Quality of life in patients with relapsed/refractory multiple myeloma during ixazomib-thalidomide-dexamethasone induction and ixazomib maintenance therapy and comparison to the general population

References

• Landgren O, Iskander K. Modern multiple myeloma therapy: deep, sustained treatment response and good clinical outcomes. J Intern Med. 2017;281(4):365–382.
   PubMed Web of Science ®Google Scholar
• Stephens RJ, Hopwood P, Girling DJ, et al. Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients' self-ratings? Qual Life Res. 1997;6(3):225–236.
   PubMed Web of Science ®Google Scholar
• Fromme EK, Eilers KM, Mori M, et al. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004;22(17):3485–3490.
   PubMed Web of Science ®Google Scholar
• Cocks K, King MT, Velikova G, et al. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer. 2012;48(11):1713–1721.
   PubMed Web of Science ®Google Scholar
• Sonneveld P, Verelst SG, Lewis P, et al. Review of health-related quality of life data in multiple myeloma patients treated with novel agents. Leukemia. 2013;27(10):1959–1969.
   PubMed Web of Science ®Google Scholar
• Macquart-Moulin G, Viens P, Bouscary M-L, et al. Discordance between physicians' estimations and breast cancer patients' self-assessment of side-effects of chemotherapy: an issue for quality of care. Br J Cancer. 1997;76(12):1640–1645.
   PubMed Web of Science ®Google Scholar
• Moreau P, Masszi T, Grzasko N, et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374(17):1621–1634.
   PubMed Web of Science ®Google Scholar
• Leleu X, Masszi T, Bahlis NJ, et al. Patient-reported health-related quality of life from the phase III TOURMALINE-MM1 study of ixazomib-lenalidomide-dexamethasone versus placebo-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma. Am J Hematol. 2018;93(8):985.
   Web of Science ®Google Scholar
• Dimopoulos MA, Gay F, Schjesvold F, et al. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019;393(10168):253–264.
   PubMed Web of Science ®Google Scholar
• Johnson DC, Corthals SL, Walker BA, et al. Genetic factors underlying the risk of thalidomide-related neuropathy in patients with multiple myeloma. J Clin Oncol. 2011;29(7):797–804.
   PubMed Web of Science ®Google Scholar
• Royle K-L, Gregory WM, Cairns DA, et al. Quality of life during and following sequential treatment of previously untreated patients with multiple myeloma: findings of the Medical Research Council Myeloma IX Randomised Study. Br J Haematol. 2018;182(6):816–829.
   PubMed Web of Science ®Google Scholar
• Ludwig H, Moreau P, Dimopoulos MA, et al. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019;9(3):23.
   PubMed Web of Science ®Google Scholar
• Ludwig H, Poenisch W, Knop St, et al. Ixazomib-thalidomide-dexamethasone for induction therapy followed by Ixazomib maintenance treatment in patients with relapsed/refractory multiple myeloma. Br J Cancer. 2019; in print.
   PubMed Web of Science ®Google Scholar
• Nolte S, Liegl G, Petersen MA, et al. General population normative data for the EORTC QLQ-C30 health-related quality of life questionnaire based on 15,386 persons across 13 European countries, Canada and the Unites States. Eur J Cancer. 2019;107:153–163.
   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(5):365–376.
   PubMed Web of Science ®Google Scholar
• Cocks K, Cohen D, Wisløff F, et al. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670–1678.
   PubMed Web of Science ®Google Scholar
• Katz S, Ford AB, Moskowits RW, et al. Studies of illness in the aged. The Index of ADL: a standardized measure of biological and psychosocial function. JAMA. 1963;185(12):914–919.
   PubMed Web of Science ®Google Scholar
• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9(3):179–186.
   PubMed Web of Science ®Google Scholar
• Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–383.
