AUTHOR=Vitale Elsa , Rizzo Alessandro , Maistrello Lorenza , Nardulli Patrizia , Talienti Tiziana , Quaresmini Davide , De Summa Simona , Massafra Raffaella , Silvestris Nicola , Brunetti Oronzo 

TITLE=The role of immune checkpoint inhibitors in the first-line treatment for patients with advanced biliary tract cancer: a systematic review and meta-analysis of randomized trials

JOURNAL=Frontiers in Oncology

VOLUME=14

YEAR=2024

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1409132

DOI=10.3389/fonc.2024.1409132

ISSN=2234-943X

ABSTRACT=<sec><title>Background</title><p>We performed a systematic review and meta-analysis to further explore the impact of the addition of immunotherapy to gemcitabine–cisplatin as first-line treatment for advanced biliary tract cancer (BTC) patients.</p></sec><sec><title>Methods</title><p>Literature research was performed, and hazard ratio values and 95% confidence intervals were calculated. Heterogeneity among studies was assessed using the tau-squared estimator <inline-formula><mml:math display="inline" id="im1" xmlns:mml="http://www.w3.org/1998/Math/MathML"><mml:mrow><mml:mo stretchy="false">(</mml:mo><mml:msup><mml:mi>τ</mml:mi><mml:mn>2</mml:mn></mml:msup><mml:mo stretchy="false">)</mml:mo></mml:mrow></mml:math></inline-formula>. The total Cochrane Q test (Q) was also assessed. The overall survival rate, objective response rate, and progression-free survival in the selected studies were assessed.</p></sec><sec><title>Results</title><p>A total of 1,754 participants were included. Heterogeneity among the studies selected was found to be non-significant (p = 0.78; tau<sup>2</sup> = 0, I<sup>2</sup> = 0%). The model estimation results and the forest plot suggested that the test for the overall effect was significant (Z = −3.51; p&lt; 0.01).</p></sec><sec><title>Conclusion</title><p>The results of the current meta-analysis further confirm the role of immune checkpoint inhibitors plus gemcitabine–cisplatin as the new standard first-line treatment for advanced BTC patients.</p></sec><sec><title>Systematic review registration</title><p><uri xlink:href="https://www.crd.york.ac.uk/prospero" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.crd.york.ac.uk/prospero</uri>, identifier CRD42023488095.</p></sec>