Title

Management of Hereditary Breast Cancer

Authoring Organizations

Publication Month/Year

April 3, 2020

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Target Patient Population

Women with hereditary breast cancer with germline mutations, advanced or early stage

Target Provider Population

Medical oncologists, radiation oncologists, surgical oncologists, oncology nurses, patients/caregivers

Inclusion Criteria

Female, Adolescent, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Operating and recovery room, Outpatient, Radiology services

Scope

Assessment and screening, Management

Diseases/Conditions (MeSH)

D061325 - Hereditary Breast and Ovarian Cancer Syndrome

Keywords

breast cancer, Hereditary Breast Cancer, Hereditary Cancer, PARP Inhibitors, germline mutations, Breast Cancer, breast_cancer

Source Citation

DOI: 10.1200/JCO.20.00299 Journal of Clinical Oncology

Supplemental Methodology Resources

Data Supplement

Methodology

Number of Source Documents
58
Literature Search Start Date
January 1, 1999
Literature Search End Date
September 26, 2019
Description of External Review Process
The ASCO/ASTRO/SSO Writing Panel included medical oncology, surgical oncology, radiation oncology, patient representative, and 2 methodologists. ASCO's Clinical Practice Guideline Oversight Committee, ASTRO's Clinical Practice Guideline Committee, and SSO's Breast Cancer Disease Site Work Group concurrently conducted external review prior to respective Society endorsement determination.
Description of Public Comment Process
ASCO Guidelines are available for open comment for a 2 week period. Guideline recommendations available for open comment are posted on asco.org/open‐comment‐guidelines. Prospective reviewers must contact ASCO to request to review the draft guideline recommendations and are required to sign a non‐disclosure and confidentiality agreement before receiving the draft guideline recommendations. Reviewers must identify themselves by name and affiliation; anonymous comments will not be accepted. Guidelines staff review and summarize comments and bring relevant comments to the Expert Panel Co‐ chairs, and to the entire panel if necessary. Any changes made from the open comment process will be reviewed by the entire panel prior to CPGC approval. Comments are advisory only and ASCO is not bound to make any changes based on feedback from open comment. ASCO does not respond to reviewers or post responses to comments; however, major edits to the draft will be reflected in the open comment discussion.
Public Comment Process Start Date
April 10, 0003
Public Comment Process End Date
April 29, 0005
Specialties Involved
Family Medicine, Internal Medicine General, Medical Genetics And Genomics, Oncology, Medical Oncology, Surgical Oncology, Radiation Oncology, Oncology, Oncology, Oncology
Description of Systematic Review
The Protocol specifies the purpose of the guideline product, target patient population, clinical outcomes of interest, key features of the systematic literature review, and a proposed timeline for completion. ASCO staff, the Expert Panel Co‐Chairs, and possibly other panel members selected by the Co‐Chairs (the Expert Panel Steering Committee), will typically draft the protocol for full panel review. A standard protocol worksheet is used for consistency. Once the Co‐Chairs have approved a first draft of the Protocol, the Protocol will be shared with the full Expert Panel. At the discretion of the Guidelines Director, the CPGC leadership and/or the CPGC Methodology Subcommittee may review the Protocol to make suggestions for revision intended to clarify aspects of the plan for developing the guideline. These suggestions are sent to the Expert Panel Co‐Chairs. Work on the systematic literature review can proceed upon the sign‐off of the Protocol by the Expert Panel.
List of Questions
This clinical practice guideline addresses 10 clinical questions: What is the appropriate surgical management of the index malignancy for women with newly diagnosed nonmetastatic breast cancer who have a BRCA1/2 mutation? What is the appropriate surgical management of the index malignancy for women with newly diagnosed nonmetastatic breast cancer who have a selected moderate-penetrance mutation? Among women with breast cancer who have a BRCA1/2 germline mutation or selected moderate-penetrance non-BRCA1/2 germline mutation who are undergoing therapeutic mastectomy, what is the role of nipple-sparing mastectomy? What is the role of contralateral prophylactic mastectomy for women with breast cancer who have a BRCA1/2 mutation or a selected moderate-penetrance gene mutation? Among women with breast cancer who have a BRCA1/2 germline mutation or selected moderate-penetrance mutation who are undergoing contralateral risk-reducing mastectomy (CRRM), what is the role of nipple-sparing mastectomy? What is the role of RT in women with breast cancer who have a BRCA1/2 germline mutation or selected moderate-penetrance non-BRCA1/2 germline mutation? What is the role of platinum chemotherapy in women who have a BRCA1/2 mutation or selected moderate-penetrance germline mutation and advanced breast cancer? What is the role of (neo)adjuvant platinum chemotherapy in women who have a BRCA1/2 mutation or selected moderate-penetrance germline mutation and breast cancer? What is the role of poly (ADP-ribose) polymerase (PARP) inhibitors in women who have a BRCA1/2 mutation or selected moderate-penetrance germline mutation and advanced breast cancer? What is the role of PARP inhibitors in women who have a BRCA1/2 mutation or selected moderate-penetrance mutation and nonmetastatic breast cancer?
