{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:52:30Z","timestamp":1787017950480,"version":"build-2736575974"},"reference-count":29,"publisher":"S. Karger AG","issue":"8","license":[{"start":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T00:00:00Z","timestamp":1733443200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T00:00:00Z","timestamp":1733443200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Oncology"],"abstract":"<jats:p>Introduction: The TOPAZ-1 phase III trial showed a survival benefit with durvalumab plus gemcitabine and cisplatin in patients with advanced biliary tract cancer (BTC). To understand this combination\u02bcs real-world efficacy and tolerability, we conducted a retrospective analysis of its first-line treatment outcomes. Methods: We included patients with unresectable, locally advanced, or metastatic BTC treated with cisplatin, gemcitabine, plus durvalumab. The primary endpoint was overall survival (OS). Results: Thirty-three patients were enrolled. Median OS was NR and median progression free survival (PFS) was 7.6 months, after a median follow-up of 13.5 months. The investigator-assessed overall response rate was 34.5%, with stable disease in 53.0% of patients. High baseline CEA levels were associated with poor survival. Any grade adverse events (AEs) occurred in 97% of patients. Immune-related AEs (irAEs) occurred in 16% (grade &gt;2: 6%). Presence of TP53 mutation was related to a worse OS; conversely the presence of ARID1A genomic alteration was related to a better PFS. A tendence toward a better OS was found for BRCAness patients which did not reach the statistical significance. On the other hand, BRCAness patients showed significantly higher PFS compared to no BRCAness patients. Conclusion: This real-world analysis largely confirmed the TOPAZ-1 findings, supporting gemcitabine, cisplatin, and durvalumab as a first-line standard of care for patients with advanced BTC.<\/jats:p>","DOI":"10.1159\/000541891","type":"journal-article","created":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T12:01:07Z","timestamp":1733486467000},"page":"677-698","source":"Crossref","is-referenced-by-count":6,"title":["Survival Outcomes of Durvalumab in Combination with Cisplatin and Gemcitabine in Advanced Biliary Tract Cancer: Real-World Results from a Single Italian 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