What is the incidence of leukemia and myelodysplastic syndrome (MDS) following administration of the regimen?
The crude incidence of treatment-related MDS/AML associated with conventional-dose chemotherapy or radiotherapy has been reported to range from 0% to 12%.5 Among 204 patients receiving Y-90 ZEVLIN following first-line treatment, 2 (1%) developed acute myelogenous leukemia (AML) at approximately 2 and 3.3 years after ZEVALIN administration, respectively.1 Among 746 patients with relapsed/refractory NHL, 19 (2.6%) patients developed MDS/AML with a median follow-up of 4.4 years. The overall incidence of MDS/AML among the 211 patients included in the clinical studies was 5.2% (11/211), with a median follow-up of 6.5 years and median time to development of MDS/AML of 2.9 years. The cumulative Kaplan-Meier estimated incidence of MDS/secondary leukemia in this patient population was 2.2% at 2 years and 5.9% at 5 years. The incidence of MDS/AML among the 535 patients in the expanded access programs was 1.5% (8/535) with a median follow-up of 4.4 years and median time to development of MDS/AML
