Taxanes are increasingly used in the management of small cell lung cancer (SCLC), but optimal dose and combination with other antineoplastic agents remains to be determined. We used two different dosage regimens of paclitaxel (P) in combination with carboplatin (C) in 148 chemotherapy-naive SCLC patients (age up to 75 years, WHO performance status 0-1) divided in two groups. All patients received C (AUC=6) with P at a dose of either 175 mg/m2 (Group A, 76 pts [68 men]) or 190 mg/m2 (Group B, 78 pts [73 men]), all given on day 1. The regimen was repeated every 28 days for up to 8 cycles. All responders received radiotherapy at the primary tumor site (48 Gy given over 4 weeks) between cycles 6 and 8. Complete responders were given additional prophylactic cranial irradiation. The overall response (OR) rate was 63.1% in Group A (LD: 81.1%, ED: 60%), and 66.6% in Group B (LD: 77.5%, ED: 58.3%) [not significant difference]. Median survival was 270 days in Group A (95% CI: 222-318) and 300 days in Group B (95% CI: 247-352) [p=0.05]. The median time to progression was 200 days in both groups. Toxicity: grade 3/4 neutropenia: 6.5% in Group A, 14.1% in Group B; grade 3/4 anaemia: 5.2% and 10.2%; grade 3 thrombocytopenia: 5.2% and 1.2%; and grade 1/2 neurotoxicity: 27% and 16.6%, respectively. Compared to conventional regimens in the management of SCLC, the combination of P with C is equally effective and well tolerated. There is no significant difference in response or survival rates with the higher dose of P, as indicated in the present study. Pneumon 2004, 17(2):186-194.