title: A phase 2 trial of fludarabine and mitoxantrone chemotherapy followed by yttrium-90 ibritumomab tiuxetan for patients with previously untreated, indolent, nonfollicular, non-Hodgkin lymphoma.
abstract: BACKGROUND
  A prospective, single-arm, open-label, nonrandomized Phase 2 study of combined fludarabine and mitoxantrone (FM) plus radioimmunotherapy was conducted to evaluate efficacy and safety in patients with untreated, indolent, nonfollicular non-Hodgkin lymphoma (NHL).
  
  
  METHODS
  Between February 2005 and June 2006, at their institute, the authors treated 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone lymphomas, 8 lymphoplasmacytic lymphomas, and 8 small lymphocytic lymphomas) using a novel regimen that consisted of 6 cycles of FM chemotherapy followed 6 to 10 weeks later by yttrium-90 (90Y) ibritumomab tiuxetan.
  
  
  RESULTS
  After FM chemotherapy, the overall response rate was 80.5% and included a 50% complete remission (CR) rate (13 patients) and a 30.5% partial remission (PR) rate (8 patients). Of the 20 patients (13 with CR and 7 with PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration <25%) for subsequent 90Y ibritumomab tiuxetan, 100% obtained a CR at the end of the entire treatment regimen. At a median follow-up of 20 months, the estimated 3-year progression-free survival rate was 89.5%, and the estimated 3-year overall survival rate was 100%. The 90Y ibritumomab tiuxetan toxicity included grade >or=3 hematologic toxicity in 16 of 20 patients; the most common grade >or=3 toxicities were neutropenia (11 patients) and thrombocytopenia (16 patients) (adverse events were graded according to the World Health Organization criteria for toxicity). Transfusions of erythrocytes and/or platelets were given to 5 patients.
  
  
  CONCLUSIONS
  The current study established the feasibility, tolerability, and efficacy of the FM plus 90Y ibritumomab tiuxetan regimen for the treatment of patients with untreated, indolent, nonfollicular NHL.
authors.affiliation: Institute of Hematology and Medical Oncology L&A Seragnoli, University of Bologna, Bologna, Italy. plzinzo@med.unibo.it
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.forename: Monica
authors.initials: M
authors.lastname: Tani
authors.forename: Stefano
authors.initials: S
authors.lastname: Fanti
authors.forename: Vittorio
authors.initials: V
authors.lastname: Stefoni
authors.forename: Gerardo
authors.initials: G
authors.lastname: Musuraca
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.forename: Alessio
authors.initials: A
authors.lastname: Perrotti
authors.forename: Mariapaola
authors.initials: M
authors.lastname: Fina
authors.forename: Enrico
authors.initials: E
authors.lastname: Derenzini
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009503:Neutropenia / Q000139:chemically induced; D016499:Radioimmunotherapy / Q000009:adverse effects / Q000379:methods*; D016019:Survival Analysis; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D015021:Yttrium Radioisotopes; C422802:ibritumomab tiuxetan; D008942:Mitoxantrone; D014740:Vidarabine; C024352:fludarabine