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Venetoclax in combination with FLAG-IDA-based protocol for patients with acute myeloid leukemia: a real-world analysis

Venetoclax in combination with intensive therapies is explored in both the upfront and relapse/refractory (R/R) setting, and available data suggest that such regimens are effective albeit with added hematological and infectious toxicity. We conducted a multicenter retrospective cohort study of patie...

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Published in:Annals of hematology 2022-08, Vol.101 (8), p.1719-1726
Main Authors: Wolach, Ofir, Frisch, Avraham, Shargian, Liat, Yeshurun, Moshe, Apel, Arie, Vainstein, Vladimir, Moshe, Yakir, Shimony, Shai, Amit, Odelia, Bar-On, Yael, Ofran, Yishai, Raanani, Pia, Nachmias, Boaz, Ram, Ron
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Language:English
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Summary:Venetoclax in combination with intensive therapies is explored in both the upfront and relapse/refractory (R/R) setting, and available data suggest that such regimens are effective albeit with added hematological and infectious toxicity. We conducted a multicenter retrospective cohort study of patients with acute myeloid leukemia (AML) treated with venetoclax in combination with FLAG-IDA protocol. Twenty-five patients were included in this analysis (median age 53.4 years). Most patients were treated for R/R AML ( n  = 24, 96%) with a median of one (range 0–3) previous lines of therapy and 44% of patients ( n  = 11) having prior allogeneic hematopoietic cell transplantation (HCT). Median follow-up was 10 (range, 4–26) months. Platelet and neutrophil recovery were observed at a median of 31 (95% CI 17.6–38.3) and 23 (95% CI 20–28) days, respectively. The most common adverse events were infectious (blood stream infections, 48% and invasive fungal infections, 32%). Thirty-day mortality was 12%. Composite complete remission (CRc) was 72% for the entire cohort and 91% in patients treated for post-HCT relapse. Incidences of relapse-free and overall survival at 12 months were 67% (95% CI 58–76%) and 50% (95% CI 31–69%), respectively. Real-world data show that the addition of venetoclax to FLAG-IDA protocol is effective in patients with high-risk AML, most notably in the post-HCT relapse setting. Prophylaxis and surveillance for infections are crucial.
ISSN:0939-5555
1432-0584
DOI:10.1007/s00277-022-04883-y