.. ●

Background on Breast Cancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Radical Mastectomy as the Standard Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Radical Mastectomy Reconsidered. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

NIH Consensus Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Three Surgeons. ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dr. Leslie Wise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dr. George Crile, Jr.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dr. Oliver Cope..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes in Medical Practice: Personal Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changes in Medical Practice: Professional Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conclusions: Reflections on the Change Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix A: Cost Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix B: Evidence unselected Treatments for Breast Cancer. . . . . . . . . . . . . . . . .

References .,... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page

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28

LIST OF TABLES

TableNo. Page

1. Definitions of Treatments for Breast Cancer... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Sequence of Steps Associated With Breast Cancer Detection and Treatment. . . . .

3. Summary of Some Clinical Trials in the Treatment of Breast Cancer

(McPherson and Fox). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. Summary of Some Clinical Trials in the Treatment of Breast Cancer

(Henderson and Canellos). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. Ten-Year Survival in Breast Cancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. Types of Breast Cancer Surgery Performed at the Hillside Medical Center,

1973-78 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. Results of Partial Mastectomy, 1955-72. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A-1. Breast Surgery at Massachusetts General Hospital, 1976. . . . . . . . . . . . . . . . . . .

A-2. Breast Surgery in the United States, 1975. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B-1. Survival Rates by Type of Operation: Radical v. Extended Radical

Mastectomy: 5-and 10-Year Survival. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B-2. Distribution of 15,132 Cases of Breast Cancer Diagnosed in 1972,

by Type of Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B-3. Distribution of 24,136 Cases of Breast Cancer, by Stage of Cancer

and Type of Surgery, 1950-72. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FIGURE

‘4

5

10

11

11

14

15

22

22

24

24

25

Figure No. Page

A-l. Alternative Strategies of Inpatient v. Outpatient Biopsy at Massachusetts

General Hospital, 1976. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Case Study #17:

Surgery for Breast Cancer

Karen Schachter

Formerly, Research Assistant

Harvard School of Public Health

Boston, Mass.

Duncan Neuhauser

Professor of Community Health

Case Western Reserve University

School of Medicine

Cleveland, Ohio

INTRODUCTION

Review of the best evidence leads to the conclusion that radical mastectomy is rarely if ever

justified for the treatment of breast cancer. Less

extensive surgery is as beneficial and less costly.

These assertions are likely to provoke irritation,

and what follows in this case study has not

pleased several of the reviewers of an earlier

draft. ’ Consider the individual parts of that initial sentence again. What is “the best evidence?”

Randomized clinical trials are considered the

best technique for evaluation in clinical medicine, but they are not the only source of evidence. How, for example, should longstanding

professional-expert opinion be weighed? Although statisticians will be comfortable in

voting for evidence from randomized clinical

trials, some surgeons feel that such evidence is

inadequate to overthrow existing logical models

of cancer treatment.

“Leads to the conclusion” implies a system by

which decisions are made. The scientific

method, formal logic, consensus methods, the

courts of law, and Congress are all mechanisms

IOTA Note: As with all OTA case studies, this case was reviewed by a large number of medical and health policy experts. It

is interesting to note that some reviewers felt the case was biased in

favor of less extensive surgery, others felt that the authors were

too conservative despite “overwhelming evidence” in t’aver of

lesser surgery, and others felt that the case was balanced. Thus, despite some movement toward less extensive surgery, the medical

profession still holds a range of strong feelings about the proper

methods of treating breast cancer.

for coming to conclusions. In the treatment of

breast cancer, there are several less extensive

surgical alternatives to the Halsted “radical

mastectomy” (see table 1 ). The existence of these

several alternatives, particularly when used

with chemotherapy and radiation therapy in

varied combinations, provides a broad array of

possible courses of action. In this case study, we

would like to simplify the problem by focusing

on more surgery —radical mastectomy —or less

—the several simpler alternatives.

The assertion that radical mastectomy “is

rarely if ever justified” implies that because of

variation in each human being no simple rules

are possible in medicine. To rule out all radical

mastectomies under every conceivable circumstance—a course that is almost implied—would

be folly indeed. Decision rules in medicine must

be subject to modification based on the individual patient and the wise clinical judgment

of the physician. One can also go to the other

extreme of saying that an intelligent woman,

fully informed of the options, may choose any

type of treatment including none at all.

What is “beneficial?” The debate in the clinical literature focuses on prolongation of life.

There has been little debate over the issue of

quality of life—the quality of life with less extensive surgery is greater. There is little or- no

debate on that point. The statement that less ex3
Table 1 .— Definitions of Treatments

for Breast Cancer

Surgery

(A mastectomy is the excision (removal by cutting) of the

breast.)

A.

B.

c.

Radical mastectomy (or Halsted radical mastectomy):

The excision of the breast, pectoral (chest) muscles, axillary lymph nodes, and associated skin and subcutaneous tissue.

If the above form of mastectomy is coupled with en

bloc resection (removal as a whole) of the internal mammary nodes, it is often termed an extended radical

mastectomy.

If a radical mastectomy is performed, except that the

pectorals major muscle is left in place, the procedure

may be termed a modified radical mastectomy.

Simple mastectomy, complete mastectomy, or total

mastectomy: Excision of the entire breast and the immediately adjacent lymph nodes. This is a less extensive

procedure than any of those listed in “A” above, although sometimes the term “simple mastectomy” is

used when “partial mastectomy” is meant. This form of

mastectomy preserves the pectorals muscles, but the

fascia (fibrous tissue enclosing the muscles) is removed.

Partial mastectomy (or segmental mastectomy): Excision of that portion of the breast including the tumor, an

area of surrounding normal tissue, and associated skin

(but not normally the areola or nipple). Exploration of the

normal breast tissue surrounding the tumor extends

down to the fascia of the pectorals major.

The terms lumpectomy and tylectomy have come to

be commonly used interchangeably with partial mastectomy. However, some experts feel that techniques

such as Iumpectomy often involve only the removal of

the “lump” or actual tumor and a minor portion of surrounding tissue and should therefore more accurately

be termed local excision.

Radiation therapy

The use of high-voltage ionizing radiation as an adjuvant

(assisting; in combination with) therapy for treatment of

localized or disseminated (spread) cancer. Radiation

therapy may also be used as a primary (sole) treatment.

Chemotherapy

The use of antitumor drugs or hormones as an adjuvant

therapy for breast cancer Subsequent forms of chemotherapy may be used to treat remaining symptoms after the initial treatment of the cancerous tissue is completed. Chemotherapy may also be used as the primary treatment for

breast cancer.

SOURCE Off Ice of Technology A:;sessment, U S. Congress, 1981 (Synthesis of

deflnltlons provided In H S Gallagher, et al (eds ), The Breasf, 1978,

and D Eddy, Screening ]or Cancer 1980

tensive surgery is ‘less costly” than radical

mastectomy implies a cost-benefit or cost-effectiveness analysis (CBA or CEA). A brief cost

analysis is presented in appendix A to this case

study. However, if one accepts the conclusion

that radical mastectomy does not lead to greater

life expectancy, but lowers quality of life and is

more costly than “lesser” surgery, a formal CBA

or CEA is unnecessary. The answer in that case

is: Do not perform radical mastectomies. Readers of this case study, therefore, should not expect a formal economic analysis.

The primary issue this case study does cover

is: Why does change in medical treatment occur? Change in medical practice requires convincing other individuals that such change is

desirable. The local social context of medicine in

general, and surgery in particular, falls in the

orbit of the hospital medical staff. To examine

the subject of change, this case study undertakes

to describe the experiences of three surgeons

who became convinced that less extensive surgery for the treatment of breast cancer was

preferred: Dr. Leslie Wise, at Long Island Jewish

Hillside Medical Center; Dr. Oliver Cope, at

Harvard Medical School: and Dr. George Crile,

Jr., at the Cleveland Clinic. These three surgeons are singled out because they have been advocates of a view running counter to conventional surgical wisdom, not because they are

representative of all surgeons, and not necessarily because they were the first to change

nor because their research was definitive. The

present study examines the subject of change in

medical practice by considering the personal

and social factors that led some individuals to

depart from the mainstream. It is our belief that

this approach is a departure from the clinical,

statistical, economic, and decision-analytical literature.

Readers looking to this case study for an exhaustive literature review are directed elsewhere. Statisticians looking for a close critique

of research designs or a formal comparison of

medical conservatism to Bayesian priors will

not find them here. Decision analysts and economists looking for formal decision models or

CBAs will not find those either. Our concern in

this study is with the interplay of evidence,

logic, and the social context of surgery. This is

because we feel central issues and problems are

to be found in that interplay.

Any description of the current debate on how

to detect and treat breast cancer can at best be a

distant photograph of a vast] y complex and rapidly moving target. That debate involves a large

and complicated set of topics and issues. Before
Case Study #l7. Surgery for Breast Cancer ● 5

the questions concerning surgical alternatives

can be put into context, the topics and issues

need to be defined. The sequence of steps associated with breast cancer detection and treatment is shown in table 2. Three sets of related

questions and issues are as follows.

Population.—There is major debate over

whether routine examination (screening) of

asymptomatic patients is worth doing.

● Is the benefit from new cases found sufficient to offset the risks of exposure to radiation and the costs involved?

Table 2.—Sequence of Steps Associated With

Breast Cancer Detection and Treatment

Identify population for detection:

Symptomatic

Asymptomatic (screening?)

If to be evaluated, select test for diagnostic evaluation:

Patient self-examination

Physician physical exam

Mammography

Thermography

Needle biopsya

If results of evaluation are positive, select type of section

biopsy:

Inpatient and frozen section biopsya

Outpatient and permanent section biopsya

If section biopsy is positive, select primary treatment

(based on assessment of quantity and quality of life):

Chemotherapy

Radiation therapy

Surgery

Partial mastectomy (Iumpectomy, tylectomy)

Simple mastectomy (total mastectomy)

Modified radical mastectomy

Radical mastectomy

Extended radical mastectomy

If further treatment is necessary, select adjuvant treatment:

Radiation therapy

Cosmetic surgery

a

A biopsy is a procedure, usually employed for diagnostic purposes, whereby

cells or tissues are removed from the living body and examined under a

microscope or with various chemical procedures. A needle biopsy revolves the

removal of cells by extraction with a needle A section biopsy, by contrast, entails the removal of a piece (“sectIon”) of the questionable tissue, the

specimen thus obtained may be fixed for microscopic examination by freezing

(frozen section) or by use of a permanent fixing agent such as forma ehyde

(permanent section)

Diagnostic Evaluation.—Several tests are

available.

●

●

●

●

●

●

●

How accurate are they?

How should they be sequenced?

What cutoff points define positive and negative findings?

