1. 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).
- Author
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Tomás JF, Montalbán C, De Sevilla AF, Martínez-López J, Díaz N, Canales M, Martínez R, Sánchez-Godoy P, Caballero MD, Peñalver J, Prieto E, Salar A, Burgaleta C, Queizán JA, Bajo R, De Oña R, and De La Serna J
- Subjects
- Adult, Aged, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Murine-Derived adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemotherapy, Adjuvant, Clinical Trials as Topic, Cooperative Behavior, Cyclophosphamide adverse effects, Drug Administration Schedule, Drug-Related Side Effects and Adverse Reactions epidemiology, Female, Humans, Male, Middle Aged, Neoadjuvant Therapy, Rituximab, Spain, Treatment Outcome, Vidarabine administration & dosage, Vidarabine adverse effects, Young Adult, Antibodies, Monoclonal, Murine-Derived administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Cyclophosphamide administration & dosage, Lymphoma, Follicular drug therapy, Vidarabine analogs & derivatives
- 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.
- Published
- 2011
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