To: CCBG, PCC

From: Neil Murphy, MD

OB/GYN Chief Clinical Consultant

RE: Value of clinical breast exams in a Primary care practice

Date: September 3, 2003

I was asked to evaluate the data on the value of clinical breast
examination in a primary care context. I will proceed from the overall
perspective of all screening tests to the specific question of the
clinical breast exam. I will present data from randomized controlled
trials (RCT) whenever possible, or from consensus statements from
benchmark organizations.

## Primary Care: Is there enough time for prevention?

In April 2003 Yarnall et al suggested that to fully satisfy the USPSTF
recommendations, 1773 hours of a physician\'s annual time, or 7.4 hours
per working day, would be needed for the provision of preventive
services.

Yarnall et al assumed a 6-minute breast exam based on the 1999 Barton
article which utilizes the vertical stripping technique. Yarnall et al
also assumed that CBE was a USPSTF Level A recommendation, which is no
longer the case. (see AHRQ Recommendations below)

The technique included proper positioning of the patient, thoroughness
of search, use of a vertical-strip search pattern, proper position and
movement of the fingers, and a CBE duration of at least 3 minutes per
breast. The value of inspection is unproved. Professional and lay
examiners improved their sensitivity on silicone breast models after
being taught this technique.

They concluded time constraints limit the ability of physicians to
comply with preventive services recommendations.

**[Agency for Health Care Research and Quality (AHRQ)]{.underline}**

The AHRQ released this information on Preventive Care for Women to the
public in April 2003

The Task Force has made the following recommendations, based on
scientific evidence, about which screening tests you should have.

-   **Mammograms:** Have a mammogram every 1 to 2 years starting at age
    40.

-   **Pap Smears:** Have a Pap smear every 1 to 3 years if you have been
    sexually active or are older than 21.

-   **Cholesterol Checks:** Have your cholesterol checked regularly
    starting at age 45. If you smoke, have diabetes, or if heart disease
    runs in your family, start having your cholesterol checked at age
    20.

-   **Blood Pressure:** Have your blood pressure checked at least every
    2 years.

-   **Colorectal Cancer Tests:** Have a test for colorectal cancer
    starting at age 50. Your doctor can help you decide which test is
    right for you.

-   **Diabetes Tests:** Have a test to screen for diabetes if you have
    high blood pressure or high cholesterol.

-   **Depression:** If you\'ve felt \"down,\" sad, or hopeless, and have
    felt little interest or pleasure in doing things for 2 weeks
    straight, talk to your doctor about whether he or she can screen you
    for depression.

-   **Osteoporosis Tests:** Have a bone density test at age 65 to screen
    for osteoporosis (thinning of the bones). If you are between the
    ages of 60 and 64 and weigh 154 lbs. or less, talk to your doctor
    about whether you should be tested.

-   **Chlamydia Tests and Tests for Other Sexually Transmitted
    Diseases:** Have a test for Chlamydia if you are 25 or younger and
    sexually active. If you are older, talk to your doctor to see
    whether you should be tested. Also, talk to your doctor to see
    whether you should be tested for other sexually transmitted
    diseases.

<http://www.ahrq.gov/ppip/healthywom.htm>

**[Clinical Breast Exam]{.underline}**

### National Cancer Institute

Clinical Breast Examination (CBE)

