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Brief Summary

GUIDELINE TITLE

ACR Appropriateness Criteria® conservative surgery and radiation-stage I and II breast carcinoma.

BIBLIOGRAPHIC SOURCE(S)

  • White JR, Halberg FE, Rabinovitch R, Green S, Haffty BG, Solin LJ, Strom EA, Taylor ME, Edge SB, Expert Panel on Radiation Oncology-Breast. ACR Appropriateness Criteria® conservative surgery and radiation--stage I and II breast carcinoma. [online publication]. Reston (VA): American College of Radiology (ACR); 2008. 14 p. [55 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Expert Panel on Radiation Oncology–Breast Work Group: Francine E. Halberg, MD; Brenda M. Shank, MD, PhD; Bruce G. Haffty, MD; Alvaro A. Martinez, MD; Beryl McCormick, MD; Marsha D. McNeese, MD; Nancy P. Mendenhall, MD; Sandra E. Mitchell, MD; Rachel Abrams Rabinovitch, MD; Lawrence J. Solin, MD; Marie E. Taylor, MD; Sonja Eva Singletary, MD; Steven Leibel, MD. ACR Appropriateness Criteria® conservative surgery and radiation in the treatment of stage I and II carcinoma of the breast. [online publication]. Reston (VA): American College of Radiology (ACR); 2000.

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

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

ACR Appropriateness Criteria®

Clinical Condition: Conservative Surgery and Radiation—Stage I and II Breast Carcinoma

Variant 1: Premenopausal 45-year-old woman, left breast 1.9 cm upper inner quadrant (UIQ), primary with lumpectomy, margins (–), GIII infiltrating ductal carcinoma (IDC), estrogen receptor/progesterone receptor (ER/PR) (–), Her2 (–), sentinel lymph node (SN) 1/3 (+) micro metastases; chemotherapy planned.

Treatment Rating Comments
Principles of Treatment
Modified radical mastectomy 9 If by patient choice.
LND + RT 9  
No LND + breast and nodal RT 7  
No LND + breast RT 5 LND is standard of care.
Simple mastectomy 2 LND is standard of care.
LND + accelerated partial breast irradiation (PBI) No consensus No consensus for standard of care outside of protocol participation.
Radiation Volumes (assume LND done, 10 additional negative nodes)
Whole breast ± boost 9  
Supraclavicular + apical axillary nodes (level III) (assumes breast RT given) 6  
IMN (assumes breast RT given) 6  
Full axilla (level I-III) (assumes breast RT given) 2  
RT Doses (180-200 cGy/day unless specified otherwise), assume LND done, 10 additional negative nodes
Whole breast: 42 Gy (16 fractions) no boost 4 No published experience using boost with this fractionation.
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 45-49 Gy 1  
Total tumor bed dose: 50 Gy 3  
Total tumor bed dose: 60-66 Gy 9  
SCL ± axillary apex: 45-50 Gy 6 If treated.
IMN: 45-50 Gy 6 If treated.
Radiation Volumes (assume NO LND done and breast RT planned)
SCL + full axilla 8  
Level 1-2 axilla (without SCL) 8  
IMN 7  
SCL + apical nodes (without axilla) 3  
RT Doses (180-200 cGy/day unless specified otherwise), assume No LND done
Full axilla: 45-50 Gy 9  
Whole breast: 42 Gy (16 fractions) no boost 4 No published experience using boost with this fractionation.
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 45-49 Gy 1  
Total tumor bed dose: 50 Gy 3  
Total tumor bed dose: 60-66 Gy 9  
SCL: 45-50 Gy 6 If treated.
IMN: 45-50 Gy 6 If treated.
Other Treatment Factors
CT based multiplane or 3D treatment planning with dose homogeneity compensation 9  
Lung inhomogeneity correction 9  
Fluoroscopic 2D planning with single-slice homogeneity corrections 4  
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 2: 74-year-old woman, 1.2 cm well differentiated IDC, ER/PR (+) Her2 (–) upper outer quadrant (UOQ), primary excised with lumpectomy, margins (–), clinically negative axilla; anti-endocrine therapy planned; Karnofsky performance status (KPS)=90.

Treatment Rating Comments
Principles of Treatment
Modified radical mastectomy 9 If by patient choice.
Sentinel lymph node biopsy (SN) + RT breast 9  
Breast RT, no further surgery 8  
SN biopsy, no RT 7  
No further surgery or RT 7  
Breast RT + low axilla RT, no further surgery 7  
SN biopsy + accelerated PBI 6 Long term follow-up is limited.
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 3: Postmenopausal 56-year-old woman, 1.7 cm UOQ primary excised with lumpectomy–infiltrating lobular carcinoma associated with scattered lobular cancer in situ (LCIS), LCIS at margins, SN biopsy (–); ER/PR (+), Her2 (–); chemotherapy and anti-endocrine therapy planned.

