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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

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Abstract

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.

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Acknowledgments

This work was fully supported by Yuhan pharmaceutical Co., Seoul, Korea. The outstanding support and assistance of Jiyon Lee R.N. on data management are gratefully acknowledged.

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Correspondence to Joung-Soon Jang.

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Jang, JS., Lim, H.Y., Hwang, I.G. et al. Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial. Cancer Chemother Pharmacol 65, 641–647 (2010). https://doi.org/10.1007/s00280-009-1069-7

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