Title:
Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia
Languages of Item:
English
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 < 0.001). VEN + LDAC vs PBO + LDAC patients had significantly longer TTD in GHS/QoL (P = 0.011), PF (P = 0.020), and fatigue (P = 0.004), and a trend in HS-VAS (P = 0.057). Approximately 43%, 35%, 32%, and 18% of patients treated with VEN + AZA, AZA + PBO, VEN + LDAC, or LDAC + PBO, respectively, saw improvements >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. © 2022, The Author(s).
Authors:
Pratz, K.W.
Panayiotidis, P.
Recher, C.
Wei, X.
Jonas, B.A.
Montesinos, P.
Ivanov, V.
Schuh, A.C.
DiNardo, C.D.
Novak, J.
Pejsa, V.
Stevens, D.
Yeh, S.-P.
Kim, I.
Turgut, M.
Fracchiolla, N.
Yamamoto, K.
Ofran, Y.
Wei, A.H.
Bui, C.N.
Benjamin, K.
Kamalakar, R.
Potluri, J.
Mendes, W.
Devine, J.
Fiedler, W.
Journal:
Blood cancer journal
Publisher:
Springer Nature BV
Keywords:
azacitidine; cytarabine; placebo; venetoclax; antineoplastic agent; cytarabine; fused heterocyclic rings; sulfonamide; venetoclax, acute myeloid leukemia; aged; Article; cancer combination chemotherapy; cancer patient; controlled study; deterioration; double blind procedure; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; European Quality of Life 5 Dimensions 5 Level questionnaire; fatigue; female; health status; human; low drug dose; major clinical study; male; multicenter study; outcome assessment; patient-reported outcome; phase 3 clinical trial; PROMIS Cancer Fatigue Short Form 7a; quality of life; quality of life assessment; randomized controlled trial; time; time to deterioration; visual analog scale; acute myeloid leukemia; fatigue, Antineoplastic Combined Chemotherapy Protocols; Bridged Bicyclo Compounds, Heterocyclic; Cytarabine; Fatigue; Humans; Leukemia, Myeloid, Acute; Quality of Life; Sulfonamides
Official URL (Publisher):
DOI:
10.1038/s41408-022-00668-8
