PHASE-II TRIAL OF DOCETAXEL IN NON-HODGKINS-LYMPHOMAS - A STUDY OF THE CANCER AND LEUKEMIA GROUP-B

Purpose: To evaluate the new anticancer agent, docetaxel, with a novel mechanism of action in patients with non-Hodgkin's lymphoma Internati onal Working Formulation (IWF) A through H, to determine the response rate by histologic group and the toxicities of this agent in this popu lation. Patients and Methods: Sixty-eight patients previously treated for non-Hodgkin's lymphoma with two prior cytotoxic regimens for low-g rade and one prior regimen for intermediate-grade lymphoma were entere d onto this phase II trial, Central pathologic review was required. Tw enty-four IWF A to C and 31 IWF D to H patients with normal hepatic an d renal function, performance status (PS) 0 to 2, and adequate hematol ogic function were eligible, patients received docetaxel 100 mg/m(2) i ntravenously over 1 hour without corticosteroid premedications every 3 weeks with weekly hematologic monitoring, and tumor assessment every 3 weeks, For grade 3 or 4 hematologic toxicity, the docetaxel dosage w as lowered to 75 mg/m(2). Patients received a maximum of six cycles of therapy. Results: The major response rate was 13% (95% confidence lim its, 3% to 32%) for IWF A to C and 16% (95% confidence limits, 5% to 3 4%) for IWF D to H; response durations ranged from 1.4 to 20 months. T ime to response ranged from 1.3 to 2.8 months, patients refractory to previous chemotherapy were less apt to respond to docetaxel, but the d ifferences were not statistically different in this small sample size, Twelve percent of IWF A to C and 6% of IWF D to H patients discontinu ed treatment because of toxicity, The major toxicity was granulo cytop enia (grade 3 to 4), which occurred in virtually all patients during t he first course of therapy. Conclusion: This study confirms that docet axel has limited but definite activity in patients with non-Hodgkin's lymphoma and suggests that the previously reported responses with taxa nes can not be attributed solely to the use of corticosteroid premedic ations. (C) 1997 by American Society of Clinical Oncology.