We aimed to compare fatigue of newly diagnosed patients with myelodysplastic syndromes (MDS) with that of the general population (GP). We also investigated the ability of the IPSS and IPSS-R to capture severity of patient-reported fatigue at diagnostic workup. A sample of 927 newly diagnosed patients with MDS was consecutively enrolled in a large international observational study and all patients completed the FACIT-Fatigue questionnaire at baseline. Fatigue was compared with that of the GP (N = 1075) and a 3-point difference in mean scores was considered as clinically meaningful. Fatigue of MDS patients was on average 4.6 points below the mean of the GP (95% CI, −5.9 to −3.2, p < 0.001), reflecting clinically meaningful worse fatigue. Unlike the IPSS, the IPSS-R identified clearly distinct subgroups with regard to burden of fatigue. Mean scores differences compared with GP ranged from nonclinically relevant for very low risk (Δ = −1.8, 95% CI, −4.0 to 0.5, p = 0.119) to large clinically meaningful differences for very high-risk IPSS-R patients (Δ = −8.2, 95% CI, −10.3 to −6.2, p < 0.001). At diagnostic workup, fatigue of MDS is clinically meaningful worse than that reported by the GP. Compared with the IPSS classification, the IPSS-R provides a better stratification of patients with regard to fatigue severity.
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The authors gratefully acknowledge all patients who participated in GIMEMA-PROMYS Study for dedicating their time in completing quality of life questionnaires and having contributed in advancing knowledge in this research area. We also acknowledge the important contribution over the years to the coordination of the Data Management activities of Dr Francesco Sparano. LBO institutional affiliation has since changed to Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, FL, USA.
Author LBO was funded by National Institutes of Health, National Cancer Institute training grant T32-CA-193193.
Conception and design: FE, FC, LBO, and DC. Data analysis and interpretation: all authors. Statistical analysis: FC, FE. Manuscript writing: FE, FC, LBO, and DC. Final approval of manuscript: all authors.
Conflict of interest
FE: Consultancy: Bristol-Myers Squibb, Amgen, Orsenix, Incyte, Takeda; Research funding to his insitution: Amgen. DC: President, FACIT.org. AP: Advisory board: Sanofi, Amgen, Novartis. GAP: Honoraria: Jannsen, Novartis, Celgene. ML: Consultancy: Abbvie, Gilead Sci, Novartis, Daiichi Sankyo, MSD, Sanofi; Honoraria for speaking: Gilead Sci, Novartis. MB: Honoraria: Novartis, Pfizer, Incyte, Celgene. RS: Honoraria, Membership on an entity’s Board of Directors or advisory committees: Novartis, Celgene; Research funding: Teva. UP: Research funding and Honoraria: Celgene, Amgen, Janssen, Novartis. MV: personal fees: Pfizer, Amgen, Novartis. DP: received support for active participation on congresses from Roche and Sanofi Genzyme.
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Efficace, F., Cottone, F., Oswald, L.B. et al. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia 34, 2451–2459 (2020). https://doi.org/10.1038/s41375-020-0746-8
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