This protocol addresses a distinct and clinically important scenario: a relatively younger patient with higher-risk MDS who, despite being a potential candidate for intensive approaches, does not currently have an available allogeneic stem cell donor.
Higher-risk myelodysplastic syndrome is defined as an IPSS-R score of 4.0 or above — encompassing high- and very high-risk patients, as well as the remaining intermediate-risk patients in this range. This protocol applies specifically to patients who are 70 years of age or younger, have no unfavourable karyotype, and for whom no allogeneic stem cell donor is currently available.
In fit patients meeting this profile, treatment may involve an AML-like intensive chemotherapy regimen — considered particularly where marrow blast burden is substantial and ideally used as a bridge toward transplant should a donor become available — or an alternative structured hypomethylating agent schedule, generally pursued over multiple courses. The complete criteria for selecting between these pathways, their sequencing, and the full regimen specifications are available in the protocol below.
The complete regimen — including agent selection, scheduling, and eligibility details — is in the full protocol.DOI: 10.1016/j.annonc.2020.11.002