Health-related quality of life and symptoms of chronic myeloid leukemia patients after discontinuation of tyrosine kinase inhibitors: results from the EURO-SKI Trial.
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
10 Jul 2024
10 Jul 2024
Historique:
received:
23
04
2024
accepted:
03
07
2024
revised:
26
06
2024
medline:
11
7
2024
pubmed:
11
7
2024
entrez:
10
7
2024
Statut:
aheadofprint
Résumé
Limited data is available on the health-related quality of life (HRQoL) and symptoms of patients with chronic myeloid leukemia (CML) who are in treatment-free remission (TFR). We herein report HRQoL results from the EURO-SKI trial. Patients who had been on tyrosine kinase inhibitors (TKIs) therapy for at least 3 years and achieved MR4 for at least 1 year were enrolled from 11 European countries, and the EORTC QLQ-C30 and the FACIT-Fatigue questionnaires were used to assess HRQoL and fatigue respectively. Patients were categorized into the following age groups: 18-39, 40-59, 60-69 and ≥70 years. Of 728 patients evaluated at baseline, 686 (94%) completed HRQoL assessments. The median age at TKI discontinuation was 60 years. Our findings indicate that HRQoL and symptom trajectories may vary depending on specific age groups, with younger patients benefiting the most. Improvements in patients aged 60 years or older were marginal across several HRQoL and symptom domains. At the time of considering TKI discontinuation, physicians could inform younger patients that they may expect valuable HRQoL benefits. Considering the marginal improvements observed in patients aged 60 years or above, it may be important to further investigate the value of TFR compared to a lowest effective dose approach in this older group of patients.
Identifiants
pubmed: 38987274
doi: 10.1038/s41375-024-02341-4
pii: 10.1038/s41375-024-02341-4
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Nature Limited.
Références
Kris MG, Benowitz SI, Adams S, Diller L, Ganz P, Kahlenberg MS, et al. Clinical cancer advances 2010: annual report on progress against cancer from the American Society of Clinical Oncology. J Clin Oncol. 2010;28:5327–47.
doi: 10.1200/JCO.2010.33.2742
pubmed: 21060039
Bower H, Bjorkholm M, Dickman PW, Hoglund M, Lambert PC, Andersson TM. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the general population. J Clin Oncol. 2016;34:2851–7.
doi: 10.1200/JCO.2015.66.2866
pubmed: 27325849
Hochhaus A, Baccarani M, Silver RT, Schiffer C, Apperley JF, Cervantes F, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34:966–84.
doi: 10.1038/s41375-020-0776-2
pubmed: 32127639
pmcid: 7214240
Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010;11:1029–35.
doi: 10.1016/S1470-2045(10)70233-3
pubmed: 20965785
Branford S. Why is it critical to achieve a deep molecular response in chronic myeloid leukemia? Haematologica. 2020;105:2730–7.
doi: 10.3324/haematol.2019.240739
pubmed: 33054104
pmcid: 7716360
Mikhaeel S, Atallah E. SOHO state of the art updates and next questions | update on treatment-free remission in chronic myeloid leukemia (CML). Clin Lymphoma Myeloma Leuk. 2023;23:333–9.
doi: 10.1016/j.clml.2023.02.008
pubmed: 36934065
Saußele S, Richter J, Hochhaus A, Mahon FX. The concept of treatment-free remission in chronic myeloid leukemia. Leukemia. 2016;30:1638–47.
doi: 10.1038/leu.2016.115
pubmed: 27133824
pmcid: 4980559
Schoenbeck KL, Flynn KE. Health-related quality of life of patients with chronic myeloid leukemia as measured by patient-reported outcomes: current state and future directions. Curr Hematol Malig Rep. 2021;16:491–9.
doi: 10.1007/s11899-021-00656-y
pubmed: 34648119
Efficace F, Baccarani M, Breccia M, Cottone F, Alimena G, Deliliers GL, et al. Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib. Leukemia. 2013;27:1511–9.