Description of Study Criteria
The recommendations for the local therapy clinical questions were developed by using a systematic review of the literature and clinical experience. The literature review involved searches of PubMed for the period from January 1, 2010, through September 26, 2019 (surgery search), or January 1, 1999, through September 26, 2019 (RT search). The searches were broad and included a combination of treatment, genetic mutation, and breast cancer search terms (see Data Supplement [online only] 1 for more details of the literature search). Articles from the search were included if they reported data on outcomes of local therapy (therapeutic or prophylactic mastectomy, nipple-sparing mastectomy, RT) among women with newly diagnosed nonmetastatic or advanced breast cancer and a high- or moderate-penetrance germline mutation. Disease outcomes considered in the studies included in the literature were ipsilateral events, including true recurrences and new primary tumors, survival, cosmesis, contralateral breast cancer (CBC), and treatment toxicity/complications. An article was excluded from the local therapy literature review if (1) it was a narrative (v systematic) review of the literature, (2) it reported on a single case, (3) it reported on a study with a variant that was not pathogenic or likely pathogenic (eg, single-nucleotide polymorphisms or variant overexpression in the tumor), (4) it was a meeting abstract not subsequently published in peer-reviewed journal, or (5) it reported exclusively on a study of a group of women who received postmastectomy RT versus breast-conserving surgery (BCS) plus RT.
Description of Search Strategy
Upon approval of the Protocol, a systematic review of the medical literature is conducted. ASCO staff use the information entered into the Protocol, including the clinical questions, inclusion/exclusion criteria for qualified studies, search terms/phrases, and range of study dates, to perform the systematic review. Literature searches of selected databases, including The Cochrane Library and Medline (via PubMed) are performed. Working with the Expert Panel, ASCO staff complete screening of the abstracts and full text articles to determine eligibility for inclusion in the systematic review of the evidence. Unpublished data from meeting abstracts are not generally used as part of normal ASCO guideline development (“Meeting Data”). However, abstract data from reputable scientific meetings and congresses may be included on a case‐by‐case basis after review by the CPGC leadership. Expert Panels should present a rationale to support integration of abstract data into a guideline. The CPGC leadership will consider the following inclusion criteria for the unpublished scientific meeting data: 1) whether the data were independently peer reviewed in connection with a reputable scientific meeting or congress; 2) the potential clinical impact of the unpublished data; 3) the methodological quality and validity of the associated study; 3) the potential harms of not including the data; and 4) the availability of other published data to inform the guideline recommendations.
Description of Study Selection
Literature search results were reviewed and deemed appropriate for full text review by two ASCO staff reviewers in consultation with the Expert Panel Co-Chairs. Data were extracted by two staff reviewers and subsequently checked for accuracy through an audit of the data by another ASCO staff member. Disagreements were resolved through discussion and consultation with the Co-Chairs if necessary. Evidence tables are provided in the manuscript and/or in Data Supplement.
Description of Evidence Analysis Methods
ASCO guideline recommendations are crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology. ASCO adopted a five‐step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings. The ASCO approach was primarily adapted from those developed by the AHRQ,, USPSTF, and GRADE, however with the validation of the GRADE methodology, the sole use of GRADE is being evaluated by the Clinical Practice Guidelines Committee.
Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect. Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect. Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect. Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
Description of Recommendation Grading
ASCO uses a formal consensus methodology based on the modified Delphi technique in clinically important areas where there is limited evidence or a lack of high‐quality evidence to inform clinical guidance recommendations. Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice. Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field). Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
Description of Funding Source
ASCO provides funding for Guideline Development.
Company/Author Disclosures
ASCO Conflict of Interest Policy complies with the CMSS Code for Interactions with Companies. ASCO requires disclosure by individuals involved in drafting, reviewing, and approving guideline recommendations.
Percentage of Authors Reporting COI
100