3-HOUR PACLITAXEL INFUSION IN PATIENTS WITH REFRACTORY AND RELAPSED NON-HODGKINS-LYMPHOMA

Purpose: Paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ) is a novel antimicrotubule agent with antitumor activity against ovarian and breast carcinomas. Its activity when administered as a 3-hour int ravenous infusion in patients with relapsed non-Hodgkin's lymphoma (NH L) has not been studied. Patients and Methods: Patients with relapsed NHL were treated with a 3-hour infusion of 200 mg/m(2) of Taxol every 3 weeks in an outpatient setting. All patients received premedication (dexamethasone, diphenhydramine, and cimetidine) to prevent allergic r eactions. Responses were assessed after two courses of therapy, and pa tients who achieved at least partial remission (PR) continued to recei ve Taxol for a maximum of eight courses. Results: Of 60 eligible patie nts, 54 (90%) were assessable for treatment toxicity and 53 (88%) were for treatment response (22 with primary refractory and 31 with relaps ed disease). Twelve patients (23%) achieved a PR (n = 6) or complete r emission (CR; n = 6) (95% confidence interval, 12% to 36%). Responses were observed in intermediate-grade (31%), low-grade (14%), and mantle -cell (17%) lymphomas. In the intermediate-grade lymphomas, there was a trend for a higher response rate in relapsed versus primary refracto ry disease (54% v 13%; P = .08). Treatment related toxicity included a lopecia (100%), peripheral neuropathy (37%), myalgia or arthralgia (25 %), and neutropenic fever (11%). None of the patients had allergic rea ctions or cardiac toxicity. Conclusion: At this dose and schedule, Tax ol is an active agent in patients with relapsed NHL and can be safely administered in on outpatient setting. Combination programs with Taxol should be investigated for treatment of NHL. (C) 1995 by American Soc iety of Clinical Oncology.