Treatment Rating Comments
Principles of Treatment
Completion mastectomy 9 If by patient choice.
Whole breast RT, ± boost 9  
Reexcision + RT if negative LCIS margin 3 Re-excision of LCIS generally not necessary but pleomorphic LCIS needs special consideration.
Accelerated PBI No consensus No consensus for standard of care outside of protocol participation.
RT Doses (180-200 cGy/day unless otherwise stated)
Whole breast: 42 Gy (16 fractions) no boost 4 No published experience using boost with this fractionation.
Whole breast: 45-50 Gy 8  
Total tumor bed dose: 45-49 Gy 1  
Total tumor bed dose: 50 Gy 3  
Total tumor bed dose: 60-66 Gy 9  
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 4: Premenopausal 42-year-old woman, 1.8 cm UOQ, IDC, no ductal carcinoma in situ (DCIS), SN biopsy negative, primary excised with lumpectomy, 1 focus of microscopic margin involvement, ER/PR (+), Her2 (–); chemotherapy and anti-endocrine therapy planned.

Treatment Rating Comments
Principles of Treatment
Completion mastectomy 9 If by patient choice.
Reexcision + whole breast RT if negative margins 9  
No further surgery, breast RT 7 Reexcision is highly desirable, but no further surgery is acceptable.
Reexcision + accelerated PBI if negative margins No consensus No consensus for standard of care outside of protocol participation.
RT Doses - Assume no Re-excision, (1.8‒2.0 Gy/day ‒ unless noted otherwise)
Whole breast: 42 Gy (16 fractions) 4  
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 42 Gy (16 fractions) 1  
Total tumor bed dose: 45-50 Gy 1  
Total tumor bed dose: 60-62 Gy 7  
Total tumor bed dose: 64-66 Gy 9  
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 5: Premenopausal 41-year-old woman, 1.1 cm GII IDC, UOQ, ER/PR (+), Her2 (–) primary excised with lumpectomy, margins (–), SN biopsy negative, BRCA 1 mutation positive.

Treatment Rating Comments
Principles of Treatment
Completion mastectomy 9 If by patient choice with appropriate counseling.
Completion mastectomy + contralateral mastectomy 9 If by patient choice with appropriate counseling.
Breast RT 9 If by patient choice with appropriate counseling.
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 6: Postmenopausal 56-year-old woman, 2.5 cm UOQ moderately differentiated, extensive intraductal component (EIC) present, SN (–), ER/PR (+), Her2 (–), primary excised with lumpectomy, 1 focus of margin involvement; chemotherapy and anti-endocrine therapy planned.

Treatment Rating Comments
Principles of Treatment
Completion mastectomy 9 If by patient choice.
Reexcision + whole breast RT if negative margins 9  
No reexcision + RT 4 Reexcision highly desirable.
Reexcision + accelerated PBI if negative margins No consensus No consensus for standard of care outside of protocol participation.
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 7: Premenopausal 46-year-old women, 2.6 cm UOQ IDC, primary excised with lumpectomy, margins (–), little DCIS, 2/10 LNs (+), level I-II axillary node dissection, ER/PR (–), Her2 (–), chemotherapy planned, patient desires breast conservation.

Treatment Rating Comments
Principles of Treatment
Whole breast RT + nodal RT 8  
Whole breast RT alone 7  
Completion mastectomy 1 Patient desires breast conservation.
Nodal Radiation Volumes (assume breast RT given)
Supraclavicular + apical (level III) axillary nodes 8  
Internal mammary nodes 8  
Full axilla (level 1-3) 3  
RT Doses, Negative Re-excision (1.8-2.0 Gy/day unless specified otherwise)
Whole breast: 42 Gy (2.6 Gy/day) (no boost) 4 Limited published experience using boost with this fractionation.
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 42 Gy (16 fractions) 1  
Total tumor bed dose: 45-50 Gy 1  
Total tumor bed dose: 60-66 Gy 9  
SCL ± axillary apex: 45-50 Gy 8  
IMN: 45-50 Gy 8  
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 8: Healthy 67-year-old woman, 0.5 cm well-differentiated IDC, ER/PR (+), Her2 (‒), primary excised with lumpectomy, margins (–); anti-endocrine therapy planned.

Treatment Rating Comments
Principles of Treatment
Mastectomy + sentinel LN biopsy 9 If by patient choice.
Sentinel LN biopsy alone 3 Needs RT.
Sentinel lymph node biopsy + whole breast RT 9  
Sentinel lymph node biopsy + accelerated PBI 6 Long-term follow-up is limited.
RT Doses (1.8-2.0 Gy/day unless specified otherwise)
Whole breast: 42 Gy (16 fractions) 8  
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 42 Gy (16 fractions) 8  
Total tumor bed dose: 45-49 Gy 1  
Total tumor bed dose: 50 Gy 8  
Total tumor bed dose: 60 Gy 9  
Total tumor bed dose: 64-66 Gy 5  
PBI: 34-38.5 Gy over 8-10 fractions 6 Long-term follow-up is limited.
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Variant 9: Postmenopausal 55-year-old woman, clinical T2N1, core biopsy shows poorly differentiated IDC, palpable LN FNA (+), ER (–), Her2 (3+), treated with neoadjuvant chemotherapy with excellent clinical response; primary excised with lumpectomy, 1.0 cm pathologic residual, margins (–), 1/20 LNs (+), planning trastuzumab (Herceptin) for 12 months; patient desires breast conservation.

