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"Although a small phase II experience, these results in elderly lymphomapatients treated with Zevalin following CHOP without rituximab demonstratehigh rates of complete remissions and overall survival and are consistent withthe potential to use Zevalin as consolidation therapy in aggressive lymphoma,"noted Jack W. Singer, M.D., Chief Medical Officer of CTI. "We continue to beimpressed with the high rate of conversion of partial to complete remissionsfollowing Zevalin consolidation irrespective of whether or not rituximabtherapy is utilized. This publication demonstrates this in elderly patientswith DLBCL while similar data in indolent lymphomas were reported at ASH 2007from the Phase III FIT study. We are currently testing this clinicallyimportant potential of Zevalin consolidation in our ongoing phase IIIpost-marketing commitment trial."
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Details of the Study
The phase II trial, reported by P.L. Zinzani et. al. from the Institute ofHematology and Medical Oncology at the University of Bologna and theDepartment of Nuclear Medicine at S. Orsola-Malpighi Hospital in BolognaItaly, was a prospective, single-arm, open-label, non-randomized studycombining CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, andprednisone) plus Zevalin, which was conducted to evaluate the efficacy andsafety of this regimen as first-line therapy in elderly (60 years of age orolder) DLBCL patients. The ORR was 100 percent, including 95 percent CR and 5percent partial remission (PR). Four (80 percent) of the five patients whoachieved less than a CR with CHOP improved their remission status afterreceiving Zevalin. With a median follow-up of 15 months, the 2-yearprogression-free survival was estimated to be 75 percent, with a 2-yearoverall survival of 95 percent. The toxicity associated with Zevalin includedsevere (grade 3 or 4) hematologic toxicity in 12 of 20 patients; the mostcommon severe side effects were neutropenia (12 patients) and thrombocytopenia(7 patients). Transfusions of platelets were given to one patient.
About Zevalin(R)
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy calledradioimmunotherapy and is indicated for the treatment of patients withrelapsed or refractory low-grade or follicular B-cell NHL, including patientswith Rituximab-refractory NHL. It was approved by the FDA in February of 2002as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex haveoccurred within 24 hours of rituximab infusions. Yttrium-90 Zevalinadministration results in severe and prolonged cytopenias in most patients.Severe cutaneous and mucocutaneous reactions have been reported. The mostserious adverse reactions of the Zevalin therapeutic regimen were primarilyhematologic, including neutropenia, thrombocytopenia, and anemia.Infusion-related toxicities were associated with pre-administration ofrituximab. The risk of he