Quality of life and mental health in real-world patients with resected stage III/IV melanoma receiving adjuvant immunotherapy

References

• Donia M, Ellebaek E, Øllegaard TH, et al. The real-world impact of modern treatments on the survival of patients with metastatic melanoma. Eur J Cancer. 2019;108:25–32.
   PubMed Web of Science ®Google Scholar
• Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2019;381(16):1535–1546.
   PubMed Web of Science ®Google Scholar
• Long GV, Flaherty KT, Stroyakovskiy D, et al. Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study. Ann Oncol. 2017;28(7):1631–1639.
   PubMed Web of Science ®Google Scholar
• Dummer R, Ascierto PA, Gogas HJ, et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018;19(10):1315–1327.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Chiarion-Sileni V, Grob J-J, et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med. 2016;375(19):1845–1855.
   PubMed Web of Science ®Google Scholar
• Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377(19):1824–1835.
   PubMed Web of Science ®Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378(19):1789–1801.
   PubMed Web of Science ®Google Scholar
• Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377(19):1813–1823.
   PubMed Web of Science ®Google Scholar
• Mandala M, Larkin J, Ascierto PA, et al. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021;9(8):e003188–9.
   PubMed Web of Science ®Google Scholar
• Haanen JBAG, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(4):iv119–iv142.
   PubMed Web of Science ®Google Scholar
• Schneider BJ, Naidoo J, Santomasso BD, et al. Management of Immune-Related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update. J Clin Oncol. 2021;39(36):4073–4126.
   PubMed Web of Science ®Google Scholar
• Johnson DB, Nebhan CA, Moslehi JJ, et al. Immune-checkpoint inhibitors: long-term implications of toxicity. Nat Rev Clin Oncol. 2022;19(4):254–267.
   PubMed Web of Science ®Google Scholar
• Coens C, Suciu S, Chiarion-Sileni V, et al. Phase III trial (EORTC 18071/CA184029) of postoperative adjuvant ipilimumab compared to placebo in patients with resected stage III cutaneous melanoma: health related quality of life (HRQoL) results. Lancet Oncol. 2017;27(6):1181–1182.
   Google Scholar
• Donia M, Kimper-Karl ML, Høyer KL, et al. The majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials. Eur J Cancer. 2017;74:89–95.
   PubMed Web of Science ®Google Scholar
• von Elm E, Altman D, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344–349.
   Google Scholar
• Ellebaek E, Svane IM, Schmidt H, et al. The Danish metastatic melanoma database (DAMMED): a nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients. Cancer Epidemiol. 2021;73:101943.
   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
• 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
• Fayers P, Aaronson N, Bjordal K, et al. EORTC QLQ-C30 scoring manual The EORTC QLQ-C30 introduction. EORTC QLQ-C30 Scoring Man. 2001;30:1–67.
   Google Scholar
• King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996;5(6):555–567.
   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. J Clin Oncol. 1998;16(1):139–144.
   PubMed Web of Science ®Google Scholar
• Brezden CB, Phillips KA, Abdolell M, et al. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2000;18(14):2695–2701.
   PubMed Web of Science ®Google Scholar
• Falleti MG, Sanfilippo A, Maruff P, et al. The nature and severity of cognitive impairment associated with adjuvant chemotherapy in women with breast cancer: a meta-analysis of the current literature. Brain Cogn. 2005;59(1):60–70.
   PubMed Web of Science ®Google Scholar
• Dirven L, Groenvold M, Taphoorn MJB, et al. Psychometric evaluation of an item bank for computerized adaptive testing of the EORTC QLQ-C30 cognitive functioning dimension in cancer patients. Qual Life Res. 2017;26(11):2919–2929.
   PubMed Web of Science ®Google Scholar
• Liegl G, Petersen MA, Groenvold M, et al. Establishing the European norm for the health-related quality of life domains of the computer-adaptive test EORTC CAT core. Eur J Cancer. 2019;107:133–141.
   PubMed Web of Science ®Google Scholar
• Berger AM, Mooney K, Alvarez-Perez A, et al. Cancer-related fatigue, version 2.2015. J Natl Compr Canc Netw. 2015;13(8):1012–1039.
