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Randomized Phase III Study of Fludarabine Phosphate Versus Cyclophosphamide, Vincristine, and Prednisone in Patients With Recurrent Low-Grade Non-Hodgkin’s Lymphoma Previously Treated With an Alkylating Agent or Alkylator-Containing Regimen

From the Division of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia; Hamilton Regional Cancer Center, Hamilton, London Regional Cancer Centre, London, and St Catherine’s Clinic, St Catherine’s, Ontario; McGill Oncology Group, Hopital Saint-Luc, and Berlex Canada, Montreal, Quebec; Toronto-Sunnybrook Regional Cancer Centre, Toronto; Saskatoon Cancer Centre, Saskatoon, Saskatchewan; and Cancercare Manitoba, Winnipeg, Manitoba, Canada.

Address reprint requests to Richard Klasa, MDCM, FRCPC, Division of Medical Oncology, British Columbia Cancer Agency, 600 W 10th Ave, Vancouver, British Columbia V5Z 4E6, Canada; email: rklasa{at}bccancer.bc.ca

PURPOSE: To compare in a phase III study the safety and efficacy of fludarabine to that of cyclophosphamide, vincristine, and prednisone (CVP) in recurrent, low-grade, non-Hodgkin’s lymphoma after previous response to systemic treatment.

PATIENTS AND METHODS: Patients were randomized to fludarabine (25 mg/m² intravenously on days 1 to 5, every 28 days) or CVP (cyclophosphamide 750 mg/m² and vincristine 1.2 mg/m² both intravenously on day 1 and prednisone 40 mg/m² orally on days 1 to 5, every 21 days). The primary outcome assessed was progression-free survival (PFS); secondary outcomes included treatment-free survival (TFS), overall survival (OS), treatment-related toxicity, and quality of life (QoL) according to the European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire C-30 version 1.0 instrument.

RESULTS: Ninety-one patients were randomized, 47 to fludarabine and 44 to CVP. There was no difference in response rates, with 64% (complete response [CR], 9%) for fludarabine versus 52% (CR, 7%) for CVP (P = .72). With a median follow-up of 42 months, median PFS (11 months v 9.1 months; P = .03) and TFS (15 months v 11 months; P = .02) were superior in patients receiving fludarabine. No difference in median overall survival was detected (57 months for fludarabine v 44 months for CVP; P = .95). Three patients receiving fludarabine died of treatment-related toxicity compared with none of the patients receiving CVP. Peripheral neuropathy and alopecia were more common with CVP. Patients receiving fludarabine had higher scores for social function (P = .008); no other differences in QoL were detected.

CONCLUSION: In recurrent low-grade lymphoma, fludarabine improves PFS, TFS, and social function scores in comparison with CVP but does not improve OS.

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