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[Phase II trial of prolonged infusion of low-dose gemcitabine in advanced non-small cell lung cancer treatment].

BACKGROUND & OBJECTIVE
Gemcitabine combined with cisplatin has been taken as the front-line regimen for patients with advanced non-small-cell lung cancer (NSCLC). The routine use of gemcitabine is intravenous injection of a dose of 1,000 mg/m(2) within 30 minutes on days 1 and 8, and the treatment is repeated every 3 weeks. This study was to evaluate the efficacy and safety of 6-hour continuous infusion of low dose of gemcitabine plus cisplatin for patients with advanced NSCLC.


METHODS
Forty-eight patients with measurable stage III B/IV NSCLC and without chemotherapy were enrolled. All of them received 6-hour continuous infusion of gemcitabine 250 mg/m(2) on day 1 and 8 plus cisplatin 75 mg/m(2) on day 2-4 for more than 2 cycles. The cycle was repeated every 3 weeks.


RESULTS
All 48 patients were evaluated for toxicity and 46 for response. The overall response rate was 32.5% (completed and partial response rates were 2.2% and 30.3%, respectively). The median time to progression was 5.1 months, median survival time was 10.2 months; and 1-year survival rate was 36.6%. The main hematologic toxicity consisted of 60.4% neutropenia, 39.5% thrombocytopenia. Grade III-IV neutropenia and thrombocytopenia were 20.8% and 12.5%, respectively.


CONCLUSION
Six-hour prolonged infusion of low dose gemcitabine combined with cisplatin is a relatively safe and effective regimen for patients with advanced NSCLC.