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