This protocol addresses newly diagnosed acute myeloid leukaemia in patients who are not eligible for intensive induction — specifically those aged 75 years or older, those with an ECOG performance score of 3 or above, or those with pre-existing heart, kidney, lung, or liver disease. These factors are among the strongest predictors of non-relapse induction-related mortality and define this population as unsuitable for standard intensive chemotherapy.
Initial management in this setting used a hypomethylating agent — azacitidine or decitabine — as first choice, or low-dose cytarabine as an alternative (except in patients with adverse-risk cytogenetics, where low-dose cytarabine has very poor activity).
Escalation to this protocol is triggered when the patient has not responded or derived clinical benefit after at least 4 consecutive cycles of hypomethylating agent therapy.
Pre-existing heart, kidney, lung or liver disease, mental illness, an Eastern Cooperative Oncology Group (ECOG) performance score 3 and age 75 years are the strongest predictors for nonrelapse induction-related mortality and should be considered to determine ineligibility to intensive induction and consolidation ChT [V, B].
The HMAs azacitidine and decitabine are currently the first choice in newly diagnosed unfit AML patients [II, B].
Patients responding to initial treatment should be re-evaluated regarding their ability to undergo alloHCT using RIC, which may cure a proportion of these patients.
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