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The study, conducted at the Institute of Hematology and Medical Oncologyat University of Bologna, Italy, investigated the use of a single dose ofZevalin(R) (Ibritumomab Tiuxetan) as consolidation therapy following treatmentwith a regimen of fludarabine and mitoxantrone (FM chemotherapy) among 26patients with newly diagnosed non-follicular indolent NHL. Non-follicularlymphomas are also referred to as intermediate grade compared to the low gradefollicular or high grade diffuse B cell variety. FM chemotherapy resulted in50 percent of patients achieving a complete remission (CR) and 30 percentachieving a partial remission (PR). Of the 20 patients (13 with CR and 7 withPR) who were evaluable for Zevalin consolidation, 100 percent obtained a CR atthe end of treatment. With a median follow up of 20 months, the estimatedthree-year progression free survival (PFS) was 89.5 percent. The most commongreater than or equal to grade 3 toxicities included neutropenia (11 patients)and thrombocytopenia (16 patients).
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"This single arm, non-randomized phase II trial provides additionalinsights into the potential utility of RIT in intermediate grade NHL, asubtype where CRs are infrequent with rituximab therapy," noted Jack W.Singer, M.D., Chief Medical Officer of CTI.
The study results are reported in the current issue of CANCER athttp://www3.interscience.wiley.com/journal/104532863/issue
Study Details
Between February 2005 and June 2006 26 eligible patients with previouslyuntreated, indolent, nonfollicular NHL (10 marginal zone, 8 lymphocytoplasmic,and 8 small lymphocytic) were treated using a novel regimen that consisted of6 cycles of fludarabine/mitoxantrone (FM) chemotherapy followed 6 to 10 weekslater by yttrium-90(90Y) ibritumomab tiuxetan (Zevalin(R)). After chemotherapythe overall response rate was 80.5% and included 50% CR and 30.5% PR. Of the20 patients (13CR/7PR) who were evaluable (at least a PR with normal plateletcounts 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. TheFM treatment was well-tolerated; there were no treatment-related deaths.Reversible hematologic toxicities included neutropenia grade 4 in 5 patientsand grade 3 in 13 patients. Only 1 patient developed febrile neutropenia.Following Zevalin administration grade 3-4 thrombocytopenia occurred in 16 of20 patients with grade 3-4 neutropenia reported in 11 of 20 patients. Fourpatients received GCSF and 3 patients received platelet transfusions. Only 1patient experience febrile neutropenia. The authors concluded "In this studywe established the feasibility, tolerability and efficacy of sequentialtreatement with 6 cycles of FM chemotherapy followed by 90Y ibritumomabtiuxetan as front line therapy for patients with untreated, indolent,nonfollicular NHL. To our knowledge the data represent the first demonstrationin the literature of the real role of 90Y ibritumomab tiuxetan in thetreatment of indolent nonfollicular NHL. Because this novel sequentialtreatment appears to be promising compared with results reported for CHOP andCVP- containing regimens plus rituximab, we believe the current phase II trialrepresents an important first step and positive new angle in therapy to combatindolent, nonfollicular NHL"
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