What added information is obtained with

each added test?

What decision rules define positive?

What decision rules should be used for repeated testing?

Once a patient is found to be positive by

preliminary tests, should a section biopsy

be performed on an inpatient basis or on an

outpatient basis?

Treatment.—Breast cancer patients may be

treated with chemotherapy, radiation therapy,2

surgery, or a combination of these alternatives.

●

●

●

How sure are we that treatment provides

benefit?

How should benefits—which can be expressed as increases in either the quantity

or the quality of life—be combined,

weighted, and assessed?

If treatment includes surgery, as it usualIy

does, what followup radiation therapy, if

any, should be used? Should cosmetic

surgery be performed?

The answers at each step affect the other

steps. Each answer has major cost and benefit

implications. Because there is little agreement

on the answers to these questions, many combined strategies are possible and worth consideration. Although prior to 1970 there was little question that radical mastectomy was the

standard treatment within the United States,

that standard is now changing. This analysis

draws a number of observations about the

change process involved.

— 

2Radiation therapy alone (without surgery) is sometimes used as

primary treatment, often on patients refusing surgery. Although

the studies are few and have used small numbers of patients, the

results seem to be comparable to surgery,
BACKGROUND ON BREAST CANCER

According to American Cancer Society estimates, about 108,000 cases of breast cancer

were diagnosed in 1980, nearly all of which will

result in surgery. Approximately 35,000 deaths

in the past year were due to the disease (1).

Nearly 1 out of 12 women will develop breast

cancer at some point in their lives. The breast is

the foremost site of cancer incidence and cause

of death in American women. Despite new technology, the survival rates of women afflicted

with the disease are not much improved over the

rates of 50 years ago. Although American Cancer Society statistics indicate that when breast

cancer is discovered in a localized state, the 5-

year survival rate is 85 percent, the general

prognosis is not very encouraging. Almost 50

percent of women with breast cancer eventually

die of the disease (26,54),

The extent or severity of breast cancer varies

from one case to the next. For the purposes of

this case study, we will refer to the classifications of the Manchester staging system when

discussing the clinically recognizable symptoms

of a cancer’s spread or extent of severity. That

system consists of four “stages” (levels) as

follows:

Stage I: Carcinoma (cancer) confined to

breast. No evidence of axillary,3 supraclavicular, 4

or distant5 metastasis

(transfers, or spreading, of disease

from one organ or part of the body to

another).

Stage II: Carcinoma of breast with apparent

axillary nodeb involvement. No evidence of supraclavicular or distant

metastasis.

Stage 111: Carcinoma of breast with ulceration,

inflammatory changes, or edema

(swelling due to fluids in the tissue) of

greater than one third of breast. Ax3

Involving the axilla (the area between the chest and the arm).

‘Involving the area above I he clavicle (shoulder bone).

‘Involving distant parts or organs of the body.

6

The “axillary nodes” refer to the lymph nodes of the axilla, the

area between the chest and the arm (including the armpit and surrounding tissue). Lymph nodes are small masses of tissue that

serve as sources of lymphocytes (a type of white blood cell) and as

bodily defense mechanisms by removing toxins and bacteria.

Stage IV:

illary nodes large and fixed (unnaturally held in place). Satellite skin

nodules (attendant lesions on the surface of the skin).

Distant metastasis present (i.e., the

disease has spread to distant parts or

organs of the body. )

Normally, patients with stages I and II breast

cancer are considered “operable,” that is, there

is merit in applying treatment techniques to try

and remove the malignancy or halt its spread.

Often for patients at stage 111 and nearly always

for patients at stage IV, the medical techniques

applied are done for palliation, because there is

little likelihood of survival.

Discussion of breast cancer dates back to ancient times. Hippocrates referred to it in his

writing, although he believed that it, like all

malignancies, was incurable and better left

alone. When afflicted women sought medical

advice, their tumors were often already ulcerated and so implanted in the chest wall that a

slow destruction of internal organs had already

begun. In most cases, crude and painful treatment probably hastened the patient’s death.

During the Roman era, Celsus, a philosopher

of science, advocated the application of caustic

agents to symptoms of early breast tumors. He

believed that once tumors reached a certain

turning point, they became malignant and no

treatment could alleviate their damage. In the

second century B. C., Galen began to propound

theories that cancer was due to a bodily accumulation of black bile. He first noted the

crab-like appearance of some tumors, and called

the disease “cancer” (16,39).

Until the 19th century, breast cancers were

treated by a variety of means, including bleeding, purging, dieting, pressing the breast between lead plates, applying salves and goat

dung, and in a brutally crude manner amputating the breast. With discovery of anesthesia in

1848, extended surgical operations became feasible. In 1867, the British surgeon Sir Charles

Moore published a paper in the St. Bartholomew’s Hospital Report describing the techniques of radical mastectomy.
Moore was the first physician to chronicle the

procedure of radical mastectomy, but Dr.

William Stewart Halsted of Johns Hopkins

University received credit for implementing it.

At first, Halsted devised an ultraradical operation in which the lymph nodes of the lower neck

were removed as well as the breast, pectoral

muscles, 7

and axillary nodes. This procedure

7

The pectoral muscles are the muscles of the chest. The pechad high mortality rates and low cure rates,

however, so Halsted returned to Moore’s technique, employing the radical mastectomy as the

routine treatment for breast cancer. In 1885, he

published his first results in a study of 50 patients treated surgically (16,28,30).

toralis major and pectorals minor are the key ones in terms of this

discussion.

RADICAL MASTECTOMY AS THE STANDARD TREATMENT

For 80 years, the radical mastectomy remained the “treatment of choice” for surgeons

working with breast cancer. In 1970, 80 percent

of all women in the United States diagnosed as

having breast cancer received a radical mastectomy. This surgery involves removal of the

breast along with the muscles of the chest wall

(the pectorals major and the pectorals minor).

In addition, the axillary chain of lymph nodes is

dissected and removed.

Radical mastectomy is a debilitating operation with frequent postoperative complications

and side effects. It leaves an extensive scar that

extends over the patient’s shoulder. Halsted advised removing the fat under the flap of skin left

to close the wound, leaving the chest itself

covered by a sheet of skin stretched tightly over

the ribs. The removal of this fat creates a noticeable depression in the chest that is difficult or

impossible to conceal. Skin grafts often are necessary to adequately cover the exposed rib cage

(16).

Two principles of surgery for cancer of the

breast that were advocated by Halsted have remained deeply ensconced in the minds of many

surgeons to this day. The first principle is the

removal of the pectoral muscles. Halsted wrote

(28):

About eight years ago (1882), I began not only

to typically clean out the axilla in all cases of

cancer of the breast but also to excise in almost

every case the pectorals major muscle, or at

least a generous piece of it, and to give the tumor

on all sides an exceedingly wide berth.

One New York surgeon who has strictly adhered to this practice is Dr. Guy Robbins. Robbins, who bases his rationale on the many cases

he has seen in which the nodes under the pectoral muscles have been cancerous, is one of

those who is convinced that the only way to ensure removal of all local and regional cancer is

to perform a radical mastectomy.

Halsted’s second principle involves operative

technique (28):

The suspected tissues should be removed in

one piece (meaning the muscles and breast)

1) lest they would become infected by the division of tissues invaded by the disease, or of lymphatic vessels containing cancer cells, and 2)

because shreds or pieces of cancerous tissue

might readily be overlooked in a piecemeal extirpation.

This principle further implies that radical

mastectomy is the only way to ensure the excision of all possible cancer cells. In addition, the

immediacy that this principle connotes probably fostered the mode of operating that can be

characterized as: Perform biopsy with the patient under anesthesia; if malignancy is found,

perform an immediate radical mastectomy with

the patient under the same anesthesia.

The prospect of going into surgery and

awakening without a breast has caused untold

anxiety to many women. In recent years, some

surgeons have been performing a two-step procedure: 1 ) incisional or excisional biopsy under

local or general anesthesia, and 2) further surgery, if required, several days later. They do
8 ● Background Paper #2: Case Studies of Medical Technologies

this working within the logical model that cancer cells will not spread appreciably in the short

time before further surgery and that a respite of

several days before surgery gives the patient

with cancer time to cope with the diagnosis.

At the time Halsted was practicing medicine,

early detection techniques and routine selfexamination were nonexistent. The average case

of breast cancer was usually characterized by a

tumor so large that it often filled the entire

breast or was fixed to the chest. Ulcerating

malignant lesions were common and extensive

axillary node involvement almost inevitable.

For a surgeon confronted with these symptoms,

the logical course was to remove as much cancerous and possibly precancerous tissue as

possible.

The patient mix today is very different from

that of a century ago, and alternative treatments

are available. With the present emphasis on

bodily self-awareness and routine physical examinations, tumors are frequently much smaller

when detected than were the tumors reported by

Halsted. A question now common among surgeons is whether a radical procedure is necessary to cure the less extensive cancer. Despite

mounting evidence in favor of the lesser procedures, many surgeons still perform radical

mastectomies as routine breast cancer surgery.

RADICAL MASTECTOMY RECONSIDERED

Considerable research on the efficacy of the

radical mastectomy has been conducted over the

last several decades. As stated above, until only

a few years ago, it was the nearly automatic

treatment of choice for breast cancer. From the

point of view of the innovators who advocate

less extensive procedures, the radical mastectomy holds a traditional prominence in the

minds of American surgeons that has been difficult to break. Only recently have alternatives

to the procedure become available, and many of

them remain controversial. A large amount of

medical literature is amassing on the disadvantages of radical mastectomy, but the radical

procedure remains the point of comparison used

in clinical trials designed to test the efficacy of

other procedures. As yet, no other form of therapy has been proven to give better survival rates

than radical mastectomy. However, it should be

noted that lesser procedures may be just as effective with respect to survival as the radical

operation (55). In addition, lesser surgery produces fewer side effects and may require less extensive restorative or cosmetic surgery.

The basis of radical mastectomy is similar to

that of other cancer operations: It is designed to

eradicate the primary cancerous growth by removal of that growth along with a wide margin

of normal tissue and en bloc resection (removal)

of the regional draining lymph nodes. According to Drs. Leslie Wise and Oliver Cope,

however, the radical mastectomy does not meet

these criteria because the procedure does not involve removal of the supraclavicular and internal mammary nodes (both regional lymph

drainage pathways from the breast), R. S.

Handley ran a study in which he found that in

25 percent of all operable breast cancers (stage I

and II), the internal mammary nodes were

already invaded by the disease (33). This observation has been substantiated by a series conducted by Dahl- Iverson, Caceres, and Veronesi

(55).

