在晚期肝细胞癌患者中,乐伐替尼治疗失败后索拉非尼与纳武单抗的对比研究。
Sorafenib versus nivolumab after lenvatinib treatment failure in patients with advanced hepatocellular carcinoma.
作者信息
Kim Yuna, Lee Jae Seung, Lee Hye Won, Kim Beom Kyung, Park Jun Yong, Kim Do Young, Ahn Sang Hoon, Goh Myung Ji, Kang Wonseok, Kim Seung Up
机构信息
Department of Internal Medicine.
Institute of Gastroenterology, Yonsei University College of Medicine.
出版信息
Eur J Gastroenterol Hepatol. 2023 Feb 1;35(2):191-197. doi: 10.1097/MEG.0000000000002466. Epub 2022 Nov 1.
BACKGROUND AND AIM
An optimal sequential anti-hepatocellular carcinoma (HCC) agent that can be used after failed lenvatinib treatment has not been established. Here, we compared the outcomes of sorafenib and nivolumab as second-line agents after failed lenvatinib treatment in patients with advanced HCC.
METHODS
Patients with advanced HCC who had received sorafenib or nivolumab as second-line agents after failed lenvatinib treatment were recruited from two Korean tertiary institutions between November 2018 and June 2020.
RESULTS
The median age of the 60 participants (52 treated with sorafenib and eight treated with nivolumab) at baseline was 56.8 years. The demographic, laboratory and tumor variables, as well as lenvatinib treatment duration, were similar between the two groups. The median durations of sorafenib and nivolumab treatment were 1.2 and 2.6 months, respectively ( P = 0.164). Twenty-four (40.0%) patients died during the follow-up period (median, 15.8 months). The median overall survival (OS) of the study population was 5.8 months. The median OS of patients treated with sorafenib was significantly longer than the median OS of patients treated with nivolumab (8.7 vs. 3.0 months; P = 0.046). Sorafenib treatment (vs. nivolumab) was independently associated with a lower risk of mortality (hazard ratio = 0.194; 95% confidence interval, 0.053-0.708; P = 0.013). Worse Eastern Cooperative Oncology Group performance status, larger maximal tumor size, lymph node metastases and higher total bilirubin levels were independently associated with increased mortality risk (all P < 0.05).
CONCLUSIONS
Lenvatinib-sorafenib sequential treatment resulted in significantly better survival did than lenvatinib-nivolumab sequential treatment in patients with advanced HCC. Larger studies are needed to validate our results.
背景与目的
尚未确立一种在乐伐替尼治疗失败后可使用的最佳序贯抗肝细胞癌(HCC)药物。在此,我们比较了索拉非尼和纳武单抗作为晚期HCC患者乐伐替尼治疗失败后的二线药物的疗效。
方法
2018年11月至2020年6月期间,从韩国两家三级医疗机构招募了在乐伐替尼治疗失败后接受索拉非尼或纳武单抗作为二线药物治疗的晚期HCC患者。
结果
60名参与者(52名接受索拉非尼治疗,8名接受纳武单抗治疗)的基线中位年龄为56.8岁。两组之间的人口统计学、实验室和肿瘤变量以及乐伐替尼治疗持续时间相似。索拉非尼和纳武单抗治疗的中位持续时间分别为1.2个月和2.6个月(P = 0.164)。24名(40.0%)患者在随访期间死亡(中位时间,15.8个月)。研究人群的中位总生存期(OS)为5.8个月。接受索拉非尼治疗的患者的中位OS显著长于接受纳武单抗治疗的患者(8.7个月对3.0个月;P = 0.046)。索拉非尼治疗(与纳武单抗相比)与较低的死亡风险独立相关(风险比=0.194;95%置信区间,0.053 - 0.708;P = 0.013)。较差的东部肿瘤协作组体能状态、较大的最大肿瘤尺寸、淋巴结转移和较高的总胆红素水平与死亡风险增加独立相关(所有P < 0.05)。
结论
在晚期HCC患者中,乐伐替尼 - 索拉非尼序贯治疗的生存效果明显优于乐伐替尼 - 纳武单抗序贯治疗。需要更大规模的研究来验证我们的结果。