Role of Combination Chemotherapy with 5-Fluorouracil, Cisplatin and Paclitaxel for Advanced Gall Bladder Cancer

Abstract

Aim: The prognosis for patients with advanced Gallbladder carcinoma is poor. Due to unresectability and relatively ineffective chemotherapy available, a need exists for effective chemotherapeutic regimen. The aim of this study was to determine the efficacy and safety profile of 5-fluorouracil, cisplatin and paclitaxel in patients with advanced Gallbladder cancer. Material and Methods: From January 2002 to July 2004, 40 patients of advanced carcinoma Gallbladder received 5-fluorouracil, cisplatin and paclitaxel. On day 1, paclitaxel was given (150 mg/m 2 ), cisplatin was given on day 2 (50 mg/m 2 ) and 5-fluorouracil was given from day 1 to day 3 (500 mg/m 2 ). This cycle was repeated every three weeks and patient assessment was done. Results: Forty patients were enrolled in this study. Thirty-five were assessed for response. Five patients were lost in follow up. There were thirty females and ten males. A median of three cycles of treatment (range one to seven) was administered. Two patients achieved complete response and eleven had partial responses giving an overall response rate of 32.5% in the intention-to-treat population (95% confidence interval 11.1% to 46.5%). The median response duration was 5.3 months. The median time to progression and overall survival was 4.1 months and 11.2 months, respectively. The most common grade 3 adverse effects were neutropenia (30%), nausea (20%), vomiting (15%), diarrhea (10%), stomatitis (5%), and peripheral neuropathy (5%). Only one case had febrile neutropenia. There was no treatment related death. Conclusions: The combination of 5-fluorouracil, cisplatin and paclitaxel has promising anti-tumor activity and is well tolerated in patients with advanced and metastatic Gallbladder cancer.