{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T18:21:37Z","timestamp":1790014897314,"version":"4.0.1"},"reference-count":28,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,4,30]],"date-time":"2022-04-30T00:00:00Z","timestamp":1651276800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Pembrolizumab is the recommended first\u2010line therapy for patients with advanced non\u2010small\u2010cell lung cancer (NSCLC) and a programmed death ligand\u20101 (PD\u2010L1) tumor proportion score (TPS) of \u226550% without driver mutations. However, its efficacy and safety for patients \u226575\u2009years have not been prospectively investigated; this was the aim of this study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter and open\u2010label single\u2010arm phase II study was conducted at 12 institutions. Chemotherapy\u2010na\u00efve patients with advanced NSCLC and a PD\u2010L1 TPS of \u226550% without <jats:italic>EGFR<\/jats:italic> mutations or translocation of the <jats:italic>ALK<\/jats:italic> received pembrolizumab every 3\u2009weeks. The primary endpoint was progression\u2010free survival (PFS) with a threshold of 4.3\u00a0months. The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010six patients were enrolled between October 2017 and March 2020. The median PFS was 9.6 (95% confidence interval [CI] 2.1\u201320.6) months. The lower limit of the 95% CI did not exceed the target. The median OS was 21.6\u00a0months. The ORR and DCR were 41.7% and 70.8%, respectively. The proportion of patients with grade \u22653 treatment\u2010related adverse events was 15.4%. The quality of life score did not change significantly during treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>While this study showed that pembrolizumab was a tolerable treatment for elderly patients, the safety requires further confirmation in a larger study. Although the primary endpoint, the median PFS (9.6\u00a0months), was slightly shorter than that (10.3\u00a0months) of the previous phase III study (KEYNOTE\u2010024 study), the median PFS did not achieve the expected value.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1759-7714.14428","type":"journal-article","created":{"date-parts":[[2022,4,30]],"date-time":"2022-04-30T08:41:45Z","timestamp":1651308105000},"page":"1611-1618","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Phase 2 study of first\u2010line pembrolizumab monotherapy in elderly patients with non\u2010small\u2010cell lung cancer expressing high <scp>PD\u2010L1<\/scp>"],"prefix":"10.1111","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3557-0049","authenticated-orcid":false,"given":"Takeshi","family":"Masuda","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine Hiroshima University Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazunori","family":"Fujitaka","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Hiroshima University Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Internal Medicine JA Onomichi General Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8654-5532","authenticated-orcid":false,"given":"Kosuke","family":"Hamai","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Hiroshima Prefectural Hospital  Hiroshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoko","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Respiratory Internal Medicine Hiroshima Red Cross Hospital &amp; 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