   PubMed Web of Science ®Google Scholar
• Smets E, Garssen B, Bonke B, et al. The multidimensional fatigue inventory (MFI); psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39(3):315–325.
   PubMed Web of Science ®Google Scholar
• Thong MSY, Mols F, van de Poll-Franse LV, et al. Identifying the subtypes of cancer-related fatigue: results from the population-based PROFILES registry. J Cancer Surviv. 2018;12(1):38–46.
   PubMed Web of Science ®Google Scholar
• Massie MJ. Prevalence of depression in patients with cancer early studies of depression in cancer patients. J Natl Cancer Inst Monogr. 2004;32(32):57–71.
   Google Scholar
• Cuijpers P, Dekker J, Noteboom A, et al. Sensitivity and specificity of the major depression inventory in outpatients. BMC Psychiatry. 2007;7:39–38.
   PubMed Web of Science ®Google Scholar
• Bech P, Rasmussen NA, Olsen LR, et al. The sensitivity and specificity of the major depression inventory, using the present state examination as the index of diagnostic validity. J Affect Disord. 2001;66(2–3):159–164.
   PubMed Web of Science ®Google Scholar
• Bech P, Rasmussen NA, Olsen LR, et al. The sensitivity and specificity of the major depression inventory, using the present state examination as the index of diagnostic validity. J Affect Disord. 2001;66(2–3):159–164.
   Google Scholar
• Koch L, Bertram H, Eberle A, et al. Fear of recurrence in long-term breast cancer survivors – still an issue. Results on prevalence, determinants, and the association with quality of life and depression from the cancer survivorship – a multi-regional population-based study. Psychooncology. 2014;23(5):547–554.
   PubMed Web of Science ®Google Scholar
• Luigjes-Huizer YL, Tauber NM, Humphris G, et al. What is the prevalence of fear of cancer recurrence in cancer survivors and patients? A systematic review and individual participant data meta-analysis. Psychooncology. 2022;31(6):879–892.
   PubMed Web of Science ®Google Scholar
• Thewes B, Zachariae R, Christensen S, et al. The concerns about recurrence questionnaire: validation of a brief measure of fear of cancer recurrence amongst Danish and Australian breast cancer survivors. J Cancer Surviv. 2015;9(1):68–79.
   PubMed Web of Science ®Google Scholar
• Brehaut JC, O’Connor AM, Wood TJ, et al. Validation of a decision regret scale. Med Decis Making. 2003;23(4):281–292.
   PubMed Web of Science ®Google Scholar
• Becerra-Perez MM, Menear M, Turcotte S, et al. More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study. BMC Fam Pract. 2016;17(1):1–11.
   PubMed Web of Science ®Google Scholar
• Bottomley A, Coens C, Mierzynska J, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(5):655–664.
   PubMed Web of Science ®Google Scholar
• Mamoor M, Postow MA, Lavery JA, et al. Quality of life in long-term survivors of advanced melanoma treated with checkpoint inhibitors. J Immunother Cancer. 2020;8(1):e000260.
   PubMed Web of Science ®Google Scholar
• Boekhout AH, Rogiers A, Jozwiak K, et al. Health-related quality of life of long-term advanced melanoma survivors treated with anti-CTLA-4 immune checkpoint inhibition compared to matched controls. Acta Oncol. 2021;60(1):69–77.
   PubMed Web of Science ®Google Scholar
• Schadendorf D, Larkin J, Wolchok J, et al. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017;82:80–91.
   PubMed Web of Science ®Google Scholar
• Joseph RW, Liu FX, Shillington AC, et al. Health-related quality of life (QoL) in patients with advanced melanoma receiving immunotherapies in real-world clinical practice settings. Qual Life Res. 2020;29(10):2651–2660.
   PubMed Web of Science ®Google Scholar
• Waldmann A, Schubert D, Katalinic A. Normative data of the EORTC QLQ-C30 for the German population: a population-based survey. PLOS One. 2013;8(9):e74149–8.
   PubMed Web of Science ®Google Scholar