title: 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.affiliation: U.O. Ematologia 1, IRCCS AOU San Martino-IST, Genova, Italy.
authors.forename: Adalberto
authors.initials: A
authors.lastname: Ibatici
authors.forename: Gian Matteo
authors.initials: GM
authors.lastname: Pica
authors.forename: Sandro
authors.initials: S
authors.lastname: Nati
authors.forename: Umberto
authors.initials: U
authors.lastname: Vitolo
authors.forename: Barbara
authors.initials: B
authors.lastname: Botto
authors.forename: Chiara
authors.initials: C
authors.lastname: Ciochetto
authors.forename: Mario
authors.initials: M
authors.lastname: Petrini
authors.forename: Sara
authors.initials: S
authors.lastname: Galimberti
authors.forename: Elena
authors.initials: E
authors.lastname: Ciabatti
authors.forename: Enrico
authors.initials: E
authors.lastname: Orciuolo
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Zinzani
authors.forename: Nicola
authors.initials: N
authors.lastname: Cascavilla
authors.forename: Fabio
authors.initials: F
authors.lastname: Guolo
authors.forename: Giulio
authors.initials: G
authors.lastname: Fraternali Orcioni
authors.forename: Angelo M
authors.initials: AM
authors.lastname: Carella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D010865:Pilot Projects; D011832:Radiation Injuries / Q000209:etiology; D016499:Radioimmunotherapy / Q000009:adverse effects / Q000379:methods*; D012074:Remission Induction; D016019:Survival Analysis; 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; follicular lymphoma; high complete remission rate