Phase II trial of carboplatin and paclitaxel in non-small cell lung cancer patients previously treated with chemotherapy.

The purpose of this phase II trial was to evaluate the efficacy and toxicity of carboplatin plus paclitaxel in the treatment of advanced non-small cell lung cancer (NSCLC) previously treated with chemotherapy. Patients with a performance status (PS) of 0 or 1 who had received one or two previous chemotherapy regimens for advanced NSCLC were eligible. Paclitaxel 200mg/m(2) was infused over 3h and followed by carboplatin (area under the curve 6) infusion over 1h, once every 3 weeks. Thirty patients were enrolled. A complete response was observed in 1 patient and a partial response in 10 patients, for an overall response rate of 36.7%. The median time to progression was 5.3 months. The median survival time was 9.9 months, and the 1-year survival rate was 47%. Hematological toxicity in the form of grade 3/4 neutropenia occurred in 54%, but grade 3 febrile neutropenia developed in only 3%. Non-hematological grade 3 toxicities were less frequent. There were no treatment-related deaths. The combination of carboplatin plus paclitaxel is an active and well-tolerated regimen for the treatment of NSCLC patients who have previously been treated with chemotherapy and have a good PS.