Challenges associated with systemic therapy for older patients with inoperable non-small cell lung cancer

References

• Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359–86.
   PubMed Web of Science ®Google Scholar
• Cancer Research UK. Lung cancer incidence statistics. 2015 [cited 2019 Aug] . Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer/incidence
   Google Scholar
• American Cancer Society. Key statistics for lung cancer; 2018 [cited 2019 Aug]. Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics
   Google Scholar
• International Association for the Study of Lung Cancer. Iaslc 2015 statement on tobacco control and smoking cessation; 2015 [cited 2019 Aug]. Available from: https://www.iaslc.org/sites/default/files/wysiwyg-assets/News/iaslc_2015_tobacco_statement_long.pdf
   Google Scholar
• Nations. U. World population ageing; 2015 [cited 2019 Aug]. Available from: http://www.un.org/en/development/desa/population/publications/pdf/ageing/WPA2015_Report.pdf.
   Google Scholar
• Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ. 1997;315(7115):1059.
   PubMedGoogle Scholar
• Hutchins LF, Unger JM, Crowley JJ, et al. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341(27):2061–2067.
   PubMed Web of Science ®Google Scholar
• Talarico L, Chen G, Pazdur R. Enrollment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US food and drug administration. J Clin Oncol. 2004;22(22):4626–4631.
   PubMed Web of Science ®Google Scholar
• Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol. 2005;23(13):3112–3124.
   PubMed Web of Science ®Google Scholar
• Muss HB, Biganzoli L, Sargent DJ, et al. Adjuvant therapy in the elderly: making the right decision. J Clin Oncol. 2007;25(14):1870–1875.
   PubMed Web of Science ®Google Scholar
• Wildiers H, Mauer M, Pallis A, et al. End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer–alliance for clinical trials in oncology–international society of geriatric oncology position article. J Clin Oncol. 2013;31(29):3711–3718.
   PubMed Web of Science ®Google Scholar
• Le Saux O, Falandry C, Gan HK, et al. Inclusion of elderly patients in oncology clinical trials. Ann Oncol. 2016;27(9):1799–1804.
   PubMed Web of Science ®Google Scholar
• Sacher AG, Le LW, Leighl NB, et al. Elderly patients with advanced NSCLC in phase III clinical trials: are the elderly excluded from practice-changing trials in advanced NSCLC? J Thorac Oncol. 2013;8(3):366–368.
   PubMed Web of Science ®Google Scholar
• Gridelli C. The ELVIS trial: a phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly lung cancer vinorelbine Italian study. Oncologist. 2001;6(Suppl 1):4–7.
   PubMed Web of Science ®Google Scholar
• Kudoh S, Takeda K, Nakagawa K, et al. Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan thoracic oncology group trial (WJTOG 9904). J Clin Oncol. 2006;24(22):3657–3663.
   PubMed Web of Science ®Google Scholar
• Quoix E, Zalcman G, Oster JP, et al. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011;378(9796):1079–1088.
   PubMed Web of Science ®Google Scholar
• Berardi R, Porfiri E, Scartozzi M, et al. Elderly patients with advanced non-small cell lung cancer. A phase II study with weekly cisplatin and gemcitabine. Oncology. 2003;65(3):198–203.
   PubMed Web of Science ®Google Scholar
• Gridelli C, Morabito A, Cavanna L, et al. Cisplatin-based first-line treatment of elderly patients with advanced non-small-cell lung cancer: joint analysis of MILES-3 and MILES-4 phase III trials. J Clin Oncol. 2018;36(25):2585–2592.
   PubMed Web of Science ®Google Scholar
• Gridelli C, Perrone F, Gallo C, et al. Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the multicenter Italian lung cancer in the elderly study (MILES) phase III randomized trial. J Natl Cancer Inst. 2003;95(5):362–372.
   PubMed Web of Science ®Google Scholar
• Schuette WSC, Engel-Riedel W, Schumann C, et al. 65Plus: open-label study of bevacizumab in combination with pemetrexed or pemetrexed/carboplatin as first-line treatment of patients with advanced or recurrent nonsquamous non-small-cell lung cancer. Lung Cancer (Auckl). 2017;8:217–229.
   PubMedGoogle Scholar
• Ramalingam SS, Dahlberg SE, Langer CJ, et al. Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern cooperative oncology group trial 4599. J Clin Oncol. 2008;26(1):60–65.
   PubMed Web of Science ®Google Scholar
• Leighl NB, Zatloukal P, Mezger J, et al. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010;5(12):1970–1976.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639.
