Fludarabine-mitoxantrone-rituximab regimen in untreated intermediate/high-risk follicular non-Hodgkin's lymphoma: experience on 142 patients.

There is no international consensus on front-line optimal chemotherapy regimen for advanced stage follicular lymphoma (FL) patients, or a clear definition of cure for this disease. Aim of this study was to test the degree of effectiveness and the safety of the regimen containing fludarabine, mitoxantrone, and rituximab in a subset of poor prognosis FL patients with particular focus on the long-term disease-free survival. A retrospective study was conducted on 142 intermediate/high-risk FL patients treated in first-line with fludarabine, mitoxantrone, and rituximab regimen. Responses, safety, and survival were evaluated. The prognostic value of positron emission tomography (PET) was also investigated in a 56-patients subset. Overall response rate was 95.5% including 88% of complete responses. With a median follow-up of 48 months, 18% of patients had disease relapse, yielding an estimated 12-year disease-free survival (DFS) of 72%. All cases showed the lymphoma recurrence within 40 months: after this timing the DFS curve presented a plateau. Overall survival was 73% at 12 years. Post-treatment PET positivity remains a highly significant predictor of disease progression. The observed high rate of complete responses following the use of fludarabine, mitoxantrone-based regimen in combination with rituximab seems to be the first step to improve DFS. Our study could be the starting point to consider DFS as a potential alternative endpoint of future clinical trials on FL patients.