{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T16:24:29Z","timestamp":1792081469706,"version":"4.4.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"26","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2020,9,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To evaluate first-line pembrolizumab monotherapy efficacy and safety in patients with unresectable cutaneous squamous cell carcinomas (CSCCs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>\n                      Patients, predominantly men, with their CSSCs\u2019 immunohistochemically determined programmed cell death-ligand 1 (PD-L1) status determined (tumor proportion score threshold, 1%), received pembrolizumab (200 mg every 3 weeks). The primary endpoint was the 39-patient primary cohort\u2019s objective response rate at week 15 (ORR\n                      <jats:sub>W15<\/jats:sub>\n                      ). Secondary objectives were best ORR, overall survival (OS), progression-free survival (PFS), duration of response (DOR), safety, ORR according to PD-L1 status and health-related quality of life using Functional Assessment of Cancer Therapy\u2013General (FACT-G) score. An 18-patient expansion cohort, recruited to power the study to evaluate the ORR\n                      <jats:sub>W15<\/jats:sub>\n                      difference between PD-L1+ and PD-L1\u2013 patients, was assessed for ORR, disease control rate, and safety, but not survival.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Median age of all patients was 79 years. The primary cohort\u2019s ORR\n                      <jats:sub>W15<\/jats:sub>\n                      was 41% (95% CI, 26% to 58%), including 13 partial and 3 complete responses. Best responses were 8 partial and 8 complete responses. At a median follow-up of 22.4 months, respective median PFS, DOR, and OS were 6.7 months, not reached, and 25.3 months, respectively. Pembrolizumab-related adverse events affected 71% of the patients, and 4 (7%) were grade \u2265 3. One death was related to rapid CSCC progression; another resulted from a fatal second aggressive head and neck squamous cell carcinoma diagnosed 15 weeks postinclusion. ORR\n                      <jats:sub>W15<\/jats:sub>\n                      for the entire population was 42%; it was significantly higher for PD-L1+ patients (55%) versus PD-L1\u2013 patients (17%; P = .02). Responders\u2019 W15 total FACT-G score had improved ( P = .025) compared with nonresponders.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>First-line pembrolizumab monotherapy exhibited promising anti-CSCC activity, with durable responses and manageable safety. PD-L1 positivity appears to be predictive of pembrolizumab efficacy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.19.03357","type":"journal-article","created":{"date-parts":[[2020,7,30]],"date-time":"2020-07-30T16:02:31Z","timestamp":1596124951000},"page":"3051-3061","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":163,"title":["Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas"],"prefix":"10.1200","volume":"38","author":[{"given":"Eve","family":"Maubec","sequence":"first","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, H\u00f4pital Avicenne, Bobigny, France"},{"name":"Universit\u00e9 Paris 13, Bobigny, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marouane","family":"Boubaya","sequence":"additional","affiliation":[{"name":"Assistance Publique\u2013H\u00f4pitaux de Paris, H\u00f4pital 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