{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T21:05:06Z","timestamp":1793135106726,"version":"4.5.0"},"reference-count":49,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Immune checkpoint inhibitors (ICIs) have broadened the metastatic urothelial carcinoma (mUC) therapeutic scenario. The association of programmed death ligand 1 (PD-L1) with response and survival in patients treated with ICIs is still controversial.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To evaluate the association of PD-L1 with response rate and overall survival among patients with mUC treated with ICIs.<\/jats:p>\n <\/jats:sec>\n \n Data Sources<\/jats:title>\n PubMed, Embase, American Society of Clinical Oncology and European Society for Medical Oncology Meeting Libraries, and Web of Science were searched up to December 10, 2023.<\/jats:p>\n <\/jats:sec>\n \n Study Selection<\/jats:title>\n Two authors independently screened the studies. Included studies were randomized and nonrandomized clinical trials enrolling patients with mUC receiving ICIs with available overall survival (OS), progression-free survival (PFS), or overall response rate (ORR) data, separated between patients with PD-L1\u2013positive and \u2013negative tumors.<\/jats:p>\n <\/jats:sec>\n \n Data Extraction and Synthesis<\/jats:title>\n \n The Preferred Reporting Items for Systematic Reviews and Meta-analyses (\n PRISMA<\/jats:ext-link>\n ) reporting guideline was followed. Two reviewers independently extracted data. Fixed- or random-effects models were used depending on the heterogeneity among the studies.\n <\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Primary outcomes were odds ratios (ORs) for ORR and hazard ratios (HRs) for OS, comparing patients with PD-L1\u2013positive tumors and patients with PD-L1\u2013negative tumors. Secondary outcomes were the PFS HR between patients with PD-L1\u2013positive and \u2013negative tumors and OS HR between ICI arms and non-ICI arms of only randomized clinical trials.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 14 studies were selected, comprising 5271 patients treated with ICIs (2625 patients had PD-L1\u2013positive tumors). The ORR was 13.8% to 78.6% in patients with PD-L1\u2013positive tumors and 5.1% to 63.2% in patients with PD-L1\u2013negative tumors, with an association between PD-L1 status and ORR favoring patients with PD-L1\u2013positive tumors (OR, 1.94; 95% CI, 1.47-2.56;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Median OS ranged from 8.4 to 24.1 months in patients with PD-L1\u2013positive tumors and from 6.0 to 19.1 months in patients with PD-L1\u2013negative tumors. The pooled HR showed a significant reduction for patients with PD-L1\u2013positive tumors compared with those with PD-L1\u2013negative tumors in the risk of death (HR, 0.71; 95% CI, 0.57-0.89;\n P<\/jats:italic>\n \u2009=\u2009.003) and risk of progression (HR, 0.55; 95% CI, 0.44-0.69;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001) when ICIs were administered. PD-L1 is not likely to be a predictive biomarker of ICI response.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n This systematic review and meta-analysis suggests that PD-L1 expression is associated with improved ORR, OS, and PFS for patients with mUC who receive ICIs, but it is unlikely to be useful as a predictive biomarker. Developing predictive biomarkers is essential to select patients most likely to benefit from ICIs and avoid toxic effects and financial burden with these agents.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.1215","type":"journal-article","created":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T11:01:05Z","timestamp":1709722865000},"page":"e241215","source":"Crossref","is-referenced-by-count":54,"title":["Significance of PD-L1 in Metastatic Urothelial Carcinoma Treated With Immune Checkpoint Inhibitors"],"prefix":"10.1001","volume":"7","author":[{"given":"Brigida Anna","family":"Maiorano","sequence":"first","affiliation":[{"name":"Oncology Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Di Maio","sequence":"additional","affiliation":[{"name":"Oncology Department, University of Turin, Turin, Italy"},{"name":"Medical Oncology 1, AOU Citt\u00e0 della Salute e 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