   PubMedGoogle Scholar
• Fayers P, Aaronson NK, Bjordal K, et al. The EORTC QLO-C30 Scoring manual. 3rd ed. Brussels: European Organisation for Research and Treatment of Cancer; 2001.
   Google Scholar
• Osoba D, Bezjak A, Brundage M, et al. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005;41(2):280–287.
   PubMed Web of Science ®Google Scholar
• Stewart AK, Rajkumar SV, Dimopoulos MA, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372(2):142–152.
   PubMed Web of Science ®Google Scholar
• Delforge M, Minuk L, Eisenmann J-C, et al. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015;100(6):826–833.
   PubMed Web of Science ®Google Scholar
• Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53(282):457–481.
   Web of Science ®Google Scholar
• Bland JM, Altman DG. The logrank test. BMJ. 2004;328(7447):1073.
   PubMed Web of Science ®Google Scholar
• Basch E, Geoghegan C, Coons SJ, et al. Patient-reported outcomes in Cancer Drug Development and US Regulatory Review: perspectives from industry, the food and drug administration, and the patient. JAMA Oncol. 2015;1(3):375–379.
   PubMed Web of Science ®Google Scholar
• Gnanasakthy A, Barrett A, Evans E, et al. A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012-2016). Value Health. 2019;22(2):203–209.
   PubMed Web of Science ®Google Scholar
• Maguire R, Fox PA, McCann L, et al. The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. BMJ Open. 2017;7(5):e015016.
   PubMedGoogle Scholar
• Stewart AK, Dimopoulos MA, Masszi T, et al. Health-related quality-of-life results from the open-label, randomized, phase III ASPIRE trial evaluating carfilzomib, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in patients with relapsed multiple myeloma. J Clin Oncol. 2016;34(32):3921–3930.
   PubMed Web of Science ®Google Scholar
• Delforge M, Dhawan R, Robinson D, et al. Health-related quality of life in elderly, newly diagnosed multiple myeloma patients treated with VMP vs. MP: results from the VISTA trial. Eur J Haematol. 2012;89(1):16–27.
   PubMed Web of Science ®Google Scholar
• Catamero D, Noonan K, Richards T, et al. Distress, fatigue, and sexuality: understanding and treating concerns and symptoms in patients with multiple myeloma. CJON. 2017;21(5):7–18.
   Web of Science ®Google Scholar
• Osborne TR, Ramsenthaler C, de Wolf-Linder S, et al. Understanding what matters most to people with multiple myeloma: a qualitative study of views on quality of life. BMC Cancer. 2014;14:496.
   PubMed Web of Science ®Google Scholar
• Wagner LI, Robinson D, Weiss M, et al. Content development for the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM): use of qualitative and quantitative methods for scale construction. J Pain Symptom Manage. 2012;43(6):1094–1104.
   PubMed Web of Science ®Google Scholar
• Dancey JE, Dodd LE, Ford R, et al. Recommendations for the assessment of progression in randomised cancer treatment trials. Eur J Cancer. 2009;45(2):281–289.
   PubMed Web of Science ®Google Scholar
• Carrasco DR, Sukhdeo K, Protopopova M, et al. The differentiation and stress response factor XBP-1 drives multiple myeloma pathogenesis. Cancer Cell. 2007;11(4):349–360.
   PubMed Web of Science ®Google Scholar
• Strasser-Weippl K, Ludwig H. Psychosocial QOL is an independent predictor of overall survival in newly diagnosed patients with multiple myeloma. Eur J Haematol. 2008;81(5):374–379.
   PubMed Web of Science ®Google Scholar
• Viala M, Bhakar AL, de la Loge C, et al. Patient-reported outcomes helped predict survival in multiple myeloma using partial least squares analysis. J Clin Epidemiol. 2007;60(7):670–679.
   PubMed Web of Science ®Google Scholar
• Gotay CC, Kawamoto CT, Bottomley A, et al. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008;26(8):1355–1363.
   PubMed Web of Science ®Google Scholar