Accrual Delayed in Adjuvant Bevacizumab Trial

Extract

Researchers have temporarily halted accrual to a trial of bevacizumab (Avastin) and two chemotherapy regimens for early-stage colon cancer after they found an unexpected number of non-cancer-related deaths in one of the study arms. The data safety monitoring board (DSMB) recommended that enrollment be delayed until 60-day mortality data could be collected and reviewed for all patients currently in the study. Experts say that the imbalance in deaths is likely to be a statistical anomaly, but they agree that the safety committee acted appropriately.

Thus far, about 2,100 patients with stage II and III colon cancer have enrolled in the international phase III trial, which is run by Genentech, of South San Francisco, Calif., and Roche, in Basel, Switzerland. Called AVANT, the trial is designed to compare disease recurrence rates in patients treated after surgery with one of three regimens: FOLFOX (oxaliplatin, leucovorin, and 5-fluorouracil), FOLFOX plus bevacizumab, or XELOX (capecitabine and oxaliplatin) plus bevacizumab.