Attenuated dose of gemcitabine with cisplatin in patients (pts) with unresectable or metastatic biliary tract cancer (ABC): Results of single Thai institution.

Abstract

265 Background: Combination of gemcitabine/cisplatin becomes a recent standard regimen for pts with advanced (ABC). We previously reported the encouraging activity of gemcitabine (1250 mg/m2) with cisplatin and reported grade 3/4 toxicities of anemia and neutropenia in 33% and 22% respectively. (Charoentum et al. World J Gastroenterol 2007.). This study examines the toxicity and activity of attenuated dose gemcitabine (1000 mg/m2) with cisplatin in Thai pts with ABC. Methods: Chemotherapy-naive patients with histological/cytological proven ABC, aged > 18 years, ECOG 0-2 and adequate organs function were treated with gemcitabine (1000 mg/m2 in a 30-min infusion D1, 8 q 21 d) followed by cisplatin (75 mg/m2D1) for maximum 6 cycles. Results: From November 2007 to June 2012, 37 patients were evaluated. Median age was 56 yrs (range 34 - 66), 54% were male, 76% were metastatic disease and 97% were ECOG PS 0/1. The median number of cycle was 4 (range 3-6). Among the 34 pts with measurable disease, there were 11 PR, 15 SD and 8 PD (response rate 32%). The most common hematologic toxicity of interests was gr 3 anemia in 11% and gr 4 neutropenia in 6%. Non-hematologic toxicity was generally mild. No cases of febrile neutropenia or treatment-related death were observed. The median progression free survival was 6 months (range 3-13). Conclusions: Treatment with attenuated dose of gemcitabine in combination with cisplatin in this study appears more tolerable than our previous reports in Thai pts with advanced ABC. The efficacy of both regimen appears similar.