No randomized trials of CBE as a sole screening modality have been done.
The Canadian National Breast Screening Study compared CBE plus
mammography to CBE alone in women aged 50 to 59. CBE was conducted by
trained health professionals with periodic evaluations of performance
quality. The frequency of cancer diagnosis, stage, interval cancers, and
breast cancer mortality were similar in the 2 groups, and compared
favorably with other trials of mammography alone. One explanation for
this finding was the careful training and supervision of the health
professionals performing CBE.\[[7]{.underline}\] Breast cancer
mortality, with follow-up 11 to 16 years after entry (mean= 13 years),
was similar in the 2 screening arms (mortality rate ratio 1.02 (95%
confidence interval (CI)= 0.78-1.33)).\[[8]{.underline}\] The
investigators estimated the operating characteristics for CBE alone. For
19,965 women aged 50 to 59, sensitivity was 83%, 71%, 57%, 83%, and 77%
for years 1 through 5 of the trial, respectively, and specificity ranged
between 88% and 96%. Positive predictive value (PPV), which is the
proportion of cancers detected per abnormal examination, was estimated
to be 3% to 4%. For 25,620 women aged 40 to 49, who were examined only
at entry, the estimated sensitivity was 71%, specificity 84%, and PPV
1.5%.\[[9]{.underline}\] An analysis of 752,081 CBEs performed between
1995 and 1998 as part of the National Breast and Cervical Cancer Early
Detection Program found that 6.9% of CBEs were abnormal and that 3.8
invasive cancers and 1.2 cases of DCIS were detected per 1000
examinations. Sensitivity was 58.8%, specificity 93.4%, and PPV
4.3%.\[[10]{.underline}\] A study of screening in women with a positive
family history of breast cancer showed that, after a normal initial
evaluation, the patient or clinical breast examination identified more
cancers than did mammography.\[[11]{.underline}\]

Breast Self Examination (BSE)

Monthly BSE is frequently advocated, but evidence for its effectiveness
is weak.\[[12]{.underline},[13]{.underline}\] The only large,
well-conducted randomized clinical trial (RCT) of BSE yet completed
randomized 266,064 women according to workplace in Shanghai to BSE
instruction, reinforcement, and encouragement or instruction on the
prevention of breast cancer. Neither group received breast cancer
screening through other modalities. After 10 to 11 years of follow-up,
there were 135 breast cancer deaths in the instruction group and 131 in
the control group (relative risk (RR) 1.04; 95% CI 0.82-1.33). Although
the number of invasive breast cancers diagnosed in the two groups was
about the same, women in the instruction group had more breast biopsies
and more benign lesions diagnosed than in the control
group.\[[14]{.underline}\]

One large randomized trial of BSE as a screening intervention has yet to
report results.\[[15]{.underline}\]

Case-control, nonrandomized trials, and cohort evidence about the
effectiveness of BSE is mixed; results are difficult to interpret
because of selection and recall biases. For example, a small
case-control study in Seattle, Washington, compared self-reported
practice of BSE in women with advanced breast cancer to that in
age-matched controls.\[[16]{.underline}\] The frequency of practicing
BSE did not differ in these groups, and there was no decrease in the
risk of advanced stage breast cancer associated with BSE (RR 1.15; 95%
CI= 0.73-1.81). BSE proficiency was low in both groups of women.

In the UK Trial of Early Detection of Breast Cancer, 2 districts invited
more than 63,500 women aged 45 to 64 to educational sessions about BSE.
After 10 years of follow-up, there was no difference in mortality rates
in these 2 districts compared to 4 centers without organized BSE
education (RR 1.07; 95% CI 0.93-1.22).\[[17]{.underline}\]

A case-control study nested within the Canadian National Breast
Screening Study (NBSS) suggests that well-performed BSE may be
effective. This study compared self-reported BSE frequency before
enrollment in the trial with breast cancer mortality. Women who examined
their breasts visually, used their finger pads for palpation, and used
their 3 middle fingers had a lower breast cancer
mortality.\[[18]{.underline}\]

A device called the Sensor Pad was designed to improve the accuracy of
BSE and has been approved by the United States Food and Drug
Administration (FDA); however, there is no evidence as to its efficacy
to decrease breast cancer mortality.

**[Agency for Health Care Research and Quality (AHRQ)]{.underline}**

The USPSTF concludes that the evidence is insufficient to recommend for
or against routine CBE alone to screen for breast cancer.

[**I recommendation**](../standard.htm) (Evidence is insufficient to
recommend for or against)\
*Rationale:* No screening trial has examined the benefits of CBE alone
(without accompanying mammography) compared to no screening, and design
characteristics limit the generalizability of studies that have examined
CBE. The USPSTF could not determine the benefits of CBE alone or the
incremental benefit of adding CBE to mammography. The USPSTF therefore
could not determine whether potential benefits of routine CBE outweigh
the potential harms.

