Development of a Derived Induction Failure and Relapse (DIFR) Variable for Acute Myeloid Leukemia (AML) Using Real-World (RW) Data from an Electronic Health Record (EHR)-Derived Database
Fullerton C1, Zhang Q1, Magee K1, Richey M1, Williams T1, Donnelly D1, Wadé N2, Dolor A1, Sawas A1
1Flatiron Health, New York, NY, USA, 2Flatiron Health, Stone Mountain, GA, USA
OBJECTIVES: This study employed a derivation approach to identify rw disease progression in AML, as defined by induction failure and relapse events.
METHODS: Patients with AML diagnosed between 1/1/2014 and 3/31/2022 from the nationwide Flatiron Health EHR-derived de-identified database were included in the study. Using AML consensus guidelines, dIFR events were determined when one or more of the following was present: bone marrow biopsy (BMBx) blasts >5%, documented provider assessment of BMBx was “Failure to Respond'' or “Relapse”, or peripheral blood blasts >0%. Performance of the dIFR variable was assessed through inter-rater agreement (i.e., event and date agreement via duplicate abstraction), association with downstream events (i.e., new therapy start/current therapy stop, drug change within a line, or death) and rw overall survival (rwOS) and rw event-free survival (rwEFS) and their correlation in the overall cohort and clinically distinct subgroups (e.g., age, cytogenetic risk).
RESULTS: Of the total 6781 patients, demographic and clinical characteristics were comparable to the AML population in the US SEER database. Inter-rater agreement for dIFR event and date were strong (>97%, >90%). The proportion of patients with a dIFR event after the first line initiation (64%) and those with downstream event(s) (53%, predominantly being a new therapy start) align with clinical expectations. Median rwOS, rwEFS were 14, 4.7 months, respectively. There was alignment among poor prognostic subgroups having a shorter median rwOS and rwEFS vs better prognostic subgroups. Spearman’s rank correlation between rwOS and rwEFS was strong (⍴ = 0.7).
CONCLUSIONS: Performance of the novel dIFR variable was strong, as evidenced by inter-rater agreement and alignment with clinical expectations of downstream events and rw endpoint analyses. This study demonstrates the feasibility of a derived rw progression approach, which can unlock the ability to conduct rw outcome studies across large AML cohorts.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Clinical Outcomes, Real World Data & Information Systems, Study Approaches
Clinical Outcomes Assessment, Electronic Medical & Health Records, Reproducibility & Replicability
No Additional Disease & Conditions/Specialized Treatment Areas