杨俊兰, 焦顺昌, 戴广海, 李方, 赵宏, 李瑛. 氟特嗪胶囊治疗晚期胃癌的Ⅱ期临床研究[J]. 中国肿瘤临床, 2008, 35(1): 8-11.
引用本文: 杨俊兰, 焦顺昌, 戴广海, 李方, 赵宏, 李瑛. 氟特嗪胶囊治疗晚期胃癌的Ⅱ期临床研究[J]. 中国肿瘤临床, 2008, 35(1): 8-11.
YANG Junlan, JIAO Shunchang, DAI Guanghai, LI Fang, ZHAO Hong, LI Ying. A Phase Ⅱ Multicentric Trial of FTQ Combined with Cisplatin for Treatment of Advanced Gastric Cancer[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2008, 35(1): 8-11.
Citation: YANG Junlan, JIAO Shunchang, DAI Guanghai, LI Fang, ZHAO Hong, LI Ying. A Phase Ⅱ Multicentric Trial of FTQ Combined with Cisplatin for Treatment of Advanced Gastric Cancer[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2008, 35(1): 8-11.

氟特嗪胶囊治疗晚期胃癌的Ⅱ期临床研究

A Phase Ⅱ Multicentric Trial of FTQ Combined with Cisplatin for Treatment of Advanced Gastric Cancer

  • 摘要: 目的: 以替加氟加顺铂为对照组,观察氟特嗪胶囊(FTQ)加顺铂,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,共有226例晚期胃癌患者进入随机临床研究,其中191例患者可评价疗效。 结果: 试验组的有效率(31.31%对6.52%)、临床好转率(53.54%对23.91%)及临床受益率(90.91%对76.09%)均明显高于对照组。氟特嗪胶囊组的血液学毒性与替加氟组基本相同,但其消化道反应明显低于替加氟组。 结论: 氟特嗪胶囊加顺铂的联合方案是治疗晚期胃癌有效且安全的方案。

     

    Abstract: Objective: To explore the clinical toxicities and anti-tumor effects of FTQ combined with cisplatin on patients with advanced gastric cancer. Methods: One hundred and ninety one patients were divided into two groups. In the observation group, FTQ (80 mg/m2) was administered orally twice per day for 14 consecutive days in each cycle and cisplatin (25 mg/m2) was administered on the 1st to the 3rd day of every cycle (21 days for each cycle). Three cycles were performed. The control group also received 3 cycles of treatment. TS-1(80 mg/m2) was administered three times per day for 14 consecutive days in each cycle and cisplatin was administered in the same way as in the observation group. Results: The overall response rate was 31.31% in the observation group and 6.52% in the control group. The rate of improvement was 53.54% in the observation group and 23.91% in the control group. The clinical benefit rate was 90.91% in the observation group and 76.09% in the control group. The two groups presented with similar incidence rate of leucopenia and thrombocytopenia. But the incidence rate of vomiting was higher in the control group than that in the observation group. Conclusion: FTQ combined with cisplatin is well tolerated and can be generally administered to patients with advanced gastric cancer.

     

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