The USPSTF concludes that the evidence is insufficient to recommend for
or against teaching or performing routine breast self-examination (BSE).

**[I recommendation](../standard.htm).** Evidence is insufficient to
recommend for or against)\
*Rationale:* The USPSTF found poor evidence to determine whether BSE
reduces breast cancer mortality. The USPSTF found fair evidence that BSE
is associated with an increased risk for false-positive results and
biopsies. Due to design limitations of published and ongoing studies of
BSE, the USPSTF could not determine the balance of benefits and
potential harms of BSE.

The U.S. Preventive Services Task Force (USPSTF) recommends screening
mammography, with or without clinical breast examination (CBE), every
1-2 years for women aged 40 and older.

**[B recommendation](../standard.htm).** (Evidence recommends that
clinicians routinely provide)

*Rationale:* The USPSTF found fair evidence that mammography screening
every 12-33 months significantly reduces mortality from breast cancer.
Evidence is strongest for women aged 50-69, the age group generally
included in screening trials. For women aged 40-49, the evidence that
screening mammography reduces mortality from breast cancer is weaker,
and the absolute benefit of mammography is smaller, than it is for older
women. Most, but not all, studies indicate a mortality benefit for women
undergoing mammography at ages 40-49, but the delay in observed benefit
in women younger than 50 makes it difficult to determine the incremental
benefit of beginning screening at age 40 rather than at age 50.

The absolute benefit is smaller because the incidence of breast cancer
is lower among women in their 40s than it is among older women. The
USPSTF concluded that the evidence is also generalizable to women aged
70 and older (who face a higher absolute risk for breast cancer) if
their life expectancy is not compromised by comorbid disease. The
absolute probability of benefits of regular mammography increase along a
continuum with age, whereas the likelihood of harms from screening
(false-positive results and unnecessary anxiety, biopsies, and cost)
diminish from ages 40-70. The balance of benefits and potential harms,
therefore, grows more favorable as women age. The precise age at which
the potential benefits of mammography justify the possible harms is a
subjective choice. The USPSTF did not find sufficient evidence to
specify the optimal screening interval for women aged 40-49

<http://www.ahrq.gov/clinic/uspstf/uspsbrca.htm>

# Other

1.)

[American Cancer Society]{.underline}

Women in their 20s and 30s should have a clinical breast examination
(CBE) as part of a regular health exam by a health expert preferably
every 3 years. After age 40, women should have a breast exam by a health
professional every year. There may be some benefit in having the CBE
shortly before the mammogram. During the exam, the doctor can show you
how to learn what your own breasts feel like.

[Editorial Note:]{.underline} Please note the American Cancer Society
offered no evidence on which to base the above suggestion.

2.)

Barton, MB, et al Does This Patient Have Breast Cancer? The Screening
Clinical Breast Examination: Should It Be Done? How? *JAMA.*
1999;282:1270-1280.

[Data Sources]{.underline}

We searched the English-language literature using the MEDLINE database
(1966-1997) and manual review of all reference lists, as well as
contacting investigators of several published studies for clarifications
and unpublished data.

[Study Selection and Data Extraction]{.underline}

To study CBE effectiveness, we included all controlled trials and
case-control studies in which CBE was at least part of the screening
modality; for technique, we included both clinical studies and those
that used silicone breast models. All 3 authors reviewed and agreed on
the studies selected for inclusion in the pooled analyses.

#### Conclusions

Indirect evidence supports the effectiveness of CBE in screening for
breast cancer. Although the screening clinical examination by itself
does not rule out disease, the high specificity of certain abnormal
findings greatly increases the probability of breast cancer.

<http://jama.ama-assn.org/cgi/content/abstract/282/13/1270>

**[Methods of Clinical Breast Exam]{.underline}**

The two most popular methods of CBE in the US are the concentric circle
and the vertical strip method.

