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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)415-420
Number of pages6
JournalAnnals of Oncology
Volume23
Issue number2
DOIs
Publication statusPublished - Feb 2012

Keywords

  • Y-ibritumomab tiuxetan
  • Fludarabine
  • Follicular lymphoma
  • Mitoxantrone
  • Radioimmunotherapy
  • Rituximab

ASJC Scopus subject areas

  • Oncology
  • Hematology

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