A 7-day azacitidine treatment schedule significantly delayed the time to leukemia in patients with higher-risk myelodysplastic syndromes (MDS) compared with a 5-day treatment schedule. These findings were published in the International Journal of Hematology.
A phase 3 head-to-head trial of 7-day azacitidine (AZA-7) and a 5-day azacitidine (AZA-5) treatment schedules found a trend for AZA-7 to improve survival. In this analysis, data from the JALSG MDS212 study were reviewed for evidence of an effect on delaying transformation to leukemia.
The AZA-7 (92 patients) and AZA-5 (95 patients) cohorts were median age 73 (range, 57 to 91) and 74 (range, 48 to 86), male:female ratios were 64:28 and 66:29, and bone marrow blasts were 11% (range, 2% to 27%) and 8% (range, 1% to 29%), respectively.
Patients received a median of 5 cycles of AZA-7 and 6 cycles of AZA-5; median dose intensities were 72.0% and 74.3%, respectively.
At the last follow-up, 59 patients in the AZA-7 cohort and 68 patients in the AZA-5 cohort had died. The median survival time was 538 days for AZA-7 and 477 days for AZA-5 (P =.293). AZA-7 was associated with a 10.6% higher 2-year overall survival.
Complete remission was achieved by 14.1% of AZA-7 and 6.6% of AZA-5 recipients (P =.156). No significant differences in erythroid, platelet, or neutrophil responses were observed.
More AZA-5 recipients transformed to leukemia than AZA-7 recipients (54 vs 40). AZA-7 was associated with decreased risk for transformation to leukemia (hazard ratio [HR], 1.75; P =.023).
This study was limited as it was not a prespecified analysis.
Although this study did not provide definitive evidence of superiority, these results demonstrated that AZA-7 treatment schedule associated with improved survival and significantly decreased risk for transformation to leukemia.
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Miyazaki Y, Kiguchi T, Sato S, et al; Japan Adult Leukemia Study Group. Prospective comparison of 5‑ and 7‑day administration of azacitidine for myelodysplastic syndromes: a JALSG MDS212 trial. Int J Hematol. Published online May 4, 2022. doi:10.1007/s12185-022-03347-3