Low dose Vidaza and thalidomide is an effective combination for patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML)

Abstract

6570 Vidaza and thalidomide were administered to 29 patients with MDS or AML. Vidaza was given at a dose of 75mg/kg subq × 5 days q28 days and Thalidomide starting at 50mg/day and increasing to 100mg. Therapy was well tolerated. Median age was 70 years, and there were 16 males. Two patients had RA, 2 RARS, 9 RAEB, 4 CMMoL, 10 AML and 2 Unknowns. According to IPSS, 1 had low, 7 had Int-1, 5 had Int-2 and 4 had high risk disease, and 2 unclassified (10 had AML). Eleven patients had normal, 14 abnormal and 4 unknown for cytogenetics. Seven patients went off the study due to disease progression (5) or refused therapy (1), died within a week of treatment initiation (1) while 2 are on the first cycle and too early for evaluation. Twenty-five patients are evaluable for outcome. Ten patients received 5 or more cycles of Vidaza. HI was seen in 14/25 (56%), and stable disease in 6/25 (24%) while 5/25 (20%) had disease progression. Six patients experienced complete remission (CR) and are still receiving therapy (24%), 1 experienced HI-E, 2 HI-ANC, 3 HI-P, and 2 had a bilineage improvement (HI-P and ANC and HI-E and ANC). Of 10 AML patients, three went off study due to disease progression, 1 had stable disease, 6 responded with 4 complete remissions (CR), 1 HI-ANC and 1 HI-P. Interestingly, 6/10 AMLs had a history of prior MDS, 3/6 achieved CR, 2/6 had HI (ANC and platelets) and 1 has stable disease (continuing treatment). Among the 4 de novo AMLs, 1 had CR and 3 showed disease progression. We conclude that a combination of low dose Vidaza and thalidomide is well tolerated, and highly effective therapy for the treatment of patients with MDS as well as AML arising from a prior MDS. The ability to treat secondary MDS as out-patient and achieve such a high response rate represents a paradigm shift in AML therapy. No significant financial relationships to disclose.