[A randomized clinical trial of gemcitabine plus cisplatin compared with gemcitabine plus vinorelbine in the treatment of non-small cell lung cancer].

BACKGROUND

Although platinum-based chemotherapy has become a standard treatment for non-small cell lung cancer (NSCLC), its severe toxicities limit clinical application and a new alternative regimen is required. The aim of this study was to assess efficacy, survival rate and toxicity of gemcitabine+cisplatin regimen (GP) versus gemcitabine +vinorelbine regimen (GN) in the treatment of advanced NSCLC patients.

METHODS

One hundred and three patients with stage III or IV NSCLC were enrolled into this study, and 52 patients and 51 patients were randomly divided into GP group and GN group respectively. Gemcitabine 1000mg/m² on days 1 and 8 and cisplatin 80mg/m² on day 1 were administered to patients in GP group, while gemcitabine 1000mg/m² on days 1 and 8 and vinorelbine 25mg/m² on days 1 and 8 were given to patients in GN group. Both regimens were repeated every 3 weeks, no more than 6 cycles for each patient.

RESULTS

An objective response rate of 34.6% was observed in GP arm versus 27.5% in GN arm and 1-year survival rate was 68.8% in GP arm and 73.1% in GN arm with no significant difference in statistical analysis (P > 0.05). The median survival time was 19.5 months for GN arm and 14.4 months for GP arm. Nausea and vomiting were the major dose-limiting toxicity. The incidence of grade III+IV nausea and vomiting was significantly higher in GP arm than that in GN arm (51.9% vs 2.0%, P=0.0005).

CONCLUSIONS

Both GP regimen and GN regimen are effective regimens when used in Chinese advanced NSCLC patients, however grade III+IV nausea and vomiting in GP regimen are significantly lower than that in GP regimen.