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## Complete Summary

#### GUIDELINE TITLE

Local regional recurrence (LR) and salvage surgery\--breast cancer.

#### BIBLIOGRAPHIC SOURCE(S)

Green S, Shank BM, Haffty BG, Halberg FE, Mitchell SE, Rabinovitch RA,
Solin LJ, Strom EA, Taylor ME, White JR, Cobleigh MA, Edge SB, Mauch PM,
Expert Panel on Radiation Oncology-Breast Work Group. Local regional
recurrence (LR) and salvage surgery \-- breast cancer. \[online
publication\]. Reston (VA): American College of Radiology (ACR); 2006.
12 p. \[41 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: McCormick B, Mendenhall NP,
Shank BM, Haffty BG, Halberg FE, Martinez AA, McNeese MD, Mitchell SE,
Rabinovitch RA, Solin LJ, Taylor ME, Singletary SE, Leibel S. Local
regional recurrence and salvage surgery. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215(Suppl):1181-92.

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Breast cancer

-   Local-regional recurrence after breast-conserving therapy (BCT)

-   Local-regional recurrence after modified radical mastectomy (MRM)

#### GUIDELINE CATEGORY

Risk Assessment\
Treatment

#### CLINICAL SPECIALTY

Internal Medicine\
Oncology\
Radiation Oncology\
Radiology\
Surgery

#### INTENDED USERS

Health Plans\
Hospitals\
Managed Care Organizations\
Physicians\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of radiologic treatment procedures for
patients with local-regional recurrence of breast cancer after
breast-conserving therapy (BCT) or modified radical mastectomy (MRM)

#### TARGET POPULATION

Women with local-regional recurrence of breast cancer after
breast-conserving therapy (BCT) or modified radical mastectomy (MRM)

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Chemotherapy

2.  Simple mastectomy (SM)

    -   Alone

    -   Plus sentinel lymph node biopsy (SNLB)

    -   Plus lymph node dissection (LND) or modified radical mastectomy

3.  Lumpectomy

    -   Alone

    -   Plus radiation therapy (RT)

    -   Plus lymph node (LN) staging and RT

4.  Quadrantectomy

5.  Hormone therapy

6.  Complete excision of recurrence

7.  Hyperthermia

    -   Alone

    -   Plus RT

8.  RT, including consideration of volumes, doses, and modality (wedge
    filters, computer planning, photons with bolus, electrons)

9.  Modified radical mastectomy

#### MAJOR OUTCOMES CONSIDERED

-   Ten-year overall and disease-free survival rates

-   Recurrence rates

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The guideline developer performed literature searches of peer-reviewed
medical journals and the major applicable articles were identified and
collected.

#### NUMBER OF SOURCE DOCUMENTS

The total number of source documents identified as the result of the
literature search is not known.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Not Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not stated

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

One or two topic leaders within a panel assume the responsibility of
developing an evidence table for each clinical condition, based on
analysis of the current literature. These tables serve as a basis for
developing a narrative specific to each clinical condition.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Delphi)

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Since data available from existing scientific studies are usually
insufficient for meta-analysis, broad-based consensus techniques are
needed for reaching agreement in the formulation of the appropriateness
criteria. The American College of Radiology (ACR) Appropriateness
Criteria panels use a modified Delphi technique to arrive at consensus.
Serial surveys are conducted by distributing questionnaires to
consolidate expert opinions within each panel. These questionnaires are
distributed to the participants along with the evidence table and
narrative as developed by the topic leader(s). Questionnaires are
completed by participants in their own professional setting without
influence of the other members. Voting is conducted using a scoring
system from 1-9, indicating the least to the most appropriate imaging
examination or therapeutic procedure. The survey results are collected,
tabulated in anonymous fashion, and redistributed after each round. A
maximum of three rounds is conducted and opinions are unified to the
highest degree possible. Eighty percent agreement is considered a
consensus. This modified Delphi technique enables individual, unbiased
expression, is economical, easy to understand, and relatively simple to
conduct.

