贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性

肝癌电子杂志 ›› 2024, Vol. 11 ›› Issue (2): 61-65.

贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性

张超¹, 孙永琨^2,*, 苏爱江¹, 赵建军², 周建国², 李智宇², 周华¹, 赵盼¹, 陈楠¹, 刘娜¹

1.北京市朝阳区三环肿瘤医院内科,北京 100122;
2.国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肿瘤内科,北京 100021

收稿日期:2024-02-05 出版日期:2024-06-30 发布日期:2024-09-05
通讯作者: ^*孙永琨,E-mail: hsunyk@126.com
基金资助:
深圳市医疗卫生“三名工程”项目（SZSM202011010）; 吴阶平医学基金会临床科研专项资助基金（320.6790.17198-4）

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

Zhang Chao¹, Sun Yongkun^2,*, Su Aijiang¹, Zhao Jianjun², Zhou Jianguo², Li Zhiyu², Zhou Hua¹, Zhao Pan¹, Chen Nan¹, Liu Na¹

1. Department of Medicine, Beijing Chaoyang Sanhuan Cancer Hospital, Beijing 10012, China;
2. Department of Medica l Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Received:2024-02-05 Online:2024-06-30 Published:2024-09-05
Contact: ^*Sun Yongkun, E-mail: hsunyk@126.com

摘要/Abstract

摘要： 目的：分析贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性。
方法：选取2022年10月至2023年7月北京市朝阳区三环肿瘤医院收治的Ⅳ期胆道腺癌患者22例,进行单中心、单臂、前瞻性Ⅱ期临床研究。治疗方案为贝伐珠单抗5 mg/kg静脉滴注第1天,白蛋白紫杉醇150 mg/m²静脉滴注第1天,替吉奥40~60 mg口服第1~10天,2次/d,每14天为1个周期,直到疾病进展或出现不能耐受的毒性。主要研究终点为客观缓解率（objective response rate, ORR）,次要终点为疾病控制率（disease control rate, DCR）、无进展生存期、安全性。
结果：22例患者可评价疗效21例,中位治疗6个周期,中位治疗线数二线,ORR为42.9%（9/21）,DCR为85.7%（18/21）,疾病进展3例（14.3%,3/21）。中位无进展生存期为8个月[95%置信区间（95% confidence interval, 95%CI：4.5~11.5]。22例患者3级不良反应发生率为68.2%（15/22）,主要为中性粒细胞减少4例（18.1%）,血小板减少2例（9.1%）,胃肠道反应2例（9.1%）,总胆红素（total bilirubin, TBIL）/直接胆红素（direct bilirubin, DBIL）升高1例（4.5%）,贫血1例（4.5%）。其他不良反应包括神经毒性、转氨酶升高、出血、腹泻、乏力、血压升高、蛋白尿等,均为1、2级。4例（18.1%）患者治疗过程中合并感染。3例患者因不良反应停止治疗。无治疗相关性死亡。
结论：贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌显示了良好的抗肿瘤活性和安全性,具有较好的临床应用价值。

关键词: 胆道腺癌, 贝伐珠单抗, 白蛋白紫杉醇, 替吉奥

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)

张超, 孙永琨, 苏爱江, 赵建军, 周建国, 李智宇, 周华, 赵盼, 陈楠, 刘娜. 贝伐珠单抗联合白蛋白紫杉醇和替吉奥治疗晚期胆道腺癌的近期疗效和安全性[J]. 肝癌电子杂志, 2024, 11(2): 61-65.

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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