Fludarabine-based chemotherapy in untreated mantle cell lymphomas: an encouraging experience in 29 patients

Background and Objectives. A prospective study to evaluate the role of fludarabine alone or In combination with Idarubicin in untreated patients with mantle cell lymphoma (MCL). Design and Methods. Twenty-nine untreated patients with mantle cell lymphoma were stochastically treated with Intravenous fludarabine at a dose of 25 mg/m(2)/day for 5 days (11 patients) or with a combination of fludarabine and idarubicin (RU-ID) (fludarabine 25 mg/m(2) i.v. on days 1 to 3 and idarubicin 12 mg/m(2) i.v. on day 1 (18 patients). For both regimens, cycles were given at three-week intervals for a total of six courses. According to the International Prognostic Index, the most part of high-intermediate and high risk factor patients were in the FLUID subset: 7 (39%) patients vs. 2 (18%) In the fludarabine alone subset. Results. Of the 29 patients, 8 (28%) obtained a complete response and 10 (35%) a partial response, with an overall response rate of 63%. The remaining 11 (37%) patients did not respond to the therapy. The overall response rates were 64% (7 patients) in the fludarabine group and 61% (11 patients) in the FLUID group. The complete response rate was 27% (3 patients) for fludarabine and 28% (5 patients) for FLU-ID. The toxicity was mild in terms of neutropenia and infections, and no fatalities occurred due to drug-induced side effects. Interpretation and Conclusions. These results suggest the efficacy of fludarabine alone or in combination with idarubicin in MCL patients. It will be important to increase this experience and to assess other fludarabine-containing regimens, in particular with cyclophosphamide plus idarubicin and with mitoxantrone and or cyclophosphamide, to test the true role of this approach in MCL. (C) 1999, Ferrata Storti Foundation.