希罗达联合奥沙利铂治疗晚期胃癌的临床研究

Clinical research of Xeloda combined Oxaliplatin for advanced gastric cancer

目的评价希罗达联合奥沙利铂治疗晚期胃癌的临床疗效。方法将入选胃癌病例按计算机生成随机数字分为试验组和对照组,每组各30例。试验组采用希罗达联合奥沙利铂治疗,对照组采用5-氟尿嘧啶联合奥沙利铂及亚叶酸钙治疗,完成2周期化疗,采用实体瘤的疗效评价标准(RECIST)评价近期疗效,且通过评价肿瘤疼痛等情况对比两组患者的临床受益情况。结果 60例病例均完成2周化疗。(1)近期疗效:试验组30例,2例完全缓解,11例部分缓解,15例稳定,2例进展,客观有效率为43.3%;对照组30例,1例完全缓解,11例部分缓解,14例稳定,4例进展,客观有效率为40.0%。两组近期有效率比较无统计学差异(P>0.05)。(2)临床受益率:试验组与对照组均为2周期化疗后评价临床受益,试验组30例,21例受益,9例未受益,临床受益率为70.0%;对照组30例,12例受益,18例未受益,临床受益率为40.0%,试验组临床受益率显著高于对照组,差异有统计学意义(P<0.05)。结论两种方案治疗晚期胃癌,近期疗效相当,但试验组临床受益率优于对照组。

Objective This study was designed to investigate the efficacy and clinical benefit ofxeloda combined oxaliplatin for advanced gastric cancer. Methods 60 cases of advanced gastric cancer patients were randomly assigned to the experimental group and the control group. The patients in experimental group were treated using xeloda combined oxaliplatin, those in the control group were treated by 5-Fu combined oxaliplatin, leucovorin for 2 weeks. The outcome assessments were RECIST standard and clinical benefit considering cancer pain, etc. Results All the patients completed the treatment. （1） short term efficacy： In the test group, 2 patients reached complete response, 11 partial response, 15 stability of disease, 2 progress of disease, the overall response rate was 43.3%. In the control group, 1 patients reached complete response, 11 partial response, 14 stability of disease, 4progress of disease, the overall response rate was 40.0%. There was no statistical difference of objective response rate between two groups（P〉0.05）. （2） The clinical benefit response： The clinical benefit response was evaluated after two chemotherapy cycles. The clinical benefit response was 21 cases and non-clinical benefit response was 9 in test group. 12 cases was beneficial response and 18 patients was non-clinical benefit in control group. The test group was higher than the control group in the rate of clinical benefit response, and there was significantly difference between two groups （P〈0.05）. Conclusion The overall short term effects were similar between the two treatment schemes of advanced gastric cancer. But the clinical benefit response was better in test group than in control group.