{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T06:21:54Z","timestamp":1790922114792,"version":"4.1.0"},"reference-count":50,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T00:00:00Z","timestamp":1769212800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T00:00:00Z","timestamp":1769212800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2026,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Event\u2010free survival (EFS) and complete response rate (CRR) are recommended as primary endpoints in bladder cancer trials to enable timely assessment of therapeutic benefit. However, their surrogacy relationship with overall survival (OS) in high\u2010risk non\u2013muscle\u2010invasive bladder cancer (HR NMIBC) remains unclear. This meta\u2010analysis evaluated EFS and CRR as surrogate endpoints for OS in bacillus Calmette\u2010Gu\u00e9rin (BCG)\u2013naive or \u2013remote HR NMIBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A systematic literature review identified trials enrolling BCG\u2010naive or \u2010remote HR NMIBC patients and reporting EFS, CRR, and OS. Weighted linear regression models estimated trial\u2010level associations between the hazard ratio (HR) for EFS and HR for OS, odds ratio for CRR and HR for OS, and arm\u2010level association between median EFS and median OS. Strength of association was quantified using the correlation coefficient (\n                      <jats:italic>R<\/jats:italic>\n                      ) and coefficient of determination (\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      ). Sensitivity analyses evaluated consistency across EFS definitions, publication year, and BCG treatment history.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Ten eligible trials were identified for surrogacy analyses of EFS and CRR. Strong correlations were observed between EFS and OS at the trial level (\n                      <jats:italic>R<\/jats:italic>\n                      \u00a0=\u00a00.85;\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u00a0=\u00a00.72) and arm level (\n                      <jats:italic>R<\/jats:italic>\n                      \u00a0=\u00a00.90;\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      \u00a0=\u00a00.82). Trial\u2010level associations between CRR and OS were weaker (\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u00a0=\u00a00.36 for 3\u2010month CRR;\n                      <jats:italic>R<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u00a0=\u00a00.30 for 6\u2010month CRR). Sensitivity analyses confirmed robustness of the primary results.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In BCG\u2010naive or \u2010remote HR NMIBC, EFS shows strong correlation with OS at the trial and arm levels, supporting its potential as a surrogate endpoint. Further validation incorporating additional trials across varied therapeutic modalities is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.70220","type":"journal-article","created":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:08:59Z","timestamp":1769263739000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Event\u2010free survival and complete response rate as surrogate endpoints for overall survival in high\u2010risk non\u2013muscle\u2010invasive bladder cancer: A meta\u2010analysis of bacillus Calmette\u2010Gu\u00e9rin\u2014naive or \u2014remote cases"],"prefix":"10.1002","volume":"132","author":[{"given":"Rituparna","family":"Bhattacharya","sequence":"first","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kal\u00e9","family":"Kponee\u2010Shovein","sequence":"additional","affiliation":[{"name":"Analysis Group Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5917-1005","authenticated-orcid":false,"given":"Yipeng","family":"Gao","sequence":"additional","affiliation":[{"name":"Analysis Group Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Song","sequence":"additional","affiliation":[{"name":"Analysis Group Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingyi","family":"Liu","sequence":"additional","affiliation":[{"name":"Analysis Group Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Wei","sequence":"additional","affiliation":[{"name":"Analysis Group Inc  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekta","family":"Kapadia","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haojie","family":"Li","sequence":"additional","affiliation":[{"name":"Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish M.","family":"Kamat","sequence":"additional","affiliation":[{"name":"Department of Urology The University of Texas MD Anderson Cancer Center  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,24]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"National Cancer Institute.Cancer Stat Facts: Bladder Cancer. 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