title: Phase II study of (90)Y Ibritumomab tiuxetan (Zevalin) in patients with previously untreated marginal zone lymphoma.
abstract: The best upfront therapy for patients with non-gastric extranodal marginal zone lymphomas (MZLs) is not defined. We assessed the safety and efficacy of radioimmunotherapy with (90)yttrium ((90)Y) ibritumomab tiuxetan as upfront therapy in MZL (NCT00453102). A total of 16 patients were enrolled, 81% with advanced-stage disease and 44% with bulky disease. The overall response rate (ORR) at 12 weeks post-therapy was 87.5% (90% confidence interval [CI]: 65.6-97.7%), including a complete response in eight (50%), complete response unconfirmed in one (6%) and partial response in five (31%) patients. With a median follow-up of 65.6 months (range 4.0-96.5), the median progression-free survival (PFS) was 47.6 months (range 4.0-93.3) and median overall survival (OS) was not reached. The 5-year PFS was 40% (90% CI: 19.9-59.5%) and 5-year OS was 71.8% (90% CI: 46.8-86.5%). Overall, (90)Y ibritumomab tiuxetan was well tolerated and led to long-term responses and PFS rates.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, University of Miami Miller School of Medicine , Miami, FL , USA.
authors.forename: Izidore S
authors.initials: IS
authors.lastname: Lossos
authors.forename: Jesus C
authors.initials: JC
authors.lastname: Fabregas
authors.forename: Tulay
authors.initials: T
authors.lastname: Koru-Sengul
authors.forename: Feng
authors.initials: F
authors.lastname: Miao
authors.forename: Deborah
authors.initials: D
authors.lastname: Goodman
authors.forename: Aldo N
authors.initials: AN
authors.lastname: Serafini
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hosein
authors.forename: Alexandra
authors.initials: A
authors.lastname: Stefanovic
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Rosenblatt
authors.forename: James E
authors.initials: JE
authors.lastname: Hoffman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000209:etiology; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000209:etiology; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D018442:Lymphoma, B-Cell, Marginal Zone / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D016499:Radioimmunotherapy / Q000009:adverse effects / Q000379:methods*; D012074:Remission Induction; D013921:Thrombocytopenia / Q000209:etiology; D016896:Treatment Outcome; D015021:Yttrium Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D015021:Yttrium Radioisotopes; C422802:ibritumomab tiuxetan
keywords: 90Y ibritumomab tiuxetan; Marginal zone lymphoma; radioimmunotherapy