The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index.


Journal

Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895

Informations de publication

Date de publication:
09 2020
Historique:
received: 22 11 2019
accepted: 05 02 2020
revised: 31 01 2020
pubmed: 23 2 2020
medline: 20 11 2020
entrez: 23 2 2020
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 32086447
doi: 10.1038/s41375-020-0746-8
pii: 10.1038/s41375-020-0746-8
pmc: PMC7509847
mid: NIHMS1629554
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

2451-2459

Subventions

Organisme : NCI NIH HHS
ID : T32 CA193193
Pays : United States

Références

Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127:2391–405.
doi: 10.1182/blood-2016-03-643544
Malcovati L, Hellstrom-Lindberg E, Bowen D, Ades L, Cermak J, Del Canizo C, et al. Diagnosis and treatment of primary myelodysplastic syndromes in adults: recommendations from the European LeukemiaNet. Blood. 2013;122:2943–64.
doi: 10.1182/blood-2013-03-492884
Steensma DP, Bennett JM. The myelodysplastic syndromes: diagnosis and treatment. Mayo Clin Proc. 2006;81:104–30.
doi: 10.4065/81.1.104
Malcovati L, Germing U, Kuendgen A, Della Porta MG, Pascutto C, Invernizzi R, et al. Time-dependent prognostic scoring system for predicting survival and leukemic evolution in myelodysplastic syndromes. J Clin Oncol. 2007;25:3503–10.
doi: 10.1200/JCO.2006.08.5696
Bejar R. Prognostic models in myelodysplastic syndromes. Hematol Am Soc Hematol Educ Program. 2013;2013:504–10.
doi: 10.1182/asheducation-2013.1.504
Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood 1997;89:2079–88.
doi: 10.1182/blood.V89.6.2079
Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Sole F, et al. Revised international prognostic scoring system for myelodysplastic syndromes. Blood. 2012;120:2454–65.
doi: 10.1182/blood-2012-03-420489
Montalban-Bravo G, Garcia-Manero G. Myelodysplastic syndromes: 2018 update on diagnosis, risk-stratification and management. Am J Hematol. 2018;93:129–47.
doi: 10.1002/ajh.24930
Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000;96:3671–4.
pubmed: 11090046
Abel GA, Efficace F, Buckstein RJ, Tinsley S, Jurcic JG, Martins Y, et al. Prospective international validation of the Quality of Life in Myelodysplasia Scale (QUALMS). Haematologica. 2016;101:781–8.
doi: 10.3324/haematol.2015.140335
Stauder R, Yu G, Koinig KA, Bagguley T, Fenaux P, Symeonidis A, et al. Health-related quality of life in lower-risk MDS patients compared with age- and sex-matched reference populations: a European LeukemiaNet study. Leukemia. 2018;32:1380–92.
doi: 10.1038/s41375-018-0089-x
Sekeres MA, Gore SD, Stablein DM, DiFronzo N, Abel GA, DeZern AE, et al. The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes. Leuk Lymphoma. 2019;60:3161–71.
Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, et al. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015;168:361–70.
doi: 10.1111/bjh.13138
Steensma DP, Heptinstall KV, Johnson VM, Novotny PJ, Sloan JA, Camoriano JK, et al. Common troublesome symptoms and their impact on quality of life in patients with myelodysplastic syndromes (MDS): results of a large internet-based survey. Leuk Res. 2008;32:691–8.
doi: 10.1016/j.leukres.2007.10.015
Troy JD, de Castro CM, Pupa MR, Samsa GP, Abernethy AP, LeBlanc TW. Patient-reported distress in myelodysplastic syndromes and its association with clinical outcomes: a retrospective cohort study. J Natl Compr Canc Netw. 2018;16:267–73.
doi: 10.6004/jnccn.2017.7048
Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, et al. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015;16:1506–14.
doi: 10.1016/S1470-2045(15)00206-5
Platzbecker U. Treatment of MDS. Blood. 2019;133:1096–107.
doi: 10.1182/blood-2018-10-844696
Fenaux P, Platzbecker U, Ades L. How we manage adults with myelodysplastic syndrome. Br J Haematol. 2019. https://doi.org/10.1111/bjh.16206 . [E-pub ahead of print].
Vardiman JW, Harris NL, Brunning RD. The World Health Organization (WHO) classification of the myeloid neoplasms. Blood. 2002;100:2292–302.
doi: 10.1182/blood-2002-04-1199
Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009;114:937–51.
doi: 10.1182/blood-2009-03-209262
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.
doi: 10.1093/jnci/85.5.365
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manag. 1997;13:63–74.
doi: 10.1016/S0885-3924(96)00274-6
Cella D, Zagari MJ, Vandoros C, Gagnon DD, Hurtz HJ, Nortier JW. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol. 2003;21:366–73.
doi: 10.1200/JCO.2003.02.136
Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997;34(3 Suppl 2):13–9.
pubmed: 9253779
Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the functional assessment of cancer therapy (FACT) anemia and fatigue scales. J Pain Symptom Manag. 2002;24:547–61.
doi: 10.1016/S0885-3924(02)00529-8
Pfeilstocker M, Tuechler H, Sanz G, Schanz J, Garcia-Manero G, Sole F, et al. Time-dependent changes in mortality and transformation risk in MDS. Blood. 2016;128:902–10.
doi: 10.1182/blood-2016-02-700054
Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, et al. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005;106:2912–9.
doi: 10.1182/blood-2005-05-2004
Escalante CP, Chisolm S, Song J, Richardson M, Salkeld E, Aoki E, et al. Fatigue, symptom burden, and health-related quality of life in patients with myelodysplastic syndrome, aplastic anemia, and paroxysmal nocturnal hemoglobinuria. Cancer Med. 2019;8:543–53.
doi: 10.1002/cam4.1953
Abel GA, Buckstein R. Integrating frailty, comorbidity, and quality of life in the management of myelodysplastic syndromes. Am Soc Clin Oncol Educ Book. 2016;35:e337–44.
doi: 10.1200/EDBK_158639
Santini V. Treatment of low-risk myelodysplastic syndromes. Hematol Am Soc Hematol Educ Program. 2016;2016:462–9.
doi: 10.1182/asheducation-2016.1.462