Treatment Rating Comments
Principles of Treatment
Radiation therapy breast and nodes 9  
Radiation therapy breast only 3  
Completion mastectomy 1 Patient desires breast conservation.
Radiation Volumes (assume breast RT given)
Supraclavicular + apical axillary nodes 9  
Internal mammary nodes 5  
Full axilla (level I-III) 3  
RT Doses (1.8-2.0 Gy/day unless specified otherwise)
Whole breast: 42 Gy (16 fractions) 1  
Whole breast: 45-50 Gy 9  
Total tumor bed dose: 45-59 Gy 1  
Total tumor bed dose: 50 Gy 3  
Total tumor bed dose: 60-66 Gy 9  
SCL ± axillary apex: 45-50 Gy 9  
IMN: 45-50 Gy 9 Cardiac irradiation should be especially avoided with concurrent Herceptin.
Rating Scale: 1=Least appropriate, 9=Most appropriate

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

Management Guidelines

The vast majority of women with stage I or II breast cancer are good candidates for breast-conserving therapy (BCT). Whole-breast irradiation with or without boost is the standard of care following lumpectomy. Contraindications to BCT include patients with very extensive malignant-appearing calcifications on the mammogram. Postbiopsy mammograms should be obtained to assess the completeness of resection in patients whose tumors demonstrate microcalcifications on mammograms.

Two nonadjacent primary tumors in the same breast is a relative contraindication to RT. Pregnancy is an absolute contraindication. A history of well-documented collagen vascular disease and a history of prior RT to a high total dose, or significant volume, or both are considered relative contraindications to a breast-conserving approach. Any other patient who desires a breast-conserving approach and in whom negative margins of excision around the primary tumor can be obtained, (e.g., in patients with extensive intraductal component [EIC]-positive tumors), is a good candidate for BCT.

RT to the entire breast, to a total dose of 45‒50 Gy in 1.8‒2 Gy fractions for 4.5‒5.5 weeks, generally followed by a supplemental boost dose of radiation to the surgical tumor bed, is recommended. Regional nodal irradiation is not recommended for patients with negative axillary nodes. The role of regional nodal irradiation in patients with one to three positive nodes is uncertain.

Abbreviations

  • 2D, 2-dimensional
  • 3D, 3-dimensional
  • BRCA, breast cancer
  • CT, computed tomography
  • DCIS, ductal carcinoma in situ
  • EIC, extensive intraductal component
  • ER, estrogen receptor
  • FNA, fine needle aspiration
  • IDC, infiltrating ductal carcinoma
  • IMN, internal mammary (lymph) node
  • KPS, Karnofsky performance status
  • LCIS, lobular cancer in situ
  • LN, lymph node
  • LND, lymph node dissection
  • PBI, partial breast irradiation
  • PR, progesterone receptor
  • RT, radiation therapy
  • SCL, supraclavicular node
  • SN, sentinel lymph node
  • UIQ, upper inner quadrant
  • UOQ, upper outer quadrant

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • White JR, Halberg FE, Rabinovitch R, Green S, Haffty BG, Solin LJ, Strom EA, Taylor ME, Edge SB, Expert Panel on Radiation Oncology-Breast. ACR Appropriateness Criteria® conservative surgery and radiation--stage I and II breast carcinoma. [online publication]. Reston (VA): American College of Radiology (ACR); 2008. 14 p. [55 references]

ADAPTATION

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

DATE RELEASED

1996 (revised 2008)

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

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Panel Members: Julia R. White, MD; Francine E. Halberg, MD; Rachel Rabinovitch, MD; Sheryl Green, MB, ChB; Bruce G. Haffty, MD; Lawrence J. Solin, MD; Eric A. Strom, MD; Marie E. Taylor, MD; Stephen B. Edge, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Expert Panel on Radiation Oncology–Breast Work Group: Francine E. Halberg, MD; Brenda M. Shank, MD, PhD; Bruce G. Haffty, MD; Alvaro A. Martinez, MD; Beryl McCormick, MD; Marsha D. McNeese, MD; Nancy P. Mendenhall, MD; Sandra E. Mitchell, MD; Rachel Abrams Rabinovitch, MD; Lawrence J. Solin, MD; Marie E. Taylor, MD; Sonja Eva Singletary, MD; Steven Leibel, MD. ACR Appropriateness Criteria® conservative surgery and radiation in the treatment of stage I and II carcinoma of the breast. [online publication]. Reston (VA): American College of Radiology (ACR); 2000.

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.

ACR Appropriateness Criteria® Anytime, Anywhere™ (PDA application). Available from the ACR Web site.

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

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on September 10, 2009.

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