Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas: phase 2 study of the Italian Lymphoma Foundation |
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Authors: | Ferrario Andrea Pulsoni Alessandro Olivero Barbara Rossi Giuseppe Vitolo Umberto Tedeschi Alessandra Merli Francesco Rigacci Luigi Stelitano Caterina Goldaniga Maria Mannina Donato Musto Pellegrino Rossi Francesca Gamba Enrica Baldini Luca |
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Institution: | Hematology Unit 1, IRCCS Foundation, Ca Granda Hospital "Maggiore Policlinico", University of Milan, Milan, Italy. |
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Abstract: | BACKGROUND: Indolent nonfollicular non‐Hodgkin B‐cell lymphomas (INFLs) are clonal mature B‐cell proliferations for which treatment has not been defined to date. METHODS: 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/m2 intravenously on day 1 of each cycle and on days 1 and 14 of cycles 4 and 5; fludarabine 25 mg/m2 intravenously on days 2‐4, cyclophosphamide 250 mg/m2 intravenously on Days 2‐4) every 28 days for 6 cycles followed by a maintenance phase with 4 infusions of rituximab (375 mg/m2 intravenously on day 1) every 2 months for responders. RESULTS: 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. CONCLUSIONS: FCR induction therapy followed by a short maintenance phase is a highly effective regimen with acceptable toxicity. Cancer 2012. © 2011 American Cancer Society. |
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Keywords: | indolent nonfollicular lymphomas chemotherapy fludarabine cyclophosphamide rituximab |
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