Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study

References

• Perner S, Wagner PL, Demichelis F, et al. EML4-ALK fusion lung cancer: a rare acquired event. Neoplasia. 2008;10:298–302.
   PubMed Web of Science ®Google Scholar
• Wong DW, Leung EL, So KK, et al. The EML4-ALK fusion gene is involved in various histologic types of lung cancers from nonsmokers with wild-type EGFR and KRAS. Cancer. 2009;15;115:1723–1733.
   Web of Science ®Google Scholar
• Bang YJ. The potential for crizotinib in non-small cell lung cancer: a perspective review. Ther Adv Med Oncol. 2011;3:279–291.
   PubMedGoogle Scholar
• Dagogo-Jack I, Shaw AT. Crizotinib resistance: implications for therapeutic strategies. Ann Oncol. 2016 ;27:iii42–iii50.
   PubMed Web of Science ®Google Scholar
• Golding B, Luu A, Jones R, et al. The function and therapeutic targeting of anaplastic lymphoma kinase (ALK) in non-small cell lung cancer (NSCLC). Mol Cancer. 2018;17:52.
   PubMed Web of Science ®Google Scholar
• Kim DW, Tiseo M, Ahn MJ, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. JCO. 2017;35:2490–2498.
   PubMed Web of Science ®Google Scholar
• Huber RM, Kim D-W, Ahn M-J, et al. Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK + non–small cell lung cancer (NSCLC): Efficacy updates and exploratory analysis of CNS ORR and overall ORR by baseline (BL) brain lesion status. J Clin Oncol. 2018;36:9061.
   Web of Science ®Google Scholar
• Leidy NK, Revicki DA, Geneste B. Recommendations for evaluating the validity of quality of life claims for labeling and promotion. Value Health. 1999;2:113–127.
   PubMedGoogle Scholar
• Patrick DL, Chiang YP. Measurement of health outcomes in treatment effectiveness evaluations: conceptual and methodological challenges. Med Care. 2000;38:II–25.
   Web of Science ®Google Scholar
• Bordoni R, Ciardiello F, von Pawel J, et al. Patient-reported outcomes in OAK: a phase III study of atezolizumab versus docetaxel in advanced non-small-cell lung cancer. Clin Lung Cancer. 2018;19:441–449.
   PubMed Web of Science ®Google Scholar
• Cella DF, Patel JD. Improving health-related quality of life in non-small-cell lung cancer with current treatment options. Clin Lung Cancer. 2008;9:206–212.
   PubMed Web of Science ®Google Scholar
• Paracha N, Abdulla A, MacGilchrist KS. Systematic review of health state utility values in metastatic non-small cell lung cancer with a focus on previously treated patients. Health Qual Life Outcomes. 2018;16:179.
   PubMed Web of Science ®Google Scholar
• Quinten C, Martinelli F, Coens C, et al. A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites. Cancer. 2014;120:302–311.
   PubMed Web of Science ®Google Scholar
• Sprangers MA, Schwartz CE. Integrating response shift into health-related quality of life research: a theoretical model. Soc Sci Med. 1999;48:1507–1515.
   PubMed Web of Science ®Google Scholar
• Corner J, Hopkinson J, Fitzsimmons D, et al. Is late diagnosis of lung cancer inevitable? Interview study of patients' recollections of symptoms before diagnosis. Thorax. 2005;60:314–319.
   PubMed Web of Science ®Google Scholar
• Gralla RJ, Griesinger F. Interpreting clinical trials in lung cancer: impact of methodology and endpoints. J Thorac Oncol. 2007;2:S51–S58.
   PubMed Web of Science ®Google Scholar
• Iyer S, Roughley A, Rider A, et al. The symptom burden of non-small cell lung cancer in the USA: a real-world cross-sectional study. Support Care Cancer. 2014;22:181–187.