Proponents of radical mastectomy find many

justifications for the procedure. One is their

belief in the disease model which postulates that

cancer cells will grow and metastasize until

removed by surgery or eradicated by radiotherapy or chemotherapy, A natural progression of

this hypothesis is “the more surgery the better. ”

According to the aforementioned disease

model, a localized cancer develops and grows,

spreads to regional lymph nodes (e. g., the axillary or internal mammary nodes), and then

spreads further through the person’s system.

The blood stream is not considered important in

this spreading. There is, however, a developing

alternative hypothesis. This hypothesis considers a tumor to be not merely a locally arising
Case Study #17: Surgery for Breast Cancer ● 9

phenomenon but rather a systemic (of the bodily system) disease. The presence of cancer involvement in the lymph nodes, therefore, is not

seen as evidence of a spreading out of the

disease from a localized “point of origin” in the

breast. This alternative view of breast cancer

biology detracts from the Halsted principle that

extensive surgery is necessary to stop the spread

of the disease (20,21,40,48).

Surgeons who advocate radical mastectomy

find intrinsic faults in clinical trials that invalidate or bring into question the results of the

trials. According to Dr. George Crile, Jr. (15):

It is further argued [by such surgeons] that

when survival rates from uncontrolled studies

are compared, they favor the radical operations,

but considering that the criticisms of the randomized series rest on arguments of selection

and inadequate randomization, this latter assertion cannot be taken seriously.

Surgeons who advocate radical mastectomy

also argue that complete resection of the axillary

nodes is an essential diagnostic procedure even

if it is not a therapeutic one. According to

McPherson and Fox (42), this is a matter of

opinion because it depends on the perception of

the disease model and possible role of the axillary nodes in immune response.

McPherson and Fox (42) have summarized

the results of eight trials reported between 1965

and 1971 (see table 3). Radical and simple

mastectomy produced the same results in terms

of survival, but simple mastectomy resulted in

less mutilation, less morbidity, and less

recovery time. These investigators concluded

that for stage I patients, tylectomy (lumpectomy) is equivalent to radical mastectomy with

respect to survival. For stage II patients, only a

1972 study by Atkins, et al., showed that radical mastectomy prolonged life more than did

tylectomy.

Henderson and Canellos, in an extensive literature review (35), have summarized more recent trials (see table 4). They concluded that

there is no difference in survival between simple

and radical mastectomy.

Dr. George Crile, Jr., argues against radical

mastectomy because of the deformity, morbidity, and psychological trauma it causes. He suggests that surgeons in the United States have

adhered to the procedure for two reasons. First,

Halsted’s reputation as a surgeon and the dominant role of Johns Hopkins Medical School

helped forge an influential tradition. Second,

radical mastectomy was a more difficult and

challenging operation than the ones it replaced,

and in the fee-for-service medical system of this

country, the more complex the surgery, the

more financial remuneration for the surgeon.

According to Crile, fee-for-service surgery does

condition behavior to some extent. In addition,

surgeons might be more liable to malpractice

suits in the event of a local recurrence after a

simple procedure than after extensive surgery.

However, Dr. Guy Robbins recommends radical mastectomy in patients with invasive breast

carcinoma who cannot medically tolerate the

extended radical mastectomy (47). Patients with

the dominant mass in the outer half of the breast

are routinely subjected to a radical mastectomy.

According to Robbins, breast cancer is multifocal, so nothing short of extended radical, radical, or modified radical mastectomy is adequate

treatment. Table 5 is a composite of results cited

in one of Robbins’ articles (47). His summary of

studies shows radical surgery producing greater

survival, but there is no demonstration that the

patient populations being compared are similar.

After analyzing the survival rates of breast

cancer patients, Dr. Maurice Fox suggests that

the disease diagnosed as breast cancer includes

two entities that are “as yet, not reliably

distinguished—one with a fatal outcome and the

other with an outcome only modestly different

from that of a group of women of similar ages

without evidence of the disease” (24). Although

nearly all patients with breast cancer are

treated, those suffering a rapidly fatal outcome

show a mortality not significantly different

from untreated patients in the 19th century.

Along the same lines, Fox states that “there is

suggestive evidence for the existence of an entity

that, by histological criteria, is malignant, but is

biologically benign” (24).

An ongoing series of controlled clinical trials

sponsored by the National Cancer Institute of

the National Institutes of Health (NIH) con-
Table 3.—Summary of Some Clinical Trials in the Treatment of Breast Cancer (McPherson and FOX)

Percentage of patients

Percentage of free of recurrence

Total number patients surviving at 5 years

Studya Comparison Stage of patients 5 years 10 years 15 years Local Any Within stage contrasts

Copenhagen: Extended radical Operable 206 67% 42% 37% 78% 58% No difference in 10-year survival of

Kaae and Johansen,

1968 (37)

Cambridge:

Brinkley and

Haybittle, 1966 (5)

London:

Atkins, et al.,

1972 (4)

Scotland:

Hamilton, et al.,

1974 (31)

U. S. A.:

Fisher, et al.,

1970

Hammersmith:

Burn,

1974 (9)

Manchester:

Cole,

1964 (12)

Edinburgh:

Bruce,

1971 (7)

Simple + XRT 219 66 44 36 81 57 operable cases (stage I excluded)

Radical + XRT Stage II 91 54 49 51 Trial stopped because of excess

Simple + XRT 113 66 46 58 of patients in radical group experiencing delay in healing of wound

Tylectomy + XRT Stages 182 71 60 63 Large difference in 10-year

Radical + partial I & II 188 74 70 87 survival and local recurrence faXRTb voring radical treatment among

clinical stage II

Radical Stages 1, 256 73 64

Simple + radical + II & III 242 70 60

XRT

Radical + XRT Stages 195 56

Radical + drug

51

I &II 233 62 50

Radical + partial Stages 92 72 91

XRT I & II 98 74 95

Simple + complete 50% 5-year survival of stage II paXRT tients in both treatment groups

—..

Radical + postop Operable 709 57 45 84 66

XRT 752 62 49 86 60

Radical + no

initial XRT

Radical Operable 200 75

Simple + XRT 184 70

XRT = X-ray therapy a

bNumbers in parentheses refer 10 references in the list that appears at the end of this case study Also received chemotherapy

SOURCE: K. McPherson and M. Fox, “Treatment of Breast Cancer,“ in Costs, Risks, and Benefits of Surgery, J. P. Bunker, et al. (eds.) (New York: Oxford University Press, 1977).
Table 4.—Summary of Some Clinical Trials in the Treatment of Breast Cancer (Henderson and Canellos)

Total Percentage

number of of patients

Study a Comparison Stage patients surviving

Cardiff:

—

Radical + XRT 55%

Forrest, et al., 1977 (23) Simple + XRT 61

USA: Radical Axillary nodes 354 79

Fisher, et al., National Surgical Adjuvant Breast Simple + XRT clinically 282 81

Project, 1977 (20) Simple uninvolved 344 76

Radical Axillary nodes 277 62

Simple + XRT clinically involved 224 62

Manchester:

— .—. —

Simple + XRT + 139 38

Lythgoe, et al., oöphorectomy

1978 (41) Stage

Radical + II 129 53

oöphorectomy

XRT = X.ray therapy

aNUr-rlberS in parentheses refer to references numbers In the IISt that appears at the end Of this case study

bAll three of these trlal~ report f~ll~~up 3 to 5 years, none of the survlvai result differences are Statlstlcally SlgrllflCEIr)t

SOURCE 1. C Henderson and G P Canellos, “Cancer of the Breast,” N Errg J Med 302(1) 17, Jan 3.1980. and 302(2) 78, Jan 10, 1980

Table 5.—Ten-Year Survival in Breast Cancer

Number Percentage of

Source Years Stage Surgical method of patients patients surviving

Crile 1955-57 I-II Simple mastectomy 69 48%

Crile 1955-57 I-II Radical mastectomy 62 34

Crile 1957-66 I-II Partial mastectomy 32 34

Crile 1957-66 I-II “Total mastectomy” 32 ?

Memorial 1960 I-II Radical mastectomy 304 61

Payne 1955-64 all op. Radical mastectomy 2,171 59.4

Atkins a

10 years I-II Radical mastectomy 188 70b

‘Randonllzed Cllnical trl.sl

bApproxlmately.

SOURCE G F Robbms, “The Rationale for Treatment of Women With Potentially Curable Breast Carcinoma,” Surg C/In N Am 54(4) 793, 1974.

tinues to provide information indicating that

there is little significant difference in outcomes

between extensive surgery and less extensive

surgery. Some of the earlier results of these

trials—conducted under the auspices of the National Surgical Adjuvant Project for Breast and

Bowel Cancers (NSABP), with Dr. Bernard

Fisher as project chairman—have already been

summarized (see tables 3 and 4). More recent

results (21,22) add to the evidence concerning

the lack of advantage in survival rates with extensive surgery. These results also lend additional weight to the hypothesis that breast cancer is a systemic disease—a hypothesis from

which the lack of advantage of more extensive

surgery is both logical and expected. For example, findings from a trial involving 1,665 women

with primary breast cancer indicate no significant difference in outcomes for women treated

by radical mastectomy v. women treated by

simple (total) mastectomy plus radiation

therapy (22) . Further, results from that trial of

women treated with simple mastectomy alone

v. women treated with simple mastectomy plus

radiation therapy indicate that the radiation

therapy did not change the probability of death

due to “distant” disease (disease at a site away

from the breast–a metastasized cancer (22).

This finding emerged despite the fact that in the

nonradiated cases, axiliary and internal mammary nodes with positive involvement of cancer

were left untreated. This finding adds weight to

the systemic disease hypothesis and further

detracts from the Halstedian hypothesis.
As evidenced by the above material, the radical mastectomy is no longer the unqualified

standard treatment, although versions of it continue to be the most widely used form of treatment. An extensive literature is developing on

the various forms of radical mastectomy, on the

alternatives to radical mastectomy, and on the

appropriate role of each in the treatment of

breast cancer. The history of these arguments

and the rationales behind the various treatments

NIH CONSENSUS PANEL

Several conclusions regarding the treatment

of primary breast cancer were reached by the

NIH consensus panel. It was the consensus of

the panel that (46):

. . . a procedure which preserves the pectoral

muscles, i.e., a total mastectomy with axillary

dissection, provides equivalent benefit to

women who) have stage I and selected stage II

breast cancer. Therefore, total mastectomy with

axillary dissection should be recognized as the

current treatment standard.

