{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T22:18:42Z","timestamp":1787005122302,"version":"build-2736575974"},"reference-count":26,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"unspecified","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["NIH RA37CA230400"],"award-info":[{"award-number":["NIH RA37CA230400"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["U01CA230691"],"award-info":[{"award-number":["U01CA230691"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2021,6,2]]},"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The benefit of immune checkpoint inhibitors (ICIs) in patients with leptomeningeal metastases (LMM) is unknown.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We undertook a phase II trial of pembrolizumab in patients with LMM from solid tumors. Eligible patients had radiologic\/cytologic LMM and Eastern Cooperative Oncology Group performance status 0\u20131. Pembrolizumab was administered intravenously at 200\u2009mg q3W until disease progression\/unacceptable toxicity. The primary endpoint was central nervous system (CNS) response after four cycles, defined radiologically\/cytologically\/clinically. Serial cerebrospinal fluid (CSF) was assessed for tumor-derived DNA (t-DNA) aneuploidy and cytokines.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Thirteen of a planned 16 patients were treated between April 2017 and December 2019. The study closed early for poor accrual. Median age was 57 years (range: 22\u201379). Sixty-two percent of patients had tumors not traditionally ICI-responsive (hormone-receptor (HR)-positive breast carcinoma=39%; high-grade glioma=23%), while 38% had ICI-responsive tumors (non-small cell lung cancer (NSCLC)=23%, head and neck carcinoma=8%, cutaneous squamous carcinoma (CSC)=8%). CNS response was observed in 38% of patients at 12 weeks (95%\u2009CI 13.9% to 68.4%) by pre-defined criteria and LM-RANO, and 2 achieved durable complete responses (CSC=1, overall survival (OS) 3+ years; NSCLC=1, OS 9 months). Median CNS progression-free survival and OS was 2.9 months (95%\u2009CI 1.3 to NR) and 4.9 months (95%\u2009CI 3.7 to NR), respectively. Grade 3+ treatment-related adverse events occurred in 15% of patients. Sensitivity for LMM detection by t-DNA and cytopathology was 84.6% (95% CI 54.6% to 98.1%) and 53.9% (95% CI 25.1% to 80.8%), respectively. Pre-therapy and on-therapy CSF cytokine analysis demonstrated complete responders clustered together.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Pembrolizumab conferred a 38% CNS response rate in patients with LMM, a tolerable safety profile, and deep responses in selected patients with ICI-responsive tumors. CSF t-DNA may be sensitive for LMM detection, and immunologic subsets of CNS response warrant further study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03091478\">NCT03091478<\/jats:ext-link>\n                  <\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2021-002473","type":"journal-article","created":{"date-parts":[[2021,8,11]],"date-time":"2021-08-11T13:00:50Z","timestamp":1628686850000},"page":"e002473","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":62,"title":["Pembrolizumab for patients with leptomeningeal metastasis from solid tumors: efficacy, safety, and cerebrospinal fluid biomarkers"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03091478","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3470-8686","authenticated-orcid":false,"given":"Jarushka","family":"Naidoo","sequence":"first","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Immunology, The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Oncology, Beaumont Hospital and RCSI University of Health Sciences, Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karisa C","family":"Schreck","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Neurology, John Hopkins Medicine, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Fu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Sidney Kimmel Comprehensive Cancer Center, John Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Sidney Kimmel Comprehensive Cancer Center, John Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Carvajal-Gonzalez","sequence":"additional","affiliation":[{"name":"Department of Neurology, John Hopkins Medicine, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roisin M","family":"Connolly","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Cancer Research@UCC, College of Medicine and Health, University College Cork, Cork, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar A","family":"Santa-Maria","sequence":"additional","affiliation":[{"name":"Department of Immunology, The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Immunology, Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2976-0911","authenticated-orcid":false,"given":"Evan J","family":"Lipson","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Immunology, The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3285-3484","authenticated-orcid":false,"given":"Matthias","family":"Holdhoff","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Neurosurgery, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick M","family":"Forde","sequence":"additional","affiliation":[{"name":"Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"},{"name":"Department of Immunology, The Bloomberg\u2013Kimmel Institute for Cancer Immunotherapy, Johns Hopkins 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