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.