The panel also agreed that a two-step procedure

should be performed in most cases. This procedure would involve the

biopsy before discussion

natives with the patient.

study of a diagnostic

of therapeutic alterTHREE SURGEONS

It is evident from the discussion presented so

far that changes in surgical opinion and practice with respect to the treatment of breast

cancer have occurred and that these changes

have been institutionalized in the actions of the

NIH consensus panel. We turn now to the experiences of three surgeons during the formation

of these changes. Our intention here is to shed

light on the importance of personal and social

context factors in the changing of surgical opinion.

for breast cancer are presented in the references

cited in appendix B. Otherwise, it is sufficient

for the purposes of this case study to note that

the arguments over rationales and outcomes

gradually led to a reconsideration of what the

standard treatment for breast cancer should be

and thus were part of a process of change in

medical practice. The debate led NIH to hold a

consensus development conference on the subject in 1979.

The question of the benefits of postoperative

radiotherapy was left open until further results

of clinical trials could be obtained. Lesser

surgical procedures such as segmental (partial)

mastectomy, the combination of minimal surgery plus primary radiotherapy, and radiotherapy alone were considered as possibilities,

but the panel felt that trials exploring these

modes of treatment were at too early a stage to

allow definitive conclusions.

The consensus panel expressed enthusiasm for

the possibilities posed by segmental mastectomy

and primary radiotherapy. It supported further

clinical investigation of these treatments and

suggested that patients and physicians do the

same, so that the optimal treatment for greater

patient survival and minimal patient morbidity

might be found.

Dr. Leslie Wise

Dr. Leslie Wise has been chairman of the

Department of Surgery at Long Island Jewish/

Hillside Medical Center in New Hyde Park,

N. Y., since September of 1975 (49). The Hillside

Medical Center comprises a 59&bed acute care

hospital, a 527-bed geriatric unit, and a 203-bed

psychiatric facility. Wise is responsible for the

surgical service of the hospital, its six residency

programs, research projects, and the teaching of
Case Study #17: Surgery for Breast Cancer ● 13

medical students. He is also a professor of

surgery at the State University of New York at

Stony Brook and oversees the surgical service at

the affiliated Queens Hospital Center, a municipal hospital in the City of New York.

Wise has long been an advocate of less radical

surgery (lumpectomy, local excision) for breast

cancer. In three articles on the treatment of

breast cancer he has published over the last 10

years, Wise has taken a nontraditional point of

view, arguing that lesser surgery and followup

radiation therapy is as effective a mode of treatment as the Halsted radical mastectomy. In the

first article, entitled “Local Excision and Irradiation: An Alternative Method for the Treatment

of Breast Cancer” (1971) (54), Wise and his colleagues proceed from the premise that despite

technical progress and variation in mastectomy

technique, the overall survival rate of patients

has not changed over the last several decades.

This suggests “that no single approach is clearly

superior to others and that survival rate is influenced more by the biological behavior of the

tumor than by the particular method of treatment employed. ”

Wise argues that since all mastectomies result

in deformity, often accompanied by emotional

trauma and physical complications, and since

the type of surgical intervention does not have a

marked effect on mortality rates, then logically

the treatment which has the least mutilating results and fewest complications would be most

satisfactory. According to his research, local excision of the tumor (lumpectomy or tylectomy),

combined with followup radiation therapy,

seems a viable solution to the problem.

The main text of the 1971 article by Wise and

his colleagues (54) describes a British study that

they performed on a group of women with clinically curable (stages I and 11) breast cancer.

The project critically compared the progress of

96 patients treated by local excision and radiation with that of 207 women treated by radical

mastectomy with or without adjuvant radiotherapy, depending on the histology of the axillary nodes. In summary, the results of the

study showed no significant difference between

the survival rates of the two groups over a 15-

year period (1950 to 1964). Apparently, the

mode of treatment did not alter the overall

prognosis in these cases. Wise and the other investigators concluded (54):

The present study together with previous

publications on this subject would suggest that

local excision with modern irradiation may be a

suitable alternative to radical mastectomy for

early breast cancer.

Subsequent publications on breast cancer by

Wise reiterate his hypothesis that lumpectomy

and radiotherapy are as effective a cure for

breast cancer in some circumstances as any

other method. In “Controversies in the Management of Potentially Curable Breast Cancer”

(1974) (55), he summarizes a number Of studies

performed on patients receiving different modes

of treatment, including radiotherapy, prophylactic oöphorectomy (removal of an ovary

or ovaries), and chemotherapy. For clinical

stage I cancers, the results of his research strongly suggest the use of local excision followed by

radiation, and for clinical stage II tumors, “simple mastectomy with removal of accessible

palpable axillary glands followed by prophylactic radiotherapy gives just as good results as

with the more mutilating procedures. ”

In his third article, “Routine Axillary Node

Removal in the Treatment of Breast Cancer: An

Illogical Approach” (1976) (38), Wise further investigates these contentions supporting lesser

surgery through an analysis of the relation of

lymphatic drainage pathways to malignant

metastasis. En bloc routine axillary dissection is

criticized as extensive and unnecessary surgery.

Wise and the other authors of the 1976 article

contend that:

. on the basis of data accumulated at the

present time, formal axillary dissection probably

has no role in the management of women with

primary breast cancer. The morbidity and cosmetic deformity accompanying the procedure

are further grounds for rejecting its use.

Local excision of the tumor, limited excision

of affected axillary nodes when feasible, and

postoperative irradiation are again advocated as

treatments preferable to, and as adequate as,

any of the more debilitating procedures.
14 ● Background Paper #.2: Case Studies of Medical Technologies

Since his arrival at Long Island Jewish, Wise

has sought to acquaint his colleagues with his

point of view. In 1978, a study was conducted

there in order to determine trends in the treatment of breast cancer and to ascertain whether

Wise was successful in encouraging his staff to

perform less radical breast surgery (lumpectomy) as a more frequent mode of treatment for

the disease. Data were obtained from the operating room log, tumor registry, and Wise’s surgical files. Samplings were taken as to the types

of surgery performed during two 2-year intervals. The first interval covered the period from

September 1973 through August 1975 (the 2

years before Wise’s arrival). The second covered

the period from September 1975 through December 1977 (the 2 years after he became chief

of surgery). In March of 1979, another review of

data was obtained to cover the entire year of

1978. The results, listed by procedures, are

shown in table 6.

The most obvious change since Wise’s arrival

at Long Island Jewish has been the increase in

the use of the modified radical procedure. In the

years since September of 1975, the modified

radical operation has been performed nearly

twice as often as the Halsted radical mastectomy, Wise himself is still performing the majority of lumpectomies. In his first 2 years, he

performed 5 out of 9 procedures; and in 1978,

he performed 12 out of 19.

As of January 1977, there had been a noticeable increase in the number of lesser operations

that Wise has performed. This may indicate that

as a result of popular books and articles on the

subject, more women in the community are

seeking alternatives in breast cancer treatment.

Dr. George Crile, Jr.

Dr. George Crile, Jr., holds the position of

Emeritus Consultant in Surgery at the Cleveland

Clinic, an institution founded by his father in

1921. The Cleveland Clinic is equipped with

1,010 beds. All physicians practicing at the

facility are salaried, and there is no fee-for-service surgery. No radical mastectomy has been

performed at the Cleveland Clinic since 1968.

Crile has spent the last 20 years involved i n

clinical research on the relative efficacy of lesser

procedures such as simple and partial mastectomy compared to the radical Halsted operation.

Although trained to use the Mayo Clinic

radical mastectomy, Crile began to investigate

other procedures after seeing the results of the

1955 McWhirter studies in Great Britain (16).

McWhirter treated women with breast cancer

by a combination of simple mastectomy and

radiation, and in Crile’s words, the results of the

treatment “appeared to be as good as or better

than those I was obtaining with radical mastectomy” (16). Impressed by those results, Crile

himself began to try the same method, removing

the cancer-bearing breast and irradiating the axillary nodes.

Although results of the treatment seemed as

good as those of the radical operation, the highdose radiation needed to destroy malignant cells

caused frequent complications. In response to

this, Crile reasoned that equally good results

might be obtained if the breast were removed

and the muscles left intact during surgery, and if

no positive nodes were detected during the

surgery, no nodes were removed or irradiated

Table 6.—Types of Breast Cancer Surgery Performed at the Hillside Medical Center, 1973-78

Standard Modified Lumpectomy for

radical radical Simple patient over 80 years,

Period mastectomy mastectomy mastectomy Lumpectomy or 2d operation

September 1973-August 1975. . . 71 67 12 1 5

September 1975-December 1977 47 89 12 7 2

January 1978-December 1978 . . . 19 32 6 18 3

SOURCE: Data obtained from the Long Island Jewish/Hillside Medical Center operating room log, tumor registry, and Dr. Wise’s surgical files
Case Study #17: Surgery for Breast Cancer • 15

after the surgery. If moderate nodal involvement were apparent, the nodes would be excised, but radiation would be used only if nodal

metastasis was extensive.

In 1955, Crile and his colleagues began a clinical study in which he treated his patients as simply as possible, using no prophylactic radiation

and removing the nodes only if they showed

malignant involvement. His colleagues treated

patients by the conventional radical mastectomy, often using prophylactic X-ray therapy.

After 5 and 10 years, more patients were living

after the simple operations than after the more

radical operations in which nodes were removed. Although the study was small, necessitating a larger trial in which the diseases were

of the same stage before definite conclusions

could be drawn, Crile observed” three apparent

points (16):

1) If there were microscopic deposits of cancer

in nodes, the patients whose nodes were not removed until the involvement could be felt had

just as high a rate of survival as did those whose

similarly involved nodes had been removed prophylactically at the first operation (in short, we

had lost nothing by deferring operation until the

presence of cancer in the nodes could be felt); 2)

the patients whose nodes did not contain any

cancer and were not removed did better than a

similar group whose uninvolved nodes were removed; 3) the necessity for performing a secondary operation for cancer that appeared in nodes

later on was much less than we had expected.

By 1958, Crile was beginning to perform partial mastectomies. This procedure involves

removal of the tumor, of at least an inch of apparently healthy breast tissue on each side of it,

and of the overlying skin and underlying fascia

(connective tissue). The breast is left at about

two-thirds of its original size. A study of patients receiving partial mastectomies was begun

in 1955. In the early years of the study, only 10

to 12 percent of patients with operable cancers

were treated with this procedure. Because the efficacy of the partial compared to the simple

mastectomy was not known, the lesser procedure was reserved for old or debilitated patients, for those who refused mastectomy, or for

patients whose degree of axillary metastasis necessitated radiation. Patients with small (2 cm),

favorable, peripherally located, and nonmulticentric tumors were also eligible for the procedure.

