Efficacy of fludarabine and mitoxantrone (FN) combination regimen in untreated indolent non-Hodgkin's lymphomas

Purpose: In the last years, fludarabine (FLU) alone or in combination with other drugs has been reported to be effective in the treatment of previousl y treated low-grade non-Hodgkin's lymphomas (LG-NHL). The aim of this study was to define the therapeutic efficacy and toxicity of a combination of FL U and mitoxantrone (FN regimen) in untreated LG-NHL. Patients and methods: We used a two-drug combination of FLU (25 mg/m(2) i.v . on days 1 to 3) and mitoxantrone (10 mg/m(2) i.v. on day 1) to treat 27 p reviously untreated patients with LG-NHL. Chemotherapy was repeated every f our weeks for a total of six cycles. Among 27 patients, 17 (63%) were diagn osed with follicular, 6 (22%) with small lymphocytic, and 4 (15%) with immu nocytoma subtypes. Results: Of the 27 patients, 18 (67%) achieved complete response (CR) and 6 (22%) partial response, while the remaining 3 (11%) showed no benefit from the treatment. Regarding histology, in the follicular subtype we observed an overall response rate of 94%, with a 76.5% CR rate. The estimated two-ye ar relapse-free survival was 83%, and overall survival was 92%. Hematologic grade 3-4 toxicity was seen in only five (3.3%) patients; no opportunistic infections or deaths were associated with the administration of the FN reg imen. Conclusions: These preliminary data show that the FN regimen is a very acti ve, well-tolerated combination chemotherapy for untreated patients with adv anced LG-NHL.