Here are 4 randomized studies that evaluate those two techniques in
teaching settings. There were no randomized studies that compared
patient outcomes.

1.)\
Stefanek ME, Wilcox P, Huelskamp AM. Breast self-examination proficiency
and training effects: women at increased risk of breast cancer. Cancer
Epidemiol Biomarkers Prev. 1992 Nov-Dec;1(7):591-6.\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1302572&dopt=Abstract>

BSE proficiency was assessed in 101 first-degree relatives of breast
cancer patients. Participants were stratified by BSE frequency and
randomized to one of two training techniques (MammaCare or concentric
circle). BSE performance was assessed at baseline and at three follow-up
visits at 4-month intervals.

[Conclusion]{.underline}

Significant improvement occurred on self-report measures, lump detection
ability (true positives) on both models, and the projected grid.
Improvement occurred across both training groups by the first follow-up,
with no changes at subsequent visits. Both training techniques
significantly improved BSE proficiency and were viewed positively by
participants.

2.)

Campbell HS, Fletcher SW, Pilgrim CA, Morgan TM, Lin S. Improving
physicians\' and nurses\' clinical breast examination: a randomized
controlled trial. Am J Prev Med. 1991 Jan-Feb;7(1):1-8\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1867894&dopt=Abstract>

We conducted a randomized trial to evaluate changes in physicians\' and
nurses\' lump detection accuracy and examination skills after a training
program emphasizing development of tactile skills and using silicone
breast models containing lumps of varying sizes, degrees of hardness,
and depth of placement.

#### Conclusion

There were no significant differences in the proportion of abnormal
breast examinations reported or the number of mammograms ordered by
experimental and control physicians. Our results show health
professionals can be taught successfully to improve their clinical
breast examination accuracy and skills.

3.)

Pilgrim C, Lannon C, Harris RP, Cogburn W, Fletcher SW Improving
clinical breast examination training in a medical school: a randomized
controlled trial. J Gen Intern Med. 1993 Dec;8(12):685-8.\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8120686&dopt=Abstract>

To evaluate a new program for teaching clinical breast examination, a
class of 156 second-year medical students were randomized into an
experimental group (practice and feedback on silicone breast models and
women volunteers) and a control group (lecture only). During a simulated
practical clinical examination routinely conducted at the end of the
second year, the experimental group students used more suggested
palpation techniques during a patient examination (4.6 vs 2.0; p \<
0.0001) and found more simulated lumps in a silicone model (4.7 vs 4.4;
p \< 0.05).

Conclusion

Practice with immediate feedback is more effective than lecture alone in
teaching clinical breast examination.

4.)

Fletcher SW, O\'Malley MS, Earp JL, Morgan TM, Lin S, Degnan D. How best
to teach women breast self-examination. A randomized controlled trial.
Ann Intern Med. 1990 May 15;112(10):772-9.\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2184711&dopt=Abstract>

One third of patients received nurse instruction stressing tactile
skills (Mammacare group) (Mammatech Corporation, Gainesville, Florida);
one third, traditional nurse instruction emphasizing technique
(traditional group); and one third, no nurse instruction (control
group). Half of each group received physician encouragement.

CONCLUSIONS: Mammacare instruction resulted in more long-term improved
lump detection and examination technique use than did traditional
instruction or physician encouragement. Breast self-examination
instruction should emphasize lump detection skills.

5.) See also non-randomized study abstracts (Resources)

**[Local experience]{.underline}**

For the 52 providers the local MammaCare have trained over the past year
and a half the average rate of lump detection prior to taking this
course of 34% (4 or 5 lumps out of 14) and the average lump detection
rate at the end of the course of 88% (20 lumps out of 22).

Data from the women we have screened since 1994 which indicates that 9
out of the 159 cases (5.66%) of breast cancer that were detected were in
women who had abnormal clinical breast exams and negative or benign
mammograms.

Anecdotal evidence from local providers skilled in breast examination
with both a concentric or vertical stripping method based MammaCare
technique revealed that their clinical exams lasted from 2 to 6 minutes
total, depending on the size of the breast.

