{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T16:14:14Z","timestamp":1790352854815,"version":"4.1.0"},"reference-count":78,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"9","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Precis Oncol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>PD-L1 positivity in biliary tract cancers (BTCs) is reported from 4% to 76%. BTC clinical trials have not demonstrated PD-L1 expression as a predictor of response to chemotherapy combined with immune checkpoint inhibitor (chemo-ICI). This meta-analysis examines PD-L1 positivity rates in BTC and association between PD-L1 expression and outcomes in patients treated with chemo-ICI.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Materials and Methods<\/jats:title>\n            <jats:p>Observational studies or clinical trials reporting tissue-based PD-L1 expression by Tumor Proportional Score\/Combined Positive Score using immunohistochemistry were included. Clinical trials of BTC treated with chemo-ICI were included to assess PD-L1 expression on treatment response. PubMed, Embase, Web of Science, and Cochrane Library were searched for relevant studies before November 15, 2023. Methods of PD-L1 assessment, including antibody clone, cutoff for PD-L1 positivity, and anatomical subtype, were analyzed. Overall survival (OS) and objective response rates (ORRs) were the main outcomes. The generic inverse variance method and random-effect model were used to assess pooled effect sizes.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>\n              Fifty-six studies met eligibility criteria. Among 7,768 patients, pooled PD-L1 positivity was 30%. Positivity rates varied significantly by antibody clone (5H1, 58%\n              <jats:italic toggle=\"yes\">v<\/jats:italic>\n              SP142, 17%;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              = .02). Clinical trials reported a higher positivity rate compared with observational studies (48%\n              <jats:italic toggle=\"yes\">v<\/jats:italic>\n              26%;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              &lt; .01). Across five phase I\/II clinical trials (194 patients), PD-L1 \u22651% patients tended to have a better ORR than PD-L1 &lt;1% patients (64%\n              <jats:italic toggle=\"yes\">v<\/jats:italic>\n              46%;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              = .08). In two randomized controlled trials (874 patients), PD-L1 \u22651% had a statistically significant improvement in OS (hazard ratio [HR], 0.83;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              &lt; .01), while PD-L1 &lt;1% did not (HR, 0.85;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              = .2).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Given the high PD-L1 positivity rate seen in this study, as well as a possible signal of predictive response for chemo-ICI treatment, PD-L1 expression should be further explored as a predictive biomarker.<\/jats:p>\n          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