title: Long term efficacy and safety of Fludarabine, Cyclophosphamide and Rituximab regimen followed by (90)Y-ibritumomab tiuxetan consolidation for the treatment of relapsed grades 1 and 2 follicular lymphoma.
abstract: BACKGROUND
  In this retrospective study, we investigated the efficacy and safety of radioimmunotherapy with (90)Yttrium- ibritumomab tiuxetan ((90)Y-RIT) in 9 patients with recurrent follicular lymphoma (FL) who were treated in a consolidation setting after having achieved complete (CR) or partial remission (PR) with Fludarabine, Cyclophosphamide and Rituximab (FCR).
  
  
  METHODS
  The median age was 63 years (range 46-77). All patients were relapsed with histologically confirmed CD20-positive (grade 1 or 2) FL, at relapse they received FCR every 28 days: F (25 mg/m(2)x 3 days), C (1 gr/m(2) day 1) and R (375 mg/m(2) day 4) for 4 cycles. Those who achieved at least a PR with <25 % bone marrow involvement were treated with (90)Y-RIT 11.1 or 14.8 MBq/Kg, at 3 months after completing FCR. Patients underwent a further restaging at 12 weeks after (90)Y-RIT with a total body CT scan, FDG-PET/CT and bilateral bone marrow biopsy.
  
  
  RESULTS
  Nine patients completed the treatment: FCR followed by (90)Y-RIT (6 patients at 14.8 MBq/Kg, 3 patients at 11.1 MBq/Kg). After FCR, 7 patients obtained CR and 2 PR; after (90)Y-RIT 2 patients in PR converted to CR 12 weeks later. With a median follow up of 95 months (range 20-114) since FCR and 88 months (range 13-104) since (90)Y-RIT 3 deaths were not related to lymphoma; all 3 deceased patients obtained CR before (90)Y-RIT and died still in CR. The median overall (OS) and progression free survival (PFS) have not been reached, in this analysis both OS or PFS are 67 % at 7.5 year. The most common grade 3 or 4 adverse events were hematologic.
  
  
  CONCLUSIONS
  These results confirm the long term efficacy and safety of 4 cycles of FCR followed by (90)Y-RIT in relapsed grades 1 and 2 FL and suggest that this regimen could be a therapeutic option for this setting of patients, specially at age of 60-75 with no unexpected toxicities.
authors.affiliation: Department of Hematology Regina Elena National Cancer Institute, Via Elio Chianesi, 53 - 00144 Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pisani
authors.affiliation: Department of Nuclear Medicine Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Sciuto
authors.affiliation: Unit of Hematology and Stem Cell Transplant Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy.
authors.forename: Maria Laura
authors.initials: ML
authors.lastname: Dessanti
authors.affiliation: Biostatistics Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Diana
authors.initials: D
authors.lastname: Giannarelli
authors.affiliation: Department of Radiology Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Ramy
authors.initials: R
authors.lastname: Kayal
authors.affiliation: Department of Nuclear Medicine Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Sandra
authors.initials: S
authors.lastname: Rea
authors.affiliation: Department of Hematology Regina Elena National Cancer Institute, Via Elio Chianesi, 53 - 00144 Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Marchesi
authors.affiliation: Department of Pathology Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Mirella
authors.initials: M
authors.lastname: Marino
keywords: 90Y-ibritumomab tiuxetan; Follicular lymphoma; Radioimmunotherapy