title: Paclitaxel activity for the treatment of non-Hodgkin's lymphoma: final report of a phase II trial.
abstract: In order to determine the activity of paclitaxel in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL), we conducted a phase II clinical trial in which eligible patients received paclitaxel 200 mg/m2 intravenously over 3 h. Treatment was repeated every 3 weeks. Patients achieving complete or partial responses after two courses of paclitaxel 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 lymphoma. The median number of prior treatment regimens was two (range one to 10 regimens). 45 patients had lowgrade, 44 had intermediate-grade, and seven had mantle cell lymphoma. 24/96 patients responded (10 complete and 14 partial remissions) for an overall response rate of 25% (95% CI 17-35%). Patients with relapsed lymphoma had a higher response 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 = 50% v 10/31 = 32%; P = 0.22). The treatment was very well tolerated with the most common side-effects being alopecia (100%), peripheral neuropathy (35% of > or = grade II), and arthralgia/myalgia (25% of > or = grade II). After the first course of paclitaxel, grade III/IV thrombocytopenia and neutropenia were observed in 21% and 23% of the patients respectively. 23 episodes of neutropenic fever developed after 250 courses of paclitaxel therapy (8%). We conclude that paclitaxel, at this dose and schedule, is an active new drug for the treatment of non-Hodgkin's lymphoma. The activity of paclitaxel combination programmes are currently under investigation.
authors.affiliation: Department of Hematology, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: A
authors.initials: A
authors.lastname: Younes
authors.forename: J P
authors.initials: JP
authors.lastname: Ayoub
authors.forename: A
authors.initials: A
authors.lastname: Sarris
authors.forename: F
authors.initials: F
authors.lastname: Hagemeister
authors.forename: L
authors.initials: L
authors.lastname: North
authors.forename: O
authors.initials: O
authors.lastname: Pate
authors.forename: P
authors.initials: P
authors.lastname: McLaughlin
authors.forename: M A
authors.initials: MA
authors.lastname: Rodriguez
authors.forename: J
authors.initials: J
authors.lastname: Romaguera
authors.forename: R
authors.initials: R
authors.lastname: Kurzrock
authors.forename: A
authors.initials: A
authors.lastname: Preti
authors.forename: C
authors.initials: C
authors.lastname: Bachier
authors.forename: T
authors.initials: T
authors.lastname: Smith
authors.forename: F
authors.initials: F
authors.lastname: Cabanillas
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel