Phase II clinical study on the modified DCF regimen for treatment of advanced gastric carcinoma  

作　　者：Yihebali Chi REN Jian-hong YANG Lin CUI Cheng-xu LI Jun-ling WANG Jin-wan 

机构地区：[1]Department of Medical Oncology, Cancer Hospital ＆ Institute,Chinese Academy of Medical Sciences, Beijing 100021, China

出　　处：《Chinese Medical Journal》2011年第19期2997-3002,共6页中华医学杂志（英文版）

摘　　要：Background A phase Ⅲ trial involving docetaxel, cisplatin, and fluorouracil （DCF） in the treatment of advanced gastric cancer was shown to have superior efficacy compared to cisplatin and fluorouracil alone, but with a high rate of hematologic toxicity. To reduce toxicity while maintaining the efficacy of DCF, we reduced the doses of docetaxel （D） and cis-platinum （CDDP）, and administered 5-fluorouracil （5-FU） via a continuous intravenous （CIV） infusion.Methods Chemotherapy-naive patients with gastric adenocarcinomas received D （60 mg/m2 1 hour on day 1）, CDDP （30 mg/m2on days 1 and 2）, and 5-FU （1500 mg·m-2·24 h-1 CIV on days 1 and 8 every 3 weeks）. The primary endpoint was the response rate.Results Fourteen patients were enrolled. Based on the efficacy evaluation following at least 2 cycles of treatment, there was 7.1% complete remission （CR）, 71% partial remission （PR）, 14% stable disease （NC/SD）, and 7.1% progressive disease （PD）. The median survival time was 13 months. Nine patients （64%） had grade Ⅲ-Ⅳ neutropenia, and 4 patients （29%） had grade Ⅳ neutropenia, among whom 1 had grade Ⅳ neutropenia with grade Ⅲ nausea and vomiting.Conclusion The modified DCF regimen is highly active and has a favorable toxicity profile in Chinese patients with gastric cancer.Background A phase Ⅲ trial involving docetaxel, cisplatin, and fluorouracil （DCF） in the treatment of advanced gastric cancer was shown to have superior efficacy compared to cisplatin and fluorouracil alone, but with a high rate of hematologic toxicity. To reduce toxicity while maintaining the efficacy of DCF, we reduced the doses of docetaxel （D） and cis-platinum （CDDP）, and administered 5-fluorouracil （5-FU） via a continuous intravenous （CIV） infusion.Methods Chemotherapy-naive patients with gastric adenocarcinomas received D （60 mg/m2 1 hour on day 1）, CDDP （30 mg/m2on days 1 and 2）, and 5-FU （1500 mg·m-2·24 h-1 CIV on days 1 and 8 every 3 weeks）. The primary endpoint was the response rate.Results Fourteen patients were enrolled. Based on the efficacy evaluation following at least 2 cycles of treatment, there was 7.1% complete remission （CR）, 71% partial remission （PR）, 14% stable disease （NC/SD）, and 7.1% progressive disease （PD）. The median survival time was 13 months. Nine patients （64%） had grade Ⅲ-Ⅳ neutropenia, and 4 patients （29%） had grade Ⅳ neutropenia, among whom 1 had grade Ⅳ neutropenia with grade Ⅲ nausea and vomiting.Conclusion The modified DCF regimen is highly active and has a favorable toxicity profile in Chinese patients with gastric cancer.

关 键 词：gastric cancer modified DCF regimen DOCETAXEL CIS-PLATINUM 5-FLUOROURACIL 

分 类 号：TQ463.5[化学工程—制药化工] TN925.93[电子电信—通信与信息系统]