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Quality of life among chronic myeloid leukemia patients in the second-line treatment with nilotinib and influential factors

Quality of Life Research volume 31, pages 733–743 (2022)Cite this article

Abstract

Purpose

This study aims to evaluate the quality of life (QoL) of chronic myeloid leukemia (CML) patients prescribed with nilotinib as a second-line therapy and explores the influential factors.

Methods

A multicenter retrospective survey was conducted via face-to-face interviews based on the EORTC QLQ-C30 questionnaire. A total of 121 adult CML patients resistant to imatinib and used nilotinib for at least 3 months were enrolled. The influential features were assessed by multiple linear regression models.

Results

Patients had the mean age of 47.49 (SD = 13.67) years, dominated by middle-aged and male groups. The mean scores of functions ranged from 75 to 83, and those of symptoms were from 5 to 28, with the highest of fatigue (28.28), insomnia (22.87), and pain (21.07). The mean global health status/QoL score was 67.70 (SD = 16.80) with considerable financial difficulties (52.34 (SD = 32.15)). Male patients reported higher functional scores and fewer symptoms compared with female patients. All aspects of QoL became worse with increasing age. Besides age and gender, level of education, duration of nilotinib usage, and comorbidities were also significantly influential factors in many QoL domains. A predicted model for expected mean scores of QoL domains was built based on these factors.

Conclusions

The CML patients treated with nilotinib had the above-moderate QoL scores, a light decrease of functional scores, great financial difficulties, and still experienced symptoms. Strategies and more therapeutic considerations to enhance QoL for CML patients targeted toward women, the old, low educational level, and long duration of nilotinib usage, and many comorbidities are needed in the setting.

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Data availability

The data supporting the results of this study are available from the corresponding author.

Code availability

The R freeware Version 3.5.1 was used for statistical analysis in this study.

References

  1. American Society of Clinical Oncology. (2014). Leukemia–chronic myeloid—CML—review. Retrieved November 23, 2015, from http://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/view-all.

  2. Gambacorti-Passerini, C., Antolini, L., Mahon, F. X., Guilhot, F., Deininger, M., Fava, C., et al. (2011). Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib. Journal of the National Cancer Institute, 103(7), 553–561. https://doi.org/10.1093/jnci/djr060

    CAS  Article  PubMed  Google Scholar 

  3. Jabbour, E., Parikh, S. A., Kantarjian, H., & Cortes, J. (2011). Chronic myeloid leukemia: mechanisms of resistance and treatment. Hematol Oncol Clin North Am, 25(5), 981–995, v, doi:https://doi.org/10.1016/j.hoc.2011.09.004.

  4. Baccarani, M., Deininger, M. W., Rosti, G., Hochhaus, A., Soverini, S., Apperley, J. F., et al. (2013). European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood, 122(6), 872–884. https://doi.org/10.1182/blood-2013-05-501569

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  5. DeRemer, D. L., Ustun, C., & Natarajan, K. (2008). Nilotinib: A second-generation tyrosine kinase inhibitor for the treatment of chronic myelogenous leukemia. Clinical Therapeutics, 30(11), 1956–1975.

    CAS  Article  Google Scholar 

  6. Saglio, G., Kim, D.-W., Issaragrisil, S., Le Coutre, P., Etienne, G., Lobo, C., et al. (2010). Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. New England Journal of Medicine, 362(24), 2251–2259.

    CAS  Article  Google Scholar 

  7. NIDA Health Consequences of Drug Misuse. Retrieved September 23, 2019, from, https://www.drugabuse.gov/publications/health-consequences-drug-misuse/mental-health-effects.

  8. Organization, W. H. WHOQOL: Measuring Quality of Life. https://www.who.int/healthinfo/survey/whoqol-qualityoflife/en/. Accessed 23 Sep 2019.

  9. Efficace, F., Castagnetti, F., Martino, B., & Breccia, M. (2018). Health-related quality of life in patients with chronic myeloid leukemia receiving first-line therapy with nilotinib. Cancer, 124(10), 2228–2237. https://doi.org/10.1002/cncr.31323

    CAS  Article  PubMed  Google Scholar 

  10. Huguet, F., Cayuela, J. M., Cambier, N., Carpentier, N., Tindel, M., Violet, I., et al. (2019). Nilotinib efficacy, safety, adherence and impact on quality of life in newly diagnosed patients with chronic myeloid leukaemia in chronic phase: A prospective observational study in daily clinical practice. British Journal of Haematology, 187(5), 615–626. https://doi.org/10.1111/bjh.16145

