Originally published as JCO Early Release 10.1200/JCO.2008.17.1058 on March 2 2009

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Hematologic Response to Three Alternative Dosing Schedules of Azacitidine in Patients With Myelodysplastic Syndromes

From the Cancer Care Centers of South Texas and US Oncology, San Antonio and Houston, TX; Hematology & Oncology Specialists, LLC, New Orleans, LA; Joliet Oncology Hematology Associates, Joliet, IL; Cancer Care Northwest, Spokane, WA; The Sarah Cannon Research Institute, Nashville, TN; Rocky Mountain Cancer Centers, LLP, Denver, CO; and Celgene Corporation, Overland Park, KS.

Corresponding author: Roger M. Lyons, MD, Cancer Care Centers of South Texas and US Oncology, 4411 Medical Dr #100, San Antonio, TX 78229; e-mail: roger.lyons{at}usoncology.com.

Purpose Azacitidine (AZA) is effective treatment for myelodysplastic syndromes (MDS) at a dosing schedule of 75 mg/m²/d subcutaneously for 7 days every 4 weeks. The initial phase of this ongoing multicenter, community-based, open-label study evaluated three alternative AZA dosing schedules without weekend dosing.

Patients and Methods MDS patients were randomly assigned to one of three regimens every 4 weeks for six cycles: AZA 5-2-2 (75 mg/m²/d subcutaneously for 5 days, followed by 2 days no treatment, then 75 mg/m²/d for 2 days); AZA 5-2-5 (50 mg/m²/d subcutaneously for 5 days, followed by 2 days no treatment, then 50 mg/m²/d for 5 days); or AZA 5 (75 mg/m²/d subcutaneously for 5 days).

Results Of patients randomly assigned to AZA 5-2-2 (n = 50), AZA 5-2-5 (n = 51), or AZA 5 (n = 50), most were French-American-British (FAB) lower risk (refractory anemia [RA]/RA with ringed sideroblasts/chronic myelomonocytic leukemia with < 5% bone marrow blasts, 63%) or RA with excess blasts (30%), and 79 (52%) completed six treatment cycles. Hematologic improvement (HI) was achieved by 44% (22 of 50), 45% (23 of 51), and 56% (28 of 50) of AZA 5-2-2, AZA 5-2-5, and AZA 5 arms, respectively. Proportions of RBC transfusion–dependent patients who achieved transfusion independence were 50% (12 of 24), 55% (12 of 22), and 64% (16 of 25), and of FAB lower-risk transfusion-dependent patients were 53% (nine of 17), 50% (six of 12), and 61% (11 of 18), respectively. In the AZA 5-2-2, AZA 5-2-5, and AZA 5 groups, 84%, 77%, and 58%, respectively, experienced 1 grade 3 to 4 adverse events.

Conclusion All three alternative dosing regimens produced HI, RBC transfusion independence, and safety responses consistent with the currently approved AZA regimen. These results support AZA benefits in transfusion-dependent lower-risk MDS patients.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-5, 2007, and at the 49th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2007.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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