PHASE-II STUDY OF DOCETAXEL FOR ADVANCED OR METASTATIC PLATINUM-REFRACTORY NON-SMALL-CELL LUNG-CANCER

Purpose: We conducted a phase II study to determine the response to an d toxicity of docetaxel (Taxotere; Rhone-Poulenc Rorer pharmaceuticals , Inc, Collegeville, PA) in patients with advanced non-small-cell lung cancer refractory to prior platinum-containing chemotherapy (PCC) reg imens. Patients and Methods: Ferry-four patients with stage IIIb or IV platinum-refractory non-small-cell lung cancer were treated with 100 mg/m(2) of docetaxel intravenously over 1 hour every 3 weeks. The resp onses of 42 of 44 patients were assessable. Most patients had a Zubrod performance status of 1; the predominant histologic type was adenocar cinoma (61%), and 91% of patients had stage IV disease. Results: Nine of 42 assessable patients (21%) achieved a partial response to treatme nt. The median response duration (from response to progression) was 17 weeks, and the projected median survival duration of all patients is 42 weeks (51 weeks for adenocarcinoma and 22 weeks for nonadenocarcino ma). Grade 3/4 neutropenia occurred in 85% of patients and was associa ted with fever that required intravenous antibiotics in 16% of patient s (3% of cycles). Other acute side effects included easily heated hype rsensitivity reactions and dermatitis. Cumulative side effects include d fluid retention and neuropathy. Conclusion: Docetaxel administered a t 100 mg/m(2) intravenously every 3 weeks has notable activity against platinum-refractory non-small-cell lung cancer, with a 21% major resp onse rate, Primary side effects were neutropenia, hypersensitivity, an d fluid retention. (C) 1995 by American Society of Clinical Oncology.