A phase 2 trial of fludarabine and mitoxantrone chemotherapy followed by yttrium-90 ibritumomab tiuxetan for patients with previously untreated, indolent, nonfollicular, non-Hodgkin lymphoma

Pier Luigi Zinzani, Monica Tani, Stefano Fanti, Vittorio Stefoni, Gerardo Musuraca, Umberto Vitolo, Alessio Perrotti, Mariapaola Fina, Enrico Derenzini, Michele Baccarani

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND. A prospective, single-arm, open-label, nonrandomized Phase 2 study of combined fludarabine and mitoxantrone (FM) plus radioimmunotherapy was conducted to evaluate efficacy and safety in patients with untreated, indolent, nonfollicular non-Hodgkin lymphoma (NHL). METHODS. Between February 2005 and June 2006, at their institute, the authors treated 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone lymphomas, 8 lymphoplasmacytic lymphomas, and 8 small lymphocytic lymphomas) using a novel regimen that consisted of 6 cycles of FM chemotherapy followed 6 to 10 weeks later by yttrium-90 (90Y) ibritumomab tiuxetan. RESULTS. After FM chemotherapy, the overall response rate was 80.5% and included a 50% complete remission (CR) rate (13 patients) and a 30.5% partial remission (PR) rate (8 patients). Of the 20 patients (13 with CR and 7 with PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration 90Y ibritumomab tiuxetan, 100% obtained a CR at the end of the entire treatment regimen. At a median follow-up of 20 months, the estimated 3-year progression-free survival rate was 89.5%, and the estimated 3-year overall survival rate was 100%. The 90Y ibritumomab tiuxetan toxicity included grade ≥3 hematologic toxicity in 16 of 20 patients; the most common grade ≥3 toxicities were neutropenia (11 patients) and thrombocytopenia (16 patients) (adverse events were graded according to the World Health Organization criteria for toxicity). Transfusions of erythrocytes and/or platelets were given to 5 patients. CONCLUSIONS. The current study established the feasibility, tolerability, and efficacy of the FM plus 90Y ibritumomab tiuxetan regimen for the treatment of patients with untreated, indolent, nonfollicular NHL.

Original languageEnglish
Pages (from-to)856-862
Number of pages7
JournalCancer
Volume112
Issue number4
DOIs
Publication statusPublished - Feb 15 2008

Keywords

  • Chemotherapy
  • Efficacy
  • Indolent
  • Nonfollicular non-Hodgkin lymphoma
  • Radioimmunotherapy
  • Tolerability

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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