Journal of Clinical Oncology, Vol 10, 790-794, Copyright © 1992 by American Society of Clinical Oncology
Phase II trial of fludarabine phosphate in lymphoma: an effective new agent in low-grade lymphoma
JR Redman, F Cabanillas, WS Velasquez, P McLaughlin, FB Hagemeister, F Swan Jr, MA Rodriguez, WK Plunkett and MJ Keating
Department of Hematology, University of Texas, M.D. Anderson Cancer Center, Houston.
PURPOSE: In a phase II trial we investigated fludarabine phosphate (FAMP)
as therapy for patients with relapsed lymphoma to determine its
effectiveness and toxicity in this disease. PATIENTS AND METHODS: The 67
assessable patients had a median age of 56 years and had received a median
of three chemotherapy regimens before treatment with FAMP. The starting
dose was 25 mg/m2 administered intravenously over 30 minutes daily for 5
days every 3 to 4 weeks. RESULTS: High response rates were observed for
follicular small cleaved-cell lymphoma (FSCCL) (62%), follicular mixed
small- and large-cell lymphoma (80%), and follicular large-cell lymphoma
(FLCL) (100%). Responses also occurred in small lymphocytic lymphoma (SLL)
(33%), transformed lymphoma (33%), mycosis fungoides (40%), and Hodgkin's
disease (25%). No responses were observed in other intermediate- or
high-grade lymphomas (N = 20). Overall, there were five patients with a
complete response, 23 patients with a partial response, and an overall
response rate of 37%. Toxicity was primarily hematologic and infectious. No
significant gastrointestinal, hepatic, renal, or neurologic toxicity
occurred. CONCLUSIONS: We conclude that FAMP has major activity in
follicular lymphoma. Fundamental research is needed to understand this
differential efficacy in low-grade lymphoma yet lack of efficacy in
intermediate- and high-grade lymphoma. Clinical investigations should be
done using FAMP in varying dose schedules and in combination regimens.
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