The primary objective of this study is to describe the response to treatment with biosimilar EPO alpha in MDS patients who had already been treated with "originator" EPO alpha and were responsive, and in patients who started treatment with biosimilar EPO alpha
Age ≥ 18 years at the time of enrollment
Acquisition of informed consent to study participation and data processing
- Presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage)
Poor compliance with treatment
Very impaired general clinical condition (ECOG performance status > 3)
Concomitant treatment with antineoplastic cytotoxic drugs
All patients with MDS who started treatment with biosimilar EPO alpha at the "Seràgnoli" Institute, U.O. of Hematology of IRCCS AOU of Bologna during the period from 01 Jun 2018 to 31 Dec 2021 will be enrolled in the study. Specifically, the population will consist of * patients who initiated treatment after having already been treated with "originator" EPO alfa and responsive to treatment at the time of initiation of biosimilar EPO alfa, and * patients who started treatment without previous treatment with biosimilar EPO alfa
Cohort
Retrospective
Not listed
Response and maintenance of ORR
response to treatment (ORR) (assessed according to the response criteria established by the International Working Group (23) in patients who initiated treatment with biosimilar EPO alfa \- maintenance of ORR (assessed according to the response criteria established by the International Working Group (23) from the date of biosimilar drug initiation), in patients previously on treatment and responsive to "originator" EPO alfa who were subsequently treated with biosimilar EPO alfa
A measure of the frequency of major clinical outcomes in two groups of patients who had different modes of treatment administration with biosimilar EPO alpha
1\) DOR to EPO alpha: to biosimilar drug only in patients who started treatment with biosimilar EPO alpha; to "originator" drug + biosimilar in patients already on treatment and responsive to "originator" EPO alpha who were subsequently treated with biosimilar EPO alpha ; 2) incidence of adverse events in year/person (in both patient groups) according to NCI-CTCAE v.5.0 ; 3) number of patients who discontinued treatment with the biosimilar drug due to intolerance, loss of response, disease progression (DP), evolution into AML, or death (both groups) ; 4) number of patients who resumed the originator drug due to intolerance or failure to respond to the biosimilar drug ; 5) ORR and incidence of adverse events of patients who resumed treatment with "originator" EPO alfa after discontinuation of the biosimilar drug ; 6) incidence of evolution into AML in year/person (both groups) ; 7) OS and causes of death (both groups)
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