Safety and efficacy of 90 Y ttrium‐ I britumomab‐ T iuxetan for untreated follicular lymphoma patients. An I talian cooperative study
2013; Wiley; Volume: 164; Issue: 5 Linguagem: Inglês
10.1111/bjh.12695
ISSN1365-2141
AutoresAdalberto Ibatici, Gian Matteo Pica, S 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 Michele Carella,
Tópico(s)Cutaneous lymphoproliferative disorders research
ResumoSummary 90 Y ttrium ( 90 Y )‐ I britumomab‐ T iuxetan combines the targeting advantage of a monoclonal antibody with the radiosensitivity of F ollicular L ymphoma ( 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 )‐ I britumomab‐ T iuxetan 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 )‐ I britumomab‐ T iuxetan 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 )‐ I britumomab‐ T iuxetan was demonstrated to be highly effective and safe as first‐line treatment for advanced‐stage FL .
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