Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial

Kyung Hee LeeBong Seog KimSang Cheul OhSam Yong KimSang Jae LeeJoung-Soon JangHo Yeong LimIn Gyu HwangHong Suk SongNaeChoon YooSoYoung YoonYeul Hong KimEunsik ParkJae Ho ByunMyung Ah LeeSuk Joong Oh
Dept. of Internal Medicine (내과학)
Issue Date
Cancer Chemotherapy and Pharmacology, Vol.65(4) : 641-647, 2010
Purpose : Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer. Methods : We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m2 (day 1 and 8) and oxaliplatin 100 mg/m2 (day 1), every 3 weeks. Results : Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1–6.5, 95% CI) and median overall survival was 8.3 months (5.8–10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%). Conclusions : The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs. Keywords : Biliary tract cancers – Chemotherapy – Gemcitabine – Oxaliplatin
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