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Fludarabine, Cyclophosphamide, and Rituximab in Patients With Advanced, Untreated, Indolent B-Cell Nonfollicular Lymphomas: Phase 2 Study of the Italian Lymphoma Foundation

Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclopho...

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Published in:Cancer 2012-08, Vol.118 (16), p.3954-3961
Main Authors: FERRARIO, Andrea, PULSONI, Alessandro, MANNINA, Donato, MUSTO, Pellegrino, ROSSI, Francesca, GAMBA, Enrica, BALDINI, Luca, OLIVERO, Barbara, ROSSI, Giuseppe, VITOLO, Umberto, TEDESCHI, Alessandra, MERLI, Francesco, RIGACCI, Luigi, STELITANO, Caterina, GOLDANIGA, Maria
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Language:English
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Summary:Indolent nonfollicular non-Hodgkin B-cell lymphomas (INFLs) are clonal mature B-cell proliferations for which treatment has not been defined to date. In this phase 2 study of patients with advanced INFL, the authors evaluated the efficacy and safety of first-line rituximab, fludarabine, and cyclophosphamide (FCR) as induction immunochemotherapy (rituximab 375 mg/m(2) intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m(2) intravenously on days 2-4, cyclophosphamide 250 mg/m(2) intravenously on Days 2-4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m(2) intravenously on day 1) every 2 months for responders. Forty-seven patients were enrolled. Among 46 evaluable patients (28 men; median age, 59 years), 19 were diagnosed with lymphoplasmacytic lymphoma, 21 were diagnosed with small lymphocytic lymphoma, and 6 were diagnosed with nodal marginal zone lymphoma. The overall response rate after maintenance was 89.1% with a 67.4% complete remission (CR) rate (CR/unconfirmed CR) and a 21.7% partial response rate. After a median follow-up of 40.9 months, the failure-free survival and progression-free survival rates both were 90.1%, and the overall survival rate was 97.4%. The main toxicity was hematologic, and related grade 3 and 4 neutropenia was observed in 55.3% of patients. FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity.
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.26708