Bevacizumab plus gemcitabine/oxaliplatin showed antitumor activity in advanced biliary-tract cancers

Treatment with gemcitabine and oxaliplatin plus bevacizumab in patients with advanced biliary-tract cancers demonstrated antitumor activity and had a tolerable safety profile.

In this phase-2 trial, researchers randomly assigned 35 patients to bevacizumab (Avastin, Genentech) 10 mg/kg, followed by gemcitabine 1,000 mg/m² and oxaliplatin 85 mg/m² on days one and 15 every 28 days. They also analyzed changes in whole-body PET scans as an early predictive marker of clinical outcome. Median follow-up was 12.7 months.

Median PFS was seven months (95% CI, 5.3-10.3); six-month PFS was 63% (95% CI, 47-79). Median OS was 12.7 months (95% CI, 7.3-18.1). The objective response rate was 40% (95% CI, 24-58); 29% of patients had stable disease (95% CI, 21-55).

Treatment was well tolerated, and the most common adverse events included fatigue, peripheral sensory neuropathy, a transient rise in aminotransferases, myelosuppression and gastrointestinal adverse events.

For [¹⁸F]FDG-PET analyses, the mean maximum standard uptake value (SUV_max) was 5.72 at baseline and 3.73 posttreatment (P<.0001). The median decrease in SUV_max was 36.4%. Change from baseline was more pronounced among patients with partial response or stable disease than among those with progressive disease.

SUV_max change from baseline was found to be a predictor for PFS with an HR of 1.35 (95% CI, 1.14-1.60), and a 20% increase in SUV_max predicted PFS (HR=9.71; 95% CI, 2.63-35.76) as well. OS was predicted by change in SUV_max (HR=1.25; 95% CI, 1.05-1.50), and a 20% increase predicted OS (HR=10.12; 95% CI, 2.41-42.53) also.

Zhu AX. Lancet Oncol. 2009;doi:10.1016/S1470-2045(09)70333-X.