The impact and perception of mandatory tumor biopsies (Bx) for correlative studies in clinical trials of novel anticancer agents.

6006 Background: Trials of molecular targeted agents often require serial tumor bx to acquire tissues for correlative studies.,Three complementary, self-administered questionnaires were circulated to: trial patients (TPs) who had previously undergone serial research-related bx, clinic patients (CPs) who had prior diagnostic but not research-related bx, and academic medical oncologists (MOs) in Canada. Questionnaires focused on 4 domains: demographics, bx-attributed risks, bx-provoked anxiety, and ethics of additional unrelated testing.,10/14 (72%) TPs, 231/325 (71%) CPs and 127/206 (62%) MOs responded. Correlative testing of bx specimens was considered worthwhile by 96% of MOs. Clinical trials with mandatory bx were acceptable to 43% of CPs. Side effects from a previous bx, primarily pain, were reported by 30% of TPs and 35% of CPs. In assessing risks attributed to the bx, all 3 groups agreed that pain was the most acceptable, and bleeding the least. A 5-10% risk of a major bx complication was reported to be acceptable to 1% of MOs and 24% of CPs. Based on the Hospital Anxiety and Depression Scale, 30% of TPs reported anxiety prior to their initial research-related bx, while 56% of CPs reported anxiety prior to their previous diagnostic bx. For all patients, anxiety level decreased in 28%, remained the same in 65%, increased in 9%, after their bx (p<0.001). Over 90% of MOs felt the average patient would have borderline anxiety prior to their bx. Among the patients, 96% would authorize their samples for further unrelated research, 84% would agree to genetic testing and 93% wish to be informed of the results. Among the MOs, all considered it ethical to request for further unrelated research testing on the specimens, 83% would request genetic testing and 63% felt that patients should be informed of the results.,Patients and MOs have different views about mandatory tumor bx. While nearly all MOs see the value in the bx, their threshold for acceptable risk is lower and they anticipate more associated anxiety than patients. Patients tend to tolerate the bx well, have average associated anxiety and readily allow their specimens to be tested for research purposes. No significant financial relationships to disclose.