   PubMed Web of Science ®Google Scholar
• Midwest CEPAC. Treatment Options for Advanced Non-Small Cell Lung Cancer: Effectiveness, Value and Value-Based Price Benchmarks: Institute of Clinical and Economic Review; 2016 [cited 2018, November 29]. Available from: https://icer-review.org/wp-content/uploads/2016/10/MWCEPAC_NSCLC_Final_Evidence_Report_Meeting_Summary_110116.pdf
   Google Scholar
• NICE. The diagnosis and treatment of lung cancer (update) Velindre NHS Trust, Cardiff, Wales.: National Collaborating Centre for Cancer; 2011 [cited 2018, December 3]. Available from: https://www.nice.org.uk/guidance/cg121/evidence/cg121-lung-cancer-full-guideline3
   Google Scholar
• Fitzmaurice C, Allen C, Global Burden of Disease Cancer Collaboration, et al. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 32 Cancer Groups, 1990 to 2015: a systematic analysis for the Global Burden of Disease Study. JAMA Oncol. 2017;3:524–548.
   PubMed Web of Science ®Google Scholar
• Jakovljevic M, Malmose-Stapelfeldt C, Milovanovic O, et al. Disability, work absenteeism, sickness benefits, and cancer in selected European OECD countries-forecasts to 2020. Front Pub Health. 2017;5:23.
   PubMed Web of Science ®Google Scholar
• Bakker C, van der Linden S. Health related utility measurement: an introduction. J Rheumatol. 1995;22:1197–1199.
   PubMed Web of Science ®Google Scholar
• Feeny D, Barr R, Furlong W. Quality of life of the treatment process in pediatric oncology: an approach to measurement. In: Osoba D, editor. Effect of cancer on quality of life. 1st ed. Boca Raton, FL: CRC Press; 1991. p. 73–86.
   Google Scholar
• Torrance GW, Furlong W, Feeny D. Health utility estimation. Expert Rev Pharmacoecon Outcomes Res. 2002;2:99–108.
   PubMedGoogle Scholar
• Dagovic A, Walstra KM, Gutzwiller FS, et al. Resource use and costs of newly diagnosed cancer initial medical care. European J Oncol. 2015;19:166–184.
   Google Scholar
• Jakovljevic MB. Oncology monoclonal antibodies expenditure trends and reimbursement projections in the emerging Balkan market. FE. 2014;15:27–32.
   Google Scholar
• NICE. Guide to the methods of technology appraisal 2013. Process and methods. 2013 [cited 2018, December 3]. Available from: https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781
   Google Scholar
• Rowen D, Brazier J, Young T, et al. Deriving a preference-based measure for cancer using the EORTC QLQ-C30. Value Health. 2011;14:721–731.
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 ;45:228–247.
   PubMed Web of Science ®Google Scholar
• Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–655.
   PubMed Web of Science ®Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B, 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;85:365–376.
   PubMed Web of Science ®Google Scholar
• Booton R, Lorigan P, Anderson H, et al. A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1). Ann Oncol. 2006;17:1111–1119.
   PubMed Web of Science ®Google Scholar
• Ferguson MK, Parma CM, Celauro AD, et al. Quality of life and mood in older patients after major lung resection. Ann Thorac Surg. 2009;87:1007–1012; discussion 1012–1013.
   PubMed Web of Science ®Google Scholar
• Movsas B, Moughan J, Sarna L, et al. Quality of life supersedes the classic prognosticators for long-term survival in locally advanced non-small-cell lung cancer: an analysis of RTOG 9801. JCO. 2009;27:5816–5822.
   PubMedGoogle Scholar
• Nowak AK, Stockler MR, Byrne MJ. Assessing quality of life during chemotherapy for pleural mesothelioma: feasibility, validity, and results of using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Lung Cancer Module. JCO. 2004;22:3172–3180.
   PubMed Web of Science ®Google Scholar
• Turner NJ, Muers MF, Haward RA, et al. Do elderly people with lung cancer benefit from palliative radiotherapy? Lung Cancer. 2005;49:193–202.
   PubMed Web of Science ®Google Scholar
• Fayers P, Bottomley A, Group E, et al. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of cancer. Eur J Cancer. 2002;38:125–133.
   PubMed Web of Science ®Google Scholar
• Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–1736.
   PubMed Web of Science ®Google Scholar
• Janssen MF, Pickard AS, Golicki D, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22:1717–1727.
   PubMed Web of Science ®Google Scholar
• McTaggart-Cowan H, Teckle P, Peacock S. Mapping utilities from cancer-specific health-related quality of life instruments: a review of the literature. Expert Rev Pharmacoecon Outcomes Res. 2013;13:753–765.
