title: Frontline treatment of follicular lymphoma with fludarabine, cyclophosphamide, and rituximab followed by rituximab maintenance: toxicities overcome its high antilymphoma effect. Results from a Spanish Cooperative Trial (LNHF-03).
abstract: We assessed the efficacy of fludarabine, cyclophosphamide, and rituximab in combination (FCR) as frontline treatment in patients with follicular lymphoma (FL) followed by rituximab maintenance. Seventy-five untreated patients with FL received FCR followed by maintenance with rituximab 375 mg/m(2) weekly during 4 weeks and every 6 months for 2 years. The overall response rate was 100%, with 89% complete remission (CR) and 11% partial remission (PR). Molecular remission was observed in all but one patient. Only eight patients completed all therapy planned. With a median follow-up of 47 months, the 5-year overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) were 77%, 93%, and 72%, respectively. Age below 60 and low Follicular Lymphoma International Prognostic Index (FLIPI) correlated with a better EFS. Ten patients died due to toxic complications. The FCR regimen is highly effective in untreated patients with FL, with 89% CR, including molecular responses, and a low progression rate. However, the high incidence of treatment-related mortality makes this regimen unsafe and it cannot be recommended as an upfront therapy in FL.
authors.affiliation: MD Anderson International España, Madrid, Spain. jftomas@mdanderson.es
authors.forename: José Francisco
authors.initials: JF
authors.lastname: Tomás
authors.forename: Carlos
authors.initials: C
authors.lastname: Montalbán
authors.forename: Alberto Fernández
authors.initials: AF
authors.lastname: De Sevilla
authors.forename: Joaquín
authors.initials: J
authors.lastname: Martínez-López
authors.forename: Nicolás
authors.initials: N
authors.lastname: Díaz
authors.forename: Miguel
authors.initials: M
authors.lastname: Canales
authors.forename: Rafael
authors.initials: R
authors.lastname: Martínez
authors.forename: Pedro
authors.initials: P
authors.lastname: Sánchez-Godoy
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Caballero
authors.forename: Javier
authors.initials: J
authors.lastname: Peñalver
authors.forename: Elena
authors.initials: E
authors.lastname: Prieto
authors.forename: Antonio
authors.initials: A
authors.lastname: Salar
authors.forename: Carmen
authors.initials: C
authors.lastname: Burgaleta
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Queizán
authors.forename: Roberto
authors.initials: R
authors.lastname: Bajo
authors.forename: Raquel
authors.initials: R
authors.lastname: De Oña
authors.forename: Javier
authors.initials: J
authors.lastname: De La Serna
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic; D003299:Cooperative Behavior; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D000069283:Rituximab; D013030:Spain; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine