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

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.

• Authors: Franck Morschhauser, John Radford, Achiel Van Hoof, Barbara Botto, Ama Z S Rohatiner, Gilles Salles, Pierre Soubeyran, Herve Tilly, Angelika Bischof-Delaloye, Wim L J van Putten, Jelle W Kylstra, Anton Hagenbeek
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 31 Issue 16 Pg. 1977-83 (Jun 01 2013) ISSN: 1527-7755 [Electronic] United States
• PMID: 23547079 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antineoplastic Agents
• Yttrium Radioisotopes
• ibritumomab tiuxetan

Topics

• Adult
• Aged
• Antibodies, Monoclonal (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Disease-Free Survival
• Female
• Follow-Up Studies
• Humans
• International Cooperation
• Kaplan-Meier Estimate
• Lymphoma, Follicular (drug therapy, pathology, radiotherapy, therapy)
• Maintenance Chemotherapy
• Male
• Middle Aged
• Neoplasm Staging
• Neoplasms, Second Primary (diagnosis, etiology)
• Radioimmunotherapy (methods)
• Time Factors
• Treatment Outcome
• Yttrium Radioisotopes (therapeutic use)