Blood Cancer Journal (Apr 2022)

Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia

  • Keith W. Pratz,
  • Panayiotis Panayiotidis,
  • Christian Recher,
  • Xudong Wei,
  • Brian A. Jonas,
  • Pau Montesinos,
  • Vladimir Ivanov,
  • Andre C. Schuh,
  • Courtney D. DiNardo,
  • Jan Novak,
  • Vlatko Pejsa,
  • Don Stevens,
  • Su-Peng Yeh,
  • Inho Kim,
  • Mehmet Turgut,
  • Nicola Fracchiolla,
  • Kazuhito Yamamoto,
  • Yishai Ofran,
  • Andrew H. Wei,
  • Cat N. Bui,
  • Katy Benjamin,
  • Rajesh Kamalakar,
  • Jalaja Potluri,
  • Wellington Mendes,
  • Jacob Devine,
  • Walter Fiedler

DOI
https://doi.org/10.1038/s41408-022-00668-8
Journal volume & issue
Vol. 12, no. 4
pp. 1 – 9

Abstract

Read online

Abstract Phase 3 trials Viale-A and Viale-C evaluated health-related quality of life (HRQoL) in patients with AML unfit for intensive chemotherapy who received venetoclax (VEN) + (AZA) (Viale-A) or low-dose cytarabine (LDAC) (Viale-C) or placebo (PBO) + AZA or LDAC. Patient-reported outcomes included: EORTC QLQ-C30 global health status (GHS/QoL) and physical functioning (PF), PROMIS Cancer Fatigue Short Form 7a (Fatigue), and EQ-5D-5L health status visual analog scale (HS-VAS). Time to deterioration (TTD), defined as worsening from baseline in meaningful change thresholds (MCT) of ≥10, 5, or 7 points for GHS/QoL or PF, fatigue, and HS-VAS, respectively, was assessed; differences between groups were analyzed using Kaplan-Meier and unadjusted log-rank analyses. VEN + AZA vs PBO + AZA patients had longer TTD in GHS/QoL (P = 0.066) and fatigue (P = 0.189), and significantly longer TTD in PF (P = 0.028) and HS-VAS (P MCT in GHS/QoL. Overall, VEN may positively impact HRQoL in patients with AML ineligible for intensive chemotherapy, leading to longer preservation of functioning and overall health status.