泰索帝联合顺铂及健择联合顺铂治疗非小细胞肺癌随机对照临床研究

背景与目的:晚期非小细胞肺癌(non鄄smallcelllungcancer,NSCLC)的治疗仍是一个难点,传统化疗方案的有效率在40%左右,随着新药泰素、泰索帝及健择等的不断出现,NSCLC的疗效有了很大的提高。本研究采用随机对照研究的方法,探讨新药泰索帝联合顺铂(TP)及健择联合顺铂(GP)治疗晚期NSCLC疗效及不良反应。方法:采用临床随机对照研究的方法观察经两个方案治疗后43例患者的缓解率(RR)、疾病进展时间(TTP)、中位生存时间(MST)和1年、2年生存率。43例患者中TP组22例,GP组21例。结果:TP组CR1例、PR9例,RR45.4%,TTP4.6个月,MST10.6个月(95%CI9.3～11.3个月)。GP组无CR,PR9例,RR42.9%,TTP4.7个月,MST11.3个月(95%CI6.8～14.8个月)。两组疗效比较无显著性差异(P=0.71)。GP组1、2年生存率分别为34.1%、11.2%,TP组分别为38.1%、15.3%,两组生存率无显著性差异(P=0.89)。TP组不良反应以粒细胞下降为主,GP组以乏力和血小板降低为主要表现,但均可耐受。结论:泰索帝或健择联合顺铂治疗晚期NSCLC具有较好的耐受性和较高的临床缓解率,并获得较高的1年和2年生存率,两组疗效和生存率没有显著性差异。

A randomized trial of docetaxol plus cisplatin versus gemzar plus cisplatin in treating advanced non-small cell lung cancer

BACKGROUND & OBJECTIVE: Treating advanced non-small cell lung cancer (NSCLC) is difficult. The response rate (RR) of NSCLC patients to traditional c hemotherapy regimen is about 40%. Now the RR has been improved with application of new drugs, such as taxol, docetaxal, and gemzar. This randomized trial was de signed to determine treatment efficacies of docetaxol plus cisplatin and gemzar plus cisplatin on advanced NSCLC, and observe their cytotoxicities. METHODS: A t otal of 43 advanced NSCLC patients were randomized into 2 groups, 22 in TP group (docetaxol plus cisplatin) and 21 in GP group (gemzar plus cisplatin), and rece ived relevant treatments. The RR, time to progression (TTP), mean survival time (MST), and 1- and 2-year survival rates of the patients were analyzed. RESULTS: The RR was 45.4% in TP group with 1 case of complete remission (CR) and 9 cases of partial remission (PR), and 42.9% in GP group with 9 cases of PR. The TTP was 4.6 months in TP group, and 4.7 months in GP group; the MST was 10.6 months in TP group 95% confidence interval (CI), 9.3-11.3 months], and 11.3 months in GP group (95% CI, 6.8-14.8 months). The 1- and 2-year survival rates were 38.1% and 15.3% in TP group, and 34.1% and 11.2% in GP group. The differences of RR and s urvival rate between the 2 groups were not significant (P=0.71, P=0.89). The maj or cytotoxicity of TP was leukopenia; the major cytotoxicities of GP group were fatigue and thrombocytopenia. All adverse reactions were tolerable. CONCLUSION: TP and GP regimens may enhance the remission rate of NSCLC patients with tolerab le adverse reaction, and improve the short-term survival rate, but the differenc es in treatment efficacies of TP and GP groups are not significant.