title: Fludarabine-mitoxantrone-rituximab regimen in untreated intermediate/high-risk follicular non-Hodgkin's lymphoma: experience on 142 patients.
abstract: 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.
authors.affiliation: Institute of Hematology "L. e A. Seràgnoli,", University of Bologna, Bologna, Italy.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.forename: Cinzia
authors.initials: C
authors.lastname: Pellegrini
authors.forename: Alessandro
authors.initials: A
authors.lastname: Broccoli
authors.forename: Beatrice
authors.initials: B
authors.lastname: Casadei
authors.forename: Lisa
authors.initials: L
authors.lastname: Argnani
authors.forename: Stefano
authors.initials: S
authors.lastname: Pileri
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008224:Lymphoma, Follicular / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D011379:Prognosis; D012008:Recurrence; D012189:Retrospective Studies; D000069283:Rituximab; D016019:Survival Analysis; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine