Clinical outcomes of transarterial chemoembolization combined with durvalumab for advanced and metastatic biliary tract cancer.

Abstract

Background: This study aimed to evaluate the safety and efficacy of TACE combined with durvalumab for treating advanced and metastatic BTC. Research design and methods: Data were collected retrospectively from a single center. The TACE procedures were performed 1 to 19 times, with repetitions occurring every 4 to 12 weeks based on the patient's liver function and tumor shrinkage. Durvalumab was given as an intravenous injection every three weeks at a dose of 1000 to 1500 mg.

Results: The estimated median progression-free survival (PFS) was 9.0 months (95% CI: 6.8 to 11.2), with a 1-year PFS rate of 23.8%. The estimated median overall survival (OS) was 16.0 months (95% CI: 7.5 to 24.5), with a 1-year OS rate of 58.7%. The investigator-confirmed objective response rate (ORR) was 35.9%. Elevated baseline carcinoembryonic antigen (CEA) levels and neutrophil-to-lymphocyte ratio (NLR) ≥ 3 showed negative correlations with PFS (p = 0.035, CEA; p = 0.038, NLR) and OS (p = 0.040, NLR). Adverse events occurred in 36 patients (92.3%). Additionally, 7 patients (17.9%) experienced immune-mediated AEs (imAEs).

Conclusions: These results indicate promising efficacy and acceptable safety for the combination of TACE and durvalumab as a first-line treatment for advanced and metastatic BTC.