If consensus cannot be reached by the Delphi technique, the panel is
convened and group consensus techniques are utilized. The strengths and
weaknesses of each test or procedure are discussed and consensus reached
whenever possible. If \"No consensus\" appears in the rating column,
reasons for this decision are added to the comment sections.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Criteria developed by the Expert Panels are reviewed by the American
College of Radiology (ACR) Committee on Appropriateness Criteria.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**ACR Appropriateness Criteria®**

**Clinical Condition: Local Regional Recurrence (LR) and Salvage
Surgery---Breast Cancer**

**Variant 1: 37-year-old, 1.2 cm LR in breast 2.5 years after BCT with
lumpectomy and axillary node dissection + RT for T1bN0 lesion. ER/PR
(-). EOD workup negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Chemotherapy         8                   Consider clinical trial.

  Simple mastectomy    8                    
  (SM)                                     

  SM + sentinel lymph  3                    
  node biopsy (SLNB)                       

  SM + lymph node      2                    
  dissection (LND) or                      
  modified radical                         
  mastectomy                               

  Lumpectomy           2                   Only in a clinical trial

  Quadrantectomy       2                    

  Lumpectomy + RT      1                   Only in a clinical trial

  Hormone therapy      1                    

  **RT Volumes**                           

  Whole breast +/-     1                    
  boost                                    

  Chest wall (after    1                    
  mastectomy)                              

  Supraclavicular      1                    
  (adequate LND)                           

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 2: 52-year-old, 0.5 cm LR in breast 15 years after BCT with
lumpectomy and axillary node dissection + RT for T1bN0 lesion. ER/PR
(+). EOD workup negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Simple mastectomy    8                    
  (SM)                                     

  SM + SLNB            3                    

  SM + LND or modified 2                    
  radical mastectomy                       

  Lumpectomy           3                   Only in a clinical trial

  Quadrantectomy       3                    

  Lumpectomy + RT      1                   Only in a clinical trial

  **RT Volumes**                           

  Whole breast +/-     1                    
  boost                                    

  Chest wall (after    1                    
  mastectomy)                              

  Supraclavicular      1                    
  (adequate LND)                           

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 3: 60-year-old, simultaneous breast skin + SCL recurrence 3
years after BCT with lumpectomy + RT for T1bN0 lesion. ER/PR (-). EOD
workup negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Chemotherapy         9                    

  Simple mastectomy    2                    
  (SM)                                     

  SM + LND or modified 2                    
  radical mastectomy                       

  Lumpectomy           2                    

  Quadrantectomy       2                    

  Lumpectomy + RT      2                    

  Hormone therapy      2                    

  **RT Volumes**                           

  Supraclavicular      8                    
  (adequate LND)                           

  Whole breast +/-     2                    
  boost                                    

  Chest wall (after    2                    
  mastectomy)                              

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 4: 42-year-old, 3.0 cm LR in breast 6 years after BCT + chemo
for T1cN0 lesion. ER/PR (-). EOD workup positive: liver and multiple
bone metastases.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Chemotherapy         9                    

  Simple mastectomy    2                    
  (SM)                                     

  SM + LND or modified 2                    
  radical mastectomy                       

  Lumpectomy           2                    

  Quadrantectomy       2                    

  Lumpectomy + RT      2                    

  Hormone therapy      2                    

  **RT Volumes**                           

  Whole breast +/-     2                    
  boost                                    

  Chest wall (after    2                    
  mastectomy)                              

  Supraclavicular      2                    
  (adequate LND)                           

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 5: 55-year-old, 1.5 cm LR in breast 7 years after BCT with
lumpectomy only + RT for original diagnosis of DCIS, not otherwise
specified. Biopsy: invasive ductal carcinoma. ER/PR (-). EOD workup
negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Chemotherapy         8                    

  SM + LND or modified 8                    
  radical mastectomy                       

  SM + sentinel lymph  8                    
  node biopsy (SLNB)                       

  Simple mastectomy    2                    

  Lumpectomy           2                    

  Quadrantectomy       2                    

  Lumpectomy + RT      2                    

  Hormone therapy      2                    

  **RT Volumes**                           

  Whole breast +/-     2                    
  boost                                    

  Chest wall (after    2                    
  mastectomy)                              

  Supraclavicular      2                    
  (adequate LND)                           

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 6: 55-year-old, 7 nodules (1-2 cm diameter) along MRM scar 3
years after MRM+ chemo + adjuvant chest wall/SCL RT (50 Gy). Primary and
LR both ER/PR (-).**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  Complete excision of 8                   If technically possible with
  recurrence                               primary closure with or without
                                           simple advancement flap

  Chemotherapy         7                   Consider for study.

  Radiation therapy    7                   Use judgment on RT volume.

