Edeline J, et al. - In this multicenter, open-label, randomized phase III trial, researchers investigated if gemcitabine and oxaliplatin chemotherapy (GEMOX) increased relapse-free survival (RFS) while maintaining health-related quality of life (HRQOL) in patients who had surgical resection for localized biliary tract cancer (BTC). Within 3 months after R0 or R1 resection of a localized BTC, either GEMOX (gemcitabine 1,000 mg/m² on day 1 and oxaliplatin 85 mg/m² infused on day 2 of a 2-week cycle) for 12 cycles (experimental arm A) or surveillance (standard arm B) was administered randomly (1:1) to 196 patients. A total of 126 RFS events and 82 deaths were documented at the end of a median follow-up of 46.5 months. The two arms did not differ significantly in terms of RFS (median, 30.4 months in arm A v 18.5 months in arm B). No difference was observed in time to definitive deterioration of global HRQOL (median, 31.8 months in arm A v 32.1 months in arm B) as well as in overall survival. Maximal adverse events were grade 3 in 62% (arm A) vs 18% (arm B) and grade 4 in 11% vs 3%. Overall, adjuvant GEMOX was adequately tolerated and delivered but offered no benefit in patients with resected BTC.