## Other methods of Breast Cancer prevention

### USPSTF 

The U.S. Preventive Services Task Force (USPSTF) recommends against
routine use of tamoxifen or raloxifene for the primary prevention of
breast cancer in women at low or average risk for breast cancer.

**[D recommendation](../standard.htm).** (Evidence recommends against
routinely providing the service)

*Rationale:* The USPSTF found fair evidence that tamoxifen and
raloxifene may prevent some breast cancers in women at low or average
risk for breast cancer, based on extrapolation from studies of women at
higher risk. The USPSTF concluded, however, that the potential harms of
chemoprevention may outweigh the potential benefits in women who are not
at high risk for breast cancer.

The USPSTF recommends that clinicians discuss chemoprevention with women
at high risk for breast cancer and at low risk for adverse effects of
chemoprevention. Clinicians should inform patients of the potential
benefits and harms of chemoprevention.

**[B recommendation](../standard.htm).** (Evidence recommends that
clinicians routinely provide)\
*Rationale:* The USPSTF found fair evidence that treatment with
tamoxifen can significantly reduce the risk for invasive
estrogen-receptor-positive breast cancer in women at high risk for
breast cancer and that the likelihood of benefit increases as the risk
for breast cancer increases. The USPSTF found consistent but less
abundant evidence for the benefit of raloxifene. The USPSTF found good
evidence that tamoxifen and raloxifene increase the risk for
thromboembolic events (for example, stroke, pulmonary embolism, and deep
venous thrombosis) and symptomatic side effects (for example, hot
flashes) and that tamoxifen, but not raloxifene, increases the risk for
endometrial cancer. The USPSTF concluded that the balance of benefits
and harms may be favorable for some high-risk women but will depend on
breast cancer risk, risk for potential harms, and individual patient
preferences.

<http://www.ahrq.gov/clinic/uspstf/uspsbrpv.htm>

## Summary

The primary mode of breast cancer screening in asymptotic women should
be mammography.

The USPSTF could not determine the benefits of CBE alone or the
incremental benefit of adding CBE to mammography. The USPSTF therefore
could not determine whether potential benefits of routine CBE outweigh
the potential harms.

On the other hand, it is a reality that not all breast lesions are
visible with mammography and many patients present with signs or
symptoms of breast disease. In addition, despite the evidence summarized
above, some major benchmark organizations (American Cancer Society)
continue to suggest periodic clinical breast exam. Hence we are
confronted with the question of which is the best approach to the
clinical breast exam.

My review of the evidence shows that the vertical strip palpation and
visual inspection technique appears to increase the skill of the
examiner, though there is no evidence that it improves patient's
clinical outcomes.

My suggestion is that the CCBG pursue the clinical technique with which
the provider feels she/he is best trained to maximize disease detection,
and is most comfortable. It appears that whichever technique is used,
the breast examination need not consume more than 3 minutes each,
depending on the size of the breast. In most cases, the clinical breast
examination may require much less time.

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## Resources 

**[E mail consult with Hope Baluh, MD, Chief Clinical Consultant,
Surgery, IHS]{.underline}**

"Neil- interesting topic but the bottom line to date is just have
you\'ve determined there is no strong evidence to support SBE and CBE
except as in relation to mammograghy for SCREENING- I think the issue
comes up because it just seems intuitive to providers that it\'s easy
and available so it must be a good idea\.....It is important that they
distinguish between patients at increase risk or those with specific
complaints from those who just need well-woman exams. The flavor of the
month as far as exam technique is concerned is probably not as important
as having an algorithim to follow and someone designated to field
questions or concerns for those primary care providers\...\...hope this
helps\....Hope"

6/6/03

**[Agency for Health Care Research and Quality (AHRQ) Preventive
Services]{.underline}**

<http://www.ahcpr.gov/clinic/prevenix.htm>

**Cochrane Library**

**Olsen O, Gøtzsche PC** Screening for breast cancer with mammography
(Cochrane Review). In: *The Cochrane Library*, Issue 3, 2003. Oxford:
Update Software.

Randomised trials comparing mammographic screening with no mammographic
screening.

Reviewers\' conclusions

The currently available reliable evidence does not show a survival
benefit of mass screening for breast cancer (and the evidence is
inconclusive for breast cancer mortality). Women, clinicians and policy
makers should consider these findings carefully when they decide whether
or not to attend or support screening programs.

### American Cancer Association

American Cancer Society Guidelines for the Early Detection of Breast
Cancer

**Mammogram** Women age 40 and older should have a mammogram every year,
and should continue to do so for as long as they are in good health.
While mammograms can miss some cancers, they are still a very good way
to find breast cancer.

**Clinical breast exam (CBE)** Women in their 20s and 30s should have a
clinical breast examination (CBE) as part of a regular health exam by a
health expert preferably every 3 years. After age 40, women should have
a breast exam by a health professional every year.

There may be some benefit in having the CBE shortly before the
mammogram. During the exam, the doctor can show you how to learn what
your own breasts feel like.

**Breast self-examination (BSE)** Women should report any change in
their breasts to their doctor right away. BSE is a way for women
(starting in their 20's) to find changes in their breasts.

If you decide to do BSE (and it's OK not to do it), you should ask your
doctor to watch you do it during your regular physical exam.

If you do BSE on a regular basis, you get to know how your breasts
normally feel. Then you can more easily notice changes. You should see
your doctor right away if you notice any of these changes: a lump or
swelling, skin irritation or dimpling, nipple pain or the nipple turning
inward, redness or scaliness of the nipple or breast skin, or a
discharge other than breast milk. But remember that most of the time
these breast changes are not cancer.

<http://www.cancer.org/docroot/CRI/content/CRI_2_2_3X_How_is_breast_cancer_found_5.asp?sitearea=>

**References**

Barton, MB, et al Does This Patient Have Breast Cancer? The Screening
Clinical Breast Examination: Should It Be Done? How? *JAMA.*
1999;282:1270-1280.

<http://jama.ama-assn.org/cgi/content/abstract/282/13/1270>

**Context** The clinical breast examination (CBE) is widely recommended
and practiced as a tool for breast cancer screening; however, its
effectiveness is dependent on its precision and accuracy.

**Objective** To collect evidence on the effectiveness of CBE in
screening for breast cancer and information on the best technique to
use.

**Data Sources** We searched the English-language literature using the
MEDLINE database (1966-1997) and manual review of all reference lists,
as well as contacting investigators of several published studies for
clarifications and unpublished data.

**Study Selection and Data Extraction** To study CBE effectiveness, we
included all controlled trials and case-control studies in which CBE was
at least part of the screening modality; for technique, we included both
clinical studies and those that used silicone breast models. All 3
authors reviewed and agreed on the studies selected for inclusion in the
pooled analyses.

**Data Synthesis** Randomized clinical trials demonstrated reduced
breast cancer mortality rates among women screened by both CBE and
mammography. Evidence of CBE\'s independent contribution was less
direct; CBE alone detected between 3% and 45%of breast cancers found
that screening mammography missed. The precision of CBE was difficult to
determine because of the lack of consistent and standardized examination
techniques. Studies on CBE precision reported fair agreement
(=0.22-0.59). Pooling trial data, we estimated CBE sensitivity at 54%
and specificity at 94%. The likelihood ratio of a positive CBE result is
10.6 (95% confidence interval \[CI\], 5.8-19.2), while the likelihood
ratio of a negative test result is 0.47 (95% CI, 0.40-0.56). Longer
duration of CBE and a higher number of specific techniques used were
associated with greater accuracy. The preferred technique for CBE
includes proper positioning of the patient, thoroughness of search, use
of a vertical-strip search pattern, proper position and movement of the
fingers, and a CBE duration of at least 3 minutes per breast. The value
of inspection is unproved. Professional and lay examiners improved their
sensitivity on silicone breast models after being taught this technique.

