Paclitaxel activity for the treatment of non-Hodgkin's lymphoma: final report of a phase II trial

Autor: Odeal Pate, Andreas H. Sarris, Razelle Kurzrock, Fernando Cabanillas, Jean Pierre Ayoub, Jorge E. Romaguera, Maria Alma Rodriguez, Carlos Bachier, Fredrick B. Hagemeister, Terry K. Smith, Peter McLaughlin, Anas Younes, L. B. North, A. Preti
Rok vydání: 1997
Předmět:
Zdroj: Scopus-Elsevier
ISSN: 1365-2141
0007-1048
DOI: 10.1046/j.1365-2141.1997.d01-2012.x
Popis: 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%; P0.01), 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% ofor = grade II), and arthralgia/myalgia (25% ofor = 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.
Databáze: OpenAIRE
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