Paclitaxel in combination with carboplatin as salvage treatment in refractory small-cell lung cancer (SCLC): A multicenter phase II study

Purpose: The activity and toxicity of paclitaxel plus carboplatin combinati on in patients with disease progression after initial chemotherapy for smal l-cell lung cancer (SCLC) was investigated in a multicenter phase II study. Patients and methods: Thirty-two patients (twenty-seven men) with extensive stage refractory SCLC after EP or CAV front-line chemotherapy were treated with paclitaxel 200 mg/m(2) on day 1 and carboplatin 6 AUC on day 2 in a f our-week schedule. The patients' median age was 60 years and the performanc e status (WHO) was 0 for 9, 1 for 20 and 2 for 3 patients. All patients wer e evaluable for toxicity and 29 for response. Results: Complete response was observed in one (3%) and partial response in seven (22%) for an overall response rate of 25% (95% confidence interval ( CI): 10%-40%). Seven (22%) patients had stable disease and seventeen (53%) progressive disease. All but one of the responders had been previously trea ted with EP combination and three of them had failed to respond. The median duration of response and the median TTP were 3 and 5.5 months, respectivel y. The median overall survival was seven months. Grade 3-4 neutropenia was observed in 12 (37%) patients and in 2 of these it was associated with infe ction. There were no toxic deaths. Grade 4 anaemia was observed in one (3%) patient and grade 3 thrombocytopenia in three (9.4%). Non-hematologic toxi city was very mild with grade 2-3 asthenia occurring in 10 (25%) patients; asthenia was the reason for treatment discontinuation in 3 patients. Conclusions: The combination of paclitaxel and carboplatin is a relatively active and well-tolerated regimen as salvage treatment in patients with ref ractory SCLC.