Postremission cytopenia management in patients with acute myeloid leukemia treated with venetoclax and azacitidine in VIALE-A

• Authors: PRATZ Keith W; DINARDO Courtney D; SELLESLAG Dominik; LI Junmin; YAMAMOTO Kazuhito; KONOPLEVA Marina; STEVENS Don; KANTARJIAN Hagop; TRAINA Fabiola; VENDITTI Adriano; MAYER Jiří; MONTEZ Melissa; JIN Huan; DUAN Yinghui; BRACKMAN Deanna; ZHA Jiuhong; POTLURI Jalaja; WERNER Michael; JONAS Brian A
• Year of publication: 2022
• Type: Article in Periodical
• Magazine / Source: American Journal of Hematology
• MU Faculty or unit: Faculty of Medicine
• Web: https://onlinelibrary.wiley.com/doi/pdf/10.1002/ajh.26692
• Doi: http://dx.doi.org/10.1002/ajh.26692
• Keywords: postremission cytopenia management; acute myeloid leukemia; venetoclax; azacitidine
• Description: The phase 3 VIALE-A study (NCT02993523) of venetoclax (Ven) + azacitidine (Aza) demonstrated significantly improved median overall survival (OS; 14.7 months) compared with placebo (Pbo) + Aza in patients with newly diagnosed acute myeloid leukemia (AML) who were aged ?75 years or ineligible for intensive chemotherapy. The study protocol recommended dosing schedule modification following remission to mitigate hematologic adverse events (AEs; Figure 1A); these occurred in 83% of patients in the Ven + Aza arm. This post hoc analysis of VIALE-A evaluated the frequency and management of postremission cytopenia events, Ven exposure-response relationship with postremission cytopenias, and outcomes when dosing schedule modifications were required for grade 4 cytopenias.