Phase II Study of Zevalin(R) Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicula...(alinsights into the potential utility of...),Health

The study results are reported in the current issue of CANCER at http://www3.interscience.wiley.com/journal/104532863/issue

Study Details

Between February 2005 and June 2006 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone, 8 lymphocytoplasmic, and 8 small lymphocytic) were treated using a novel regimen that consisted of 6 cycles of fludarabine/mitoxantrone (FM) chemotherapy followed 6 to 10 weeks later by yttrium-90(90Y) ibritumomab tiuxetan (Zevalin(R)). After chemotherapy the overall response rate was 80.5% and included 50% CR and 30.5% PR. Of the 20 patients (13CR/7PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration <25%) for subsequent Zevalin, 100% obtained a CR at the end of treatment. With a median follow up of 20 months, the estimated three-year progression free survival (PFS) was 89.5 percent. The FM treatment was well-tolerated; there were no treatment-related deaths. Reversible hematologic toxicities included neutropenia grade 4 in 5 patients and grade 3 in 13 patients. Only 1 patient developed febrile neutropenia. Following Zevalin administration grade 3-4 thrombocytopenia occurred in 16 of 20 patients with grade 3-4 neutropenia reported in 11 of 20 patients. Four patients received GCSF and 3 patients received platelet transfusions. Only 1 patient experience febrile neutropenia. The authors concluded "In this study we established the feasibility, tolerability and efficacy of sequential treatement with 6 cycles of FM chemotherapy followed by 90Y ibritumomab tiuxetan as front line therapy for patients with untreated, indolent, nonfollicular NHL. To our knowledge the data repr
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