Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in KRAS wild-type Advanced Biliary Tract Cancer : a randomized , Phase II trial ( Vecti-BIL Study ) Running title GEMOX and Panitumumab in wt KRAS BTC

Background: Biliary tract cancer (BTC) is a rare and lethal disease with few therapeutic options. Preclinical data suggest that the EGFR pathway could be involved in its progression. Methods: In this open-label, randomized Phase II trial we recruited chemotherapynaïve patients with advanced BTC displaying a wild-type KRAS status. Patients were randomized to gemcitabine (1000 mg/m) and oxaliplatin (100 mg/m) with (Arm A) or without (Arm B) panitumumab (6mg/kg), for up to 12 cycles. The primary endpoint was progression free survival (PFS) analyzed by intention-to-treat. This study is registered with ClinicalTrials.gov (NCT01389414). Results: We enrolled 89 patients (45 in Arm A and 44 in Arm B) between 06/2010 and 09/2013. After a median follow-up of 10.1 months, median PFS was 5.3 months in Arm A (95%CI 3.3–7.2) and 4.4 months (95%CI 2.6–6.2) in Arm B (p=0.27). No survival differences were observed, being median OS 9.9 months in Arm A and 10.2 months in Arm B (p=0.42). In subgroup analysis, no differences in PFS according to