AML-387: A Single-Center Comparison of Decitabine ± Venetoclax or FLAG in the Treatment of Secondary Acute Myeloid Leukemia

Context Secondary AML (sAML) represents up to 30% of total AML cases and is associated with a poor porgnosis. Response rates to traditional chemotherapy regimens are poor. Prior studies have shown that both fludarabine, high-dose cytarabine, and granulocyte colony stimulating factor (FLAG) and HMA-based regimens (e.g. decitabine ± venetoclax) can provide favorable responses with lower treatment related toxicities than traditional regimens such as 7+3 or CPX-351. Objective The purpose of this study was to compare response rates in patient with sAML receiving 10-day decitabine ± venetoclax to FLAG. Design Single-center retrospective cohort study of patients with sAML starting induction therapy at Michigan Medicine between January 2014 and July 2019. Setting Academic Medical Center. Patients or other participants Adult patients with sAML receiving first induction. Exclusion criteria as follows: receipt of prior therapy for this AML occurrence, or prior use of hypomethylating agent for antecedent hematologic disorder. Main outcome measures Complete response/Complete response with incomplete count recovery (CR/CRi) Results The median age was 73 (range, 37–80) in the decitabine ± venetoclax group and 67 (range, 27–82) in the FLAG group (p = 0.037). There was numerically lower but statistically similar CR/CRi rate in patients treated with decitabine ± venetoclax compared to FLAG (40 vs. 62%, p=0.076). More patients in the decitabine ± venetoclax group achieved MLFS (25% vs. 1%, p=0.002). The median overall survival was comparable in both groups (11.1 months, decitabine ± venetoclax vs. 9.5 months, FLAG; p=0.472). There was a higher incidence of documented infections (20% vs. 55%, p=0.01) with FLAG, despite days to absolute neutrophil count recovery being longer with decitabine ± venetoclax (median, 34 vs. 19 days; p Conclusions Response rates after FLAG and decitabine ± venetoclax are comparable and translate to similar overall survival in the sAML population in this real-world, single-center retrospective review. Larger studies are necessary to elucidate benefits of the individual regimens in the sAML patient population.