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

Anas Younes, Jean Pierre Ayoub, Andreas Sarris, Frederick Hagemeister, Lucille North, Odeal Pate, Peter Mclaughlin, M. Alma Rodriguez, Jorge Romaguera, Razelle Kurzrock, Alejandro Preti, Carlos Bachier, Terry Smith, Fernando Cabanillas

Research output: Contribution to journalArticle

36 Scopus citations

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 low grade, 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 ≤ grade II), and arthralgia/myalgia (25% of ≤ 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.

Original languageEnglish (US)
Pages (from-to)328-332
Number of pages5
JournalBritish Journal of Haematology
Volume96
Issue number2
DOIs
StatePublished - 1997

Keywords

  • lymphoma
  • paclitaxel
  • taxol

ASJC Scopus subject areas

  • Hematology

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