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Clinical Data Reported on Vidaza in Hematologic Malignancies and,Advanced Solid Tumors

(Vidaza) in patients with Myelodysplastic Syndromes (MDS) - R. Lyons; Abstract #7083; June 2, 2007; 8am-12pm; McCormick Place Convention Center, S Hall A2)

Interim results from a Phase II, multi-center, open-label trial comparing three alternate dosing schedules of Azacitidine (AZA) in patients with MDS were presented in a poster session on Saturday, June 2. Patients were randomized to one of three regimens that were repeated every four weeks: AZA 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); AZA 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); and AZA 5 (75 mg/m2/day x 5 days).

Of 122 patients who had received two or more cycles of therapy at the time of evaluation, 61 percent experienced hematologic improvement (HI), defined as major or minor in at least one cell line. This reflects HI of 53, 70 and 60 percent in the AZA 5-2-2, AZA 5-2-5, and AZA 5 arms, respectively.

Across each of the three alternative dose regimens, 65 percent to 80 percent of patients who were red blood cell (RBC) transfusion dependent at baseline achieved transfusion independence. Comparable beneficial effects on transfusions were demonstrated in all patients and in low-risk patients for both RBCs and platelets.

To determine whether response/improvement can be maintained after six cycles, the study includes a 12 month maintenance period, in which patients are re-randomized to one of two arms: AZA 5 every four weeks or AZA 5 every six weeks. Ten patients have completed 18 treatment cycles.

These data indicate that the three alternative azacitidine dosing schedules have safety and efficacy profiles consistent with the FDA-approved regimen. Alternate dosing schedules may offer patients and clinicians a more convenient schedule by eliminating weekend treatments. Vidaza was the first demethylating agent to be approved by
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