Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

Summary

The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.

Timeline

Start

2012-11-06

Primary completion

2020-01-08

Completion

2020-01-08

Outcome

Met primary endpoint

paper The ORRs were 70% and 49% (P = .03) for patients treated with decitabine and azacitidine, respectively. PMID 28774880 ↗

Publications

• Sasaki K, Jabbour E, Montalban-Bravo G, Darbaniyan F, Do KA, Class C, Short NJ, Kanagal-Shamana R, Kadia T, Borthakur G, Pemmaraju N, Cortes J, Ravandi F, Alvarado Y, Chien K, Komrokji R, Sekeres MA, Steensma DP, DeZern A, Roboz G, Soltysiak K, Yang H, Kantarjian HM, Garcia-Manero G. Low-Dose Decitabine versus Low-Dose Azacitidine in Lower-Risk MDS. NEJM Evid. 2022 Oct;1(10):EVIDoa2200034. doi: 10.1056/EVIDoa2200034. Epub 2022 Aug 9.
• Jabbour E, Short NJ, Montalban-Bravo G, Huang X, Bueso-Ramos C, Qiao W, Yang H, Zhao C, Kadia T, Borthakur G, Pemmaraju N, Sasaki K, Estrov Z, Cortes J, Ravandi F, Alvarado Y, Komrokji R, Sekeres MA, Steensma DP, DeZern A, Roboz G, Kantarjian H, Garcia-Manero G. Randomized phase 2 study of low-dose decitabine vs low-dose azacitidine in lower-risk MDS and MDS/MPN. Blood. 2017 Sep 28;130(13):1514-1522. doi: 10.1182/blood-2017-06-788497. Epub 2017 Aug 3.

Drugs

Indications