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

OBJECTIVE

Treating advanced non-small cell lung cancer (NSCLC) is difficult. The response rate (RR) of NSCLC patients to traditional chemotherapy 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 designed to determine treatment efficacies of docetaxol plus cisplatin and gemzar plus cisplatin on advanced NSCLC, and observe their cytotoxicities.

METHODS

A total 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 received 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 survival rate between the 2 groups were not significant (P=0.71, P=0.89). The major cytotoxicity of TP was leukopeniaû the major cytotoxicities of GP group were fatigue and thrombocytopenia. All adverse reactions were tolerable.

CONCLUSIONS

TP and GP regimens may enhance the remission rate of NSCLC patients with tolerable adverse reaction, and improve the short-term survival rate, but the differences in treatment efficacies of TP and GP groups are not significant.