Abstract
PURPOSE: Tumor biopsies are critical for delineating pharmacodynamic effects of drugs and for optimal patient selection during oncology clinical trials of molecular targeted therapies. The purpose of this study was to identify factors related to patients' willingness to provide study-related tumor biopsies in phase 1 clinical trials of molecularly targeted therapy. METHODS: An investigator-designed survey, that assessed biopsy willingness, demographic and clinical factors, was completed anonymously by patients with advanced cancer in a phase 1 clinic for targeted therapy. Data were analyzed using multivariate logistic regression models with odds ratios (OR) and 95 % confidence intervals (CI). RESULTS: Three hundred and sixty-two patients with advanced cancer (50 % male, 56 % aged ≤ 60 years) participated. In univariate analyses, willingness to provide study-related biopsy was associated with male gender, white race, higher income, using the Internet for cancer-related information, and having had a biopsy previously (p < 0.05). In multivariate analyses, male gender (OR 2.41, 95 % CI 1.54, 3.78) and having had a biopsy (OR 3.71, 95 % CI 1.68, 8.15) were associated with willingness to have one biopsy; male gender (OR 1.97, 95 % CI 1.30, 3.00) and relying on the Internet as a source of information (OR 1.87, 95 % CI 1.21, 2.89) were associated with willingness to have more than one biopsy. CONCLUSIONS: The results suggest that male gender is associated with greater stated willingness to undergo biopsy. Also, the Internet is an important source of information for patients with cancer and may strongly influence their decisions about whether to consent to biopsies in early clinical trials.