FOLFOX-4 as second-line therapy after failure of gemcitabine and platinum combination in advanced gall bladder cancer patients

Objective: There is no standard second-line chemotherapy after progression on first-line therapy including gemcitabine and platinum combination in advanced gall bladder cancer patients. So this study was undertaken to assess the efficacy and safety of FOLFOX-4 regimen in this setting. Methods: In this observational study, patients with performance status ≤2, who progressed on firstline therapy, were enrolled from May 2010 to June 2014. FOLFOX-4 based treatment was administered until progression, unacceptable toxicity or up to 12 cycles. Results: A total of 66 patients were enrolled in this study. The median age of patients was 52.5 years (32–66 years),of which 24 (36.36%) were males and 42 (63.63%) were females. The median numberof cycles could be given were 9.5 (2–12). Only 43.93% patients in this study completed full 12 cycles of chemotherapy. Sixteen patients (24.24%) in this study required the dose reduction at least in one cycle of chemotherapy due to toxicities. Disease control rate was seen in 39 (59.09%) patients, with complete response in none, partial response in 16 (24.24%), stable disease in 23 (34.84%) and progressive disease in 27 (40.90%) patients. The median progression free survival was 3.9 months; median overall survival was 7.6 months. The main Grade 3/4 side effects seen were hematological in 31.81% (n= 21) and gastrointestinal in 25.75% (n= 17) patients. Majority of patients (46%) had Grade 1/2 peripheral neuropathy. Conclusions: FOLFOX-4 is an effective and well-tolerated regimen as a second-line treatment in advancedgallbladdercancerpatients.Further studies are required,especiallyinthe Indiansubcontinent.