Phase II trial of paclitaxel and carboplatin in metastatic small-cell lungcancer: A Groupe Francais de Pneumo-Cancerologie Study

Purpose: To evaluate the efficacy and safety of paclitaxel and carboplatin in the treatment of previously untreated patients with metastatic small-cel l lung cancer (SCLC). Patients and Methods: Eligible patients were aged 18 to 75 years with an Ea stern Cooperative Oncology Group (ECOG) score less than or equal to 2 and l ife expectancy greater than or equal to 12 weeks. Paclitaxel (200 mg/m(2)) wets infused over 3 hours, before carboplatin (area ender the curve [AUC] 6 ; Calvert formula) infused over 1 hour, once every 3 weeks for six cycles m aximum. Prednisolone, dexchlorpheniramine, and ranitidine were standard pre medication. Response to treatment was assessed every two cycles, and nonres ponding patients were withdrawn from the trial to receive standard chemothe rapy. Results: Of the 50 patients entering the study, 48 and 46 patients were ass essable for toxicity and response, respectively. The overall response rate was 65%, with complete responses in three patients. Five patients had stabl e disease (11%) and 11 patients experienced progressive disease (24%). Medi an survival was 38 weeks, and median duration of response was 20 weeks. One -year survival was 22.5%. For a total of 232 cycles, grade 3 and 4 toxicity was 33% for neutropenia, 3.5% for thrombocytopenia, and 4% for anemia. Fou r patients had neutropenic fever (one toxic death), Nonhematologic toxicity was mainly grade 1 and 2 paresthesia (21% of patients); grade 3 myalgia/ar thralgia was observed in 6.5% of patients. Conclusion: First-line chemotherapy with paclitaxel and carboplatin in meta static SCLC achieved a response rate and survival similar to standard regim ens. With 1-day administration and a tolerable toxicity profile, this combi nation merits further investigation. J Clin Oncol 19:1320-1325. (C) 2001 by American Society of Clinical Oncology.