In all, 173 patients treated by partial mastectomy were observed for 5 and 10 years. The

high proportion of deaths noted in the l0-year

followup period was due primarily to causes

other than cancer, because the patient mix included a number of elderly, debilitated women

or women whose treatment could only be considered palliative. By 1970, the results of the 15-

year followup of partial mastectomy patients by

Crile and his colleagues were encouraging

enough so that the option of this treatment was

offered to all. The breakdown of indications for

the 173 partial mastectomies performed from

1955 on was as follows:

Refused mastectomy . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Palliation for advanced (stage 11 + ) cancer. . . . . . . . . . 6

Inoperable—advanced or other disease

(until 1971 many older patients and those with

concurrent diseases were selected) . . . . . . . . . . . . . . 6

Suitable size and location. . . . . . . . . . . . . . . . . . . . . .. 153

The results of the study by Crile and his colleagues are summarized in table 7. These figures

include the 5-year survival rate of the 173 patients treated by partial mastectomy and the 10-

year survival of the 63 patients operated on

before 1968. The incidence of recurrence is also

shown (this does not include the first apTable 7.-Results of Partial Mastectomy, 1955-72

Results

Lived 5 years. . . . . . . . . . . . . . . . . . . . . 132/1 73 = 76%

Lost, counted dead . . . . . . . . . . . . . . . 2 = 1 %

1955-67—lived 10 years. . . . . . . . . . . . 28/63 = 44%

Lost, counted dead . . . . . . . . . . . . . . . 2 = 3 %

Local recurrence . . . . . . . . . . . . . . . . . 21 = 12%

Axillary nodes later . . . . . . . . . . . . . . . 14 = 8%

New cancers same breast. . . . . . . . . . 6 = 3%

New cancers other breast . . . . . . . . . . 6 = 3%

al#sz (44%) Of those Who died before 10 years died of causes other than

cancer

SOURCE G Crlle, et al , “Results of Partial Mastectomy in 173 Pat!ents Fol.

lowed From Five to Ten Years,” ./ SUfg Gwecol & ObS@f 150 563.

1980
16 ● Background Paper #2: Case Studies of Medical Technologies

pearance of an involved node in a previously

untreated axilla).

None of the patients seen from 1970 on has

been followed for 10 years. Because of this,

Crile finds it impossible to draw final conclusions, but he does state that it appears that in

properly selected patients with small peripheral

cancers of the breast treated by partial mastectomy, with or without axillary dissection, the

survival rates are comparable to those obtained

by total mastectomy and radiation. In Crile’s

view, when a local recurrence or axillary metastasis after limited treatment is treated adequately, there is little lost in terms of life expectancy.

Patients should be warned of the potential for

recurrence and followup treatment. Secondary

mastectomy is not usually indicated in these instances (7.5 percent in the study).

In terms of the breast cancer controversy as a

whole, Crile believes that there has been a

definite nationwide change from the performance of routine radical mastectomies to the performance of the less debilitating modified

radical mastectomy. Crile has also noted an increase in the use and potential for reconstructive

surgery. He believes that in the long run, surgery will take second place to radiation and irridium small dose of implanted radioactive

material treatments. He has had some of the

Cleveland Clinic’s radiotherapists trained in

France, so that irridium implants would be

available for use at that facility. In Crile’s view,

chemotherapy has only a limited role to play in

the treatment of breast cancer. Crile further

believes that widespread change in the treatment of breast cancer is imminent, noting that

women as consumers and as those most affected

by treatment will be a great part of the force

behind the changing trends.

Dr. Oliver Cope

Dr. Oliver Cope is an Emeritus Clinical Professor of Surgery at the Harvard Medical School

and a consulting surgeon at the Massachusetts

General Hospital. For the last 20 years, he has

been pursuing alternatives to mastectomy for

the treatment of breast cancer. In 1977, Cope

published a book entitled The Breast: Its Problems, Benign and Malignant, and How to Deal

With Them (13). This work is a comprehensive

guide intended for the layperson that covers all

aspects of breast disease, the intricacies of

cancer treatment, and alternatives in surgery.

Cope believes (13):

An informed public can help expedite the new

opportunities for care. If women know what

questions to ask, physicians will have to pay attention, to be alert to these advances.

Since the publication of this book, Cope has

become a well-known figure both to the medical

and nonmedical world in the breast cancer controversy.

Until 1956, Cope routinely performed radical

mastectomies on patients with breast cancer.

Although he was aware of the emotional trauma

experienced by women over the loss of breast

and equally conscious of how little was known

about the disease itself, he adhered to the traditional surgery. In 1956, Cope came upon his

first patient who refused a mastectomy in any

form. She consented to local excision of the

tumor and was given radiation treatment after

the initial surgery. In 1958, a similar experience

with another patient led Cope to critically

evaluate the radical mastectomy and its accomplishments. He found evidence against the radical to be so convincing that he stopped performing it altogether in 1960. He states (13):

The years since 1956 have shown me only the

more clearly that mastectomy has not lived up

to expectations, that it cures but the minority,

that the results have not improved over the last

40 years, that it is long outdated and is to be

superseded.

Cope is against radical or modified radical

mastectomy in any form. He has spoken out

against them because “such operations are

disfiguring, thoughtless of a woman’s feelings

about herself, and damaging to her well-being”

(13). Cope concedes that 50 or 75 years ago

there was no alternative to extensive surgery,

but says that now, with an understanding of sophisticated radiation techniques and drug therapy, there are alternatives. Instead of mastectomy, Cope recommends lumpectomy, followed by radiation given in a specialized radiation center using a high power linear accelerator. If the cancer is advanced, special types
of radiation would be used without surgery

(unless otherwise indicated). Cope stresses that

tumor drugs, not adjuvant radiotherapy, would

be used in conjunction with lumpectomy. He

also believes that prompt and prolonged chemotherapy for women with metastasized disease is

a hopeful and frequently successful treatment.

Cope is a proponent of a combined approach

to the treatment of breast cancer. Treatment

should consist of a carefully monitored combination of surgery, medication, and radiation

therapy carefully oriented to the patient’s illness

and psychological makeup. Cope believes that

teamwork among colleagues is essential for

proper treatment of the disease. For several

years, he has sought to create a “Women’s Care

Center” at the Massachusetts General Hospital.

A group of specialists, including a surgeon, internist, radiotherapist, health educator, and

psychiatrist, would work with the patient to

map out an appropriate treatment regimen. Because 9 out of 10 breast lumps are benign and

only 7 percent of women ever develop cancer,

the center would try to educate women about

the appearance and disappearance of benign

tumors. This could reduce the cost of unnecessary biopsies and doctor visits.

So far, Cope notes, the vast majority of

physicians, especially surgeons, still adhere to

the traditional treatment of mastectomy in some

form. Many of these physicians are concerned

about the dangers of radiation therapy or

chemotherapy. Nevertheless, increasing numbers of physicians, especially radiotherapists,

are encouraging and performing the “lesser”

surgery.

CHANGES IN MEDICAL PRACTICE: PERSONAL FACTORS

Drs. Wise, Crile, and Cope are unusual in

several respects. They are outspoken proponents of changing a traditional medical practice. They are successful and well-known

members of their professions who have become

to a substantial extent public figures because of

their outspokenness. At the same time, however, these three surgeons have a great many

traits in common with their colleagues, with the

medical profession as a whole. They all received

a traditional, conservative medical education.

They are or were all career-oriented individuals

who sought to serve their patients as well as

make a reputation for themselves. They believe

in the scientific method and the importance of

evidence. The championing of less extensive

forms of surgery for breast cancer by these three

surgeons did not just happen. It was the result of

subtle, complex, personal, and (ultimately) not

full y understandable experiences and attitudes.

Wise, Crile, and Cope, we believe, illustrate

the role that personal factors can play in the

evaluation of medical practices. The last three

decades were a time of growing awareness and

sensitivity on the part of women and men alike

concerning their responsibility toward their

own health. The automatic authority and conservatism of professions such as medicine

became increasingly questioned. Technologies

of all types often came under harsh scrutiny.

Within this social backdrop, many members of

the medical and other professions also came to

challenge the unquestioning acceptance of prevailing methods of doing things.

The qualities that led any one such individual

to join in this questioning could be (and have

been) the subjects of many sociological studies.

For the purposes of this analysis, only two need

to be suggested: personal experience and personal sensitivity. Those factors seem to have

been present in each of the three surgeons

singled out for this case study.

It is particularly important to note that each

of these surgeons became aware very early of

the physical disfigurement, psychological trauma, and other secondary elements of morbidity

that accompanied the more extensive forms of

breast cancer surgery, especially the Halsted

radical mastectomy. Wise realized that “less

mutilation is better;” Crile hypothesized that his

training in the radical surgery may have been

appropriate in earlier years; and Cope, even

while performing radical surgery, was aware of

the emotional trauma involved for the women.
18 Ž Background Paper #2 Case Studies of Medical Technologies

Crile’s skepticism may have been further conditioned by his association with the Cleveland

Clinic—a progressive private medical institution.

These personally felt sensitivities either led

directly to attempts by these surgeons to test the

necessity of the more extensive (and thus mutilating and traumatizing) forms of surgery or

allowed them to be more open to new evidence

on nontraditional terms of surgery. For example, Cope first began questioning the radical

mastectomy procedure he had been using because of his experiences with a few individual

women. The results of those individual cases

were enough to encourage a more complete and

more regimented investigation of the efficacy of

lesser procedures as compared to the radical

standard. Wise’s experiences with groups of

U.S. and British patients similarly led him to

continue and expand his activities in regard to

evaluation of alternatives.

Thus, it may be a reasonable hypothesis that

personal sensitivities, perhaps conditioned by

the accelerating social activism in this country,

CHANGES IN MEDICAL PRACTICE:

The preceding part of this case study set out

some possible motivating factors, from the perspective of individual physicians, that led to the

change in the standard method of treating breast

cancer. It is important to note, however, that individual physicians have to operate within the

professional and institutional structure of

American medicine. One of the paramount

characteristics of that structure is conservatism.

To a substantial extent such conservatism serves

patients well, but in certain circumstances, it

can also be a disadvantage.

This dual possibility—of beneficial and harmful effect—is well illustrated in the case of treatment for breast cancer. The conservatism of

medicine, and in this case surgeons, was in part

responsible for the lack of an earlier challenge to

the more extensive forms of breast cancer surgery. On the other hand, that same conservatism does force today’s proponents of change

prompted or at least reinforced a tendency by

these and many other physicians to subject the

traditional treatment mode to a more rigorous

test of scientific value and outcome.

Again, these three surgeons were not the only

ones to bring about the debate on the relative

merits of radical mastectomies versus less extensive methods. The forms of personal influences

that they experienced and were subject to, however, may represent a less definable though

critical element in the process by which traditional forms of therapy are modified or discarded in favor of new ones.

Whether the aforementioned hypothesis will

turn out to reflect reality is impossible to say.

