PMID- 23547079 OWN - NLM STAT- MEDLINE DCOM- 20130726 LR - 20201219 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 31 IP - 16 DP - 2013 Jun 1 TI - 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. PG - 1977-83 LID - 10.1200/JCO.2012.45.6400 [doi] AB - PURPOSE: 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. PATIENTS AND 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). 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. FAU - Morschhauser, Franck AU - Morschhauser F AD - Centre Hospitalier Universitaire, Lille, France. franck.morschhauser@chru-lille.fr FAU - Radford, John AU - Radford J FAU - Van Hoof, Achiel AU - Van Hoof A FAU - Botto, Barbara AU - Botto B FAU - Rohatiner, Ama Z S AU - Rohatiner AZ FAU - Salles, Gilles AU - Salles G FAU - Soubeyran, Pierre AU - Soubeyran P FAU - Tilly, Herve AU - Tilly H FAU - Bischof-Delaloye, Angelika AU - Bischof-Delaloye A FAU - van Putten, Wim L J AU - van Putten WL FAU - Kylstra, Jelle W AU - Kylstra JW FAU - Hagenbeek, Anton AU - Hagenbeek A LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130401 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (Yttrium Radioisotopes) RN - 4Q52C550XK (ibritumomab tiuxetan) SB - IM MH - Adult MH - Aged MH - Antibodies, Monoclonal/*therapeutic use MH - Antineoplastic Agents/*therapeutic use MH - Disease-Free Survival MH - Female MH - Follow-Up Studies MH - Humans MH - International Cooperation MH - Kaplan-Meier Estimate MH - Lymphoma, Follicular/drug therapy/pathology/radiotherapy/*therapy MH - Maintenance Chemotherapy MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Neoplasms, Second Primary/diagnosis/etiology MH - Radioimmunotherapy/*methods MH - Time Factors MH - Treatment Outcome MH - Yttrium Radioisotopes/therapeutic use EDAT- 2013/04/03 06:00 MHDA- 2013/07/28 06:00 CRDT- 2013/04/03 06:00 PHST- 2013/04/03 06:00 [entrez] PHST- 2013/04/03 06:00 [pubmed] PHST- 2013/07/28 06:00 [medline] AID - JCO.2012.45.6400 [pii] AID - 10.1200/JCO.2012.45.6400 [doi] PST - ppublish SO - J Clin Oncol. 2013 Jun 1;31(16):1977-83. doi: 10.1200/JCO.2012.45.6400. Epub 2013 Apr 1.