title: Fludarabine, cyclophosphamide, and rituximab in patients with advanced, untreated, indolent B-cell nonfollicular lymphomas: phase 2 study of the Italian Lymphoma Foundation.
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/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.
  
  
  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.
authors.affiliation: Hematology Unit 1, IRCCS Foundation, Ca Granda Hospital "Maggiore Policlinico", University of Milan, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ferrario
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pulsoni
authors.forename: Barbara
authors.initials: B
authors.lastname: Olivero
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rossi
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tedeschi
authors.forename: Francesco
authors.initials: F
authors.lastname: Merli
authors.forename: Luigi
authors.initials: L
authors.lastname: Rigacci
authors.forename: Caterina
authors.initials: C
authors.lastname: Stelitano
authors.forename: Maria
authors.initials: M
authors.lastname: Goldaniga
authors.forename: Donato
authors.initials: D
authors.lastname: Mannina
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.forename: Francesca
authors.initials: F
authors.lastname: Rossi
authors.forename: Enrica
authors.initials: E
authors.lastname: Gamba
authors.forename: Luca
authors.initials: L
authors.lastname: Baldini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine