复治的晚期胃癌患者应用氟特嗪胶囊的临床观察

Curative effects of FTQ combined with cisplatin in treatment of advanced gastric cancer： a multicenter study

目的以替加氟＋顺铂为对照组，观察氟特嗪胶囊（FFQ）＋顺铂治疗晚期胃癌的安全性和有效性。方法采用多中心、随机、单盲对照方法，试验组为氟特嗪联合顺铂治疗组，对照组为替加氟联合顺铂，共有111例既往曾化疗过的晚期胃癌患者进入随机临床研究，其中102例患者可评价疗效。结果氟特嗪胶囊组和替加氟组的客观有效率分别为：28．3％（15／53）、4．1％（2／49）、临床好转率分别为50．9％（27／53）、24．5％（12／49），氟特嗪胶囊组均明显高于替加氟组。氟特嗪胶囊组的血液学毒性、消化道反应与替加氟组基本相同。结论“氟特嗪胶囊＋顺铂”的联合方案是治疗晚期胃癌有效且安全的方案。

Objective To determine the clinical toxicities and antitumor effects of a chemotherapy regimen of FTQ, a compound preparation of tegafur, the drug prototype of 5-furacil （5-FU）, gimeracil （ CDHP）, a decomposition inhibitor of 5-FU, oteracil potassium, phesphorylation inhibitor of 5-FU, and combined with cisplatin in patients with inoperable locally or metastatic advanced gastric cancer. Methods 119 patients with inoperable locally or metastatic advanced gastric cancer admitted in 10 hospitals in China were divided into 2 groups ： FTQ group （ n = 59 ）, undergoing a 3-week regime, i. e. oral use of FTQ 80 mg·m^-2·d^-1 for 14 d and then discontinuance for 1 week and intravenous drip cisplatin 75 mg/m^2 on days 1 - 3 ; and control group （ n = 60 ） undergoing a 3-week regimen including oral use of tegafur 800 mg·m^-2·d^-1 tid for 14 d and then discontinuance for 1 week and intravenous drip of cisplatin 75 mg/m^2 on days 1 - 3. The curative was evaluated after at least after 2 regimens. Results There were 102 patients in the per-protocol population. The overall response rate of the FTQ group was 28.3% （ 15/53 ）, significantly higher than that of the control group （4.1%, 2/49,P =0.004）. The clinical improvement of the FTQ group was 50.9%, significantly higher than that of the control group （24.5%, P =0. 006）. The main toxicities occurred in bone marrow and the digestive tract. The leucopenia and thrombocytopenia rates of the FTQ group were 47.45% and 32.22% respectively, both similar to those of the control group. There were no differences in the incidence rate of digestive canal side reaction between these 2 groups . Conclusion The regimen of FTQ combined with cisplatin is generally well-tolerated and has substantial antitumor activity.