Accrual delayed in adjuvant bevacizumab trial.

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 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-fl uorouracil), FOLFOX plus bevacizumab, or XELOX (capecitabine and oxalipla-tin) plus bevacizumab. Since the trial opened in December 2004, four (0.6%) patients have died of noncancer – related causes in the FOLFOX arm, three (0.4%) have died in the FOLFOX/ bevacizumab arm, and seven (1.0%) in the XELOX/bevacizumab arm. Although the absolute number of deaths is small in all three arms, a substantial number of these patients may have already been cured of their disease by surgery and thus incurring unnecessary risk. Also, several of the deaths occurred in younger patients and some were due to cardiac problems, though further details have not been released. The AVANT DSMB recommended that accrual be suspended, " but the evidence is very weak that there is anything going on, " said who is not affi liated with the trial. " I think their main concern is that there might be something , but that they don't have the information yet. " In addition to the twice-yearly meetings, which are typical for DSMBs, the AVANT trial DSMB was scheduled to assess real-time safety data every 4 weeks until the fi rst 300 patients had completed 6 weeks in the study. During the fi rst face-to-face meeting of the