Clearly, however, the standard method of treating breast cancer is changing. Simply examining

the medical literature, with its reports of clinical

experience and trials, may not be enough to explain this. It is our hope that the possible influence of personal factors will be examined further in an effort to expand understanding of

how changes in medical practice occur.

PROFESSIONAL FACTORS

to provide adequate evidence relating to the appropriate use of alternative forms of surgery.

Medicine cannot change with the appearance

of each new issue of a medical journal. Skepticism prevents a good deal of medical nonsense. Science, including medical science, does

and should proceed by argument and counterargument. Hasty change is as bad or worse than

no change. Obviously, a balance must be

sought.

In the case of radical mastectomy, surgeons’

experience with, and thus their expectations for,

that treatment had accumulated over a period of

90 years. Halsted’s and Johns Hopkins University’s reputations, combined with the probable

fact that early surgery was performed on advanced cancer cases (stage III), ensured that the

method became firmly ensconced in medical

practice. Abrupt change was unlikely, and the

evidence for change had to be very strong. The
personal, individual physician-related factors

discussed above, plus the shift in the patient

population from the 1930’s onward (especially

beginning in the 1960’s) to those with less advanced disease, helped precipitate trials of less

extensive surgery.

There are several other possible reasons for

the reluctance of the medical profession to accept less extensive surger y for breast cancer.

One is that the “burden of proof” has been

viewed as resting with the innovators as opposed to those surgeons performing the traditional forms of mastectomy. That the radical

mastectomy clearly was regarded as the treatment of choice for about 90 years is evidence

enough that the burden was on the proponents

of lesser surgery. The impact of burden of proof

is as powerful in medicine as it is in law. It was

clearly up to the proponents of change to make

a strong case for that change. Radical mastectomy is “innocent until proven guilty. ”

The structure of medical specialization has

also contributed to the situation. Chemotherapy, radiotherapy, and surgery are the domains

of three separate medical specialties—internal

medicine, radiology, and surgery (or obstetricsgynecology in certain parts of the United

States). It is human nature to believe in what

one does. Thus, to design and carry out a

clinical trial of surgery v. radiation therapy is

not as easy or feasible as it would be if these

treatment modalities were under the domain of

the same specialty. And because several of the

less extensive forms of surgery are used in conjunction with radiotherapy or chemotherapy (to

a greater extent than is radical mastectomy in

most cases), comparative trials among the forms

of surgery are also difficult to set up. Similarly,

surgeons who become identified with specific

forms of surgery for breast cancer form what

are very much like special ties-within-a-specialty. Here, too, trials are difficult to conduct, and

their persuasive value is diminished.

One other point regarding medical specialization and its influence on the acceptance or rejection of innovation is applicable to the present

case. Surgeons (to make a broad but generally

accurate observation) tend to be more concerned with prolongation of life than do other

specialists, such as psychiatrists. The innovators

in surgery for breast cancer observed here (e.g.,

Cope and Wise) have had significant associations with or interest in psychiatry and have

been more concerned with quality of life issues

such as the psychological impact of radical procedures.

There is also an international aspect to the

change process we have been examining. Much

of the early testing of less extensive surgery was

conducted abroad, especially in England, and

the acceptance of such surgery occurred earlier

in other countries than it did in the United

States. Several possible factors explain this

situation. Surgical intervention is less frequent

and less aggressive in England than it is in the

United States (8). Also, Halsted’s reputation

was much greater in the United States than

abroad; in the United States, he has often been

called the country’s greatest surgeon. A possible

economic motive may also play a role in the international difference: In England, most physicians are salaried members of the National

Health Service, while in the United States, feefor-service medicine predominates.

CONCLUSIONS: REFLECTIONS ON THE CHANGE

This is a case study on change in medical In this concluding

PROCESS

discussion, we offer some

practice. It has examined the personal and social observations concerning the change process and

or professional elements that may have con- possible areas where it might be made more ratributed to or worked against the reduction in tional.

use of radical mastectomy in favor of the use of First, physicians should write and speak diless extensive forms of surgery. All of the rectly to the public on controversial issues and

material presented so far has been descriptive. not be criticized by their peers for doing so (34).
Breast cancer is a topic to which the public

media are willing to devote substantial space,

and most women are willing and able to follow

and enhance this sort of technical and social

debate.

Second, medical conservatism has strengths

and weaknesses. Rushing to the latest fad is by

no means desirable. Conservatism, however,

often implies that a specialty group has developed a consensus, and that an outsider, fresh

to the debate, may not be in agreement with it.

Specialty groups should be willing to test their

consensus by having outsiders inquire into the

state of knowledge.

Third, an intelligent, informed patient could

reasonably choose between clearly explained

alternatives and ought to be allowed to do so.

The surgeon who is willing to provide only one

procedure and gives the patient no option does

harm. This practice is common and has led State

legislatures to propose bills requiring that

options be explained and presented to all breast

cancer patients. Such laws should be unnecessary.

Fourth, although economic incentives can

explain the present situation in part, this does

not justify overhauling fee-for-service surgery.

There is no neutral economic system. Perhaps

this case study makes the point that fee-for-service surgery and institutions with surgeons on

salary should compete in an environment where

patients can choose the economic system they

prefer. Choice and competition certainly may

be beneficial, but, in order to be so, will require

active cultivation.

Fifth, the research community and the governments that support research have failed in

several respects. Randomized clinical trials are

expensive and often difficult to perform. Why

did it take seven separate trials, performed over

15 years, to change expert consensus? A trial ignored is almost as bad as a trial not performed

and is also a waste of scarce research resources.

Much more attention should be given to considering what types of research methods and administrative procedures are needed to appropriately change expert consensus. Such consideration requires thought about strength of prior

opinion, participation by opinion leaders, and

careful marketing of the results to the practicing

surgical community. This suggests study of the

personal and social context of change, which we

have attempted to begin in this case study.

Sixth, the ground rules for consensus formation need clarification. Where does the burden

of proof lie? If the burden of proof had been

shifted, the history of the breast cancer surgery

debate would have been very different. Imagine

that in 1966 the Kaae and Johansen (37) and the

Brinkley and Haybittle (s) studies had been declared the best available evidence at that time.

The burden of proof for demonstrating the desirability of radical mastectomy would then

have fallen on those who believed in it. Since

quality of life is lower with radical surgery, any

surgeon wishing to perform radical mastectomies would have had to have conducted a trial

whose results showed enough gain in prolongation of life to offset the loss in quality. If this

situation had existed in 1966, it is likely that

almost no radical mastectomies would have

been performed in the last 15 years.
APPENDIX

Two different

lyzed in terms of

below: inpatient

A: COST ESTIMATES

treatment strategies that were anacosts in one hospital are considered

v. outpatient tissue biopsy (11).

After considering these alternative strategies, we will

attempt an analysis of national data on breast cancer

surgery .

Figure A-1 shows the alternative strategies, inpatient v. outpatient biopsy, as observed for 1976 at

Massachusetts General Hospital. For inpatient biopsy, the patient is admitted to the hospital and the

operating room is scheduled for a possible radical

mastectomy. Under total anesthesia, she has a biopsy

and immediate frozen section (tissues fixed for microscopic examination by freezing). The pathologist

concludes negative, doubtful, or positive cancer. If

negative or doubtful, the patient is returned to her

room to await the results of a permanent section,

which is considered slightly more accurate. If positive, radical mastectomy usually is performed, followed by discharge, radiation therapy, and perhaps

later reconstructive surgery. If the frozen section is

positive, radical mastectomy usually is performed

immediately. Note that this approach means the patient does not know at the start of the operation what

condition she will be in when the operation ends.

For outpatient biopsy, the patient undergoes total

anesthesia in the ambulatory surgical service and

goes home the same day to await the results of a permanent section, which are usually known within 24

hours. If positive, admission and radical mastectomy

follow. Note that the outcomes are certain here, but

two total anesthesias are required for patients

needing surgery.

Table A-1 shows the cost differences and number

of cases for 1976 a t Massachusetts General Hospital.

If one excludes the patients with treatment other than

surgery, then the total cost for the 284 patients, using

the inpatient alternative is $657,664. If the outpatient

alternative costs were applied to these patients the

costs would be $501 ,056—a savings of 24 percent.

This calculation does not consider the effect on costs

of more limited surgery or the effect of not using

radiation therapy afterwards. It also does not consider the effect of doing limited surgery such as tylectomy or the reduced need for later reconstructive

surgery.

Figure A-1 .—Alternative Strategies of Inpatient v. Outpatient Biopsy at

Massachusetts General Hospital, 1976

Radical

mastectomy

results
22 Ž Background Paper #2: Case Studies of Medical Technologies

Table A-1 .—Breast Surgery at Massachusetts Table A-2 shows the total number of procedures

General Hospital, 1976 for the United States in 1975. Unfortunately, the naAverage Number of

cost cases

Inpatient alternatives

Negative biopsy . . . . . . . . . . . . . . . $1,223 152

Positive biopsy, immediate

mastectomy . . . . . . . . . . . . . . . . . 3,270 84

Biopsy, permanent section

positive, mastectomy. . . . . . . . . . 4,106 48

Biopsy, permanent sect ion

positive, other treatment (patient

refused surgery, radiation only or

incomplete chart) . . . . . . . . . . . . . 1,850 16

Outpatient alternatives

Negative biopsy . . . . . . . . . . . . . . . 316 244

Positive, radical mastectomy . . . . 3,432 52

Positive, other treatment . . . . . . . . 940 12

Total. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 608

tional data do not separate out biopsy only and partial mastectomy and tylectomy. One can only guess

at the amount of less extensive surgery. A simple calculation of total patient days and costs yields an aggregate cost of $413.6 million, excluding radiation

therapy.

A very rough estimate is made in table A-2 to show

the possible cost savings that would result if outpatient biopsies were used uniformly and radical surgery were replaced with more limited surgery. The

savings would be $185 million per year or a 45-percent reduction in costs. This does not consider reducing the use of radiation therapy or changing from

complete mastectomy to tylectomy. So the 45-percent potential reduction in total costs is probably a

substantial underestimate.

NOTE. The cost of postsurglcal radlatlon therapy for 6 to 9 weeks IS not ln- The reader must realize the very approximate nacluded above This wculd be an added $2,000 Surgeons’ fees not

Included. ture of this cost analysis. However, the magnitude of

the difference in costs is sufficient to warrant further

SOURCE: Massachusetts General Hospital operations log and other medical

records. investigation.

Table A-2.—Breast Surgery in the United States, 1975

Number of Average length of

procedures stay (in days) Total number of days

Surgical mix in 1975

Biopsy and partial mastectomy . . . . . . . . . . . . . . . . . . . . . 223,000 3.5 780,500

Complete, modified radical, radical mastectomy . . . . . . . 103,000 12.5 1,287,500

2,068,000

Total cost @ $200/day= $413,600,000

1,135,400

Total cost @ $200/day= $227,080,000

Difference in costs between actual surgical mix and possible alternative for 1 year= $413,600,000– $227,080,000 =

$185,720,000, or 45% savings with alternative.

