Prospective Decision Analysis Study of Clinical Genomic Testing in Metastatic Breast Cancer: Impact on Outcomes and Patient Perceptions

Affiliations

PMID: 32923860
PMCID: PMC7446448 (available on 2020-11-18)
DOI: 10.1200/PO.19.00090

Abstract

Purpose: To evaluate the impact of targeted DNA sequencing on selection of cancer therapy for patients with metastatic breast cancer (MBC).

Patients and methods: In this prospective, single-center, single-arm trial, patients with MBC were enrolled within 10 weeks of starting a new therapy. At enrollment, tumor samples underwent next-generation sequencing for any of 315 cancer-related genes to high depth (> 500×) using FoundationOne CDx. Sequencing results were released to providers at the time of disease progression, and physician treatment recommendations were assessed via questionnaire. We evaluated three prespecified questions to assess patients' perceptions of genomic testing.

Results: In all, 100 patients underwent genomic testing, with a median of five mutations (range, 0 to 13 mutations) detected per patient. Genomic testing revealed one or more potential therapies in 98% of patients (98 of 100), and 60% of patients (60 of 100) had one or more recommended treatments with level I/II evidence for actionability. Among the 94 genomic text reports that were released, there was physician questionnaire data for 87 patients (response rate, 92.6%) and 31.0% of patients (27 of 87) had treatment change recommended by their physician. Of these, 37.0% (10 of 27) received the treatment supported by genomic testing. We did not detect a statistically significant difference in time-to-treatment failure (log-rank P = .87) or overall survival (P = .71) among patients who had treatment change supported by genomic testing versus those who had no treatment change. For patients who completed surveys before and after genomic testing, there was a significant decrease in confidence of treatment success, specifically among patients who did not have treatment change supported by genomic testing (McNemar's test of agreement P = .001).

Conclusion: In this prospective study, genomic profiling of tumors in patients with MBC frequently identified potential treatments and resulted in treatment change in a minority of patients. Patients whose therapy was not changed on the basis of genomic testing seemed to have a decrease in confidence of treatment success.

Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center. Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments). Cynthia D. TimmersStock and Other Ownership Interests: Array BioPharma, Seattle GeneticsJames L. ChenConsulting or Advisory Role: Novartis, Immune Design, Syapse Speakers' Bureau: Novartis, Foundation Medicine Research Funding: Eisai Patents, Royalties, Other Intellectual Property: MatchTX, a genomics software package that helps researchers, oncologists, and clinical trial managers identify the full set of biomarkers that collectively predict the outcome of patients with cancer to treatmentSiraj Mahamed AliEmployment: Foundation Medicine Leadership: Incysus Stock and Other Ownership Interests: Exelixis, Blueprint Medicines, Agios, Genocea Biosciences Consulting or Advisory Role: Revolution Medicines, Azitra (I), Princeps Tx (I) Patents, Royalties, Other Intellectual Property: Patents via Foundation Medicine and via Seres Health on microbiome in non-neoplastic disease (I)Anne M. NoonanConsulting or Advisory Role: Helsinn Healthcare, QED TherapeuticsSagar SardesaiConsulting or Advisory Role: Novartis Speakers' Bureau: Immunomedics Travel, Accommodations, Expenses: NovartisJeffrey VanDeusenStock and Other Ownership Interests: ImmunomedicsRobert WesolowskiConsulting or Advisory Role: Pfizer (Inst), Puma Biotechnology Research Funding: Acerta Pharma, AstraZenecaTravel, Accommodations, Expenses: Pfizer, Puma BiotechnologyBhuvaneswari RamaswamyConsulting or Advisory Role: PfizerMaryam B. LustbergConsulting or Advisory Role: Tempus, PledPharma Other Relationship: Hologic/Cynosure No other potential conflicts of interest were reported.