@article{3219172,
    title = "Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia",
    author = "Pratz, K.W. and Panayiotidis, P. and Recher, C. and Wei, X. and Jonas, B.A. and Montesinos, P. and Ivanov, V. and Schuh, A.C. and DiNardo, C.D. and Novak, J. and Pejsa, V. and Stevens, D. and Yeh, S.-P. and Kim, I. and Turgut, M. and Fracchiolla, N. and Yamamoto, K. and Ofran, Y. and Wei, A.H. and Bui, C.N. and Benjamin, K. and Kamalakar, R. and Potluri, J. and Mendes, W. and Devine, J. and Fiedler, W.",
    journal = "Blood cancer journal",
    year = "2022",
    volume = "12",
    number = "4",
    publisher = "Springer Nature BV",
    doi = "10.1038/s41408-022-00668-8",
    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",
    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)."
}