    CAS  Article  PubMed  Google Scholar 

  11. Cortes, J. E., Lipton, J. H., Miller, C. B., Busque, L., Akard, L. P., Pinilla-Ibarz, J., et al. (2016). Evaluating the impact of a switch to nilotinib on imatinib-related chronic low-grade adverse events in patients with CML-CP: The ENRICH Study. Clinical Lymphoma, Myeloma & Leukemia, 16(5), 286–296. https://doi.org/10.1016/j.clml.2016.02.002

    Article  Google Scholar 

  12. Ugur, M. C., Kutbay, Y. B., Ozer Kaya, O., & Ceylan, C. (2017). Assessment of Quality of Life of Chronic Myeloid Leukemia patients by using the EORTC QLQ-C30. Turkish Journal of Haematology, 34(2), 197–199. https://doi.org/10.4274/tjh.2016.0409

    Article  PubMed  PubMed Central  Google Scholar 

  13. Sacha, T., Gora-Tybor, J., Wasak-Szulkowska, E., Kyrcz-Krzemien, S., Medras, E., Becht, R., et al. (2017). Quality of Life and adherence to therapy in patients with chronic myeloid leukemia treated with nilotinib as a second-line therapy: A multicenter prospective observational study. Clinical Lymphoma, Myeloma & Leukemia, 17(5), 283–295. https://doi.org/10.1016/j.clml.2017.01.001

    Article  Google Scholar 

  14. ICD10Data.com. https://www.icd10data.com/ICD10CM/Codes/C00-D49/C81-C96/C92-/C92.10.

  15. Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. https://doi.org/10.1093/jnci/85.5.365

    CAS  Article  PubMed  Google Scholar 

  16. Zawisza, K., Tobiasz-Adamczyk, B., Nowak, W., Kulig, J., & Jedrys, J. (2010). Validity and reliability of the quality of life questionnaire (EORTC QLQ C30) and its breast cancer module (EORTC QLQ BR23). Ginekologia Polska, 81(4), 262–267.

    PubMed  Google Scholar 

  17. Shuleta-Qehaja, S., Sterjev, Z., & Shuturkova, L. (2015). Evaluation of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, Albanian version) among breast cancer patients from Kosovo. Patient Preference and Adherence, 9, 459–465. https://doi.org/10.2147/ppa.s78334

    Article  PubMed  PubMed Central  Google Scholar 

  18. Kyriaki, M., Eleni, T., Efi, P., Ourania, K., Vassilios, S., & Lambros, V. (2001). The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) in terminally ill cancer patients under palliative care: validity and reliability in a Hellenic sample. International Journal of Cancer, 94(1), 135–139. https://doi.org/10.1002/ijc.1439

    CAS  Article  PubMed  Google Scholar 

  19. Velikova, G., Coens, C., Efficace, F., Greimel, E., Groenvold, M., Johnson, C., et al. (2012). Health-Related Quality of Life in EORTC clinical trials—30 years of progress from methodological developments to making a real impact on oncology practice. European Journal of Cancer Supplements, 10(1), 141–149. https://doi.org/10.1016/S1359-6349(12)70023-X

    Article  Google Scholar 

  20. R Core Team. (2019). R: A language and environment for statistical computing. R Foundation for Statistical Computing.

  21. Scott, N. W., Fayers, P., Aaronson, N. K., Bottomley, A., de Graeff, A., Groenvold, M., et al. (2008). EORTC QLQ-C30 reference values manual.

  22. Mosweu, I., Moss-Morris, R., Dennison, L., Chalder, T., & McCrone, P. (2017). Cost-effectiveness of nurse-delivered cognitive behavioural therapy (CBT) compared to supportive listening (SL) for adjustment to multiple sclerosis. Health Economics Review. https://doi.org/10.1186/s13561-017-0172-4

    Article  PubMed  PubMed Central  Google Scholar 

  23. Efficace, F., & Cannella, L. (2016). The value of quality of life assessment in chronic myeloid leukemia patients receiving tyrosine kinase inhibitors. Hematology. American Society of Hematology. Education Program, 2016(1), 170–179. https://doi.org/10.1182/asheducation-2016.1.170

    Article  PubMed  PubMed Central  Google Scholar 

  24. Efficace, F., Baccarani, M., Breccia, M., Cottone, F., Alimena, G., Deliliers, G. L., et al. (2013). Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib. Leukemia, 27(7), 1511–1519. https://doi.org/10.1038/leu.2013.51

