长春瑞宾(盖诺)治疗消化道癌多中心、随机对照Ⅲ期临床研究

RANDOMIZED STUDY OF VINORELBINE IN ADVANCED DIGESTIVE TRACT CANCER: INITIAL RESULTS OF A PHASE Ⅲ MULTICENTER TRIAL

目的采用多中心、随机对照的原则，研究长春瑞宾（盖诺）治疗晚期消化道肿瘤的作用及地位、临床疗效和安全性。方法来源于7家医院肿瘤科51例晚期消化道肿瘤，随机分成2组，盖诺组在FP方案（5-Fu、DDP）基础上加盖诺25mg／m^2第1天、第5天静脉推注；对照组在FP方案基础上加VP-160．1第1～5天静滴。结果盖诺组总有效率RR54．2％（13／24），CR率4．2％，PD率16．7％；对照组总有效率RR40．7％（11／27），无CR，PD率29．6％。2组无统计学意义（P〉0．05）。近期综合疗效盖诺组好转率高于对照组，进展率低于对照组，亦有显著意义（P〈0．05）。结论长春瑞宾治疗晚期消化道肿瘤总有效率较高，近期综合疗效较好，长春瑞宾在消化道肿瘤上的作用及地位值得进一步研究。

Objective Evaluation of randomized study of domestic-made vinorelbine in ad- vanced digestive tract cancer, A phase Ⅲ muhicenter trial initial report. Methods 51 cases of stage Ⅲ- N advanced digestive tract cancer were randomized in two groups： vinorelbine group and control group. Results Vinorelbine group： 54.2 % （13/24） of response rate was achieved with 1 CR and 12 PR in all 24 cases, Control group： 40.7% （11/27） of response rate was achieved with 11 PR but no CR in all 27 cases （P 〉0.05）. Main toxicity was neutropenia with occurrence rate of 87.5 % （21/24）in vinorelbine group and 74.1% （20/27） in control group（P 〉0.05）. Vinorelbine group is better than control group in comprehensive response rate（P 〈 0.05）. Conclusion Vinorelbine is an effective single drug in advanced digestive tract cancer. The adverse reactions are not severe, and further clinical study should be carried out.