PACLITAXEL ACTIVITY FOR THE TREATMENT OF NON-HODGKINS-LYMPHOMA - FINAL REPORT OF A PHASE-II TRIAL

In order to determine the activity of paclitaxel in patients with rela psed or refractory non-Hodgkin's lymphoma (NHL), we conducted a phase II clinical trial in which eligible patients received paclitaxel 200mg /m(2) intravenously over 3 h. Treatment was repeated every 3 weeks. Pa tients achieving complete or partial responses after two courses of pa clitaxel continued to receive therapy for a maximum of eight courses, otherwise they were removed from the study. Of 96 evaluable patients, 45 (47%) had primary refractory disease, and 51 (53%) had relapsed lym phoma. The median number of prior treatment regimens was two (range on e to 10 regimens). 45 patients had low- grade, 44 had intermediate-gra de, and seven had mantle cell lymphoma. 24/96 patients responded (10 c omplete and 14 partial remissions) for an overall response rate of 25% (95% CI 17-35%). Patients with relapsed lymphoma had a higher respons e rate than those with primary refractory disease (19/51=37% v 5/45=11 %; P<0.01), and patients with relapsed intermediate-grade lymphoma had a higher response than those with relapsed low-grade lymphoma (9/18=5 0% v 10/31=32%; P=0.22). The treatment was very web tolerated with the most common side-effects being alopecia (100%), peripheral neuropathy (35% of greater than or equal to grade II, and arthralgia/myalgia (25 % of greater than or equal to grade II). After the first course of pac litaxel, grade III/IV thrombocytopenia and neutropenia were observed i n 21% and 23% of the patients respectively. 23 episodes of neutropenic fever developed after 250 courses of paclitaxel therapy (8%). We conc lude that paclitaxel, at this dose and schedule, is an active new drug for the treatment of non-Hodgkin's lymphoma. The activity of paclitax el combination programmes are currently under investigation.