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Research Articles

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

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Pages 2317-2328 | Accepted 10 Jul 2014, Published online: 05 Aug 2014

References

  • Druker BJ, Lydon NB. Lessons learned from the development of an abl tyrosine kinase inhibitor for chronic myelogenous leukemia. J Clin Invest 2000;105:3-7
  • Kantarjian H, O’Brien S, Jabbour E, et al. Improved survival in chronic myeloid leukemia since the introduction of imatinib therapy: a single-institution historical experience. Blood 2012;119:1981-7
  • Baran Y, Saydam G. Cumulative clinical experience from a decade of use: imatinib as first-line treatment of chronic myeloid leukemia. J Blood Med 2012;3:139-50
  • Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013;122:872-84
  • Hughes TP, Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood 2014;123:1353-60
  • Beaumont JL, Magestro M, Coombs J, et al. Assessment of patient reported outcomes (PROs) from the ENESTnd trial with minimum follow-up of 36 cycles. In: 54th ASH Annual Meeting and Exposition. Atlanta, GA: American Society of Hematology, 2012:abstract 3166
  • Efficace F, Baccarani M, Breccia M, 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
  • Ferdinand R, Mitchell SA, Batson S, Tumur I. Treatments for chronic myeloid leukemia: a qualitative systematic review. J Blood Med 2012;3:51-76
  • Larson RA, Hochhaus A, Hughes TP, et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia 2012;26:2197-203
  • Novartis Pharmaceuticals Corporation. Tasigna (nilotinib) Capsules. Washington, DC: US Food and Drug Administration, 2007:1-21. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf [Last accessed 4 September 2013]
  • National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia v4.2013. 2013:1-95. Available at: http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf [Last accessed 6 June 2013]
  • Lorimer S, Cox A, Langford NJ. A patient’s perspective: the impact of adverse drug reactions on patients and their views on reporting. J Clin Pharm Ther 2012;37:148-52
  • Jabbour EJ, Kantarjian H, Eliasson L, et al. Patient adherence to tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Am J Hematol 2012;87:687-91
  • Cortes JE, Lipton JH, Miller CB, et al. Change in chronic low-grade nonhematologic adverse events (AEs) and quality of life (QoL) in adult patients (pts) with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) switched from imatinib (IM) to nilotinib (NIL). Blood 2012;120:abstr 3782
  • Huang X, Cortes J, Kantarjian H. Estimations of the increasing prevalence and plateau prevalence of chronic myeloid leukemia in the era of tyrosine kinase inhibitor therapy. Cancer 2012;118:3123-7
  • Novartis Pharmaceuticals. A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP). ClinicalTrials.gov. 2007. Available at: http://clinicaltrial.gov/ct2/show/NCT00471497?term=ENESTnd&rank=1 [Last accessed 29 January 2014]
  • Kantarjian HM, Hochhaus A, Saglio G, et al. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol 2011;12:841-51
  • Hochhaus A, Saglio G, Larson RA, et al. Nilotinib is associated with a reduced incidence of BCR-ABL mutations vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Blood 2013;121:3703-8
  • Saglio G, Kim D-W, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 2010;362:2251-9
  • Cella D, Jensen SE, Webster K, et al. Measuring health-related quality of life in leukemia: the Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu) questionnaire. Value Health 2012;15:1051-8
  • Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Lincoln, Rhode Island: QualityMetric, Inc., 1993
  • Cella D. The manual of the functional assessment of chronic illness therapy (FACIT) measurement system. Evanston, IL: Center on Outcomes, Research, and Education, Evanston Northwestern Healthcare and Northwestern University, 1997
  • Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570-9
  • Trask PC, Cella D, Besson N, et al. Health-related quality of life of bosutinib (SKI-606) in imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia. Leuk Res 2012;36:438-42
  • Ware JE, Kosinski M, Turner-Bowker DM, et al. How to score version 2 of the SF-12 Health Survey (with a supplement documenting version 1). Lincoln, RI: QualityMetric Incorporated, 2002
  • Ware JE. SF-36 health survey update. The use of psychological testing for treatment planning and outcomes assessment 3 2004;693-718
  • MedDRA Maintenance and Support Services, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Introductory Guide MedDRA Version 17.0. International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2011:1-83. Available at: http://www.meddra.org/sites/default/files/guidance/file/intguide_17_0_english.pdf [Last accessed 29 January 2014]
  • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. 2013. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm [Last accessed 19 November 2013]
  • Albert PS. Longitudinal data analysis (repeated measures) in clinical trials. Stat Med 1999;18:1707-32
  • Gelman A, Hill J. Data analysis using regression and multilevel/hierarchical models. New York, NY: Cambridge University Press, 2006
  • Bender R, Lange S. Adjusting for multiple testing – when and how? J Clin Epidemiol 2001;54:343-9
  • Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology 1990;1:43-6
  • Hong H, Qiu J-Y, Lai Y-Y, et al. Analysis of cytogenetic response in Ph+ chronic myeloid leukemia patients treated with interferon alpha. Zhongguo Shi Yan Xue Ye Xue Za Zhi 2003;11:269-73
  • Larson RA. CML: live long and prosper. Blood 2011;118:4499-500
  • Efficace F, Breccia M, Saussele S, 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
  • 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 2013;27:1511-19
  • Swigris JJ, Brown KK, Behr J, et al. The SF-36 and SGRQ: validity and first look at minimum important differences in IPF. Respir Med 2010;104:296-304
  • Larson RA, Hochhau A, Saglio G, et al. Nilotinib versus imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): ENESTnd 4-year (y) update. J Clin Oncol 2013;31(15 Suppl):7052
  • Halyard MY, Ferrans CE. Quality-of-Life assessment for routine oncology clinical practice. J Support Oncol 2008;6:221-9, 233
  • American Society of Clinical Oncology. Outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol 1996;14:671-9
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) C for BE and R (CBER). Guidance for Industry: Non-Inferiority Clinical Trials – Draft Guidance. Rockville, MD: US Department of Health and Human Services Food and Drug Administration, 2010:1-66. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm [Last accessed 25 April 2014]
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials. Rockville, MD: US Department of Health and Human Services Food and Drug Administration, 2001:1-37. Available at: http://www.fda.gov/cder/guidance/index.htm [Last accessed 25 April 2014]

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