Patients' Understanding Of A Cyp2d6 Tamoxifen Genotyping Study.

Background: Pharmacogenomics is an emerging area for breast cancer research. Little is known about how well patients understand pharmacogenomics or the rationale for research in this area. The objective of this study was to analyze patient understanding of a clinical trial involving CYP2D6 genotyping to guide tamoxifen (T) therapy for breast cancer.Methods: We conducted a survey of understanding of pharmacogenomics and the purposes of a clinical trial among patients (pts) eligible for LCCC0801, a prospective Phase 2 study of CYP2D6 genotype-guided therapy for pts on tamoxifen for breast cancer. In this trial, we evaluated baseline endoxifen (E) levels and the impact of increased T dose to 40 mg/day among pts with any dysfunctional CYP2D6 alleles. The primary endpoint of change in E levels is not yet reported. All trial participants and those who declined participation were eligible for this survey. The research nurse administered 11 written questions at time of consent related to the purpose of this study and the nature of pharmacogenomic research. Pts had unlimited time to complete the survey written in a 5 point scale (strongly agree, agree, not sure, disagree, strongly disagree). For pts declining to enroll in the parent study, we offered an identical companion survey to which they could separately give consent.Results: Of 118 pts in the parent study, 117 completed the survey. Following informed consent, all respondents expressed confidence that they understood the purpose of the trial, 75% strongly agreed that they understood the purpose of the study. 98% of participants understood that this was a study of how different people respond to T, but 42% also incorrectly felt that this was a study of how different types of breast cancer respond to T, and 30% incorrectly felt that this study evaluated genetic risk for developing breast cancer. Though the consent form clearly stated that there may be no direct benefit to participants and that the purpose of the study was to help future pts, 68% reported that they would benefit directly, and only 22% felt the study was designed only to help future pts. When asked if the study involved genetics, 14% of pts disagreed, or were unsure. 45% of participants were uncomfortable or unsure with “having your doctor determine your T dose from the results of a genetic test.” Among a small sample of pts who declined trial participation but consented to the survey (13/30 decliners, 43%), compared to trial participants, fewer reported strong confidence in understanding the purpose of the trial (38% vs. 75%, p=0.0034), and a greater percentage identified an inaccurate purpose of the trial (69% vs. 42%, p = 0.043).Conclusions: After informed consent, a high percentage of participants in a pharmacogenomic clinical trial are able to correctly identify the primary purpose of the research, but a substantial minority hold false views about what the trial is designed to investigate. The majority of participants believe that they will directly benefit from trial participation, and few may understand that the primary purpose of the study is to improve care for future patients. Opportunities exist for improved understanding and communication of pharmacogenomic research and further evaluation of this area is needed. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6082.