Jabbour E, Short NJ, Montalban-Bravo G, et al. A randomized phase II study of low-dose decitabine versus low-dose azacitidine in lower risk MDS and MDS/MPN. Blood. 2017;130:1514-22.

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11-08-2022
Medicine

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Jabbour E, Short NJ, Montalban-Bravo G, et al. A randomized phase II study of low-dose decitabine versus low-dose azacitidine in lower risk MDS and MDS/MPN. Blood. 2017;130:1514-22.

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Tutorconsortium319 Tutorconsortium319 · Answer 1 · 2022-08-18T14:44:42+02:00

Myelodysplastic/myeloproliferative neoplasms (MDS/MPN) are clonal myeloid illnesses that exhibit both dysplastic and proliferative characteristics but are improperly categorized as either chronic myeloproliferative disorders or myelodysplastic syndromes (MDS) (CMPD). Hypomethylating medications (HMAs) improve survival for people with higher-risk myelodysplastic syndromes, despite less research on these conditions in lower-risk disorders (MDS).

"Randomized phase 2 study of low-dose decitabine vs low-dose azacytidine in lower-risk MDS and MDS/MPN." Explain the study.

Although less well-studied in lower-risk diseases, hypomethylating drugs (HMAs) increase survival in individuals with higher-risk myelodysplastic syndromes (MDS).

In this patient population, we contrasted the safety and effectiveness of low-dose decitabine and low-dose azacytidine. A Bayesian adaptive design was used to randomly assign adults with low- or intermediate 1-risk MDS or MDS/myeloproliferative neoplasm (MPN), including chronic myelomonocytic leukemia, to receive either azacytidine 75 mg/m2 intravenously/subcutaneously daily or decitabine 20 mg/m2 intravenously daily for 3 consecutive days on a 28-day cycle.

The overall response rate was the main result (ORR). 113 individuals received treatment between November 2012 and February 2016: 40 (35%) received azacytidine, while 73 (65%) received decitabine. The patients were 81% intermediate 1-risk patients, with a median age of 70. Nine cycles on average were received. For patients treated with decitabine and azacytidine, the ORRs were, respectively, 70% and 49% (P =.03).

Compared to 16% of patients receiving azacytidine treatment, 32% of those receiving decitabine treatment achieved transfusion independence (P =.2). The rates of cytogenetic response were 61% and 25%, respectively (P =.02). With a 20-month median follow-up, the median event-free survival was 18 months overall, 20 months for patients who received decitabine and 13 months for those who received azacytidine, respectively (P =.1).

The medication was well tolerated, and there was zero mortality after six weeks. Patients with lower-risk MDS and MDS/MPN can safely and effectively use low-dose HMAs. Further research is required to determine their impact on the natural course of lower-risk diseases.

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