卡博替尼治疗 8 周时肝功能 Child-Pugh B 级进展的晚期肝细胞癌患者的安全性和疗效：CELESTIAL 随机对照试验的回顾性分析。
Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child-Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial.
机构信息
USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Royal Free Hospital, University College London, London, UK.
出版信息
BMC Cancer. 2022 Apr 9;22(1):377. doi: 10.1186/s12885-022-09453-z.
BACKGROUND
Patients with hepatocellular carcinoma (HCC) and Child-Pugh B liver cirrhosis have poor prognosis and are underrepresented in clinical trials. The CELESTIAL trial, in which cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with HCC and Child-Pugh A liver cirrhosis at baseline, was evaluated for outcomes in patients who had Child-Pugh B cirrhosis at Week 8.
METHODS
This was a retrospective analysis of adult patients with previously treated advanced HCC. Child-Pugh B status was assessed by the investigator. Patients were randomised 2:1 to cabozantinib (60 mg once daily) or placebo.
RESULTS
Fifty-one patients receiving cabozantinib and 22 receiving placebo had Child-Pugh B cirrhosis at Week 8. Safety and tolerability of cabozantinib for the Child-Pugh B subgroup were consistent with the overall population. For cabozantinib- versus placebo-treated patients, median OS from randomisation was 8.5 versus 3.8 months (HR 0.32, 95% CI 0.18-0.58), median PFS was 3.7 versus 1.9 months (HR 0.44, 95% CI 0.25-0.76), and best response was stable disease in 57% versus 23% of patients.
CONCLUSIONS
These encouraging results with cabozantinib support the initiation of prospective studies in patients with advanced HCC and Child-Pugh B liver function.
CLINICAL TRIAL REGISTRATION
NCT01908426.
背景
患有肝细胞癌（HCC）和 Child-Pugh B 级肝硬化的患者预后较差，在临床试验中代表性不足。CELESTIAL 试验表明，卡博替尼可改善基线时患有 HCC 和 Child-Pugh A 级肝硬化患者的总生存期（OS）和无进展生存期（PFS），本研究评估了基线时患有 Child-Pugh B 级肝硬化的患者在第 8 周时的结局。
方法
这是一项对先前接受过治疗的晚期 HCC 成年患者进行的回顾性分析。研究者评估 Child-Pugh B 级状态。患者以 2:1 的比例随机接受卡博替尼（60mg 每日一次）或安慰剂治疗。
结果
51 例接受卡博替尼治疗和 22 例接受安慰剂治疗的患者在第 8 周时出现 Child-Pugh B 级肝硬化。卡博替尼在 Child-Pugh B 亚组中的安全性和耐受性与总体人群一致。卡博替尼组和安慰剂组患者的中位 OS 分别为 8.5 个月和 3.8 个月（HR 0.32，95%CI 0.18-0.58），中位 PFS 分别为 3.7 个月和 1.9 个月（HR 0.44，95%CI 0.25-0.76），最佳缓解情况分别为稳定疾病的患者占 57%和 23%。
结论
这些令人鼓舞的卡博替尼结果支持在晚期 HCC 和 Child-Pugh B 级肝功能患者中开展前瞻性研究。
临床试验注册
NCT01908426。
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