Auteurs

Fabio Efficace (F)

Data Center and Health Outcomes Research Unit, Italian Group for Adult Haematologic Diseases (GIMEMA), Rome, Italy. f.efficace@gimema.it.
Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA. f.efficace@gimema.it.

Francesco Cottone (F)

Data Center and Health Outcomes Research Unit, Italian Group for Adult Haematologic Diseases (GIMEMA), Rome, Italy.

Laura B Oswald (LB)

Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.

David Cella (D)

Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.

Andrea Patriarca (A)

Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.

Pasquale Niscola (P)

Hematology Unit, Sant'Eugenio Hospital, Rome, Italy.

Massimo Breccia (M)

Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy.

Uwe Platzbecker (U)

Clinic and Policlinic of Hematology and Cellular Therapy, Oncology and Hemostaseology, University Hospital Leipzig, Leipzig, Germany.

Giuseppe A Palumbo (GA)

Dipartimento di Scienze Mediche, Chirurgiche e Tecnologie Avanzate "G.F. Ingrassia", University of Catania, Catania, Italy.

Giovanni Caocci (G)

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Reinhard Stauder (R)

Department of Internal Medicine V (Hematology and Oncology), Innsbruck Medical University, Innsbruck, Austria.

Alessandra Ricco (A)

Hematology and Transplants Unit, University of Bari, Bari, Italy.

Duska Petranovic (D)

Department of Hematology, Clinical Hospital Center Rijeka, Rijeka, Croatia.

Jo Caers (J)

Department of Hematology, CHU de Liège, University of Liege, Liege, Belgium.

Mario Luppi (M)

University of Modena and Reggio Emilia, AOU Modena, Modena, Italy.

Luana Fianchi (L)

Dipartimento Scienze Radiologiche Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, Italy.

Chiara Frairia (C)

Division of Hematology, Department of Oncology, AOU Città della Salute e della Scienza, Turin, Italy.

Isabella Capodanno (I)

Hematology Unit, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy.

Elena Follini (E)

Department of Medicine and Surgery, University of Parma, Parma, Italy.

Chiara Sarlo (C)

Hematology and Stem Cell Transplantation Unit, University Campus Bio-Medico, Rome, Italy.

Paola Fazi (P)

Data Center and Health Outcomes Research Unit, Italian Group for Adult Haematologic Diseases (GIMEMA), Rome, Italy.

Marco Vignetti (M)

Data Center and Health Outcomes Research Unit, Italian Group for Adult Haematologic Diseases (GIMEMA), Rome, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH