Phase III Trial of Consolidation Therapy With Yttrium-90–Ibritumomab Tiuxetan Compared With No Additional Therapy After First Remission in Advanced Follicular Lymphoma

Abstract

Purpose We conducted an international, randomized, phase III trial to evaluate the efficacy and safety of consolidation with yttrium-90 (90Y)–ibritumomab tiuxetan in patients with advanced-stage follicular lymphoma in first remission. Patients and Methods Patients with CD20+ stage III or IV follicular lymphoma, who achieved a complete response (CR)/unconfirmed CR (CRu) or partial response (PR) after first-line induction treatment, were randomly assigned to receive 90Y-ibritumomab tiuxetan (rituximab 250 mg/m2 on day −7 and day 0 followed on day 0 by 90Y-ibritumomab tiuxetan 14.8 MBq/kg; maximum of 1,184 MBq) or no further treatment (control). The primary end point was progression-free survival (PFS), which was calculated from the time of random assignment. Results A total of 414 patients (consolidation, n = 208; control, n = 206) were enrolled at 77 centers. 90Y-ibritumomab tiuxetan consolidation significantly prolonged median PFS (after a median observation time of 3.5 years) in all patients (36.5 v 13.3...