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373(2):123–135.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540–1550.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389(10066):255–265.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823–1833.
   PubMed Web of Science ®Google Scholar
• Carbone DP, Reck M, Paz-Ares L, et al. First-line nivolumab in stage IV or recurrent non-small-cell lung cancer. N Engl J Med. 2017;376(25):2415–2426.
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodriguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018;378(22):2078–2092.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Jotte RM, Cappuzzo F, et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378(24):2288–2301.
   PubMed Web of Science ®Google Scholar
• Hellmann MD, Paz-Ares L, Bernabe Caro R, et al. Nivolumab plus ipilimumab in advanced non-small-cell lung cancer. N Engl J Med. 2019;381(21):2020–2031.
   PubMed Web of Science ®Google Scholar
• Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. N Engl J Med. 2017;377(20):1919–1929.
   PubMed Web of Science ®Google Scholar
• Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342–2350.
   PubMed Web of Science ®Google Scholar
• Harpreet Singh GK, Maher VE, Beaver JA, et al. FDA subset analysis of the safety of nivolumab in elderly patients with advanced cancers. J clin oncol. 2016;34(15_suppl):10010.
   Google Scholar
• Wheatley-Price P, Ding K, Seymour L, et al. Erlotinib for advanced non-small-cell lung cancer in the elderly: an analysis of the national cancer institute of canada clinical trials group study BR.21. J Clin Oncol. 2008;26(14):2350–2357.
   PubMed Web of Science ®Google Scholar
• Yoshioka H, Komuta K, Imamura F, et al. Efficacy and safety of erlotinib in elderly patients in the phase IV POLARSTAR surveillance study of Japanese patients with non-small-cell lung cancer. Lung Cancer. 2014;86(2):201–206.
   PubMed Web of Science ®Google Scholar
• Maemondo M, Minegishi Y, Inoue A, et al. First-line gefitinib in patients aged 75 or older with advanced non-small cell lung cancer harboring epidermal growth factor receptor mutations: NEJ 003 study. J Thorac Oncol. 2012;7(9):1417–1422.
   PubMed Web of Science ®Google Scholar
• Wu YL, Sequist LV, Tan EH, et al. Afatinib as first-line treatment of older patients with EGFR mutation-positive non-small-cell lung cancer: subgroup analyses of the LUX-lung 3, LUX-lung 6, and LUX-lung 7 trials. Clin Lung Cancer. 2018;19(4):e465–e79.
   PubMed Web of Science ®Google Scholar
• Nakao A, Hiranuma O, Uchino J, et al. Osimertinib in elderly patients with epidermal growth factor receptor T790M-positive non-small-cell lung cancer who progressed during prior treatment: a phase II trial. Oncologist. 2019 May;24(5):593–e170.
   Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177.
   PubMed Web of Science ®Google Scholar
• Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(9):829–838.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim TM, Crino L, et al. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(7):874–886.
   PubMed Web of Science ®Google Scholar
• Soria JC, Tan DSW, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017;389(10072):917–929.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Ou SH, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371(21):1963–1971.
   PubMed Web of Science ®Google Scholar
• Lim SM, Kim HR, Lee JS, et al. Open-label, multicenter, phase II study of ceritinib in patients with non-small-cell lung cancer harboring ROS1 rearrangement. J Clin Oncol. 2017;35(23):2613–2618.
   PubMed Web of Science ®Google Scholar
• Extermann M, Hurria A. Comprehensive geriatric assessment for older patients with cancer. J Clin Oncol. 2007;25(14):1824–1831.
   PubMed Web of Science ®Google Scholar
• Caillet P, Canoui-Poitrine F, Vouriot J, et al. Comprehensive geriatric assessment in the decision-making process in elderly patients with cancer: ELCAPA study. J Clin Oncol. 2011;29(27):3636–3642.
   PubMed Web of Science ®Google Scholar
• Chaibi P, Magne N, Breton S, et al. Influence of geriatric consultation with comprehensive geriatric assessment on final therapeutic decision in elderly cancer patients. Crit Rev Oncol Hematol. 2011;79(3):302–307.
   PubMed Web of Science ®Google Scholar
• Mohile SG, Dale W, Somerfield MR, et al. Practical assessment and management of vulnerabilities in older patients receiving chemotherapy: ASCO guideline for geriatric oncology. J Clin Oncol. 2018;36(22):2326–2347.
   PubMed Web of Science ®Google Scholar