Guideline Title
Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO).
Bibliographic Source(s)
Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys 2009 Jul 15;74(4):987-1001. [98 references] PubMed  |
Guideline Status
This is the current release of the guideline.
UMLS Concepts ( what's this?)
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ICD9CM:
Malignant neoplasm of breast (female), unspecified (174.9); Subtotal mastectomy (85.23)
MSH:
Breast Neoplasms; Chemotherapy, Adjuvant; Informed Consent; Mammography; Mastectomy, Segmental; Radiation Dosage; Radiotherapy; Radiotherapy, Adjuvant; Ultrasonography; Whole-Body Irradiation
MTH:
Chemotherapy Regimen; follow-up; Malignant neoplasm of female breast; Mammary Neoplasms; Mammography; Radiographic-therapeutic unit device; Segmental Mastectomy; Therapeutic radiology procedure; Ultrasonography
PDQ:
chemotherapy; mammography; radiation therapy; total-body irradiation; ultrasonography
SNOMEDCT:
Administration of antineoplastic agent (363688001); Administration of antineoplastic agent (367336001); Administration of antineoplastic agent (69960004); Malignant neoplasm of female breast (372064008); Mammography (71651007); Neoplasm of breast (126926005); Partial mastectomy (367502008); Partial mastectomy (64368001); Radiation oncology AND/OR radiotherapy (108290001); Radiographic-therapeutic unit (10850003); Total body irradiation (47479005); Ultrasonography (16310003); Ultrasonography (359659005)
SPN:
FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC
UMD:
Radiographic Systems, Digital, Mammographic (18-432); Radiotherapy Systems (13-279); Scanning Systems, Ultrasonic, Mammographic (15-656)
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Guideline Category
Management
Treatment
Clinical Specialty
Obstetrics and Gynecology
Oncology
Radiation Oncology
Radiology
Intended Users
Patients
Physicians
Guideline Objective(s)
To present guidance for patients and physicians regarding the use of accelerated partial-breast irradiation (APBI), based on current published evidence complemented by expert opinion
Target Population
Women who have undergone breast-conserving surgery for early-stage breast cancer
Interventions and Practices Considered
- Accelerated partial-breast irradiation (APBI) vs. whole body irradiation (WBI)
- Chemotherapy
- Imaging assessment, including diagnostic mammography and breast ultrasonography
- Informed patient consent
- Follow-up
Major Outcomes Considered
- Risk of ipsilateral breast tumor recurrence (IBTR)
- Local-regional failure
- Cause-specific survival
- Overall survival
- Treatment-related toxicity
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Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
Whenever possible, this consensus statement relied on an evidence-based approach using a formal systematic literature review. One author searched for English-language citations in the National Library of Medicine's PubMed database through May 30, 2008 using the Medical Subject Heading term "Breast Neoplasms/Radiotherapy," limiting results to articles whose major focus was this topic. Studies published only in abstract form were not eligible. Of 3,831 articles initially identified, a total of 645 original research articles contained any one of the following key words: accelerated, balloon, brachytherapy, catheter, implant, implantation, interstitial, intraoperative, limited, partial, MammoSite, or Savi. Of this sample, the Task Force identified four published randomized clinical trials and 38 prospective single-arm studies (see Table 1 in the original guideline document).
Bibliographies of candidate studies were also reviewed to ensure that all eligible studies were included. A total of six clinical studies were purely retrospective in nature and were not included. All prospective clinical studies were reviewed by one author and abstracted for inclusion criteria, radiotherapy methods, clinical outcomes, and toxicity.
Number of Source Documents
The Task Force identified four published randomized clinical trials and 38 prospective single-arm studies.
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence
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
A Task Force composed of all authors synthesized the published evidence.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The Health Services Research Committee, in accordance with established American Society of Radiation Oncology (ASTRO) policy, recruited a Task Force composed of recognized experts in the fields of breast cancer radiation oncology, breast cancer surgery, and radiation physics, in addition to representatives from radiation oncology private practice and residency. The Task Force was asked to provide guidance on the use of accelerated partial-breast irradiation (APBI) for patients and physicians who may be considering this treatment option and to define which patients are suitable candidates for the off-protocol use of APBI before the availability of mature results from randomized clinical trials. The Task Force was also charged with providing guidelines for proper APBI dosimetry and for informed consent.
