Favorable impact of low-dose fludarabine plus epirubicin and cyclophosphamide regimen (FLEC) as treatment for low-grade non-Hodgkin's lymphomas

Background and Objective. In recent years, conventional dose of fludarabine (FLU) alone or in combination with other drugs has been reported to be eff ective in the treatment of low-grade non-Hodgkin's lymphomas (LG-NHL). In p articular, FLU and cyclophosphamide (CY) or FLU and mitoxantrone or idarubi cin combined regimens have shown considerable therapeutic activity both as first line and salvage therapies, producing overall response rates ranging from 40-50% in previously treated patients and up to 70-90% in untreated on es. However severe neutropenia and infective complications have been report ed in a significant number of patients. Based on these premises we evaluate d the efficacy and toxicity of a new regimen combining low-doses of FLU wit h epirubicin (EPI) and CY (FLEC) in a group of advanced treatment-requiring LG-NHL patients. the aim of this study was to evaluate a strategy aimed at lowering therapy-related toxic effects without affecting the reported good response rate. Design and Methods. Thirty patients with de novo, relapsed or refractory LG -NHL entered the study. FLEC regimen was as follows: EPI 60 mg/m(2) i.v, on day one, plus FLU 15 mg/m(2)/day i.v. (max 25 mg) and CY 250 mg/m2/day i.v . for four days. Results. All 30 patients were evaluable for response, 13 (43%) fulfilled th e criteria for CR and 11 (36%) for PR with an overall response rate of 79%. None of the 13 patients who achieved CR had relapsed after a follow-up of 2 to 23 months (median duration 13 months). With regard to age, 13/14 older patients (greater than or equal to 70 years) responded to the treatment an d 9 of them maintained their response after a median of 13 months (range 2- 22); six of the 14 (43%) obtained a CR. Therapy-related toxicity was mild r egardless of age, neutropenia (43%) and fever of undetermined origin (26%) being the major side effects. Remarkably, a documented infection was record ed only in 2/30 (6%) patients. Interpretation and Conclusions. A low-dose FLU-based FLEC regimen appeared to be effective for advanced treatment-requiring LG-NHL, reproducing a simi lar overall response rate (79%) reported to have been achieved with other F LU based combination therapies. Toxic side effects were negligible and in p articular documented infections were remarkably uncommon even in the group of elderly patients. (C)1999, Ferrata Storti Foundation.