Background: A prospective, single-arm, open-label, multicenter, nonrandomised phase II trial to evaluate efficacy and safety of short fludarabine, mitoxantrone, and rituximab (FMR) induction followed by radioimmunotherapy, in untreated, intermediate/high-risk follicular non-Hodgkin's lymphoma (NHL) patients. Patients and methods: Fifty-five patients were treated using a sequential treatment schedule of four induction cycles of FMR chemoimmunotherapy, and a subsequent consolidating single administration of . 90Y-ibritumomab tiuxetan (. 90Y-IT), 8-14 weeks later. Patients were eligible for radioimmunotherapy if at least in partial response (PR) after induction, with normal platelet and granulocyte counts and a bone marrow infiltration ≤25%. Primary study end points were response rate and hematologic toxic effects; secondary end points were overall survival (OS) and progression-free survival (PFS). Results: All the 55 patients received four induction cycles with an overall response rate of 96% (38 complete responses [CR] and 15 PR). Fifty-one patients (38 in CR and 13 in PR) received . 90Y-IT. By the end of the treatment, 49/55 patients achieved a CR. With a median follow-up of 21 months, the estimated 3-year PFS was 81% and the 3-year OS 100%. Conclusions: This study has established feasibility, tolerability, and efficacy of a regimen composed by short FMR induction with . 90Y-IT consolidation in untreated intermediate/high-risk follicular NHL patients.

A phase ii trial of short course fludarabine, mitoxantrone, rituximab followed by 90y-ibritumomab tiuxetan in untreated intermediate/high-risk follicular lymphoma / P.L. Zinzani, M. Tani, A. Pulsoni, A. De Renzo, V. Stefoni, A. Broccoli, G.C. Montini, M. Fina, C. Pellegrini, L. Gandolfi, E. Cavalieri, F. Torelli, F. Scopinaro, L. Argnani, F. Quirini, E. Derenzini, M. Rossi, S. Pileri, S. Fanti, M. Baccarani. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 23:2(2012), pp. 415-420. [10.1093/annonc/mdr145]

A phase ii trial of short course fludarabine, mitoxantrone, rituximab followed by 90y-ibritumomab tiuxetan in untreated intermediate/high-risk follicular lymphoma

E. Derenzini;
2012

Abstract

Background: A prospective, single-arm, open-label, multicenter, nonrandomised phase II trial to evaluate efficacy and safety of short fludarabine, mitoxantrone, and rituximab (FMR) induction followed by radioimmunotherapy, in untreated, intermediate/high-risk follicular non-Hodgkin's lymphoma (NHL) patients. Patients and methods: Fifty-five patients were treated using a sequential treatment schedule of four induction cycles of FMR chemoimmunotherapy, and a subsequent consolidating single administration of . 90Y-ibritumomab tiuxetan (. 90Y-IT), 8-14 weeks later. Patients were eligible for radioimmunotherapy if at least in partial response (PR) after induction, with normal platelet and granulocyte counts and a bone marrow infiltration ≤25%. Primary study end points were response rate and hematologic toxic effects; secondary end points were overall survival (OS) and progression-free survival (PFS). Results: All the 55 patients received four induction cycles with an overall response rate of 96% (38 complete responses [CR] and 15 PR). Fifty-one patients (38 in CR and 13 in PR) received . 90Y-IT. By the end of the treatment, 49/55 patients achieved a CR. With a median follow-up of 21 months, the estimated 3-year PFS was 81% and the 3-year OS 100%. Conclusions: This study has established feasibility, tolerability, and efficacy of a regimen composed by short FMR induction with . 90Y-IT consolidation in untreated intermediate/high-risk follicular NHL patients.
90; Y-ibritumomab tiuxetan; Fludarabine; Follicular lymphoma; Mitoxantrone; Radioimmunotherapy; Rituximab; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols; Female; Humans; Induction Chemotherapy; Lymphoma, Follicular; Male; Middle Aged; Mitoxantrone; Prospective Studies; Radioimmunotherapy; Rituximab; Treatment Outcome; Vidarabine; Yttrium Radioisotopes
Settore MED/15 - Malattie del Sangue
2012
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/724944
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