Abstract

6696 Introduction: 90Y Ibritumomab tiuxetan (Zevalin) radioimmunotherapy (RIT) was approved by the FDA in February 2002. RIT delivers high radiation dosage to tumors, and dose-limiting toxicity is hematological. Since tMDS/tAML has been associated with prior exposure to chemotherapy and radiation, we determined the incidence of tMDS/tAML in pts treated with ibritumomab tiuxetan from 4 registrational trials that have long-term follow-up. Results: In the 4 studies, 211 pts were treated with ibritumomab tiuxetan. These pts had received a median of 2 (range 1 - 9) prior treatments. With a median follow-up of 38 mos (range 1.2 - 75.5 mos), 7 pts (3.3%) have developed tMDS/tAML. Diagnosis of tMDS/tAML occurred 8 to 50 mos (median 18 mos) following therapy and 4.3 to 14 yrs (median 8 yrs) following the diagnosis of lymphoma. The annualized rates for the development of tMDS/tAML were 0.34% and 0.70% per yr from initial NHL diagnosis and from ibritumomab tiuxetan treatment date, respectively. This compares favorab...

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