Activity of docetaxel in platinum-treated non-small-cell lung cancer: Results of a phase II multicenter trial

Purpose: Although several new chemotherapeutic agents are promising as prim ary therapy in non-small-cell lung cancer (NSCLC), few have demonstrated ac tivity in platinum-refractory disease. Based on encouraging results reporte d in two single-institution studies of docetaxel in this setting, we perfor med a multicenter phase II trial evaluating this novel taxane in previously treated NSCLC patients prospectively categorized by platinum response stat us. Patients and Methods: Eighty patients with NSCLC previously treated with pl atinum-based chemotherapy received docetaxel at a dose of 100 mg/m(2) intra venously over 1 hour, repeated every 21 days, accompanied by dexamethasone 8 mg orally twice daily for 5 days. Forty-seven patients (59%) were defined as platinum-refractory based on response status to prior therapy. Results: The median number of cycles delivered per patient was four (range, one to 21 cycles). Partial response was observed in 13 (16%) of 80 of pati ents, with similar response rates in platinum-sensitive and platinum-refrac tory patients. The median survival time was 7 months, and the I-year surviv al rare wets 25%. Docetaxel was relatively well tolerated in this previousl y treated population. Grade IV neutropenia was common in patients (77%) but typically of brief duration. Febrile neutropenia was observed in 11 patien ts (14%), with no fatal infections. Severe fluid retention was rare (4% of patients). Conclusions: This multicenter phase II trial confirms antitumor activity an d encouraging survival with docetaxel therapy in platinum-treated and plati num-refractory NSCLC. To validate these results, a phase III trial randomiz ing platinum-treated patients to docetaxel or best supportive care is under way. (C) 2000 by American Society of Clinical Oncology.