   PubMed Web of Science ®Google Scholar
• Arnold DT, Rowen D, Versteegh MM, et al. Testing mapping algorithms of the cancer-specific EORTC QLQ-C30 onto EQ-5D in malignant mesothelioma. Health Qual Life Outcomes. 2015;13:6.
   PubMed Web of Science ®Google Scholar
• Jang RW, Isogai PK, Mittmann N, et al. Derivation of utility values from European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire values in lung cancer. J Thorac Oncol. 2010;5:1953–1957.
   PubMed Web of Science ®Google Scholar
• Longworth L, Yang Y, Young T, et al. Use of generic and condition-specific measures of health-related quality of life in NICE decision-making: a systematic review, statistical modelling and survey. Health Technol Assess. 2014;18:1–224.
   PubMed Web of Science ®Google Scholar
• Khan I, Morris S. A non-linear beta-binomial regression model for mapping EORTC QLQ- C30 to the EQ-5D-3L in lung cancer patients: a comparison with existing approaches. Health Qual Life Outcomes. 2014;12:163.
   PubMed Web of Science ®Google Scholar
• Khan I, Morris S, Pashayan N, et al. Comparing the mapping between EQ-5D-5L, EQ-5D-3L and the EORTC-QLQ-C30 in non-small cell lung cancer patients. Health Qual Life Outcomes. 2016;14:60.
   PubMed Web of Science ®Google Scholar
• Lenderking WR, Lin HM, Speck RM, et al. Patient-reported outcomes and quality of life in the ALK in Lung Cancer Trial of Brigatinib (ALTA). Manuscript submitted for publication.
   Google Scholar
• Payakachat N, Ali MM, Tilford JM. Can the EQ-5D detect meaningful change? A systematic review. Pharmacoeconomics. 2015;33:1137–1154.
   PubMed Web of Science ®Google Scholar
• Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality-of-life scores. JCO. 1998;16:139–144.
   PubMed Web of Science ®Google Scholar
• Osoba D, Zee B, Pater J, et al. Psychometric properties and responsiveness of the EORTC quality of Life Questionnaire (QLQ-C30) in patients with breast, ovarian and lung cancer. Qual Life Res. 1994;3:353–364.
   PubMed Web of Science ®Google Scholar
• Lamu AN, Olsen JA. Testing alternative regression models to predict utilities: mapping the QLQ-C30 onto the EQ-5D-5L and the SF-6D. Qual Life Res. 2018;27:2823–2839.
   PubMed Web of Science ®Google Scholar
• Ratain MJ, Humphrey RW, Gordon GB, et al. Recommended changes to oncology clinical trial design: revolution or evolution? Eur J Cancer. 2008;44:8–11.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency (EMA). ICH Topic E 4: Dose response information to support drug registration Canary Wharf; London; 1994 [cited 2019, January 15]. Available from: https://www.ema.europa.eu/documents/scientific-guideline/ich-e-4-dose-response-information-support-drug-registration-step-5_en.pdf
   Google Scholar
• U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), et al. Guidance for industry: Clinical development programs for drugs, devices, and biological products for the treatment of rheumatoid arthritis (RA) Rockville, MD; 1999 [cited 2019, January 15]. Available from: https://www.fda.gov/downloads/Drugs/Guidances/ucm071579.pdf
   Google Scholar
• Carlson JJ, Canestaro W, Ravelo A, et al. The cost-effectiveness of alectinib in anaplastic lymphoma kinase-positive (ALK+) advanced NSCLC previously treated with crizotinib. J Med Econ. 2017;20:671–677.
   PubMed Web of Science ®Google Scholar
• King MT, Viney R, Simon Pickard A, et al. Australian utility weights for the EORTC QLU-C10D, a multi-attribute utility instrument derived from the cancer-specific quality of life questionnaire, EORTC QLQ-C30. Pharmacoeconomics. 2018;36:225–238.
   PubMed Web of Science ®Google Scholar
• Proskorovsky I, Lewis P, Williams CD, et al. Mapping EORTC QLQ-C30 and QLQ-MY20 to EQ-5D in patients with multiple myeloma. Health Qual Life Outcomes. 2014;12:35.
   PubMed Web of Science ®Google Scholar