  Hyperthermia + RT    6                    

  Hormone therapy      1                    

  Hyperthermia alone   1                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 7: 60-year-old, 2 cm nodule on MRM scar 4 years after MRM +
chemo for T1N1 \[3 LNs (+)\]. FNA (+). Primary ER/PR (+): PR (+): Nodule
ER/PR (+) by immunohistology. Asymptomatic EOD workup negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Complete excision of 8                    
  recurrence                               

  Radiation therapy    8                    

  Hormone therapy      8                    

  Chemotherapy         5                    

  Hyperthermia         2                    

  **RT Volumes**                           

  Chest wall           9                    

  Supraclavicular      8                    
  fossa                                    

  Axilla               2                    

  Internal mammary     2                    
  nodes (IMN)                              

  **RT Doses**                             

  Chest Wall: 4000     2                    
  cGy/16-20 fractions                      

  Chest Wall:          2                    
  4500-4680 cGy/23-26                      
  fractions                                

  Chest Wall:          8                    
  5000-5040 cGy/25-28                      
  fractions                                

  Supraclavicular:     2                    
  4000 cGy/16-20                           
  fractions                                

  Supraclavicular:     8                    
  4500-4680 cGy/23-26                      
  fractions                                

  Supraclavicular:     8                    
  5000-5040 cGy/25-28                      
  fractions                                

  IMN (excluding gross 2                    
  disease): 4500-4680                      
  cGy/23-26 fractions                      

  IMN (excluding gross 2                    
  disease): 5000-5040                      
  cGy/25-28 fractions                      

  Total dose including 2                    
  boost: 5000 cGy                          

  Total dose including 8                    
  boost: 5100-5900 cGy                     

  Total dose including 8                    
  boost: 6000-7000 cGy                     

  Total dose including 2                    
  boost: \>7000 cGy                        

  **Modality/Other                         
  Factors**                                

  Wedge filters (chest 8                    
  wall photons)                            

  Computer planning    8                    

  Photons with bolus   8                    
  (chest wall)                             

  Electrons            8                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 8: 42-year-old, 2 cm parasternal lump (2nd interspace) + 1 cm
medial SCL Node 9 months after MRM + chemo for T2N1 \[4 LNs (+)\].
Primary ER/PR (+): PR (+). Lump ER/PR (+) by immunohistology. EOD workup
negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Chemotherapy         9                    

  Radiation therapy    9                    

  Hormone therapy      8                    

  Complete excision of 2                    
  recurrence                               

  Hyperthermia         2                    

  **RT Volumes**                           

  Chest wall           9                    

  Supraclavicular      9                    
  fossa                                    

  Internal mammary     9                    
  nodes (IMN)                              

  Axilla               3                    

  **RT Doses**                             

  Chest Wall: 4000     2                    
  cGy/16-20 fractions                      

  Chest Wall:          2                    
  4500-4680 cGy/23-26                      
  fractions                                

  Chest Wall:          8                    
  5000-5040 cGy/25-28                      
  fractions                                

  Supraclavicular:     2                    
  4000 cGy/16-20                           
  fractions                                

  Supraclavicular:     2                    
  4500-4680 cGy/23-26                      
  fractions                                

  Supraclavicular:     8                    
  5000-5040 cGy/25-28                      
  fractions                                

  IMN (excluding gross 5                    
  disease): 4500-4680                      
  cGy/23-26 fractions                      

  IMN (excluding gross 8                    
  disease): 5000-5040                      
  cGy/25-28 fractions                      

  Total dose including 2                    
  gross disease site                       
  boost: 5000 cGy                          

  Total dose including 3                    
  gross disease site                       
  boost: 5100-5900 cGy                     

  Total dose including 8                    
  gross disease site                       
  boost: 6000-7000 cGy                     

  Total dose including 3                    
  gross disease site                       
  boost: \>7000 cGy                        

  **Modality/Other                         
  Factors**                                

  Wedge filters (chest 8                    
  wall photons)                            

  Computer planning    8                    

  Photons with bolus   8                    
  (chest wall)                             

  Electrons            8                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 9: 42-year-old, 2.0 cm nodule on MRM scar 6 years after MRM
for T1bN0 lesion. FNA (+). ER/PR (+) nodule. Asymptomatic EOD workup
negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Complete excision of 8                    
  recurrence                               

