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

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.

• Authors: Adalberto Ibatici, Gian Matteo Pica, Sandro Nati, Umberto Vitolo, Barbara Botto, Chiara Ciochetto, Mario Petrini, Sara Galimberti, Elena Ciabatti, Enrico Orciuolo, Pier Luigi Zinzani, Nicola Cascavilla, Fabio Guolo, Giulio Fraternali Orcioni, Angelo M Carella
• Journal: British journal of haematology (Br J Haematol) Vol. 164 Issue 5 Pg. 710-6 (Mar 2014) ISSN: 1365-2141 [Electronic] England
• PMID: 24344981 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © 2013 John Wiley & Sons Ltd.

Chemical References

• Antibodies, Monoclonal
• Yttrium Radioisotopes
• ibritumomab tiuxetan

Topics

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