Phase III intergroup study of fludarabine phosphate compared with cyclophosphamide, vincristine, and prednisone chemotherapy in newly diagnosed patients with stage III and IV Low-grade malignant non-Hodgkin's lymphoma

Anton Hagenbeek, Houchingue Eghbali, Silvio Monfardini, Umberto Vitolo, Peter J. Hoskin, Christiane De Wolf-Peeters, Ken MacLennan, Elvira Staab-Renner, Joachim Kalmus, Astrid Schott, Ivana Teodorovic, Anastassia Negrouk, Martine Van Glabbeke, Robert Marcus

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To compare the efficacy and safety of fludarabine phosphate with cyclophosphamide, vincristine, and prednisone (CVP) in 381 previously untreated, advanced-stage, low-grade (Ig) non-Hodgkin's lymphoma (NHL) patients in a phase III, multicenter study. Patients and Methods: Between 1993 and 1997, patients were randomly assigned to treatment with either fludarabine (25 mg/m2 intravenously [IV] daily for 5 days every 4 weeks) or CVP (cyclophosphamide 750 mg/m2 IV on day 1; vincristine, 1.4 mg/m2 IV on day 1; and prednisone, 40 mg/m2 orally on days 1 through 5 every 4 weeks). Results: Overall response (OR) rates were significantly improved in the fludarabine arm versus the CVP arm, both for the intent-to-treat (ITT) population and assessable patients (P <.001). Complete response (CR) rates in the ITT population were also higher after fludarabine treatment. The CR rate was 38.6% for fludarabine compared with 15.0% for CVP. There were no statistically significant differences in time to progression (TTP), time to treatment failure (TTF), and overall survival (OS) between treatment groups. WHO grades 3 and 4 hematologic adverse events were more common in the fludarabine arm. However, concerning the higher incidence of granulocytopenia, this did not translate to more infections in fludarabine-treated patients. Conclusion: Newly diagnosed IgNHL patients who received fludarabine achieved higher OR and CR rates compared with CVP-treated patients. No differences in TTP, TTF, and OS were noted. Fludarabine is a highly active single agent in IgNHL. Combination therapies incorporating fludarabine are now being further evaluated as first-line therapy in follicular NHL.

Original languageEnglish
Pages (from-to)1590-1596
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number10
DOIs
Publication statusPublished - Apr 1 2006

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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