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Efficacy and safety evaluation of docetaxel plus oxaliplatin and capecitabine in the treatment of advanced gastric adenocarcinoma: a single center non-controlled phase Ⅱ clinical trial

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Author:
No author available
Journal Title:
CHINESE JOURNAL OF GASTROINTESTINAL SURGERY
Issue:
3
DOI:
10.3760/cma.j.issn.1671-0274.2010.03.005
Key Word:
胃肿瘤;化学疗法;多西他赛;奥沙利铂;卡培他滨;治疗效果;安全性;Stomach neoplasms;Chemotherapy;Docetaxel;Oxaliplatin;Capecitabine;Treatment outcome;Safety

Abstract: Objective To assess the efficacy and safety of docetaxel plus oxaliplatin and capecitabine (DOX) in the treatment of advanced gastric adenocarcinoma. Methods A total of 30 patients were recruited to receive DOX regimen (docetaxel 75 mg/m~2 day 1, oxaliplatin 130 mg/m~2 day 1, and capecitabine 1000 mg/m~2 bid d1-14, repeated every 3 weeks). Only those who completed at least 2 cycles were assessed. Results The number of patients with complete response, partial response, stable disease and progressive disease were 1, 2, 25 and 2, respectively. The objective response rate was 10.0%(3/30) and the disease control rate was 93.3%(28/30). After a median follow-up of 261 days, the median progression free survival and overall survival time were 197 days and 466 days, respectively. The most common grade Ⅲ to Ⅵ toxicity was hematologic toxicity. The percentage of patients with grade Ⅲ to Ⅵ leucopenia, neutropenia and febrile neutropenia were 60.0%, 43.3% and 30.0%, respectively. The most common grade Ⅲ to Ⅵ non-hematologic toxicitywas fatigue, nausea, vomiting, anorexia, diarrhea, and hand-foot syndrome. Conclusions DOX regimen demonstrates promising efficacy in the treatment of advanced gastric adenocarcinoma. The associated toxicity can be well tolerated and controlled. Large scale clinical trial is necessary to obtain further evidence.

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