Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma

Myron S. Czuczman, A. Koryzna, A. Mohr, C. Stewart, K. Donohue, L. Blumenson, Z. P. Bernstein, P. McCarthy, A. Alam, F. Hernandez-Ilizaliturri, M. Skipper, K. Brown, A. Chanan-Khan, D. Klippenstein, P. Loud, M. K. Rock, M. Benyunes, A. Grillo-Lopez, S. H. Bernstein

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140 Scopus citations

Abstract

Purpose: To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. Patients and Methods: This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m 2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. Results: An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naïve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. Conclusion: Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.

Original languageEnglish (US)
Pages (from-to)694-704
Number of pages11
JournalJournal of Clinical Oncology
Volume23
Issue number4
DOIs
StatePublished - 2005

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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