  Radiation therapy    8                    

  Chemotherapy         8                    

  Hormone therapy      8                    

  Hyperthermia         2                    

  **RT Volumes**                           

  Chest wall           9                    

  Supraclavicular      8                    
  fossa                                    

  Internal mammary     5                    
  nodes (IMN)                              

  Axilla               2                    

  **RT Doses**                             

  Chest Wall: 4000     2                    
  cGy/16-20 fractions                      

  Chest Wall:          2                    
  4500-4680 cGy/23-26                      
  fractions                                

  Chest Wall:          8                    
  5000-5040 cGy/25-28                      
  fractions                                

  Supraclavicular:     2                    
  4000 cGy/16-20                           
  fractions                                

  Supraclavicular:     8                    
  4500-4680 cGy/23-26                      
  fractions                                

  Supraclavicular:     8                    
  5000-5040 cGy/25-28                      
  fractions                                

  IMN (excluding gross 8                    
  disease): 4500-4680                      
  cGy/23-26 fractions                      

  IMN (if treated):    8                    
  5000-5040 cGy/25-28                      
  fractions                                

  Total dose including 2                    
  gross disease site                       
  boost: 5000 cGy                          

  Total dose including 3                    
  gross disease site                       
  boost: 5100-5900 cGy                     

  Total dose including 8                    
  gross disease site                       
  boost: 6000-7000 cGy                     

  Total dose including 2                    
  gross disease site                       
  boost: \>7000 cGy                        

  **Modality/Other                         
  Factors**                                

  Wedge filters (chest 8                    
  wall photons)                            

  Computer planning    8                    

  Photons with bolus   8                    
  (chest wall)                             

  Electrons            8                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 10: 55-year-old, 1.5 cm LR in breast 7 years after BCT with
lumpectomy only for 1.2 cm tubular CA. Biopsy: tubular CA. ER/PR (-).
EOD workup negative.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  **Principles of                          
  Treatment**                              

  Simple mastectomy    8                    
  (SM) + lymph node                        
  dissection (LND)                         

  Modified radical     8                    
  mastectomy                               

  Lumpectomy + RT      8                    

  Lumpectomy + LN      8                    
  staging + RT                             

  Simple mastectomy    2                    
  (SM)                                     

  Lumpectomy           2                    

  Quadrantectomy       2                    

  **RT Volumes**                           

  Whole breast +/-     8                    
  boost                                    

  Chest wall (after    2                    
  mastectomy)                              

  Supraclavicular      2                    
  (adequate LND)                           

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

For almost two decades, the major focus of radiation oncologists
specializing in the management of breast cancer has been on performing
both randomized and nonrandomized trials comparing breast-conserving
surgery and radiation with the more traditional modified radical
mastectomy. With the gradual acceptance of these two local regional
therapies as equivalent in the management of early-stage invasive breast
cancer by the late 1980s, attention was then refocused on identifying
factors (pathologic, patient, or therapy-oriented), that predicted for
the success or failure of the treatment locally.

Accompanying these very real clinical goals was a philosophical
discussion on the relationship of a local recurrence to the development
of distant failure and eventually death from the disease. Early on, it
was noted that the survival rate from salvage surgery for failures in
the conserved breast was 50% or higher at five years, and local failures
following breast-conserving surgery and radiation were somehow
classified as \"different\" from local regional failures following
mastectomy, which were readily linked with the development of distant
disease and thought incurable.

The success story of systemic chemotherapy and hormone therapy in the
management of breast cancer needs to be emphasized as well. The survival
and disease-free survival patterns of patients have changed. Women who
decades ago would have died rapidly from distant disease may now survive
long enough to exhibit a local regional failure. Thus, our thoughts on
the consequences of these failures without distant disease must change
as well. A prospective randomized trial from the European Organization
for Research and Treatment of Cancer (EORTC) group comparing mastectomy
with breast-conserving surgery and radiation in patients of similar
stages with similar systemic therapy surprisingly showed almost
identical 5-year survival rates following salvage procedures for
local-only failures in both the breast-conserved arm and the mastectomy
arm.