**Conclusions** Indirect evidence supports the effectiveness of CBE in
screening for breast cancer. Although the screening clinical examination
by itself does not rule out disease, the high specificity of certain
abnormal findings greatly increases the probability of breast cancer.

Yarnall KS, Pollak KI, Ostbye T, Krause KM, Michener JL.Primary care: is
there enough time for prevention? Am J Public Health. 2003
Apr;93(4):635-41.

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12660210&dopt=Abstract>

**OBJECTIVES:** We sought to determine the amount of time required for a
primary care physician to provide recommended preventive services to an
average patient panel.

**METHODS**: We used published and estimated times per service to
determine the physician time required to provide all services
recommended by the US Preventive Services Task Force (USPSTF), at the
recommended frequency, to a patient panel of 2500 with an age and sex
distribution similar to that of the US population.

**RESULTS:** To fully satisfy the USPSTF recommendations, 1773 hours of
a physician\'s annual time, or 7.4 hours per working day, is needed for
the provision of preventive services. **CONCLUSIONS:** Time constraints
limit the ability of physicians to comply with preventive services
recommendations.

### Cochrane for Clinicians, AAFP

Should We Offer Routine Breast Cancer Screening with Mammography?

SEAN P. DAVID, M.D., S.M.,

<http://www.aafp.org/afp/20030715/cochrane.html>

**Practice Pointers**

When considering whether to implement a screening test, several factors
must be considered: (1) Does early diagnosis lead to improved survival
or quality of life, or both? (2) Are early-diagnosed patients willing
partners in the treatment strategy? (3) Are the time and energy it takes
to confirm the diagnosis and provide lifelong care well spent? (4) Do
the frequency and severity of the target disorder warrant this degree of
effort and expenditure?^8^

The analysis primarily addresses the first question. There appears to be
a benefit in reducing breast cancer mortality in the 50- to 69-year
range, but this meta-analysis did not detect a significant mortality
benefit in women aged 40 to 49. However, in a less restrictive
meta-analysis, the U.S. Preventive Services Task Force (USPSTF)
determined a summary RR for breast cancer mortality of 0.85 (95 percent
CI, 0.73 to 0.99). The key issue is whether the recognized flaws of
several of the mammography trials are serious enough to disqualify them
from inclusion in a meta-analysis. The USPSTF determined that observed
mortality reductions in the \"flawed\" trials were not likely to be
explained by the biases potentially introduced by the flaws. The USPSTF
included these trials, whereas the Cochrane review authors thought that
the trials were \"fatally\" flawed and should be excluded. The Cochrane
review did not include summary data on flawed trials, but other
meta-analyses have demonstrated a weaker but significant benefit with
screening initiated in the 40- to 49-year age group and evidence of
increasing benefit and cost-effectiveness with age. Most women diagnosed
with early-stage breast cancer are willing to undergo treatment^9^ and
report a favorable quality of life.^10^ Mammography in selected women is
cost-effective and comparable to screening for cervical cancer.

When considering one of the included studies,^11^ screening with
mammography every two years beginning at age 50 prevented one breast
cancer death for every 4,000 women screened in a given year, per 1,460
mammographic examinations, per 13.5 biopsies, and per 7.4 breast cancers
detected.^12^ In the United States in 2001, approximately 203,500 new
cases of breast cancer were diagnosed, and 39,600 women died of the
disease.^13^ Given the frequency and severity of breast cancer, which is
the second leading cause of cancer death in women,^13^ the expense and
potential harm of mammography seem to be warranted.

