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

Lisa Pleyer; Sonja Heibl; Christoph Tinchon; Sonia Vallet; Martin Schreder; Thomas Melchardt; Norbert Stute; Kim Tamara Föhrenbach Quiroz; Michael Leisch; Alexander Egle; Lukas Scagnetti; Dominik Wolf; Richard Beswick; Manuel Drost; Julian Larcher-Senn; Thomas Grochtdreis; Marc Vaisband; Jan Hasenauer; Nadja Zaborsky; Richard Greil; Reinhard Stauder

doi:10.3390/cancers15051388

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

Cancers (Basel). 2023 Feb 22;15(5):1388. doi: 10.3390/cancers15051388.

Authors

Lisa Pleyer^{1

2

3}, Sonja Heibl^{1

4}, Christoph Tinchon^{1

5}, Sonia Vallet^{1

6}, Martin Schreder^{1

7}, Thomas Melchardt^{1

2

3}, Norbert Stute^{1

2

3}, Kim Tamara Föhrenbach Quiroz², Michael Leisch^{1

2

3}, Alexander Egle^{1

2

3}, Lukas Scagnetti^{1

4}, Dominik Wolf^{1

8}, Richard Beswick⁹, Manuel Drost¹⁰, Julian Larcher-Senn¹⁰, Thomas Grochtdreis¹¹, Marc Vaisband^{1

2

12}, Jan Hasenauer¹², Nadja Zaborsky^{2

3

13}, Richard Greil^{1

2

3}, Reinhard Stauder^{1

8}

Affiliations

¹ Austrian Group for Medical Tumor Therapy (AGMT) Study Group, 1180 Vienna, Austria.
² Salzburg Cancer Research Institute (SCRI), Center for Clinical Cancer and Immunology Trials (CCCIT), Austria and Cancer Cluster Salzburg (CCS), 5020 Salzburg, Austria.
³ 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Rheumatology and Infectiology, Oncologic Center, Paracelsus Medical University, 5020 Salzburg, Austria.
⁴ 4th Medical Department of Internal Medicine, Hematology, Internistic Oncology and Palliative Medicine, Klinikum Wels-Grieskirchen GmbH, 4600 Wels, Austria.
⁵ Department for Hemato-Oncology, LKH Hochsteiermark, 8700 Leoben, Austria.
⁶ Department of Internal Medicine 2, University Hospital Krems, Karl Landsteiner Private University of Health Sciences, 3500 Krems, Austria.
⁷ 1st Department of Internal Medicine, Center for Oncology and Hematology, Klinik Ottakring, Wiener Gesundheitsverbund, 1030 Vienna, Austria.
⁸ Department of Internal Medicine V, Innsbruck Medical University, 6020 Innsbruck, Austria.
⁹ International Marketing, Swiss Business School, 8302 Zurich, Switzerland.
¹⁰ Assign Data Management and Biostatistics GmbH, 6020 Innsbruck, Austria.
¹¹ Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, 20251 Hamburg, Germany.
¹² Life and Medical Sciences Institute, University of Bonn, 53115 Bonn, Germany.
¹³ Laboratory of Immunological and Molecular Cancer Research (LIMCR), 5020 Salzburg, Austria.

Abstract

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.

Keywords: Austrian Registry of Hypomethylating Agents; EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L); acute myeloid leukaemia; azacitidine; chronic myelomonocytic leukaemia; health-related quality of life (HRQoL); mixed-effects linear models; myelodysplastic syndromes; patient-reported outcome (PRO); prognosis.

Grants and funding

The Austrian Group for Medical Tumor Therapy (AGMT) is the sponsor for the Austrian Registry of Hypomethylating Agents and received funding from Celgene/BMS, AbbVie, and Janssen Cilag. The AGMT is a non-for-profit organisation and an academic study group. The group performed administrative and legal management, as well as funding acquisition. No pharmaceutical company and no other funding source were involved in any way and had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. No medical writer or editor was involved.