SOURCES: Number of cases in 1975: National Center for Health Statistics. Surgical Operations in Short-Stay Hospitals. United States, 1975,

Vital and health statistics data: National Health Suwey, Series 13, No. 34. DHEW Publication No. (PHS)78.1785. (Hyatlsville, Md. ’ DHEW, April 1978),

Average length of stay. National Health Survey, Series 13, No. 34. DHEW Publication No, (PHS)78-1 785,

Average length of stay for complete mastectomy only: Commission on Professional and Hospital Activities (CPHA). ~errgtfr of Stay In PAS Hosp/fa/s by

Operat/on, United S’ates 1975 (Ann Arbor, Mich., CPHA, 1976).
Case Study #17 Surgery for Breast Cancer ● 23

APPENDIX B: EVIDENCE ON SELECTED TREATMENTS

FOR BREAST CANCER

Extended Radical Mastectomy

Extended radical mastectomy is the most extensive

surgery used in the primary treatment of cancer of

the breast. The rationale behind this technique is to

eliminate the cancer and stop its spreading by removing all of the lymphatic drainage pathways in the

breast region. Halsted noted the existence of malignant metastasis to the chest wall and breast bone via

the chain of internal mammary nodes under the sternum, but soon abandoned the resection of the supraclavicular nodes because the “procedure did not improve upon long-term survival rates” (29).

Sampson Handley of the Middlesex Hospital in

London further researched Halsted’s comments on

the role of the internal mammary nodes and began to

report the resection of this chain of nodes (32). Finding that the internal mammary nodes were not uncommonly involved in the spread of cancer, Handley

devised an operation to remove them as well as the

axillary nodes. The procedure did not improve mortality rates and was soon discontinued.

After World War II, the extended radical mastectomy was again pursued. Dr. Jerome Urban of Memorial Hospital in New York (51) and Drs. Andreassen, Dahl-Iverson, and Sorenson of Copenhagen (3) began to perform and report upon results

obtained by the extended radical. Andreassen and his

associates ran four series of trials. In the first series,

involving 98 patients, the supraclavicular as well as

axillary nodes were removed. None of the 98 patients

manifested clinically palpable supraclavicular nodes,

but microscopic metastasis was present in these

glands in 17 patients (33 percent). All 17 patients

were clinical stage II cases. In the second series of the

study, involving 53 patients, the internal mammary

nodes were removed along with the axillary glands.

Of 53 patients, 24 percent of those with metastasis in

the axillary nodes were found to have microscopic

metastasis in the internal mammary glands. In the

third and fourth series (1951 and 1952), the axillary

glands, supraclavicular and internal mammary nodes

were removed. The third series of 76 patients showed

the internal mammary nodes to be involved twice as

often as in the second series, but this difference was

due in part to an alteration in operative techniques,

In all the series, there were no cases of supraclavicular node involvement without axillary node involvement. After retrospective analysis, DahlIverson abandoned the extended radical mastectomy

in 1957. Its results, in his view, were not superior to

those of the standard radical mastectomy (3).

Caceres and Urban (10,50,52) also noted the high

incidence of cancer metastasis to the internal mammary nodes. In a large retrospective nonrandomized

study, Caceres compared results from the radical

mastectomy v. the supraradical mastectomy. The latter consists of a radical mastectomy combined with

en bloc extrapleural resection of the internal mammary chain together with the overlying chest wall;

the supraclavicular nodes, however, are not excised.

The results of this study are shown in table B-1. The

difference in survival rates between the two groups

was not considered statistically significant.

In 1952, Urban and Baker (53) published the results

of including the en bloc resection of the internal

mammary lymph nodes, while performing the standard radical mastectomy on women manifesting invasive breast carcinomas located in the central and

medial quadrants of the breast. They followed the

long-term progress of these women, reporting that

“as compared with results following radical mastectomy the patients had fewer local recurrences, longer

survivals and approximately the same morbidity and

mortality. ”

Urban’s data are used as a guideline at Memorial

Hospital in New York for the treatment of patients

with circumaureolar and inner quadrant lesions. The

extended radical is recommended for these patients,

providing their ages are not too advanced and there

are no other medical contraindications. Adjuvant

prophylactic radiation therapy is prescribed when

there is extensive nodal involvement. Patients

manifesting noninvasive lesions, histologically lOWgrade invasive carcinoma, lesions less than 1 cm in

diameter with a negative internal mammary node

biopsy are subject to radical or modified radical

mastectomies and subsequent radiotherapy when indicated.

The extended radical mastectomy is considered by

some surgeons to be a massive and disabling operation. According to Dr. Oliver Cope, it has now been

largely abandoned by most surgeons because of the

morbidity associated with it and because its results

seem no better than those obtained by the standard

Halsted procedure.

Modified Radical Mastectomy

Until very recently, radical mastectomy was considered the treatment of choice for patients with

breast cancer. Over the last several years, however,

the trend has shifted and the modified radical is now

the favored procedure. In 1971, a poll of New Jersey
— —

Table B-1.—Survival Rates by Type of Operation: Radical v. Extended Radical Mastectomy:

5. and 10-Year Survival

5-year survival 1 O-year survival

Percentage Percentage

of patients of patients

Type of operation Patients Survivors surviving Patients Survivors surviving

Without axillary metastasis

Radical mastectomy. . . . . . . . 43 32 74.4% 43 28 65.17.

Extended radical mastectomy. 184 153 83.1 52 35 67.3

With axillary metastasis

Radical mastectomy. . . . . . . . 70 33 47.1 70 22 31.4

Extended radical mastectomy. 241 106 44 77 19 24.7

Total

Radical mastectomy. ., . . . . . . 113 65 57.6 113 50 44.2

Extended radical mastectomy. 425 259 60.9 129 54 41.8

SOURCE, E Caceres, “Incidence In the Internal Mammary Chain In Operable Cancer of the Breast, ” Surg Gyneco/ Ohtet 108(6t 715, 1959

surgeons showed that 83 percent preferred the radical

mastectomy and only 15 percent performed modified

radicals. In 1977, a similar survey showed only 37

percent of surgeons performing the radical procedure

and 60 percent favoring the modified operation. It is

estimated that today the figure for the radical procedure has dropped to 15 percent (14).

A 1974 survey of breast surgeons in Pennsylvania

showed less than half the procedures were radical. A

similar 1978 survey would probably show less than

25 percent were radical (17). Tables B-2 and B-3

report types of surgery from the American College of

Surgeons’ review of breast cancer treatment (2).

The modified radical mastectomy removes all of

the breast tissue, its overlying skin, and the contents

of the axilla nodes. In a procedure designed by Patey

in the 1930’s to reduce cosmetic deformity, the pectoralis minor muscle is removed, but the pectorals

major is left intact. Auchinchloss devised a variation

of the surgery that preserves both muscles (17). The

modified radical is less debilitating than the radical

because there is less chance of impaired arm movement and postoperative edema of the arm.

At the Long Island Jewish/Hillside Medical Center

in New York City, most of the staff and attending

surgeons have begun to perform the modified radical

nearly twice as frequently as the traditional Halsted

procedure. One surgeon affiliated with the Community Health Program at the Medical Center states

(49):

I believe breast career to be multi-focal and feel it

absolutely essential to view the axillary nodes before I

begin the operation [ think best for the patient, In

general, I prefer the modified radical mastectomy to

the radical procedure, but will do a radical if called for

by medical or anatomical considerations.

Table B-2.— Distribution of 15,132 Cases of Breast

Cancer Diagnosed in 1972, by Type of Surgery

Percentage

Type of surgery of cases

None . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4%

Wedge excision (Iumpectomy, tylectomy). . . . . 3.4

Total (simple) mastectomy . . . . . . . . . . . . . . . . 11.5

Total mastectomy with axillary dissection . . . . 6.4

Modified radical mastectomy . . . . . . . . . . . . . . 26.2

Radical (Halsted) mastectomy . . . . . . . . . . . . . . 45.3

Radical mastectomy with internal mammary

node biopsy . . . . . . . . . . . ., . . . . . . . . . . . . . 1.5

Super (extended) radical mastectomy . . . . . . . . 0.3

Total. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100%

SOURCE: American College of Surgeons, Commlsslon on Cancer, “Final Fle.

port. Long-Term Patient Care Evaluation Study for Carcinoma of the

Female Breast” (mimeo) (Chicago ACS, Feb. 21, 1979)

According to Dr. Leslie Wise (55):

The two arguments usually given against modified

radical mastectomy are that it does not provide adequate access to resection of the axillary lymph nodes

and that the pectoral lymphatics are not removed. If

the arm is 1 if ted so that the forearm lies in front of and

parallel to the chest, then the pectoralis major is relaxed and can be retracted to expose the pectoralis

minor, which may be divided; under these conditions

the upper reaches of the axilla come in full view.

There is supportive evidence that removal of the pectoralis major and the interpectoral nodes is unlikely to

be of value unless the internal mammary nodes are

also removed.

Although there have been few clinical trials testing

the efficacy of the modified radical mastectomy, a

series run by Handley gave results which seem to be

comparable to those published for radical mastectomy.
Table B-3.— Distribution of 24,136 Cases of Breast Cancer, by Stage of Cancer” and Type of Surgery, 1950-72

In situ Localized Regional Distant

Type of surgery (N= 462) (N= 11,845) (N= 10,040) (N= 1,626)

None . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - 2.2%

-

1.60/0 3;5% -

‘-42.90/.

Wedge excision . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.6 3.3 1.3 8.5

Total (simple) mastectomy.............................. 32.5 14.1 5.8 19.9

Total mastectomy with low axillary dissection. 9.1 5.8 5.5 4.4

Modified radical mastectomy, . . . . . . . . . . . . . . . 20.1 24.3 26,1 9.9

Radical (Halsted) mastectomy . . . . . . . . . . . . . 23.2 49.3 54.5 12,4

Radical mastectomy with Internal mammary

node biops y 0.4 1.4 2.0 1.6

Super (extended) radical mastectomy. ... . . . . 0.0 0.2 0.2 0.4

Total . . . . . 1 000/0 100% -

1000/0 1 00%

a 163 cases stage not known

SOURCE American College of Surgeons Comm{sslon on Cancer Final Report Long -Telm Patient Care Evaluation Study for Carcinoma of the Female Breast”

~mlmeo~ ~Chlcago HI ACS Feb 21 1979)

Simple or Total Mastectomy

The simple or total mastectomy is considered one

of the “lesser” surgical procedures used to treat breast

cancer. The simple mastectomy was the first operation used in clinical trials to test the efficacy of the

radical mastectomy against a less extensive surgical

technique. It was also the procedure used in trials

featuring comparisons between radical surgery and

combination forms of treatment —usually total mastectomy plus radiation.

