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

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/m(2) (day 1 and 8) and oxaliplatin 100 mg/m(2) (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.

• Authors: Joung-Soon Jang, Ho Yeong Lim, In Gyu Hwang, Hong Suk Song, NaeChoon Yoo, SoYoung Yoon, Yeul Hong Kim, Eunsik Park, Jae Ho Byun, Myung Ah Lee, Suk Joong Oh, Kyung Hee Lee, Bong Seog Kim, Sang Cheul Oh, Sam Yong Kim, Sang Jae Lee
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 65 Issue 4 Pg. 641-7 (Mar 2010) ISSN: 1432-0843 [Electronic] Germany
• PMID: 19652971 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biliary Tract Neoplasms (drug therapy, pathology)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Diarrhea (chemically induced)
• Drug Administration Schedule
• Female
• Gallbladder Neoplasms (drug therapy, pathology)
• Humans
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin
• Survival Analysis
• Thrombocytopenia (chemically induced)
• Treatment Outcome
• Gemcitabine