{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T03:17:25Z","timestamp":1785208645023,"version":"3.55.0"},"reference-count":20,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T00:00:00Z","timestamp":1738627200000},"content-version":"unspecified","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme United Kingdom","doi-asserted-by":"publisher","award":["Correlative Science Grant number 293-3351"],"award-info":[{"award-number":["Correlative Science Grant number 293-3351"]}],"id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme United Kingdom","doi-asserted-by":"publisher","award":["Merck Protocol Number: 52567, Grant Number 293-145"],"award-info":[{"award-number":["Merck Protocol Number: 52567, Grant Number 293-145"]}],"id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2024,12,29]]},"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Our study was designed to determine the safety, efficacy, and immunological effects of perioperative pembrolizumab in early-stage NSCLC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This is a single-arm phase II study of perioperative pembrolizumab in patients with untreated, clinical stage IB to IIIA NSCLC. Patients received two doses of 200\u2009mg pembrolizumab, surgery, standard adjuvant chemotherapy, followed by four doses adjuvant pembrolizumab. The primary objective of this study was to determine surgical feasibility rate, and secondary objectives are pathological response rate, treatment adverse events, efficacy data, and exploratory analysis of biomarkers.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>30 patients initiated perioperative pembrolizumab, and 25 completed tumor resection. At median follow-up of 59 months after surgical resection, seven patients had disease progression, while six had died representing. A 5-year progression-free survival (PFS) from time of surgery was 72.0% (56.4%\u201391.9%) and overall survival (OS) from time of surgery was 75.8% (60.7%\u201394.7%). Major pathological response (MPR) was found in seven tumors (28%) including two complete responses (4%). Across all treated patients, four receiving neoadjuvant and four receiving adjuvant pembrolizumab experienced treatment-related adverse events of grade 3 or higher with no grade 5 events. Plasma proprotein convertase subtilisin\/kexin type 9 (PCSK9) levels increased across our patient cohort over time from baseline until postsurgery and remained elevated at the end of treatment. There was a significant difference between mean plasma PCSK9 levels for patients with MPR versus all other patients on study when checked postoperatively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Perioperative pembrolizumab was safe and effective with promising MPR rate, PFS, and OS.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2024-010395","type":"journal-article","created":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T12:50:34Z","timestamp":1738673434000},"page":"e010395","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Perioperative pembrolizumab in early-stage non-small cell lung cancer (NSCLC): safety, efficacy, and exploratory biomarker analysis"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct02818920","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-0336-0411","authenticated-orcid":false,"given":"Cameron","family":"Wood","sequence":"first","affiliation":[{"name":"Medical Oncology, Bon Secours Richmond Health System, Kilmarnock, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liliana","family":"Lyniv","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James M","family":"Isaacs","sequence":"additional","affiliation":[{"name":"Division of Hematology Oncology, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob M","family":"Kaufman","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eziafa I","family":"Oduah","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Clarke","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Crawford","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Stinchcombe","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betty C","family":"Tong","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular and Thoracic Surgery, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaofei","family":"Wang","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Biostatistics, Duke University School of Medicine, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Gu","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Biostatistics, Duke University School of Medicine, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Wigle","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery, Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantin H","family":"Dragnev","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Dartmouth-Hitchcock Norris Cotton Cancer Center, Lebanon, New Hampshire, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott J","family":"Antonia","sequence":"additional","affiliation":[{"name":"Medical Oncology, Duke University Medical Center, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent","family":"Weinhold","sequence":"additional","affiliation":[{"name":"Department of Surgery, Duke University Health System, Durham, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4414-9432","authenticated-orcid":false,"given":"Neal","family":"Ready","sequence":"additional","affiliation":[{"name":"Medical Oncology, Duke University Medical Center, Durham, North Carolina, 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