Participant Attitudes Toward an Intensive Trial of Multiple Biopsies, Multidimensional Molecular Analysis, and Reporting of Results in Metastatic Triple-Negative Breast Cancer

Author:

Kuderer Nicole M.1,Burton Kimberly A.1,Blau Sibel1,Senecal Francis1,Gadi Vijayakrishna K.1,Parker Stephanie1,Mahen Elisabeth1,Veenstra David1,Carlson Josh J.1,Lyman Gary H.1,Blau C. Anthony1

Affiliation:

1. All authors: University of Washington; Vijayakrishna K. Gadi and Gary H. Lyman, Fred Hutchinson Cancer Research Center, Seattle; and Sibel Blau, Francis Senecal, and Stephanie Parker, Northwest Medical Specialties, Puyallup and Tacoma, WA.

Abstract

Purpose Multidimensional molecular analysis of tumor tissue intensively over space and time can provide insight into how cancers evolve and escape treatment. Attitudes of participants in such trials have not been assessed. We explored patient views regarding an intensive study incorporating multiple biopsies, multidimensional molecular testing, and drug response predictions that are reported to the oncologist and patient. Patients and Methods A structured, self-administered survey was conducted among the first 15 patients enrolled in ITOMIC-001 (Intensive Trial of Omics in Cancer). Patients with metastatic triple-negative breast cancer were accrued at two sites in Washington state. Surveys containing 17 items were administered at enrollment and after the return of results. Surveys explored perceptions regarding risks, personal benefits, benefits to others, uncertainties associated with interpreting complex molecular results, concerns regarding multiple biopsies, and potential loss of confidentiality. At follow-up, three additional unique items explored patient coping. Results All participants expressed a strong desire for their experiences to benefit others, and all perceived a higher likelihood of deriving benefit than described during detailed consent discussions. Loss of confidentiality ranked lowest among patient concerns. Despite acknowledging uncertainties and risks inherent in complex molecular testing for clinical reporting, participants wanted access to findings in evaluating treatment choices, even if the best available evidence was weak. Follow-up surveys demonstrated relatively little change in attitudes, although concern about study biopsies generally declined. Study participation helped several patients cope better with their disease. Conclusion In advanced breast cancer, these findings demonstrate the feasibility of engaging motivated patients in trials that navigate the uncertainties associated with intensive spatial and longitudinal multidimensional molecular testing for the purpose of advancing precision medicine.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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