    CAS  Article  PubMed  Google Scholar 

  25. Efficace, F., Baccarani, M., Breccia, M., Alimena, G., Rosti, G., Cottone, F., et al. (2011). Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood, 118(17), 4554–4560. https://doi.org/10.1182/blood-2011-04-347575

    CAS  Article  PubMed  Google Scholar 

  26. McHorney, C. A. (2009). The Adherence Estimator: A brief, proximal screener for patient propensity to adhere to prescription medications for chronic disease. Current Medical Research and Opinion, 25(1), 215–238. https://doi.org/10.1185/03007990802619425

    Article  PubMed  Google Scholar 

  27. Pagès-Puigdemont, N., Mangues, M. A., Masip, M., Gabriele, G., Fernández-Maldonado, L., Blancafort, S., et al. (2016). Patients’ perspective of medication adherence in chronic conditions: A qualitative study. Advances in Therapy, 33(10), 1740–1754. https://doi.org/10.1007/s12325-016-0394-6

    Article  PubMed  PubMed Central  Google Scholar 

  28. Cancer-related fatigue. Clinical practice guidelines in oncology (2003). Journal of the National Comprehensive Cancer Networks, 1(3), 308–331. https://doi.org/10.6004/jnccn.2003.0029.

  29. Temel, J. S., Greer, J. A., Muzikansky, A., Gallagher, E. R., Admane, S., Jackson, V. A., et al. (2010). Early palliative care for patients with metastatic non-small-cell lung cancer. New England Journal of Medicine, 363(8), 733–742. https://doi.org/10.1056/NEJMoa1000678

    CAS  Article  Google Scholar 

  30. Zimmermann, C., Swami, N., Krzyzanowska, M., Hannon, B., Leighl, N., Oza, A., et al. (2014). Early palliative care for patients with advanced cancer: A cluster-randomised controlled trial. Lancet, 383(9930), 1721–1730. https://doi.org/10.1016/s0140-6736(13)62416-2

    Article  PubMed  Google Scholar 

  31. Au, W. Y., Caguioa, P. B., Chuah, C., Hsu, S. C., Jootar, S., Kim, D.-W., et al. (2009). Chronic myeloid leukemia in Asia. International Journal of Hematology, 89(1), 14–23.

    Article  Google Scholar 

  32. Algahtani, F. H., & Alqahtany, F. S. (2020). Evaluation and characterisation of Chronic myeloid leukemia and various treatments in Saudi Arabia: A retrospective study. Journal of Infection and Public Health, 13(2), 295–298. https://doi.org/10.1016/j.jiph.2019.12.006

    Article  PubMed  Google Scholar 

  33. Kuan, J. W., & Melaine Michael, S. (2018). The epidemiology of chronic myeloid leukaemia in southern Sarawak, Borneo Island. Medical Journal of Malaysia, 73(2), 78–85.

    CAS  Google Scholar 

  34. El-Jawahri, A., Pidala, J., Inamoto, Y., Chai, X., Khera, N., Wood, W. A., et al. (2014). Impact of age on quality of life, functional status, and survival in patients with chronic graft-versus-host disease. Biology of Blood and Marrow Transplantation, 20(9), 1341–1348. https://doi.org/10.1016/j.bbmt.2014.05.001

    Article  PubMed  PubMed Central  Google Scholar 

  35. Velenik, V., Secerov-Ermenc, A., But-Hadzic, J., & Zadnik, V. (2017). Health-related Quality of Life Assessed by the EORTC QLQ-C30 Questionnaire in the general Slovenian population. Radiology and Oncology, 51(3), 342–350. https://doi.org/10.1515/raon-2017-0021

    Article  PubMed  PubMed Central  Google Scholar 

  36. Quinten, C., Coens, C., Ghislain, I., Zikos, E., Sprangers, M. A., Ringash, J., et al. (2015). The effects of age on health-related quality of life in cancer populations: A pooled analysis of randomized controlled trials using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 involving 6024 cancer patients. European Journal of Cancer, 51(18), 2808–2819. https://doi.org/10.1016/j.ejca.2015.08.027

    Article  PubMed  Google Scholar 

  37. Juul, T., Petersen, M. A., Holzner, B., Laurberg, S., Christensen, P., & Gronvold, M. (2014). Danish population-based reference data for the EORTC QLQ-C30: Associations with gender, age and morbidity. Quality of Life Research, 23(8), 2183–2193. https://doi.org/10.1007/s11136-014-0675-y