doi: 10.1038/leu.2013.51
pubmed: 23417029
Guerin A, Chen L, Ionescu-Ittu R, Marynchenko M, Nitulescu R, Hiscock R, et al. Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase. Curr Med Res Opin. 2014;30:2317–28.
doi: 10.1185/03007995.2014.944973
pubmed: 25025755
Richter J, Soderlund S, Lubking A, Dreimane A, Lotfi K, Markevarn B, et al. Musculoskeletal pain in patients with chronic myeloid leukemia after discontinuation of imatinib: a tyrosine kinase inhibitor withdrawal syndrome? J Clin Oncol. 2014;32:2821–3.
doi: 10.1200/JCO.2014.55.6910
pubmed: 25071107
Park JS, Lee SE, Jeong SH, Jang EJ, Choi MY, Kim HJ, et al. Change of health-related profiles after Imatinib cessation in chronic phase chronic myeloid leukemia patients. Leuk Lymphoma. 2016;57:341–7.
Hochhaus A, Masszi T, Giles FJ, Radich JP, Ross DM, Gómez Casares MT, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31:1525–31.
doi: 10.1038/leu.2017.63
pubmed: 28218239
pmcid: 5508077
Atallah E, Schiffer CA, Radich JP, Weinfurt KP, Zhang M-J, Pinilla-Ibarz J, et al. Assessment of outcomes after stopping tyrosine kinase inhibitors among patients with chronic myeloid leukemia. JAMA Oncol. 2021;7:42–50.
doi: 10.1001/jamaoncol.2020.5774
pubmed: 33180106
Schoenbeck KL, Atallah E, Lin L, Weinfurt KP, Cortes J, Deininger MWN, et al. Patient-reported functional outcomes in patients with chronic myeloid leukemia after stopping tyrosine kinase inhibitors. J Natl Cancer Inst. 2022;114:160–4.
doi: 10.1093/jnci/djab184
pubmed: 34491344
Atallah E, Schiffer CA, Weinfurt KP, Zhang MJ, Radich JP, Oehler VG, et al. Design and rationale for the life after stopping tyrosine kinase inhibitors (LAST) study, a prospective, single-group longitudinal study in patients with chronic myeloid leukemia. BMC Cancer. 2018;18:359.
doi: 10.1186/s12885-018-4273-1
pubmed: 29609532
pmcid: 5879565
Efficace F, Baccarani M. Quality of life improvements in patients with chronic myeloid leukemia after stopping long-term therapy: who can benefit the most? J Natl Cancer Inst. 2022;114:9–11.
doi: 10.1093/jnci/djab185
pubmed: 34491364
Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, et al. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19:747–57.
doi: 10.1016/S1470-2045(18)30192-X
pubmed: 29735299
Mahon FX, Pfirrmann M, Dulucq S, Hochhaus A, Panayiotidis P, Almeida A, et al. European Stop Tyrosine Kinase Inhibitor Trial (EURO-SKI) in Chronic Myeloid Leukemia: Final Analysis and Novel Prognostic Factors for Treatment-Free Remission. J Clin Oncol. 2024: 42:1875–80 Jco2301647.
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
pubmed: 8433390
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
Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.
Efficace F, Baccarani M, Breccia M, Alimena G, Rosti G, Cottone F, et al. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011;118:4554–60.
doi: 10.1182/blood-2011-04-347575
pubmed: 21750313
Hinz A, Singer S, Brahler E. European reference values for the quality of life questionnaire EORTC QLQ-C30: Results of a German investigation and a summarizing analysis of six European general population normative studies. Acta Oncol. 2014;53:958–65.
doi: 10.3109/0284186X.2013.879998
pubmed: 24456505
Cocks K, King MT, Velikova G, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. J Clin Oncol. 2011;29:89–96.
doi: 10.1200/JCO.2010.28.0107
pubmed: 21098316
Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38:963–74.