In June 2008, the ASTRO Board of Directors approved a proposal to develop a consensus statement regarding APBI and also authorized the membership of the Task Force. Subsequently, the Task Force participated in a series of conference calls and face-to-face meetings to compose the consensus statement.
Rating Scheme for the Strength of the Recommendations
Cost Analysis
A formal cost analysis was not performed and published analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
The initial draft of the consensus statement was sent to external reviewers and posted on the American Society for Radiation Oncology (ASTRO) web site for public comment. The ASTRO Board of Directors integrated this feedback and approved the final document in January 2009.
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Major Recommendations
- Which patients may be considered for accelerated partial-breast irradiation (APBI) outside of a clinical trial?
Consensus Statement
All patients considered for APBI should be candidates for breast-conserving therapy (no prior radiotherapy, no history of certain collagen vascular diseases, and not pregnant) and should be committed to long-term follow-up to evaluate for recurrence, second primary cancers, and treatment toxicity. Table 1 (below) presents the Task Force's consensus for a "suitable" group, for whom treatment with APBI is considered acceptable outside of a clinical trial. Table 2 (below) presents the Task Force's consensus for a "cautionary" group, for whom caution and concern in the use of APBI should be exercised at this point in time because of limited data. Table 3 (below) presents the Task Force's consensus for an "unsuitable" group, for whom APBI is not generally considered warranted outside of a clinical trial. To help accurately determine pathologic selection criteria, consultation with a specialist in breast pathology should be considered. Although these tables provide guidance in selecting patients who may be appropriate for APBI outside the context of a clinical trial, the Task Force strongly endorsed enrollment of all eligible patients considering APBI onto the Radiation Therapy Oncology Group (RTOG) 0413/National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39 randomized trial and encouraged enrollment of other patients considering APBI, particularly those not in the "suitable" group, into prospective clinical studies to address many of the unanswered questions in APBI.
Table 1. Patients "Suitable" for APBI if All Criteria are Present
| Factor |
Criterion |
| Patient Factors |
|
| Age |
≥60 years |
| BRCA1/2 mutation |
Not present |
| Pathologic Factors |
|
| Tumor size |
≤2 cm* |
| T stage |
T1 |
| Margins |
Negative by at least 2 mm |
| Grade |
Any |
| LVSI |
No† |
| ER status |
Positive |
| Multicentricity |
Unicentric only |
| Multifocality |
Clinically unifocal with total size ≤2.0 cm‡ |
| Histology |
Invasive ductal or other favorable subtypes§ |
| Pure DCIS |
Not allowed |
| EIC |
Not allowed |
| Associated LCIS |
Allowed |
| Nodal Factors |
|
| N stage |
pN0 (i-, i+) |
| Nodal surgery |
SN Bx or ALND** |
| Treatment Factors |
|
| Neoadjuvant therapy |
Not allowed |
Abbreviations: APBI = accelerated partial-breast irradiation; BRCA 1/2 = breast cancer gene 1/2; LVSI = lymph–vascular space invasion; ER = estrogen receptor; DCIS = ductal carcinoma in situ; EIC = extensive intraductal component; LCIS = lobular carcinoma in situ; SN Bx = sentinel lymph node biopsy; ALND = axillary lymph node dissection
Criteria are derived from data (when available) and conservative panel judgment.
*The size of the invasive tumor component as defined by the American Joint Committee on Cancer
†The finding of possible or equivocal LVSI should be disregarded.
