{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:30:32Z","timestamp":1786591832930,"version":"build-2736575974"},"reference-count":12,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100017006","name":"Abramson Cancer Center","doi-asserted-by":"publisher","award":["NCI P30 CA016520"],"award-info":[{"award-number":["NCI P30 CA016520"]}],"id":[{"id":"10.13039\/100017006","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Although recent trials involving first\u2010line immune checkpoint inhibitors have expanded treatment options for patients with advanced urothelial carcinoma (aUC) who are ineligible for standard cisplatin\u2010based chemotherapy, there exists limited evidence for whether trial efficacy translates into real\u2010world effectiveness for patients seen in routine care. This retrospective cohort study compares differences in overall survival (OS) between KEYNOTE\u2010052 trial participants and routine\u2010care patients receiving first\u2010line pembrolizumab monotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A routine\u2010care patient cohort was constructed from the Flatiron Health database using trial eligibility criteria and was weighted to balance EHR and trial patient characteristics using matching\u2010adjusted indirect comparisons.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The routine\u2010care cohort was older, more likely to be female, and more often cisplatin\u2010ineligible due to renal dysfunction. ECOG performance status was comparable between the cohorts. Median OS was 9\u2009months (95% CI 7\u201316) in the weighted routine\u2010care cohort and 11.3\u2009months (9.7\u201313.1) in the trial cohort. No significant differences between the Kaplan\u2013Meier OS curves were detected (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.76). Survival probabilities were similar between the weighted routine\u2010care and trial cohorts at 12\u2010, 24\u2010, and 36\u2010 months (0.45 vs. 0.47, 0.31 vs. 0.31, 0.26 vs. 0.23, respectively). Notably, routine care patients had modestly lower survival at 3\u2009months compared to trial participants (0.69 vs. 0.83, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our results provide reassurance that cisplatin\u2010ineligible aUC patients receiving first\u2010line immunotherapy in routine care experience similar benefits to those observed in trial patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5798","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T03:34:03Z","timestamp":1714361643000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Comparing survival in trial\u2010 versus routine\u2010care advanced urothelial cancer patients on immune checkpoint blockade"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7313-3264","authenticated-orcid":false,"given":"Lucy S.","family":"Wang","sequence":"first","affiliation":[{"name":"Perelman School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca A.","family":"Hubbard","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology, &amp; Informatics University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronac","family":"Mamtani","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,29]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2021.11.012"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2020.0011"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470\u20102045(17)30616\u20102"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2021.04.008"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5218"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/1475\u20106773.13669"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.2165\/11538370\u2010000000000\u201000000"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471\u20102288\u201012\u20109"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2021.1998097"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.3233\/BLC\u2010211523"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.3390\/curroncol29020080"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2019\u20100039"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5798","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.5798","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5798","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:10:57Z","timestamp":1786590657000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5798"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,29]]},"references-count":12,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1002\/pds.5798"],"URL":"https:\/\/doi.org\/10.1002\/pds.5798","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,29]]},"assertion":[{"value":"2023-09-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5798"}}