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Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial
Cancer Chemotherapy and Pharmacology, 08/12/09
Jang JS et al. - In a study to evaluate the efficacy and safety of combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in pts with biliary tract cancers (BTCs) including gall bladder cancer, it was revealed that the GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in pts with advanced BTCs.
Methods- A multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in pts with advanced BTCs.
- Eligible pts with previously untreated locally advanced or metastatic BTCs received gemcitabine 1000 mg/m2 (day 1 and 8) and oxaliplatin 100 mg/m2 (day 1), every 3 wks.
- 53 pts were evaluated, 60% had cholangiocarcinoma and 40% gall bladder cancer; the objective response rate was 18.9% (10/53 pts including 1 Complete response) (14.9%) in the treated population.
- Stable disease was observed in 27/53 (50.9%) pts, disease control rate was achieved in 69.8% of pts.
- Median progression-free survival was 4.8 mos and median overall survival was 8.3 mos.
- Grade 3/4 toxicities included neutropenia (33.9% of pts) and thrombocytopenia (7.6%).
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