Pemetrexed plus platinum or gemcitabine plus platinum for advanced non-small cell lung cancer: final survival analysis from a multicentre randomized phase II trial in the East Asia region and a meta-analysis.

BACKGROUND AND OBJECTIVE

Pemetrexed plus platinum has shown efficacy as a first-line treatment for advanced non-small cell lung cancer (NSCLC), but little is known about its efficacy and safety in East Asian patients. We report the final analysis of overall survival (OS) from a multicentre, randomized, phase II trial in chemotherapy-naive Chinese patients with advanced NSCLC. An additional meta-analysis was performed to systematically evaluate pemetrexed/platinum as first-line treatment for advanced NSCLC.

METHODS

Eligible patients received up to six cycles of pemetrexed, 500 mg/m(2) plus cisplatin, 75 mg/m(2) (day 1) or gemcitabine, 1000 mg/m(2) (days 1 and 8) plus cisplatin, 75 mg/m(2) (day 1). OS and toxicity were assessed.

RESULTS

A total of 254 patients were randomized, and 251 were eligible for inclusion in the efficacy and safety analyses. Median OS in the pemetrexed/cisplatin arm was 15.3 months, compared with 16.9 months in the gemcitabine/cisplatin arm [hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.80-1.48; log-rank P = 0.4888). There was a trend towards improved survival in both arms. Patients in the pemetrexed/cisplatin arm showed a lower incidence of drug-related grade 3 to 4 leukopenia and thrombocytopenia. Meta-analysis showed that pemetrexed-platinum treatment was associated with 19% longer survival among females (HR 0.81; 95% CI 0.69-0.96) and 17% longer survival among patients with non-squamous cell lung cancer (HR 0.83; 95% CI 0.73-0.95).

CONCLUSIONS

In Chinese patients with advanced NSCLC, pemetrexed/cisplatin treatment resulted in comparable OS outcomes and was better tolerated than gemcitabine/cisplatin. Meta-analysis supports the use of pemetrexed-platinum as first-line treatment for female patients and those with the non-squamous cell subtype of advanced NSCLC.