PMID- 36900181 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230313 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 15 IP - 5 DP - 2023 Feb 22 TI - Health-Related Quality of Life as Assessed by the EQ-5D-5L Predicts Outcomes of Patients Treated with Azacitidine-A Prospective Cohort Study by the AGMT. LID - 10.3390/cancers15051388 [doi] LID - 1388 AB - In this prospective study (NCT01595295), 272 patients treated with azacitidine completed 1456 EuroQol 5-Dimension (EQ-5D) questionnaires. Linear mixed-effect modelling was used to incorporate longitudinal data. When compared with a matched reference population, myeloid patients reported more pronounced restrictions in usual activities (+28%, p < 0.0001), anxiety/depression (+21%, p < 0.0001), selfcare (+18%, p < 0.0001) and mobility (+15%, p < 0.0001), as well as lower mean EQ-5D-5L indices (0.81 vs. 0.88, p < 0.0001), and lower self-rated health on the EuroQol Visual Analogue Scale (EQ-VAS) (64 vs. 72%, p < 0.0001). After multivariate-adjustment, (i) the EQ-5D-5L index assessed at azacitidine start the predicted time with clinical benefit (TCB) (9.6 vs. 6.6 months; p = 0.0258; HR = 1.43), time to next treatment (TTNT) (12.8 vs. 9.8 months; p = 0.0332; HR = 1.42) and overall survival (OS) (17.9 vs. 12.9 months; p = 0.0143; HR = 1.52); (ii) Level Sum Score (LSS) predicted azacitidine response (p = 0.0160; OR = 0.451) and the EQ-5D-5L index showed a trend (p = 0.0627; OR = 0.522); (iii) up to 1432 longitudinally assessed EQ-5D-5L response/clinical parameter pairs revealed significant associations of EQ-5D-5L response parameters with haemoglobin level, transfusion dependence and hematologic improvement. Significant increases of the likelihood ratios were observed after addition of LSS, EQ-VAS or EQ-5D-5L-index to the International Prognostic Scoring System (IPSS) or the revised IPSS (R-IPSS), indicating that they provide added value to these scores. FAU - Pleyer, Lisa AU - Pleyer L AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Heibl, Sonja AU - Heibl S AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - 4th Medical Department of Internal Medicine, Hematology, Internistic Oncology and Palliative Medicine, Klinikum Wels-Grieskirchen GmbH, 4600 Wels, Austria. FAU - Tinchon, Christoph AU - Tinchon C AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Department for Hemato-Oncology, LKH Hochsteiermark, 8700 Leoben, Austria. FAU - Vallet, Sonia AU - Vallet S AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Department of Internal Medicine 2, University Hospital Krems, Karl Landsteiner Private University of Health Sciences, 3500 Krems, Austria. FAU - Schreder, Martin AU - Schreder M AUID- ORCID: 0000-0002-1699-9715 AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - 1st Department of Internal Medicine, Center for Oncology and Hematology, Klinik Ottakring, Wiener Gesundheitsverbund, 1030 Vienna, Austria. FAU - Melchardt, Thomas AU - Melchardt T AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Stute, Norbert AU - Stute N AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Fohrenbach Quiroz, Kim Tamara AU - Fohrenbach Quiroz KT AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. FAU - Leisch, Michael AU - Leisch M AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Egle, Alexander AU - Egle A AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Scagnetti, Lukas AU - Scagnetti L AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - 4th Medical Department of Internal Medicine, Hematology, Internistic Oncology and Palliative Medicine, Klinikum Wels-Grieskirchen GmbH, 4600 Wels, Austria. FAU - Wolf, Dominik AU - Wolf D AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Department of Internal Medicine V, Innsbruck Medical University, 6020 Innsbruck, Austria. FAU - Beswick, Richard AU - Beswick R AD - International Marketing, Swiss Business School, 8302 Zurich, Switzerland. FAU - Drost, Manuel AU - Drost M AD - Assign Data Management and Biostatistics GmbH, 6020 Innsbruck, Austria. FAU - Larcher-Senn, Julian AU - Larcher-Senn J AUID- ORCID: 0000-0003-3169-1900 AD - Assign Data Management and Biostatistics GmbH, 6020 Innsbruck, Austria. FAU - Grochtdreis, Thomas AU - Grochtdreis T AUID- ORCID: 0000-0002-0176-7989 AD - Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany. FAU - Vaisband, Marc AU - Vaisband M AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany. FAU - Hasenauer, Jan AU - Hasenauer J AD - Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany. FAU - Zaborsky, Nadja AU - Zaborsky N AUID- ORCID: 0000-0002-9775-185X AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. AD - Laboratory of Immunological and Molecular Cancer Research (LIMCR), 5020 Salzburg, Austria. FAU - Greil, Richard AU - Greil R AUID- ORCID: 0000-0002-4462-3694 AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria. AD - 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria. FAU - Stauder, Reinhard AU - Stauder R AUID- ORCID: 0000-0002-8993-9561 AD - Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria. AD - Department of Internal Medicine V, Innsbruck Medical University, 6020 Innsbruck, Austria. LA - eng PT - Journal Article DEP - 20230222 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC10000211 OTO - NOTNLM OT - Austrian Registry of Hypomethylating Agents OT - EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) OT - acute myeloid leukaemia OT - azacitidine OT - chronic myelomonocytic leukaemia OT - health-related quality of life (HRQoL) OT - mixed-effects linear models OT - myelodysplastic syndromes OT - patient-reported outcome (PRO) OT - prognosis COIS- L.P.: Honoraria from AbbVie, BMS and Novartis; S.H.: Honoraria from AbbVie, AOP, BMS, Janssen Cilag, Novartis and Roche; CT: No potential conflicts of interest; S.V.: Honoraria from Bristol Myers Squibb, Merck, MSD and Pfizer; consultancy fees from Roche, MSD, EUSA Pharma and Merck; Travel support from Pfizer, Roche, Pierre Fabre and Angelini; M.S.: Honoraria and consultancy BMS/Celgene; T.M.: Honoraria from AbbVie and Celgene/BMS; NS: No potential conflicts of interest; K.T.F.Q.: No potential conflicts of interest; M.L.: Honoraria from BMS, Celgene, Gilead, Takeda and Novartis; Travel support: Celgene and Novartis; AE: Honoraria, consultancy and travel support from AbbVie and BMS/Celgene; L.S.: No potential conflicts of interest; D.W.: Research Funding: BMS/Celgene, MSD, Novartis, Pfizer and Roche; Honoraria: BMS/Celgene, GEMOAB, Gilead, Incyte, MSD, Novartis, Pfizer and Roche; R.B.: No potential conflicts of interest; M.D.: No potential conflicts of interest; J.L.-S.: No potential conflicts of interest; T.G.: No potential conflicts of interest; M.V.: No potential conflicts of interest; J.H:. Research Funding: Bohringer-Ingelheim; N.Z.: No potential conflicts of interest; R.G.: Honoraria from AbbVie, Amgen, AstraZeneca, BMS/Celgene, Daiichi Sankyo, Gilead, Merck, Novartis, Roche, Takeda, BMS, MSD, Sandoz and Gilead; Research funding from Celgene, Roche, Merck, Novartis, MSD, Sandoz and Takeda; Consulting: AbbVie, Astra Zeneca, BMS/Celgene, Novartis, Roche, Takeda, Janssen, MSD, Merck, Gilead and Daiichi Sankyo; Travel support from AbbVie, Amgen, Astra Zeneca, BMS/Celgene, Daiichi Sankyo, Gilead, Janssen Cilag, MSD, Novartis and Roche; R.S.: Honoraria from BMS/Celgene. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. EDAT- 2023/03/12 06:00 MHDA- 2023/03/12 06:01 PMCR- 2023/02/22 CRDT- 2023/03/11 01:05 PHST- 2023/01/24 00:00 [received] PHST- 2023/02/10 00:00 [revised] PHST- 2023/02/17 00:00 [accepted] PHST- 2023/03/11 01:05 [entrez] PHST- 2023/03/12 06:00 [pubmed] PHST- 2023/03/12 06:01 [medline] PHST- 2023/02/22 00:00 [pmc-release] AID - cancers15051388 [pii] AID - cancers-15-01388 [pii] AID - 10.3390/cancers15051388 [doi] PST - epublish SO - Cancers (Basel). 2023 Feb 22;15(5):1388. doi: 10.3390/cancers15051388.