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-line indolent trial.
Radford, John A
Van Hoof, A
van Putten, W
AffiliationFranck Morschhauser, Centre Hospitalier Universitaire, Lille; Gilles Salles, Centre Hospitalier Lyon Sud, Pierre Bénite; Pierre Soubeyran, Institut Bergonié, Bordeaux; Herve Tilly, Centre Henri Becquerel, Rouen, France; John Radford, The Christie National Health Service Foundation Trust and The University of Manchester, Manchester; Ama Z.S. Rohatiner, St Bartholomew's Hospital, London, United Kingdom; Achiel Van Hoof, University Hospital St Jan, Brugge, Belgium; Barbara Botto, Azienda Ospedaliera Citta della Salute e delia Scienza, Torino, Italy; Angelika Bischof-Delaloye, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Wim L.J. van Putten, Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) Data Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, Amsterdam/HOVON, the Netherlands; and Jelle W. Kylstra, Spectrum Pharmaceuticals, Irvine, CA.
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AbstractPURPOSEUpdated 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. PATIENTS AND METHODSPatients 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.ResultsFor 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). CONCLUSION(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.
Citation90Yttrium-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-line indolent trial. 2013: J Clin Oncol
JournalJournal of Clinical Oncology