The relationship between local failure and distant failure must be
reanalyzed in both groups of patients (i.e., those treated with
mastectomy and those treated with breast-conserving surgery and
radiation). Conversely, the importance of obtaining local control with
initial treatment must remain important not only for the goal of
preventing either the loss of the breast in the conserved patients or
painful and difficult-to-control local failure in the mastectomy
patients, but also to potentially decrease subsequent distant metastases
that may be associated with these local failures. As chemotherapeutic
regimens for the risk of distant disease become more effective, this
goal of ensuring local control takes on a potentially greater
importance. Although some researchers have hypothesized that local
failure in the conserved breast is a predictor of distant failure as
well, others have challenged this concept and concluded that a
recurrence in the breast causes distant metastases. Data from the Early
Breast Cancer Trialists Collaborative Group (EBCTCG) demonstrate that
treatments resulting in improved local control may lead to decrease in
breast cancer mortality. The overview analysis also suggests that
avoidance of local recurrence in a conserved breast (after
breast-conserving surgery and radiation) and avoidance of a local
recurrence elsewhere (i.e., the chest wall or regional nodes) after
mastectomy are of comparable relevance to 15-year breast cancer
mortality.

**Recurrence after Breast-Conserving Surgery and Radiation**

Predictors for local regional failure after both breast-conserving
surgery and radiation can be divided into three broad categories. The
first involves factors related to the patient herself. Very young age at
the time of diagnosis, defined as either younger than age 30 or 40,
appears to be a strong predictor.

The second category consists of tumor factors that have been analyzed
after breast-conserving surgery. Most studies have found that positive
microscopic margins, gross multifocality, and an extensive intraductal
component (EIC) are associated with a higher risk of recurrence in the
conserved breast. Some series have noted larger size and lymphatic
vessel invasion as risk factors.

The third category consists of therapeutic factors, the most important
of which is the omission of breast radiation, for predicting local
recurrence. Numerous studies have demonstrated that radiation therapy
dramatically reduces the risk of recurrence in the breast. Patients
receiving systemic chemotherapy or hormone therapy appear to have higher
local control rates, all else being equal, than those who do not. The
size of the surgical procedure affects local control in many series,
which can also be related to the margin status. The addition of a
radiation boost to the lumpectomy cavity may decrease the incidence of a
recurrence in the conserved breast, particularly in women (younger than
age 40).

The generally recommended treatment for locally recurrent breast cancer
after breast conservation is salvage mastectomy. This results in local
control in 85%-95% of patients with an ipsilateral breast tumor
recurrence (IBTR). Following an IBTR, overall survival rates range from
45%-80% at 5 years and 40%-65% at 10 years.

In patients who are operable after local recurrence only, involvement of
the skin or multiple positive lymph nodes appears to be associated with
a larger risk of subsequent failure than recurrence in breast tissue
only. The incidence of nodal recurrence in breast-conserving series is
low and has not been a major management problem. However, involvement of
the nodes would have significant impact on outcome; therefore,
assessment of the axillary status for an invasive local recurrence of
the breast should be considered. The role of SLNB in this scenario
remains to be defined. Preliminary data indicate that SLNB may be
performed at the time of salvage surgery, as previous breast or axillary
surgery may not be a contraindication to SLNB.

Because of the relationship between local recurrence and distant
failure, systemic therapy must also be considered in the treatment
program of this patient group. To date, no published series has shown a
statistically significant improvement in subsequent outcome with the
administration of salvage chemotherapy or hormonal intervention at the
time of local recurrence. Factors to be considered in this clinical
decision include prior systemic therapy, if any; extent of recurrence;
time interval from initial treatment to recurrence; tumor hormone
receptor status, patient age, and general medical condition. The
National Surgical Adjuvant Breast and Bowel Project (NSABP) are
evaluating the benefit of adjuvant chemotherapy following radical
resection of locoregionally recurrent breast cancer. This prospective
randomized trial is currently open to accrual.

Some patients who present with an IBTR following conservative surgery
and radiation therapy may have a new primary tumor as opposed to a true
local recurrence. The second breast tumor has been defined as a new
primary if it is distinctly different from the original tumor with
respect to histology subtype, if it presents in a different location in
the breast, or if flow cytometry has changed from aneuploid to diploid.
The time interval between the original primary and the second tumor is
generally considerably greater for new primaries compared to true
recurrences (7.3 vs. 3.7 years). Ten-year overall survival rates (75%
vs. 55%) and distant disease-free survival rates (85% vs. 41%) tend to
be much better for patients with new primaries compared to those with
true recurrences. Thus the diagnosis of a new primary as opposed to a
true recurrence implies a different natural history and prognosis, and
has different implications for therapeutic management. Unfortunately,
most series addressing breast tumor recurrences do not adequately
distinguish between the two entities. This may be of particular
importance to breast cancer management in young women with BRCA 1/2
mutations, who are at increased risk for breast tumor recurrences due to
new primaries.

Patients with DCIS who undergo breast-conserving therapy and
subsequently sustain a recurrence in the treated breast appear to have
an excellent outcome following salvage therapy. In most series, about
half of the recurrences are invasive, with the other half recurring as
DCIS. Nevertheless, almost all these patients can be cured by
mastectomy. One study reported an overall survival rate of 92% and a
distant metastasis-free survival rate of 89% at 8 years, following
salvage therapy.

**Recurrence after Mastectomy**

Risk factors for local regional failure following mastectomy can also be
divided into clinical, pathological, and treatment-related categories.
Young age (defined as younger than 35 or 40 years) has been associated
with an increased risk of locoregional recurrence after mastectomy.
Patients with certain pathological risk factors, principally four or
more involved nodes, T3 or T4 tumors, lymphatic vessel invasion, or
involvement of the overlying skin or underlying muscle, are at increased
risk for local regional recurrence. Patients whose mastectomy specimens
yield a positive deep margin are also at increased risk for such
failure. Elective postmastectomy irradiation reduces this risk. There is
controversy regarding the risk of chest wall recurrence in the subgroup
of patients with one to three positive nodes and their need for
postmastectomy radiation therapy (See the Appropriateness Criteria®
topic on Post-mastectomy Radiation Therapy).

Systemic therapy appears to have an impact on locoregional control. In
the most recent meta-analysis of systemic therapy from the EBCTG, five
years of tamoxifen reduced the local recurrence rate by about one-half
in women with hormone receptor-positive disease (local recurrence ratio
of 0.47), while, irrespective of hormone receptor status,
polychemotherapy reduced it by about one-third (ratios 0.63-0.70
depending on patient age).

In contrast to local recurrence in the breast following BCT, local chest
wall or regional recurrence of breast cancer, or both, following
mastectomy carries a worse prognosis. Five year survival rates range
from 35%-75% and 10 year survival rates range from 25%-55%. Long-term
control of the local regional disease is achieved in only 45%-70% of
patients. Most patients develop distant metastases. Prognostic factors
include the extent of disease initially and at recurrence, the
disease-free interval, and the ER status as well as the use of surgical
excision, radiation, and hormonal therapy. Aggressive attempts at
controlling the local-regional recurrence are warranted, however,
because patients with uncontrolled local-regional disease are usually
symptomatic, are more likely to develop distant metastases, and die
sooner than patients whose local-regional recurrences are controlled.

A multidisciplinary approach is required for the management of a chest
wall recurrence after mastectomy. Surgical resection should be performed
if the size and location of the recurrence permit. In patients who have
not received prior radiation therapy, local-regional recurrences are
managed with high-dose irradiation. Local-regional recurrence after
mastectomy is a harbinger of distant metastases, so systemic treatment
should also be considered. If the patient is ER positive, tamoxifen, an
aromatase inhibitor (depending on menopausal status) or ovarian ablation
may be used. If the patient is ER negative, then chemotherapy may be
given.

**Treatment Guidelines after Breast Conserving Therapy**

For patients failing BCT that included standard whole-breast radiation
and an axillary node dissection, simple mastectomy is recommended as the
local treatment of choice when the failure is confined to the breast
parenchyma and is operable.

In the clinical situation involving recurrence in the treated breast,
along with a supraclavicular nodal failure, the recommendation is for
radiation to the untreated supraclavicular area, and chemotherapy.
Although this pattern of recurrence is not common, it is viewed as
systemic failure based on existing evidence. Similarly, for patients
with clear distant metastases as well as local failure, primary systemic
management is recommended rather than mastectomy.

In the rare clinical situation of a local recurrence for a patient whose
initial treatment consisted only of a wide local excision without
radiation or axillary dissection, treatment options include either
modified radical mastectomy or lumpectomy, axillary nodal evaluation,
and radiation therapy, in other words, the decision tree open to a
patient with newly diagnosed breast cancer, provided the systemic
work-up was negative.

Given the situation of a patient who had had lumpectomy plus radiation
therapy only, for a diagnosis of DCIS initially, with recurrence of
operable invasive cancer, modified radical mastectomy is recommended, as
well as consideration of systemic therapy.

**Abbreviations**

-   BCT, breast-conserving therapy

-   CA, carcinoma

-   DCIS, ductal carcinoma in situ

-   EOD, extent of disease

-   ER, estrogen receptor

-   FNA, fine-needle aspiration

-   LN, lymph node

-   LND, lymph node dissection

-   MRM, modified radical mastectomy

-   RT, radiation therapy

-   PR, progesterone receptor

-   SCL, supraclavicular

-   SLNB, sentinel lymph node biopsy

#### CLINICAL ALGORITHM(S)

Algorithms were not developed from criteria guidelines.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are based on analysis of the current literature and
expert panel consensus.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Selection of appropriate radiologic procedures for management of
patients with loco-regional recurrence of breast cancer

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

An American College of Radiology (ACR) Committee on Appropriateness
Criteria and its expert panels have developed criteria for determining
appropriate imaging examinations for diagnosis and treatment of
specified medical condition(s). These criteria are intended to guide
radiologists, radiation oncologists, and referring physicians in making
decisions regarding radiologic imaging and treatment. Generally, the
complexity and severity of a patient\'s clinical condition should
dictate the selection of appropriate imaging procedures or treatments.
Only those exams generally used for evaluation of the patient\'s
condition are ranked. Other imaging studies necessary to evaluate other
co-existent diseases or other medical consequences of this condition are
not considered in this document. The availability of equipment or
personnel may influence the selection of appropriate imaging procedures
or treatments. Imaging techniques classified as investigational by the
U.S. Food and Drug Administration (FDA) have not been considered in
developing these criteria; however, study of new equipment and
applications should be encouraged. The ultimate decision regarding the
appropriateness of any specific radiologic examination or treatment must
be made by the referring physician and radiologist in light of all the
circumstances presented in an individual examination.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Green S, Shank BM, Haffty BG, Halberg FE, Mitchell SE, Rabinovitch RA,
Solin LJ, Strom EA, Taylor ME, White JR, Cobleigh MA, Edge SB, Mauch PM,
Expert Panel on Radiation Oncology-Breast Work Group. Local regional
recurrence (LR) and salvage surgery \-- breast cancer. \[online
publication\]. Reston (VA): American College of Radiology (ACR); 2006.
12 p. \[41 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1996 (revised 2006)

#### GUIDELINE DEVELOPER(S)

American College of Radiology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

The American College of Radiology (ACR) provided the funding and the
resources for these ACR Appropriateness Criteria®.

#### GUIDELINE COMMITTEE

Committee on Appropriateness Criteria, Expert Panel on Radiation
Oncology--Breast Work Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Sheryl Green, MB, ChB; Brenda M. Shank, MD, PhD; Bruce
G. Haffty, MD; Francine E. Halberg, MD; Sandra E. Mitchell, MD; Rachel
Abrams Rabinovitch, MD; Lawrence J. Solin, MD; Eric A. Strom, MD; Marie
E. Taylor, MD; Julia R. White, MD; Melody A. Cobleigh, MD; Stephen B.
Edge, MD; Peter M. Mauch, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: McCormick B, Mendenhall NP,
Shank BM, Haffty BG, Halberg FE, Martinez AA, McNeese MD, Mitchell SE,
Rabinovitch RA, Solin LJ, Taylor ME, Singletary SE, Leibel S. Local
regional recurrence and salvage surgery. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215(Suppl):1181-92.

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American College of Radiology (ACR) Web
site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonRadiationOncologyBreastWorkGroup/LocalRegionalRecurrenceandSalvageSurgeryBreastCancerDoc3.aspx).

ACR Appropriateness Criteria® *Anytime*, *Anywhere*™ (PDA application).
Available from the [ACR Web
site](http://www.acr.org/SecondaryMainMenuCategories/ACRStore/FeaturedCategories/QualityandSafety/ac_pda.aspx).

Print copies: Available from the American College of Radiology, 1891
Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   ACR Appropriateness Criteria®. Background and development. Reston
    (VA): American College of Radiology; 2 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [American
    College of Radiology (ACR) Web
    site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/background_dev.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on August 31, 2006.

#### COPYRIGHT STATEMENT

Instructions for downloading, use, and reproduction of the American
College of Radiology (ACR) Appropriateness Criteria® may be found on the
[ACR Web
site.](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/ACRAppropriatenessCriteriaTermsandConditionsDoc1.aspx)

### DISCLAIMER

#### NGC DISCLAIMER

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Date Modified: 11/3/2008