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Chronic Myeloproliferative Neoplasias

Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib

Abstract

Health-related quality of life (HRQOL) is an important goal of therapy for chronic myeloid leukemia (CML) patients treated with current molecular-targeted therapies. The main objective of this study was to investigate factors associated with long-term HRQOL outcomes of CML patients receiving imatinib. Analysis was performed on 422 CML patients recruited in an observational multicenter study. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Key socio-demographic and clinical data were investigated for their association with HRQOL outcomes. Chronic fatigue and social support were also investigated. Univariate and multivariate linear regression analyses were used to identify independent factors associated with HRQOL outcomes. Fatigue was the only variable showing an independent and consistent association across all physical and mental HRQOL outcomes (P<0.01). Differences between patients reporting low versus high fatigue levels were more than eight and seven times the magnitude of a clinically meaningful difference, respectively, for the role physical (Δ=70 points) and emotional scale (Δ=63 points) of the SF-36. Fatigue did not occur as an isolated symptom and was most highly correlated with musculoskeletal pain (r=0.511; P0.001) and muscular cramps (r=0.448; P0.001). Chronic fatigue is the major factor limiting HRQOL of CML patients receiving imatinib.

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Acknowledgements

We are grateful to all patients who participated in this study and we acknowledge the essential contribution of the ‘Associazione Italiana contro le Leucemie, Linfomi e Mieloma (AIL)’, which provided logistic and administrative support to this project. This study was supported by Novartis. Novartis had no role in the design and conduct of the study; collection, management, analysis and interpretation of data; and preparation, review or approval of the manuscript.

Author contributions:

FE was the study co-ordinator and Mi Ba was the study co-coordinator of this project. Details of contribution are as follows: conception and design: FE, Mi Ba, FM; collection and assembly of data: FE, MB, GA, GR, GLD, CB, GS, R Di L, LL, DT, BM, FS, MD, Mi Ba, PL, MPS, LL, CF, DV, SS, AR; data analysis and interpretation: FE, FC, Mi Ba, FM; statistical analysis: FC, FE; manuscript writing: FE, FC, Mi Ba, FM; final approval of manuscript: FE, Mi Ba, MB, GA, GR, FC, LDG, CB, GS, RDL, LL, DT, BM, FS, MD, Mi Ba, PL, MPS, LL, CF, DV, SS, AR, MV, FM; provision of study material or patients: Mi Ba, MB, GA, GR, LDG, CB, GS, GF, LL, DT, BM, FS, MD, Mi Ba, PL, MPS, LL, CF, DV, SS, AR.

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Correspondence to F Efficace.

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Competing interests

Consultant or advisory role: FE, Mi Ba, MB, GR, CB (Novartis and Bristol Myers Squibb); research funding: FE, GR, PL (Novartis); honoraria: Mi Ba (Novartis, Bristol Myers Squibb, Pfizer and Ariad); expert testimony: DT (Novartis and Bristol Myers Squibb); AR (Novartis); other remuneration: DT (Novartis and Bristol Myers Squibb).

Additional information

Presented in part at the 54th Annual Meeting of the American Society of Hematology (ASH), 8–11 December 2012, Atlanta, GA, USA.

List of participants:

List of participants:

The following additional members of the Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA) Working Party on CML also participated in this study enrolling patients and collecting clinical data:

Petrini M (University of Pisa, Pisa, Italy);

Russo Rossi A (University of Bari, Bari, Italy);

Fioritoni G (Local Health Unit of Pescara, Hematology, Pescara, Italy);

Nobile F (‘Ospedali Riuniti’, Hematology, Reggio Calabria, Italy);

Di Raimondo F (Hospital ‘Ferrarotto’, Hematology, Catania, Italy);

Cuneo A (Arcispedale Sant'Anna’, Ferrara, Italy);

Gobbi M, Pierri I (University of Genova, clinica ematologica S Martino hospital, Genova, Italy);

Scortechini A (Hospital ‘Torrette’, Ancona, Italy);

Angelucci E (Struttura Complessa di Ematologia e Centro Trapianti. Ospedale Oncologico di Riferimento Regionale ‘Armando Busiinco’ Cagliari, Italy);

Peta A, (Azienda Ospedaliera Pugliese Ciaccio’, Hematology, Catanzaro, Italy);

Saglio G (University of Turin, Orbassano, Italy);

Pizzolo G (University of Verona, Verona, Italy);

Leone G (University of Rome ‘Cattolica S Cuore’, Department of Hematology, Rome, Italy);

Ferrari M (‘Ospedali Riuniti di Bergamo’, Hematology, Bergamo, Italy);

Longinotti M, Pardini S (University of Sassari, Hematology, Sassari, Italy);

Gherlinzoni F (Local Health Unit 9 of Treviso, Hematology, Treviso, Italy);

Zaccaria A (Hospital ‘Santa Maria delle Croci’, Hematology, Ravenna, Italy);

Fanin R, Tiribelli M, D’odorico C (University Hospital, Hematology, Udine, Italy);

Rossi G (Spedali civili Brescia, Brescia, Italy);

Ferrara F (Hospital ‘Antonio Cardarelli’, Napoli, Italy);

Lauria F (A.O. Universitaria Senese Pol. S. Maria alle Scotte—UOC di Ematologia e Trapianti, Siena, Italy).

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Efficace, F., Baccarani, M., Breccia, M. et al. Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib. Leukemia 27, 1511–1519 (2013). https://doi.org/10.1038/leu.2013.51

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