title: 90Yttrium-ibritumomab tiuxetan consolidation of first remission in advanced-stage follicular non-Hodgkin lymphoma: updated results after a median follow-up of 7.3 years from the International, Randomized, Phase III First-LineIndolent trial.
abstract: OBJECTIVE
  Updated results are presented after a median follow-up of 7.3 years from the phase III First-Line Indolent Trial of yttrium-90 ((90)Y) -ibritumomab tiuxetan in advanced-stage follicular lymphoma (FL) in first remission.
  
  
  METHODS
  Patients with CD20(+) stage III or IV FL with complete response (CR), unconfirmed CR (CRu), or partial response (PR) after first-line induction treatment were randomly assigned to (90)Y-ibritumomab consolidation therapy (rituximab 250 mg/m(2) days -7 and 0, then (90)Y-ibritumomab 14.8 MBq/kg day 0; maximum 1,184 MBq) or no further treatment (control). Primary end point was progression-free survival (PFS) from date of random assignment.
  
  
  RESULTS
  For 409 patients available for analysis ((90)Y-ibritumomab, n = 207; control, n = 202), estimated 8-year overall PFS was 41% with (90)Y-ibritumomab versus 22% for control (hazard ratio [HR], 0.47; P < .001). For patients in CR/CRu after induction, 8-year PFS with (90)Y-ibritumomab was 48% versus 32% for control (HR, 0.61; P = .008), and for PR patients, it was 33% versus 10% (HR, 0.38; P < .001). For (90)Y-ibritumomab consolidation, median PFS was 4.1 years (v 1.1 years for control; P < .001). Median time to next treatment (TTNT) was 8.1 years for (90)Y-ibritumomab versus 3.0 years for control (P < .001) with approximately 80% response rates to second-line therapy in either arm, including autologous stem-cell transplantation. No unexpected toxicities emerged during long-term follow-up. Estimated between-group 8-year overall survival rates were similar. Annualized incidence rate of myelodysplastic syndrome/acute myeloblastic leukemia was 0.50% versus 0.07% in (90)Y-ibritumomab and control groups, respectively (P = .042).
  
  
  CONCLUSIONS
  (90)Y-ibritumomab consolidation after achieving PR or CR/CRu to induction confers 3-year benefit in median PFS with durable 19% PFS advantage at 8 years and improves TTNT by 5.1 years for patients with advanced FL.
authors.affiliation: Centre Hospitalier Universitaire, Lille, France. franck.morschhauser@chru-lille.fr
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: Achiel
authors.initials: A
authors.lastname: Van Hoof
authors.forename: Barbara
authors.initials: B
authors.lastname: Botto
authors.forename: Ama Z S
authors.initials: AZ
authors.lastname: Rohatiner
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
authors.forename: Pierre
authors.initials: P
authors.lastname: Soubeyran
authors.forename: Herve
authors.initials: H
authors.lastname: Tilly
authors.forename: Angelika
authors.initials: A
authors.lastname: Bischof-Delaloye
authors.forename: Wim L J
authors.initials: WL
authors.lastname: van Putten
authors.forename: Jelle W
authors.initials: JW
authors.lastname: Kylstra
authors.forename: Anton
authors.initials: A
authors.lastname: Hagenbeek
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007391:International Cooperation; D053208:Kaplan-Meier Estimate; D008224:Lymphoma, Follicular / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016609:Neoplasms, Second Primary / Q000175:diagnosis / Q000209:etiology; D016499:Radioimmunotherapy / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D015021:Yttrium Radioisotopes; C422802:ibritumomab tiuxetan