Title

Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer

Authoring Organization

Publication Month/Year

January 27, 2020

Last Updated Month/Year

April 13, 2023

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Target Patient Population

Women diagnosed with ovarian cancer and their families.

Target Provider Population

Medical, radiation, and surgical oncologists; gynecologic oncologists; gynecologists; geneticists; genetic counsellors

Inclusion Criteria

Female, Adult, Older adult

Health Care Settings

Ambulatory, Outpatient, Radiology services

Intended Users

Radiology technologist, physician assistant, physician, nurse practitioner, nurse, genetics

Scope

Counseling, Assessment and screening

Keywords

BRCA, Germline Testing, Somatic Tumor Testing, Epithelial Ovarian Cancer

Source Citation

DOI: 10.1200/JCO.19.02960 Journal of Clinical Oncology 38, no. 11 (April 10, 2020) 1222-1245.

Supplemental Methodology Resources

Data Supplement

Methodology

Number of Source Documents
19
Literature Search Start Date
January 1, 2007
Literature Search End Date
December 31, 2019
Description of External Review Process
ASCO has a rigorous review process for guidelines. The Expert Panel included representatives from medical oncology, gynecologic oncology, molecular biology, cancer genetics, patient representatives, and a methodologist. After the Expert Panel approves the draft, the guideline is independently reviewed and approved by the Clinical Practice Guideline Oversight Committee (CPGC). Select members of the CPGC are asked to critically review the guideline prior to the next scheduled CPGC meeting. The CPGC members then present the results of their reviews to the full committee, discuss the review with the full committee, and the CPGC votes on whether to approve the guideline (with recusals from members who have relationships with affected companies). Approved ASCO Guidelines are then submitted to the Society’s journal for consideration of publication.
Description of Public Comment Process
ASCO Guidelines are available for open comment for a 2 to 3‐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.
Specialties Involved
Medical Genetics And Genomics, Obstetrics And Gynecology, Oncology, Radiology, Radiation 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
In which individuals with ovarian cancer should genomic testing for germline and somatic alterations be performed? Which genomic alterations have demonstrated clinical utility to direct therapy for women with ovarian cancer? What are the most appropriate sequencing and timing of testing?
Description of Study Criteria
A priori decision rules were established that specified only comprehensive systematic reviews with relevance to at least 1 of the 3 original questions posed would undergo formal quality assessment. Relevant systematic reviews were assessed using the 11-item Assessment of Multiple Systematic Reviews6 tool to determine whether they met a minimum threshold for methodologic quality and could be considered for inclusion in the evidence base.
Description of Search Strategy
The evidence review was conducted in a planned 2-staged approach. The first stage included searching for existing guidelines and/or systematic reviews, and this was then followed by a search for primary studies. An electronic search using PubMed was performed to systematically search for systematic reviews evaluating the clinical utility of germline and somatic tumor testing in ovarian cancer. PubMed was searched from January 1, 2007, to March 23, 2018, and the search was updated on March 7, 2019. Relevant trials released at the European Society for Medical Oncology 2019 annual meeting were also identified.
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 Supplements 1.
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