‡Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) does not exceed 2 cm
§Favorable subtypes include mucinous, tubular, and colloid
**Pathologic staging is not required for DCIS
Table 2. "Cautionary" Group: Any of these Criteria Should Invoke Caution and Concern when Considering APBI
| Factor |
Criterion |
| Patient Factors |
|
| Age |
50–59 years |
| Pathologic Factors |
|
| Tumor size |
2.1–3.0 cm* |
| T stage |
T0 or T2 |
| Margins |
Close (<2 mm) |
| LVSI |
Limited/focal |
| ER status |
Negative† |
| Multifocality |
Clinically unifocal with total size 2.1–3.0 cm‡ |
| Histology |
Invasive lobular |
| Pure DCIS |
≤3 cm |
| EIC |
≤3 cm |
Abbreviations: APBI = accelerated partial-breast irradiation; LVSI = lymph–vascular space invasion; ER = estrogen receptor; DCIS = ductal carcinoma in situ; EIC = extensive intraductal component
*The size of the invasive tumor component as defined by the American Joint Committee on Cancer
†Patients with ER-negative tumors are strongly encouraged to enroll in the National Surgical Adjuvant Breast and Bowel Project B-39/Radiation Therapy and Oncology Group 04-13 clinical trial
‡Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm
Table 3. Patients "Unsuitable" for APBI Outside of a Clinical Trial if any of these Criteria Are Present
| Factor |
Criterion |
| Patient Factors |
|
| Age |
<50 years |
| BRCA1/2 mutation |
Present |
| Pathologic Factors |
|
| Tumor size* |
>3 cm |
| T stage |
T3-4 |
| Margins |
Positive |
| LVSI |
Extensive |
| Multicentricity |
Present |
| Multifocality |
If microscopically multifocal >3 cm in total size or if clinically multifocal |
| Pure DCIS |
If >3 cm in size |
| EIC |
If >3 cm in size |
| Nodal Factors |
|
| N stage |
pN1, pN2, pN3 |
| Nodal surgery |
None performed |
| Treatment Factors |
|
| Neoadjuvant therapy |
If used |
Abbreviations: APBI = accelerated partial-breast irradiation; BRCA 1/2 = breast cancer gene 1/2; LVSI = lymph–vascular space invasion; DCIS = ductal carcinoma in situ; EIC = extensive intraductal component
If any of these factors are present, the Task Force recommends against the use of APBI outside of a prospective clinical trial.
*The size of the invasive tumor component as defined by the American Joint Committee on Cancer
- What constitutes proper informed consent for patients treated with APBI outside of a clinical trial?
Consensus Statement
Patients who choose treatment with APBI should be informed that whole-breast irradiation (WBI) is an established treatment with a much longer track record that has documented long-term effectiveness and safety. In contrast, APBI is a relatively new method with a limited track record, and thus its long-term effectiveness and safety are not fully known. Treatment with APBI may lead to an increase in the risk of ipsilateral breast tumor recurrence (IBTR), which may require mastectomy and possibly chemotherapy and could be associated with an increased risk for distant metastasis and death. Accelerated partial-breast irradiation could also lead to an increased risk of toxicity, including local fibrosis or poor cosmesis, but may also improve cosmetic outcomes by treating a smaller volume of breast tissue. Patients in the "cautionary" group should be further informed that relatively little is known regarding long-term outcomes of APBI for this patient group, and thus even greater uncertainty exists.
- Which diagnostic imaging tests are needed for patients treated with APBI?
Consensus Statement
Patients treated with APBI should undergo standard imaging assessment, which typically includes diagnostic mammography and breast ultrasonography. At present there are insufficient data to justify routine use of breast magnetic resonance imaging (MRI) in patients selected for APBI.
- For patients receiving APBI, how should multidisciplinary care be integrated with surgery and medical oncology?
Consensus Statement
The decision regarding conventional WBI vs. APBI should be made only after the patient's consultation with a radiation oncologist and a complete pathologic evaluation of the lumpectomy specimen. For patients who will receive adjuvant chemotherapy, it is recommended that APBI be performed first and that there should be an interval of at least 2 to 3 weeks between completion of APBI and initiation of chemotherapy.
- According to published clinical and dosimetric data, how do the various techniques for APBI compare?
Consensus Statement
Interstitial brachytherapy is the technique with the longest follow-up reported, whereas follow-up data for other APBI techniques remain limited. At present there are insufficient clinical and dosimetric data to determine the optimal technique for APBI delivery.
- What are the minimum requirements for APBI treatment planning and dosimetry?
Consensus Statement
Treatment with APBI requires technical expertise encompassing the tools needed to evaluate and ensure the delivery of a safe and effective dose to a specific target. Use of any APBI technique requires the ability to (1) delineate a treatment target, (2) deliver the prescription dose to the target, (3) optimize dose homogeneity, (4) limit dose to nontarget tissue, and (5) use a quality assurance program to verify that the prescribed dose is delivered accurately.
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Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of evidence supporting the recommendations is not specifically stated.
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Appropriate use of accelerated partial breast irradiation (APBI) in women with breast cancer following breast-conserving therapy
Potential Harms
- Treatment with accelerated partial-breast irradiation (APBI) may lead to an increase in the risk of ipsilateral breast tumor recurrence (IBTR), which may require mastectomy and possibly chemotherapy and could be associated with an increased risk for distant metastasis and death. APBI could also lead to an increased risk of toxicity, including local fibrosis or poor cosmesis, but may also improve cosmetic outcomes by treating a smaller volume of breast tissue. Patients in the "cautionary" group should be further informed that relatively little is known regarding long-term outcomes of APBI for this patient group, and thus even greater uncertainty exists.
