Safety and efficacy of (90) yttrium-ibritumomab-tiuxetan for untreated follicular lymphoma patients. An Italian cooperative study

Br J Haematol. 2014 Mar;164(5):710-6. doi: 10.1111/bjh.12695. Epub 2013 Dec 17.

Abstract

(90) Yttrium ((90) Y)-Ibritumomab-Tiuxetan combines the targeting advantage of a monoclonal antibody with the radiosensitivity of Follicular Lymphoma (FL). Previous studies showed that 90Y-IT is safe and effective in relapsed/refractory indolent FL, irrespective of prior treatment with rituximab. This multicentre trial aimed to evaluate the safety and the efficacy of "upfront" single-agent ((90) Y)-Ibritumomab-Tiuxetan in advanced-stage FL. The primary objective was the incidence of responses in terms of complete (CR) and partial remission (PR). Fifty patients with stage II "bulky", III or IV FL received a single treatment course with ((90) Y)-Ibritumomab-Tiuxetan as initial therapy. The median age was 60 years. Bone marrow involvement (<25%) was observed in 24 patients (48%) and 7 (14%) had an elevated lactate dehydrogenase level. The overall response (ORR) and CR rates were 94% and 86%, respectively with a median follow-up of 38·8 months. The median progression-free survival (PFS) was not reached, whereas the 3-year estimated PFS and overall survival (OS) rate was 63·4% and 90%, respectively. Grade 3/4 neutropenia and thrombocytopenia occurred in 30% and 26% of patients respectively; none experienced grade 3/4 non-haematological toxicity. No cases of secondary haematological malignancies were observed. ((90) Y)-Ibritumomab-Tiuxetan was demonstrated to be highly effective and safe as first-line treatment for advanced-stage FL.

Keywords: (90Y)-Ibritumomab-Tiuxetan; follicular lymphoma; high complete remission rate.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Female
  • Humans
  • Lymphoma, Follicular / pathology
  • Lymphoma, Follicular / radiotherapy*
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neutropenia / etiology
  • Pilot Projects
  • Radiation Injuries / etiology
  • Radioimmunotherapy / adverse effects
  • Radioimmunotherapy / methods*
  • Remission Induction
  • Survival Analysis
  • Thrombocytopenia / etiology
  • Treatment Outcome
  • Yttrium Radioisotopes / adverse effects
  • Yttrium Radioisotopes / therapeutic use*

Substances

  • Antibodies, Monoclonal
  • Yttrium Radioisotopes
  • ibritumomab tiuxetan