Safety and efficacy of 90 Yttrium- Ibritumomab- Tiuxetan for untreated follicular lymphoma patients. An Italian cooperative study.

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 90 Y- 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. [ABSTRACT FROM AUTHOR]