    Article  PubMed  Google Scholar 

  38. Laghousi, D., Jafari, E., Nikbakht, H., Nasiri, B., Shamshirgaran, M., & Aminisani, N. (2019). Gender differences in health-related quality of life among patients with colorectal cancer. Journal of Gastrointestinal Oncology, 10(3), 453–461. https://doi.org/10.21037/jgo.2019.02.04

    Article  PubMed  PubMed Central  Google Scholar 

  39. Moser, D. K., Heo, S., Lee, K. S., Hammash, M., Riegel, B., Lennie, T. A., et al. (2013). “It could be worse … lot’s worse!” Why health-related quality of life is better in older compared with younger individuals with heart failure. Age and Ageing, 42(5), 626–632. https://doi.org/10.1093/ageing/aft078

    Article  PubMed  PubMed Central  Google Scholar 

  40. Wang, J. W., Sun, L., Ding, N., Li, J., Gong, X. H., Chen, X. F., et al. (2016). The association between comorbidities and the quality of life among colorectal cancer survivors in the People’s Republic of China. Patient Preference and Adherence, 10, 1071–1077. https://doi.org/10.2147/ppa.s100873

    Article  PubMed  PubMed Central  Google Scholar 

  41. Adriaanse, M. C., Drewes, H. W., van der Heide, I., Struijs, J. N., & Baan, C. A. (2016). The impact of comorbid chronic conditions on quality of life in type 2 diabetes patients. Quality of Life Research, 25(1), 175–182. https://doi.org/10.1007/s11136-015-1061-0

    Article  PubMed  Google Scholar 

  42. Cutler, D. M., & Lleras-Muney, A. (2010). Understanding differences in health behaviors by education. Journal of Health Economics, 29(1), 1–28. https://doi.org/10.1016/j.jhealeco.2009.10.003

    Article  PubMed  Google Scholar 

  43. Case, A., Fertig, A., & Paxson, C. (2005). The lasting impact of childhood health and circumstance. Journal of Health Economics, 24(2), 365–389. https://doi.org/10.1016/j.jhealeco.2004.09.008

    Article  PubMed  Google Scholar 

  44. Goldman, D. P., & Smith, J. P. (2002). Can patient self-management help explain the SES health gradient? Proceedings of the National Academy of Sciences of the United States of America, 99(16), 10929–10934. https://doi.org/10.1073/pnas.162086599

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  45. Lagger, G., Pataky, Z., & Golay, A. (2010). Efficacy of therapeutic patient education in chronic diseases and obesity. Patient Education and Counseling, 79(3), 283–286. https://doi.org/10.1016/j.pec.2010.03.015

    Article  PubMed  Google Scholar 

  46. Efficace, F., Baccarani, M., Breccia, M., Saussele, S., Abel, G., Caocci, G., et al. (2014). International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: The EORTC QLQ-CML24. Quality of Life Research, 23(3), 825–836. https://doi.org/10.1007/s11136-013-0523-5

    Article  PubMed  Google Scholar 

  47. Efficace, F., Iurlo, A., Patriarca, A., Stagno, F., Bee, P. C., Ector, G., et al. (2020). Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia. Leukaemia & Lymphoma. https://doi.org/10.1080/10428194.2020.1838509

    Article  Google Scholar 

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Acknowledgements

The authors gratefully thank the Boards of Director of National Institute of Hematology and Blood Transfusion and Blood Transfusion Hematology Hospital in Ho Chi Minh City for allowing and facilitating to recruit and interview patients in the hospitals.

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This research did not receive any funding for the conduct and/or preparation.

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Authors and Affiliations

  1. Department of Pharmaceutical Administration and Economics, Hanoi University of Pharmacy, 13-15 Le Thanh Tong, Hoan Kiem, Hanoi, Vietnam

    Cuc Thi Thu Nguyen & Binh Thanh Nguyen

  2. School of Medicinal and Health Products Sciences, University of Camerino, Camerino, Marche, Italy

    Fabio Petrelli, Stefania Scuri & Iolanda Grappasonni

  3. Department of Organization and Drug Administration, Faculty of Pharmacy, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam

    Thuy Thi Thu Nguyen

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  1. Cuc Thi Thu Nguyen
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Nguyen, C.T.T., Nguyen, B.T., Nguyen, T.T.T. et al. Quality of life among chronic myeloid leukemia patients in the second-line treatment with nilotinib and influential factors. Qual Life Res 31, 733–743 (2022). https://doi.org/10.1007/s11136-021-02952-9

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Keywords

  • Chronic myeloid leukemia
  • Intolerance
  • Nilotinib
  • Quality of life
  • Resistance
  • Second-line