Background: The promising results of fludarabine (FLU) in chronic lymphocytic leukemia have prompted its extensive evaluation in low-grade non-Hodgkin's lymphoma (LG-NHL). Its different mechanisms of action make FLU an attractive partner for combination with other cytostatic agents.
Patients and methods: We used a three-drug combination of FLU (25 mg/m2 i.v. on days one to three), mitoxantrone (10 mg/m2 i.v. on day one) and prednisone (40 mg given orally on days one to five) (FMP) to treat 48 patients with recurrent LG-NHL.
Results: Of the 48 patients, 17 (35%) achieved complete responses (CR), 23 (48%) partial responses, while the remaining 8 (17%) showed no benefit from the treatment. The risk of lower CR rate was significantly correlated with the presence of advanced stage (IV) (P = 0.01), the number of previous regimens (> or = 3) (P = 0.006), and the follicular histologic subtype (P = 0.02). The major toxic effects observed were neutropenia and infections; there was only one fatality, due to drug-related side effects.
Conclusions: These data confirm the significant efficacy of the FMP fludarabine-mitoxantrone combination regimen in obtaining a good remission rate with moderate toxicity in a particular subset of recurrent LG-NHL.