doi: 10.2307/2529876
pubmed: 7168798
Sokal JE, Cox EB, Baccarani M, Tura S, Gomez GA, Robertson JE, et al. Prognostic discrimination in “good-risk” chronic granulocytic leukemia. Blood. 1984;63:789–99.
doi: 10.1182/blood.V63.4.789.789
pubmed: 6584184
Anota A, Hamidou Z, Paget-Bailly S, Chibaudel B, Bascoul-Mollevi C, Auquier P, et al. Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization? Qual Life Res. 2015;24:5–18.
doi: 10.1007/s11136-013-0583-6
pubmed: 24277234
Platzbecker U, Santini V, Fenaux P, Sekeres MA, Savona MR, Madanat YF, et al. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403:248.
Schafer JL, Yucel RM. Computational strategies for multivariate linear mixed-effects models with missing values. J Computational Graph Stat. 2002;11:437–57. 2002/06/01
doi: 10.1198/106186002760180608
Pfirrmann M, Baccarani M, Saussele S, Guilhot J, Cervantes F, Ossenkoppele G, et al. Prognosis of long-term survival considering disease-specific death in patients with chronic myeloid leukemia. Leukemia. 2016;30:48–56.
doi: 10.1038/leu.2015.261
pubmed: 26416462
Efficace F, Breccia M, Saussele S, Kossak-Roth U, Cardoni A, Caocci G, et al. Which health-related quality of life aspects are important to patients with chronic myeloid leukemia receiving targeted therapies and to health care professionals? : GIMEMA and EORTC Quality of Life Group. Ann Hematol. 2012;91:1371–81.
doi: 10.1007/s00277-012-1458-6
pubmed: 22543826
Hyland KA, Eisel SL, Hoogland AI, Root JC, Bowles K, James B, et al. Cognition in patients treated with targeted therapy for chronic myeloid leukemia: a controlled comparison. Leuk Lymphoma. 2023;64:415–23.
doi: 10.1080/10428194.2022.2148208
pubmed: 36476293
Schoenbeck KL, Tummala S, Goyal NG, Smith CC, Shah NP. Cognitive dysfunction associated with tyrosine kinase inhibitors in patients with CMl in chronic phase. Blood. 2020;136:2–3. 2020/11/05/
doi: 10.1182/blood-2020-142997
Kota V, Atallah E. Musculoskeletal pain in patients with chronic myeloid leukemia after tyrosine kinase inhibitor therapy cessation. Clin Lymphoma Myeloma Leuk. 2019;19:480–7.
doi: 10.1016/j.clml.2019.05.007
pubmed: 31171474
Flynn KE, Atallah E, Lin L, Shah NP, Silver RT, Larson RA, et al. Patient- and physician-reported pain after tyrosine kinase inhibitor discontinuation among patients with chronic myeloid leukemia. Haematologica. 2022;107:2641–9.
doi: 10.3324/haematol.2021.280377
pubmed: 35511672
pmcid: 9614525
Berger MG, Pereira B, Rousselot P, Cony-Makhoul P, Gardembas M, Legros L, et al. Longer treatment duration and history of osteoarticular symptoms predispose to tyrosine kinase inhibitor withdrawal syndrome. Br J Haematol. 2019;187:337–46.
doi: 10.1111/bjh.16083
pubmed: 31271217
Lou J, Huang J, Wang Z, Wen B, Tu C, Huang W, et al. Chronic myeloid leukemia patients and treatment-free remission attitudes: a multicenter survey. Patient Prefer Adherence. 2018;12:1025–32.
doi: 10.2147/PPA.S163393
pubmed: 29942119
pmcid: 6007199
Efficace F, Iurlo A, Patriarca A, Stagno F, Bee PC, Ector G, et al. Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia. Leuk Lymphoma. 2021;62:669–78.
doi: 10.1080/10428194.2020.1838509
pubmed: 33153355