TY - JOUR
TI - Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia
AU - Pratz, K.W.
AU - Panayiotidis, P.
AU - Recher, C.
AU - Wei, X.
AU - Jonas, B.A.
AU - Montesinos, P.
AU - Ivanov, V.
AU - Schuh, A.C.
AU - DiNardo, C.D.
AU - Novak, J.
AU - Pejsa, V.
AU - Stevens, D.
AU - Yeh, S.-P.
AU - Kim, I.
AU - Turgut, M.
AU - Fracchiolla, N.
AU - Yamamoto, K.
AU - Ofran, Y.
AU - Wei, A.H.
AU - Bui, C.N.
AU - Benjamin, K.
AU - Kamalakar, R.
AU - Potluri, J.
AU - Mendes, W.
AU - Devine, J.
AU - Fiedler, W.
JO - Blood cancer journal
PY - 2022
VL - 12
TODO - 4
SP - null
PB - Springer Nature BV
SN - null
TODO - 10.1038/s41408-022-00668-8
TODO - 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
TODO - 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).
ER -