During a simple mastectomy, only the breast tissue

and overlying skin are removed. The chest remains

intact as does the axilla. The surgery is often accompanied by adjuvant radiotherapy. Unlike a radical mastectomy, a simple mastectomy leaves no cosmetic deformity of the chest wall.

In 1948, Dr. Robert McWhirter of Scotland began

performing simple mastectomies followed by radiation therapy at Edinburgh’s Royal Infirmary (45).

McWhirter’s results after 5- and 10-year studies were

no worse and no better than results following radical

mastectomy (44). A similar study was carried out in

Finland by Professor Mustakallio (45). About 30

years age, Mustakallio began removing only the

breast and irradiating supicious lymph nodes in order

to destroy any remaining cancer. In some cases when

the lesiion was tiny, he removed only the tumor itself.

His reports also showed results comparable to those

obtained by radical mastectomy (45).

Two fairly recent prospective clinical trials utilizing simple mastectomy are also available for study

.

Brinkley and Haybittle (5) compared the results of

simple mastectomy plus radiation and radical mastectomy with radiotherapy for clinical stage 11 (axillary node involvement ) cases of breast cancer. The

patients were randomly allocated to a particular

treatment group; 113 received simple masectomies

and 91 had radicals. In many cases, the simple mastectomy involved removal of accessible axillary

nodes, but there was no formal en bloc dissection of

the axilla. Results suggest that patients with simple

mastectomies did slightly better than patients with

radicals in a 6-year recurrence-free followup. In

1971, the two groups were again reviewed. At this

point, all patients had been followed for at least 5

years and some for 12 years. There was no significant

different in survival rates between the groups

(radical, 49.2 percent; simple, 46.4 percent). An increased incidence of edema of the arm was noted in

the radical mastectomy patients (5,6,55).

From 1951 to 1957, a prospective clinical trial was

carried out in Copenhagen by Kaae and Johansen

(37). The results of extended radical mastectomy

(removal of the breast, chest muscles, axillary,

supraclavicular, and internal mammary nodes) without postoperative radiation were compared with simple mastectomy with postoperative radiation. A

group of 335 patients were randomly selected for extended radical mastectomy and 331 patients for simple mastectomy plus radiation therapy. For a variety

of reasons, not all of the patients were included in the

results. The 5-year study includes only 206 patients

from the extended radical group and 209 from the

simple mastectomy. The overall survival and recurrence rates at 5- and lo-year intervals were similar

with both treatments.

Dr. George Crile, Jr., of the Cleveland Clinic, an

early advocate of simple mastectomy (1957), has

studied comparative, but not randomized, groups of

simple mastectomies and radicals (15). His results

showed that in clinical stage I cases, simple mastectomy, and, if necessary, later therapeutic axillary

dissection, was as good as initial treatment with the

radical mastectomy. The 5-year survival rates for

radical mastectomy with or without radiotherapy
were 71 percent; for simple mastectomy without radiotherapy, 82 percent; and for simple mastectomy

with radiotherapy, 73 percent.

Although a number of clinical trials have suggested

that the combination of simple mastectomy and postoperative radiation therapy is as effective as radical

mastectomy in most cases, critics of the simple procedure cite the Haagensen and Miller study (27) as

evidence against it. All patients included in that trial

had cancers defined as Columbia clinical classification stage A lesions, The 10-year survival rate for the

radical mastectomy group was 70.2 percent, while

that for simple mastectomy patients was 39 percent.

Dr. Leslie Wise points out that one element often disregarded in the presentation of this study is the fact

that the radical mastectomy group came from

Haagensen’s series at New York’s Columbia-Presbyterian Hospital, whereas the simple mastectomy patients were treated in Detroit by Kennedy at a much

earlier period when cancers were much larger (55).

The two groups were completely unmatched.

Local Excision, Lumpectomy,

Tylectomy

A local excision or lumpectomy involves the removal of the cancerous tumor and a margin of

healthy tissue surrounding it (36). As early as 1943,

F. E. Adair experimented with local excision, reporting on 63 cases of operable breast cancer treated in

this way. In seven patients, onl y the lumpectomy

was performed; of this group, six patients survived 5

years. Preoperative radiotherapy followed by excision of the tumor was used in 27 cases. These patients

had a 70-percent 5-year survival rate. There was no

mention of clinical staging of the disease in this study

(55).

A further inquiry into the efficacy of local excision

was made in Helsinki by Professor Mustakallio. In

1954, he published the results of a study involving

127 patients with clinical stage I cancer who were

treated by lumpectomy and postoperative radiation

to the remaining breast (45). The results compared

favorably with those treated by radical mastectomy:

84 percent survived 5 years, and 72 percent survived

10 years. These results were backed up by F. Baclesse

in Paris, who, like Mustakallio, began to treat

women refusing mastectomy by local excision and irradiation. Baclesse began his study of 100 patients in

1940 and reported on the work in 1960 showing comparable results to the Helsinki study (13). By 1958, J.

G. DeWinter, of Brighton, England, had also reported on a smaller series of patients treated by

lumpectomy. In a 1961 publication, DeWinter stated

that local excision and radiotherapy in an unselected

group offered, “a reasonable alternative to the standard operation, ” that is, radical mastectomy (55).

In 1963, Sir Arthur Porritt presented the results of

a series of 265 patients with operable breast cancer

who were randomly selected to undergo radical mastectomy with radiation therapy (156 cases) or local

excision plus irradiation (107 cases). The 5- and 10-

year survival rates were respectively: radical mastectomy, 50 and 34 percent; local excision, 65 and 45

percent. According to Dr. Leslie Wise, these data

suggest that the lesser operation is at least as effective

as the radical procedure (55).

Dr. George Crile, Jr., reported several series of

trials with local excision. In one series reported in

1965, 20 patients who received local excisions achieved a 65-percent survival rate that was comparable to

that obtained by more extensive procedures. In that

series, 12 patients had stage I tumors and 8 had stage

II cancers. Crile reported on an additional 24 patients

treated by local excision in 1967. In that group, the

5-year survival rate was 67 percent. Crile and Hoerr

published the results of local excision on 55 patients

in 1977. The patients, 40 of whom had clinical stage I

cancers and 15 of whom had stage II lesions, were

treated from 1955 to 1964. Thirty-one of the patients

with stage I cancers were treated by local excision

alone; 6 patients had axillary dissections as well as

lumpectorny (local excision); and 3 had postoperative C. teletherapy. Of the stage 11 cases, 4 patients

had axillary dissections and 11 had postsurgical C.

teletherapy. The 5-year survival rate for the entire

group was 67 percent. There was an Ii-percent incidence of local recurrence.

In 1971, Vera Peters of Toronto reported another

similar trial. Treated by local excision and irradiation, her patients showed 5- and 10-year survival

rates of 76 and 45 percent (55). These results were

similar to those of her radical mastectomy series.

Taylor and his associates from Great Britain also

reported on a group of 77 patients manifesting stage I

and 11 cancers. Seventy-seven patients were treated

by local excision and radiotherapy. The 5- and 10-

year survival rates were 71 and 50 percent. The incidence of local recurrence or the appearance of a

new cancer which was treated by simple mastectomy

was 18 percent (55).

Drs. Leslie Wise, Aubrey York Mason, and Lauren

V. Ackerman conducted a comparative retrospective

survey of 96 patients treated by local excision followed by radiotherapy on a 1,500 Curie telecesium

unit and 207 patients treated by radical mastectomy

with or without radiation therapy, depending on the

histologic status of the axillary nodes (54). That

study was carried out between 1950 and 1964 at St.

Helier’s Hospital in London. Only patients with stage
I and stage II breast cancer, designated according to

the Manchester Plan, a clinical method of rating the

progression of the disease, were included in the

study. All of the patients were women. The age range

of patients was 25 to 90 years, and the age distribution between the two groups was statistically similar.

There was no statistically significant difference in the

distribution of the local excision and radical mastectomy cases as to the size of the tumor. The 5- and 10-

year survival rates by stage were, respectively: stage

1, local excision-96 percent and 68 percent; stage I,

radical mastectomy-81 percent and 69 percent;

stage II, local excision —74 and 53 percent; stage II,

radical mastectomy —70 and 59 percent.

The Wise, Mason, and Ackerman study was the

first published attempt to critically compare the

results from a group of local excisions of mammary

carcinoma with radical mastectomies. According to

Dr. Wise, the mode of treatment apparently did not

significantly alter the overall prognosis. There was

no significant difference between the survival rates of

the two groups, a finding which suggests that local

excision with moderate irradiation may be a suitable

alternative to radical surgery for early, operable

breast cancers. Dr. Wise plans to run a 15-year followup on the patients involved in the trial.

The results of a prospective, randomized trial for

stage I and 11 breast cancers were reported in 1972 by

Atkins, Hayward, Klugman, and Wayte. A total of

370 patients, all aged 50 years and over, participated

in the trial, which was carried out between 1961 and

1971. One group of 188 patients was treated by radical mastectomy, and another group of 182 patients

received lumpectomy and postoperative radiation.

There was no significant difference in overall survival rates between the two groups at any time up to

10 years after surgical intervention.

The arguments against local excision are varied.

Some say that lumpectomy is an inadequate cancer

operation, partly because the tumor and its draining

lymph nodes are not removed en bloc. Proponents of

the procedure argue that if this criterion is applied,

then radical mastectomy is not adequate either,

because only the axillary nodes are resected. Two

other drainage pathways are left intact: the supraclavicular and internal mammary nodes.

Another argument used against local excision is

that some breast cancers are multicentric and therefore local recurrence rates will be much higher with

lumpectomies than mastectomies. Dr. Guy Robbins,

of the Memorial Sloan-Kettering Hospital in New

York, stresses this point as one that completely invalidates the use of such limited surgery (47). Advocates of local excision counter by pointing out that

there are no facts that support the assertion.

A third argument against lumpectomy is that any

breast in which a cancer has developed is likely to be

the location of a second tumor; thus, local excision

would leave the patient with the possibility of a second breast malignancy. Supporters of lumpectomy

argue in response to this that a breast cancer patient

has a 7-percent chance of developing a contralateral

cancer in her lifetime. Supposedly, this applies to the

remaining breast, but if that breast is irradiated, the

chance of a second cancer may be less. If concern

over the 7-percent possibility of recurrence was so

great, then according to the argument every breast

cancer patient should have a prophylactic total mastectomy on the opposite side (54).
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