Epidemiologic data from the United States and the United Kingdom
demonstrate a dramatic decline in breast cancer mortality beginning in
the late 1980s.^14,15^ It is not known, however, to what extent this
benefit is the result of widespread use of mammography or improved
treatment regimens with adjuvant chemotherapy and radiation therapy.
Women who are diagnosed early and undergo treatment have lower mortality
rates than women who do not. Identifying and screening women at high
risk,^16^ improving the proportion of eligible women screened,^12^ and
eliminating disparities in access to mammography and treatment are
evidence-based ways to reduce breast cancer mortality.^17^

**Nordic Cochrane Centre**\
Kosters JP, Gotzsche PC. Regular self-examination or clinical
examination for early detection of breast cancer. Cochrane Database Syst
Rev. 2003;(2):CD003373.\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12804462&dopt=Abstract>

BACKGROUND: Breast self-examination and clinical breast examination have
been promoted for many years as general screening methods to diagnose
breast cancer at an earlier stage in order to decrease morbidity and or
mortality. The possible benefits and harms remain unclear. OBJECTIVES:
To determine whether screening for breast cancer by regular
self-examination or clinical breast examination reduces breast cancer
mortality and morbidity. SEARCH STRATEGY: The Cochrane Library and
Medline were searched for randomised trials; date of last search October
2002. The specialised register maintained by the Cochrane Breast Cancer
Group was searched. SELECTION CRITERIA: Randomised clinical trials,
including cluster randomised trials. DATA COLLECTION AND ANALYSIS:
Decisions on which trials to include were taken independently by the
reviewers based on the methods of trial. Disagreements were resolved by
discussion. Intention to treat analyses were conducted using a fixed
effect model with 95% confidence intervals. MAIN RESULTS: Two large
population-based studies (388,535 women) from Russia and Shanghai that
compared breast self-examination with no intervention were included.
There was no statistically significant difference in breast cancer
mortality, relative risk 1.05 (95% confidence interval (CI) 0.90 to
1.24) (587 deaths in total). In Russia, more cancers were found in the
breast self-examination group than in the control group (relative risk
1.24, 95% CI 1.09 to 1.41), while this was not the case in Shanghai
(relative risk 0.97, 95% CI 0.88 to 1.06). Almost twice as many biopsies
(3406) with benign results were performed in the screening group
compared to the control group (1856), relative risk 1.89, 95% CI 1.79 to
2.00. REVIEWER\'S CONCLUSIONS: Data from two large trials do not suggest
a beneficial effect of screening by breast self-examination whereas
there is evidence for harms. There were no randomised trials of clinical
breast examination. At present, breast self-examination cannot be
recommended.

**Non-randomized studies evaluating Mammacare and other examination
techniques**

Non-randomized studies

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8347364&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8151721&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8311984&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1913636&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8261382&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8777152&dopt=Abstract>

Other studies

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8890965&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9060957&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2223168&dopt=Abstract>

<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7695460&dopt=Abstract>

<http://www.apa.org/monitor/dec98/exam.html>

<http://www.mammacare.com/index.htm>

Crossing S, Manaszewicz R. Breast self examination: be alert but not
alarmed? Med J Aust. 2003 Jun 16;178(12):646-7.\
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12797856&dopt=Abstract>

## Appendix

### 

### AHRQ Standard Recommendation Language

**A**---The USPSTF strongly recommends that clinicians routinely provide
\[the service\] to eligible patients. (The USPSTF found good evidence
that \[the service\] improves important health outcomes and concludes
that benefits substantially outweigh harms.)

**B**---The USPSTF recommends that clinicians routinely provide \[the
service\] to eligible patients. (The USPSTF found at least fair evidence
that \[the service\] improves important health outcomes and concludes
that benefits outweigh harms.)

**C**---The USPSTF makes no recommendation for or against routine
provision of \[the service\]. (The USPSTF found at least fair evidence
that \[the service\] can improve health outcomes but concludes that the
balance of the benefits and harms is too close to justify a general
recommendation.)

**D**---The USPSTF recommends against routinely providing \[the
service\] to asymptomatic patients. (The USPSTF found at least fair
evidence that \[the service\] is ineffective or that harms outweigh
benefits.)

**I**---The USPSTF concludes that the evidence is insufficient to
recommend for or against routinely providing \[the service\]. (Evidence
that \[the service\] is effective is lacking, of poor quality, or
conflicting and the balance of benefits and harms cannot be determined.)

<http://www.ahrq.gov/clinic/uspstf/standard.htm>