Efficacy and safety of anlotinib with PD-1 blockades in the treatment of advanced biliary tract cancer: A real-world study.

Abstract

e16129 Background: Several clinical trials have demonstrated that antiangiogenic drugs combined with PD-1 blockades are effective for patients with advanced biliary tract cancer (BTC). However, the efficacy of this combination in real-world patients needs to be explored. Anlotinib is a novel oral multi-targeted tyrosine kinase inhibitor for tumor angiogenesis and proliferation, which had been licensed for treatment of considerable malignancies in China. The aim of this study was to investigate the efficacy and safety of anlotinib combined with PD-1 blockades in the treatment of advanced BTC in real world. Methods: This is a multi-center prospective real-world study. Patients with advanced BTC receiving anlotinib combined with PD-1 blockades were recruited. Clinical efficacy was summarized, and adverse events were documented. Tumor response was assessed by investigator according to RECIST version 1.1. The primary endpoint was overall survival (OS), secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and safety. Results: From May 2020 to Sep 2021, a total of 14 eligible pts were recruited. 1 patient was in stage IIIa, 4 pts in stage IIIb, and 9 pts in stage IV. Among them, 10 pts received anlotinib as first-line treatment, 3 pts as second-line treatment and 1 pts as third-line treatment. DCR was 85.71% (57.19%, 98.22%). At the data cut-off date, 7 pts discontinued treatment due to disease progression, the preliminarily prognostic results indicated that the median OS was 8.21 months (95%CI: 5.88, NA) and the median PFS of the 14pts was 6.28 months (95%CI: 3.17-8.21). The safety profile suggested that the most common drug-related adverse events were hypertension (21.43%), decreased white blood cell count (21.43%), decreased platelet count (21.43%), hypoalbuminemia (14.29%), vomit (14.29%), gastrointestinal bleeding (14.29%). The common grade 3 adverse event were gastrointestinal bleeding (7.14%), anemia (7.14%), biliary infection (7.14%). Conclusions: Present study indicated that the combination of anlotinib and PD-1 blockades exhibited potential efficacy and manageable adverse events in the treatment of advanced BTC in the real world. The conclusion should be validated in more patients included subsequently. Clinical trial information: NCT04954521.