Efficacy and safety of bevacizumab with nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1) in advanced biliary tract adenocarcinoma

Abstract

Abstract: Objective: To evaluate the efficacy and safety of bevacizumab with nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1) in advanced biliary tract adenocarcinoma patients.
Method: Totally 22 stageⅣ biliary tract adenocarcinoma patients were enrolled in this single arm, single center prospective phaseⅡ study. Patients were treated with bevacizumab at a dose of 5 mg/kg on day 1, nab-paclitaxel at a dose of 150 mg/m² on day 1 and S-1, 40 to 60 mg bid/day on days 1-10 of a 14-day cycle. Treatments were repeated until disease progression or unacceptable toxicity occurred. The primary endpoint was objective response rate (ORR). The secondary endpoints were median progression-free survival (PFS), disease control rate (DCR), and adverse events (AEs).
Result: The number of patients enrolled were 22, and 21 patients were evaluated for efficacy, with a median of 6 cycles of treatment and a median of 2 lines of treatment. A total of 9 patients achieved partial response (PR) with an ORR of 42.9%(9/21), DCR was 85.7%(18/21). 3 progressive disease was observed. The median PFS were 8 months (95% confidence interval [95%CI]: 4.5~11.5). The incidence of grade 3 treatment-related adverse events in 22 patients was 68.2%(15/22), and there were no grade 4 treatment-related adverse events. The most common grade 3 or 4 toxicities were neutropenia (18.1%), Thrombocytopenia in 2 cases (9.1%), gastrointestinal reaction in 2 cases (9.1%), increased total bilirubin (TBIL)/direct bilirubin (DBIL) in 1 case (4.5%), anemia in 1 case (4.5%), others including neurotoxicity, elevated aminotransferase, bleeding, diarrhea, fatigue, elevation of blood pressure, proteinuria, etc., were grade 1 to 2. During treatment, 4 cases (18.1%) were combined with infection, 3 cases stopped treatment due to adverse events, and there were no treatment-related deaths.
Conclusion: The combination of bevacizumab with nab-paclitaxel and S-1 showed explicit antitumor activities and favorable safety profile in advanced biliary tract adenocarcinoma patients, which has good clinical therapeutic value.

Key words: Biliary tract adenocarcinoma, Bevacizumab, Nab-paclitaxel, Tegafur gimeracil oteracil potassium capsule (S-1)

Zhang Chao, Sun Yongkun, Su Aijiang, Zhao Jianjun, Zhou Jianguo, Li Zhiyu, Zhou Hua, Zhao Pan, Chen Nan, Liu Na. Efficacy and safety of bevacizumab with nab-paclitaxel and tegafur gimeracil oteracil potassium capsule (S-1) in advanced biliary tract adenocarcinoma[J]. Electronic Journal of Liver Tumor, 2024, 11(2): 61-65.

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