Evaluation of docetaxel in previously untreated extensive-stage small celllung cancer: A Southwest Oncology Group phase II trial

PURPOSE This phase II multi-institutional trial of the Southwest Oncology Group was designed to evaluate the efficacy and toxicity of docetaxel in chemotherap y-naive patients with extensive-stage small cell lung cancer. PATIENTS AND METHODS Forty-seven patients with extensive-stage small cell lung cancer were enter ed onto the study. Treatment consisted of docetaxel, 100 mg/m(2), as a 1-ho ur intravenous infusion repeated every 21 days, with protocol-specified dos e reductions for toxicity. RESULTS Forty-three patients were eligible. A total of 158 cycles of docetaxel were administered (median, three cycles; range, one to nine). Ten patients (23% ) (95% confidence interval, 12% to 39%) achieved partial responses. The med ian progression-free and overall survivals were 3 and 9 months, respectivel y. Therapy was generally well tolerated. Grade 4 neutropenia occurred in 58 % of patients. Febrile neutropenia developed in five patients (12%), and in fection was documented in 14% of patients. There was one treatment-related death caused by pneumonia in a patient who had developed bilateral pneumoth oraces. Other toxicities (grade 3/4) included malaise, fatigue, and letharg y (21%); nausea (19%); stomatitis (14%); edema (9%); and sensory neuropathy (9%). DISCUSSION Docetaxel, at a dose of 100 mg/m(2), is an active agent in the treatment of small cell hmg cancer. Reversible neutropenia is the most common toxicity associated with this treatment. The overall survival (9 months) with this a gent is comparable to that reported with other new chemotherapeutic agents in small cell lung cancer and warrants additional evaluation of docetaxel i n combination therapy.