Gemcitabine-oxaliplatin first-line chemotherapy in locally advanced and metastatic gallbladder cancer - results from a tertiary centre in North India

Abstract

Introduction: In view of encouraging results of ABC-02 trial in advanced biliary tract cancer, we aimed to evaluate efficacy of gemcitabine-oxaliplatin chemotherapy in our patients with locally advanced/ metastatic gallbladder cancer (GBC). Methods: Retrospective analysis of prospectively maintained database of patients with locally advanced and metastatic GBC(July 2015- December 2017) was performed. Inclusion criteria - histologically proven locally advanced GBC(≥T3 or N2 disease) or metastatic GBC, no prior chemotherapy, ECOG status≤2, normal hematologic, renal and hepatic functions. Chemotherapy regimen included injection Gemcitabine 1250mg/m2 infusion on days 1 and 8 and oxaliplatin 100mg/m2 on day 1 every 3 weeks. Primary endpoints were overall survival(OS), progression-free survival(PFS) and R0 resection rate in those given preoperative chemotherapy. Secondary endpoints were response rate and toxicity of chemotherapy regimen. Results: Total of 52 patients received chemotherapy(mean age: 52 years, 73% females) of which preoperative chemotherapy was given in 38.5 %(n=20) and palliative chemotherapy in 61.5%(n=32). Median OS was 8.3 months and median PFS was 4.7 months. Complete response was seen in 1.9%, partial response in 11.5%, stable disease in 21.2% and progression in 65.4%.In locally advanced group, 30%(n= 6/20) underwent R0 resection. R0 resection was possible in 85.7% (6/7) patients who showed response to chemotherapy. Patients who underwent surgery had significantly better OS(p< 0.01) and PFS(p=0.01). Conclusion: Combination chemotherapy with gemcitabine-oxaliplatin showed good response rate in a select subgroup of patients. Curative surgery was feasible in majority of those who had good response. Patients who underwent curative resection had significant improvement in survival.