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Lancet Oncol. 2015 Nov;16(15):1506-14. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.

Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study.

Author information

1
Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy. Electronic address: f.efficace@gimema.it.
2
Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy.
3
Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy.
4
Department of Hematology, University of Rome Cattolica S. Cuore, Rome, Italy.
5
Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
6
Ematologia e Centro Trapianti, Ospedale Oncologico di Riferimento Regionale Armando Businco, Cagliari, Italy.
7
Department of Medical Sciences, University of Cagliari, Cagliari, Italy.
8
Department of Internal Medicine V (Hematology and Oncology), Innsbruck Medical University, Innsbruck, Austria.
9
Department of Hematology, AZ St Jan Brugge-Oostende, Belgium.
10
Academic Medical Center/University of Amsterdam, Department of Medical Psychology, Amsterdam, Netherlands.
11
Department of Medicine I, University Hospital Dresden Carl Gustav Carus, Dresden, Germany.
12
Department of Emergency and Organ Transplantation, Hematology Section, University of Bari, Bari, Italy.
13
Department of Hematology and Stem Cell Transplantation Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.
14
Department of Internal Medicine, CHU Toulouse, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
15
Hematology, Department of Biomedicine and Prevention, Tor Vergata University, Rome, Italy.
16
UO Ematologia, AOU Policlinico-V Emanuele Catania, Italy.
17
St James's Institute of Oncology, Bexley Wing, Leeds, UK.
18
Leukemia Department, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
19
Hematology Unit, S Eugenio Hospital, Rome, Italy.

Abstract

BACKGROUND:

The clinical presentation of myelodysplastic syndromes is highly variable and so accurate prediction of outcomes in these patients is crucial. We aimed to assess whether self-reported fatigue severity predicts overall survival beyond gold-standard prognostic indices in patients with higher-risk myelodysplastic syndromes.

METHODS:

We did a multicentre, prospective, observational, cohort study of patients from 37 centres in Europe, USA, and east Asia. Adults (≥18 years) with myelodysplastic syndromes were consecutively enrolled within 6 months of diagnosis with an intermediate-2-risk or high-risk score according to the International Prognostic Scoring System (IPSS). Patients were enrolled irrespective of older age, comorbidities, performance status, and progression from a lower IPSS risk score category. All patients had to complete a quality of life assessment at baseline. With use of univariate and then multivariate Cox proportional hazards regression analysis, we constructed a multivariate model of how prognostic variables, including IPSS and fatigue score from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-core 30, predicted overall survival. The primary endpoint was overall survival by baseline self-reported fatigue scale ratings. This study was registered with ClinicalTrials.gov, number NCT00809575.

FINDINGS:

Between Nov 10, 2008, and Aug 13, 2012, we enrolled 280 patients with a median age of 71 years (IQR 64-77). The median follow-up was 15 months (IQR 8-27), and the last patient was assessed Feb 16, 2015. The median overall survival from diagnosis was 17 months (95% CI 15-19). In univariate analysis, the baseline factors that were significantly associated with reduced overall survival were increasing age, transfusion dependency (defined as having received at least one red blood cell transfusion every 8 weeks over a period of 4 months), Eastern Cooperative Oncology Group (ECOG) performance status of two or more, increased white blood cell count, high-risk IPSS score, and higher self-reported fatigue severity. In multivariate analysis, baseline factors independently associated with reduced overall survival were high-risk IPSS score (hazard ratio [HR] 2·525, 95% CI 1·357-4·697; p=0·0035) and a higher score for fatigue (1·110, 1·040-1·170, for every ten points of fatigue deterioration; p=0·0007). In further multivariate models for survival, including either the WHO-based prognostic scoring system or the revised version of the IPSS classification, fatigue remained a statistically significant independent prognostic factor with a HR of 1·120 (1·050-1·180, p=0.0003) and a HR of 1·130 (1·060-1·190, p=0·0002), respectively.

INTERPRETATION:

In patients with newly diagnosed higher-risk myelodysplastic syndromes, self-reported fatigue severity provides prognostic information for survival independent from gold-standard risk classifications. Our findings suggest that fatigue assessment should be included in routine diagnostic investigation for these patients and considered as a standard baseline stratification factor in future randomised controlled trials.

FUNDING:

Associazione Italiana contro le Leucemie, Linfomi e Mieloma (AIL).

PMID:
26404501
DOI:
10.1016/S1470-2045(15)00206-5
[Indexed for MEDLINE]
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