title: A phase II trial of short course fludarabine, mitoxantrone, rituximab followed by ⁹⁰Y-ibritumomab tiuxetan in untreated intermediate/high-risk follicular lymphoma.
abstract: BACKGROUND
  A prospective, single-arm, open-label, multicenter, nonrandomised phase II trial to evaluate efficacy and safety of short fludarabine, mitoxantrone, and rituximab (FMR) induction followed by radioimmunotherapy, in untreated, intermediate/high-risk follicular non-Hodgkin's lymphoma (NHL) patients.
  
  
  METHODS
  Fifty-five patients were treated using a sequential treatment schedule of four induction cycles of FMR chemoimmunotherapy, and a subsequent consolidating single administration of (90)Y-ibritumomab tiuxetan ((90)Y-IT), 8-14 weeks later. Patients were eligible for radioimmunotherapy if at least in partial response (PR) after induction, with normal platelet and granulocyte counts and a bone marrow infiltration ≤ 25%. Primary study end points were response rate and hematologic toxic effects; secondary end points were overall survival (OS) and progression-free survival (PFS).
  
  
  RESULTS
  All the 55 patients received four induction cycles with an overall response rate of 96% (38 complete responses [CR] and 15 PR). Fifty-one patients (38 in CR and 13 in PR) received (90)Y-IT. By the end of the treatment, 49/55 patients achieved a CR. With a median follow-up of 21 months, the estimated 3-year PFS was 81% and the 3-year OS 100%.
  
  
  CONCLUSIONS
  This study has established feasibility, tolerability, and efficacy of a regimen composed by short FMR induction with (90)Y-IT consolidation in untreated intermediate/high-risk follicular NHL patients.
authors.affiliation: Institute of Hematology and Medical Oncology L e A Seràgnoli, Policlinico Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy. pierluigi.zinzani@unibo.it
authors.forename: P L
authors.initials: PL
authors.lastname: Zinzani
authors.forename: M
authors.initials: M
authors.lastname: Tani
authors.forename: A
authors.initials: A
authors.lastname: Pulsoni
authors.forename: A
authors.initials: A
authors.lastname: De Renzo
authors.forename: V
authors.initials: V
authors.lastname: Stefoni
authors.forename: A
authors.initials: A
authors.lastname: Broccoli
authors.forename: G C
authors.initials: GC
authors.lastname: Montini
authors.forename: M
authors.initials: M
authors.lastname: Fina
authors.forename: C
authors.initials: C
authors.lastname: Pellegrini
authors.forename: L
authors.initials: L
authors.lastname: Gandolfi
authors.forename: E
authors.initials: E
authors.lastname: Cavalieri
authors.forename: F
authors.initials: F
authors.lastname: Torelli
authors.forename: F
authors.initials: F
authors.lastname: Scopinaro
authors.forename: L
authors.initials: L
authors.lastname: Argnani
authors.forename: F
authors.initials: F
authors.lastname: Quirini
authors.forename: E
authors.initials: E
authors.lastname: Derenzini
authors.forename: M
authors.initials: M
authors.lastname: Rossi
authors.forename: S
authors.initials: S
authors.lastname: Pileri
authors.forename: S
authors.initials: S
authors.lastname: Fanti
authors.forename: M
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D011446:Prospective Studies; D016499:Radioimmunotherapy; D000069283:Rituximab; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015021:Yttrium Radioisotopes / Q000008:administration & dosage*
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D015021:Yttrium Radioisotopes; D000069283:Rituximab; C422802:ibritumomab tiuxetan; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine