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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
Author(s) -
Zinzani Pier Luigi,
Tani Monica,
Fanti Stefano,
Stefoni Vittorio,
Musuraca Gerardo,
Vitolo Umberto,
Perrotti Alessio,
Fina Mariapaola,
Derenzini Enrico,
Baccarani Michele
Publication year - 2008
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23236
Subject(s) - medicine , mitoxantrone , fludarabine , ibritumomab tiuxetan , chemotherapy , oncology , lymphoma , phases of clinical research , radioimmunotherapy , nuclear medicine , immunology , antibody , cyclophosphamide , monoclonal antibody
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 ( 90 Y) 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 <25%) for subsequent 90 Y 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 90 Y 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 90 Y ibritumomab tiuxetan regimen for the treatment of patients with untreated, indolent, nonfollicular NHL. Cancer 2008. © 2008 American Cancer Society.