- Reported risks of IBTR by APBI treatment technique are presented in Figure E1 in the original guideline document. At present the Task Force believes that there are insufficient data to compare the different treatment techniques with respect to their effectiveness or toxicity.
- This Consensus Statement was prepared on the basis of information available at the time the Task Group was conducting its research and discussions on the topic. There may be new developments that are not reflected in this Statement, and that may, over time, be a basis for the American Society for Radiation Oncology (ASTRO) to consider revisiting and updating the Statement.
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Qualifying Statements
- Adherence to the guidelines set forth in this Consensus Statement will not ensure successful treatment in every situation. Furthermore, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient.
- The American Society for Radiation Oncology assumes no liability for the information, conclusions, and findings contained in its consensus statements. In addition, these guidelines cannot be assumed to apply to the use of these interventions performed in the context of clinical trials, given that clinical studies are designed to evaluate or validate innovative approaches in a disease for which improved staging and treatment are needed or are being explored.
- The members of the Task Force acknowledged at the outset the limitations in the scope of current knowledge and the lack of long-term data inherent in most accelerated partial-breast irradiation (APBI) studies and further acknowledged that this consensus statement will require updating as additional information is obtained.
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Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided
Implementation Tools
Foreign Language Translations
Patient ResourcesFor information about availability, see the Availability of Companion Documents and Patient Resources fields below.
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Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness
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Identifying Information and Availability
Bibliographic Source(s)
| Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys 2009 Jul 15;74(4):987-1001. [98 references] PubMed |
Adaptation
Not applicable: The guideline was not adapted from another source.
Guideline Developer(s)
American Society for Radiation Oncology - Professional Association
Source(s) of Funding
American Society for Radiation Oncology
Guideline Committee
American Society for Radiation Oncology (ASTRO) Task Force
Composition of Group That Authored the Guideline
Task Force Members: Benjamin D. Smith, M.D., Radiation Oncology Flight, Wilford Hall Medical Center, Lackland AFB, TX, Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX; Douglas W. Arthur, M.D., Department of Radiation Oncology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA; Thomas A. Bucholz, M.D., Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, TX; Bruce G. Haffty, M.D., Department of Radiation Oncology, University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School, New Brunswick, NJ; Carol A. Hahn, M.D., Department of Radiation Oncology, Duke University Medical School, Durham, NC; Patricia H. Hardenbergh, M.D., Shaw Regional Cancer Center, Veil, CO; Thomas B. Julian, M.D., Department of Human Oncology, Allegheny General Hospital, Pittsburgh, PA; Lawrence B. Marks, M.D., Department of Radiation Oncology, University of North Carolina Medical School, Chapel Hill, NC; Dorin A. Todor, Ph.D., Department of Radiation Oncology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA; Frank A. Vicini, M.D., Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI; Timothy J. Whelan, M.D., Department of Radiation Oncology, Juravinski Cancer Center, Hamilton, ON, Canada; Julia White, M.D., Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; Jennifer Y. Wo, M.D., Harvard Radiation Oncology Residency Program, Boston, MA; and Jay R. Harris, M.D., Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women’s Hospital, Boston, MA
Financial Disclosures/Conflicts of Interest
Before initiation of this Consensus Statement, all members of the Task Group writing the Statement were required to complete conflict of interest statements. These statements are maintained at American Society for Radiation Oncology (ASTRO) Headquarters in Fairfax, VA, and pertinent conflict information is published with the report. Individuals with disqualifying conflicts have been recused from participation in this Consensus Statement.
Conflict of interest: D. W. Arthur, T. B. Julian, D. A. Todor, and F. A. Vicini have served as consultants to SenoRx, Irvine, CA.
Guideline Status
This is the current release of the guideline.
Availability of Companion Documents
The following is available:
Patient Resources
The following is available:
- Radiation therapy for breast cancer. Brochure. Fairfax (VA): American Society for Radiation Oncology; 2011. 2 p. Electronic copies: Available from the RT Answers Web site . Also available in Spanish from the RT Answers Web site .
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.
NGC Status
This NGC summary was completed by ECRI Institute on July 24, 2012. The information was verified by the guideline developer on August 22, 2012.
Copyright Statement
This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
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