卡培他滨联合顺铂一线治疗晚期胃癌的Ⅱ期临床研究

Capecitabine combined with cisplatin as first-line therapy in Chinese patients with advanced gastric carcinoma--a phase Ⅱ clinical study

目的评价卡培他滨联合顺铂一线治疗晚期胃癌的有效性和安全性。方法对符合入组标准的141例晚期胃癌患者进行卡培他滨联合顺铂方案化疗，卡培他滨1000mg／m^2，2次／d，早、晚饭后30min内口服，够1～14d；顺铂20mg／m^2静脉滴注，第1—5天。21d为1个疗程，共完成了705个周期的化疗。根据实体瘤反应评估标准（RECIST）评价疗效，根据美国国立癌症研究所抗癌药物常见不良反应评价标准（3．0版）评估不良反应。化疗结束后第1年每3个月随访1次，以后每6个月随访1次。结果完全缓解13例，部分缓解38例，稳定54例，进展36例，总有效率为36．2％。患者中位疾病进展时间为9．0个月，中位生存时间为12．0个月。最常见的血液学毒副反应是中性粒细胞减少，有24例患者（17．0％）出现3～4级中性粒细胞减少。最常见的非血液学毒性反应是手足综合征，有35例（24．8％）出现手足综合征。本组患者无治疗相关性死亡发生。结论卡培他滨联合顺铂一线治疗晚期胃癌具有较好的疗效，患者对此方案具有较好的耐受性，并且比5-Fu联合顺铂方案更方便，适合患者门诊应用。

Objective To evaluate the effectiveness and safety of the combination chemotherapy of capecitabine （X） with fractionated administration of cisplatin （C） in Chinese patients with advanced gastric cancer （AGC）. Methods 141 patients with AGC were enrolled between July 2002 and August 2004. All patients had measurable tumor according to the criteria of RECIST, Karnofsky performance status ≥ 60, adequate bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant ehemotherapy was not permitted. Patients received oral administration of capecitabine at a dose of 1000 mg/m^2 twice a day on D1- D14, and intravenous infusion of fractionated eisplatin at a dose of 20 mg/m^2/day on D1-D5. The regimen was repeated every 3 weeks, totally for 6 cycles. Results Of the 141 evaluable patients, there were 104 men and 37 women, with a median age of 54 years （range, 23-80 years）. Metastases before chemotherapy were detected in lymph nodes （46.8%）, liver （40.4%）, lung（5.7% ） and other area （ 10.6% ）. The median treatment duration was 6 cycles （range, 3-6 cycles）. The objective response rate （RR） was 36.2% （51/141）. The median follow-up period was 17.5 months. The median time to progress （TIP） was 9.0 months, and the median overall survival （OS） was 12. 0 months. The most common treatment-related adverse events （grade 3/4） were： hand-foot syndrome （HFS） （2. 1%）, leucopenia （0.7%）, abnormal alanine transaminase elevation （2. 8% ）. There was no treatment-related death. Conclusion Capecitabine combined with fractionated cisplatin is highly effective and well tolerated as a first-line treatment for advanced gastric cancer, with comparable results to 5-Fu plus cisplatin combination therapy.