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Randomized Trial of Fludarabine Versus Fludarabine and Idarubicin as Frontline Treatment in Patients With Indolent or Mantle-Cell Lymphoma

From the Institute of Hematology and Medical Oncology and University of Bologna, Bologna; Division of Hematology, Pesaro Hospital, Pesaro; Division of Hematology, University of Napoli, Napoli; Division of Hematology, Dolo Hospital, Dolo; Division of Hematology, Ravenna Hospital, Ravenna; Division of Hematology, Cesena Hospital, Cesena; Division of Hematology, Taranto Hospital, Taranto; Division of Hematology, La Cattolica University of Roma, Roma; Division of Internal Medicine, University of Bari, Bari; Division of Oncology, Forli Hospital, Forli; Division of Hematology, Latina Hospital, Latina; Division of Hematology, Potenza Hospital, Potenza; and Division of Hematology, University of Genova, Genova, Italy.

Address reprint requests to Pier Luigi Zinzani, MD, Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola, Via Massarenti 9, 40138 Bologna, Italy; email plzinzo{at}med.unibo.it

PURPOSE: A first comparative trial of fludarabine (FLU) alone versus FLU plus idarubicin (FLU-ID) for indolent or mantle-cell lymphomas.

PATIENTS AND METHODS: From September 1995 to July 1998, 199 patients aged 25 to 65 years (median, 54 years) with newly diagnosed stages II to IV indolent or mantle-cell lymphomas (standard risk according to the International Prognostic Index) were enrolled onto a multicenter, 1:1 randomized study. Of the 199 patients who were able to be assessed, 101 were assigned to the FLU group (six monthly cycles of FLU 25 mg/m²/d on days 1 through 5) and 98 to the FLU-ID group (six monthly cycles of FLU 25 mg/m²/d on days 1 through 3 and idarubicin 12 mg/m² on day 1).

RESULTS: In the FLU group, complete response (CR) and partial response rates were 47% and 37%, respectively, whereas in the FLU-ID group, they were 39% and 42%, respectively. In-depth analysis of the CR rate with respect to histologic type showed that FLU seemed to be superior to FLU-ID in treating follicular lymphomas (60% v 40%, respectively), whereas FLU-ID seemed to be more effective than FLU in treating nonfollicular lymphomas (small lymphocytic, 43% v 29%, respectively; immunocytoma, 38% v 23%, respectively; P = not significant), excluding the mantle-cell subset (in which there was no difference between the two groups). No striking differences were observed between the two protocols in terms of overall response or toxicity, which was generally mild. However, with a median follow-up of 19 months, only 29 patients (62%) who received FLU alone have maintained their initial CR, compared with 32 (84%) of those who received FLU-ID therapy (P = .021).

CONCLUSION: Although the FLU-ID regimen may not significantly improve the induction of CR in most indolent-lymphoma patients, our preliminary data do suggest that, with respect to FLU alone, it may be capable of conferring a longer-lasting CR and that it might be superior in terms of CR rate in small lymphocytic and immunocytoma subtypes.

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