PHASE-II TRIAL OF FLUDARABINE MONOPHOSPHATE AS FIRST-LINE TREATMENT IN PATIENTS WITH ADVANCED FOLLICULAR LYMPHOMA - A MULTICENTER STUDY BY THE GROUPE DETUDE DES LYMPHOMES DE LADULTE

Purpose: Fludarabine monophosphate (FAMP) is a major drug in the treat ment of chronic lymphocytic leukemia and showed efficacy in selected g roups of patients with low-grade lymphomas, most of them pretreated. T he aim of this trial wets to assess the efficacy and the toxicity of F AMP in untreated patients with follicular lymphoma. Patients and Metho ds: fifty-four untreated patients with advanced follicular lymphoma we re treated with intravenous (IV) fludarabine at a dose of 25 mg/m(2)/d during 5 days every 4 weeks, to a maximum of nine cycles. Results: Th e toxicity of the drug was mild, mainly granulocytic. Granulocytopenia greater than or equal to grade 3 (World Health Organization [WHO]) wa s observed during 48 of 328 cycles (14.6%) and in 22 of 53 (41%) patie nts assessable for toxicity. Fludarabine had to be stopped prematurely because of toxicity in nine patients: marrow toxicity in five, periph eral neuropathy in two, and interstitial pneumonitis and hepatitis in one patient each, Among 49 patients assessable for response, the overa ll response rate was 65% and the complete response (CR) rate 37%. The median progression-free survival interval for all patients was 13.6 mo nths. Conclusion: These results confirm that fludarabine is active whe n used as first-line treatment in patients with follicular lymphoma an d has a low toxicity rate. It may be used as single treatment in elder ly patients. Associations of fludarabine with other drugs active again st follicular lymphoma need to be determined. (C) 1996 by American Soc iety of Clinical Oncology.