In this Phase 2 prospective, multi-center, randomized, open-label 3-arm trial, a total of 151 MDS patients were randomized to one of three regimens administered subcutaneous every four weeks for six cycles: Vidaza 5-2-2 (75 mg/m2/day x 5 days, two days off therapy, two additional days at same dose as the first five days; N=50); Vidaza 5-2-5 (50 mg/m2/day x 5 days, followed by 2 days off therapy and five additional days at the same dose as the first five days; N=51); Vidaza 5 (75 mg/m2/day x 5 days; N=50). The majority of patients (57 percent) were classified with FAB low-risk disease (RA/RARS), while 33 percent had FAB higher-risk MDS (RAEB/RAEB-T).
"These trial data suggest that transfusion dependency is reduced with five-day dosing schedules," said Dr. Lyons. "This could succeed in normalizing cytopenias and improve the daily lives of these patients."
The study, which is ongoing, includes this preliminary analysis of the first six cycles of therapy. Across the three alternative dose regimens, between 44 and 55 percent of evaluable patients experienced HI, defined as major or minor in at least one cell line (erythroid, platelet, or neutrophil). This reflects HI of 44, 52, and 55 percent in the Vidaza 5-2-2, Vidaza 5-2-5, and Vidaza 5 arms, respectively.
Further, across the three alternative dose regimens, between 55 and 63 percent of patients who were red blood cell (RBC) transfusion dependent at baseline achieved transfusion independence. This reflects overall RBC transfusion independence rates of 55, 60, and 63 percent in the Vidaza 5-2-2, Vidaza 5-2-5, and Vidaza 5 arms, respectively. Among transfusion-dependent patients with FAB low-risk disease, RBC transfusion independence was achieved by 60, 56, and 61 percent, respectively.
Each dosing schedule offered a safety profile similar to the well-
established profile seen with standard Vidaza dosing. No treatment-related
mortalities were reported. M
|SOURCE Pharmion Corporation|
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