纳武单抗对比瑞戈非尼在索拉非尼治疗失败的肝细胞癌患者中的疗效
Effectiveness of nivolumab versus regorafenib in hepatocellular carcinoma patients who failed sorafenib treatment.
作者信息
Lee Cheol-Hyung, Lee Yun Bin, Kim Minseok Albert, Jang Heejoon, Oh Hyunwoo, Kim Sun Woong, Cho Eun Ju, Lee Kyung-Hun, Lee Jeong-Hoon, Yu Su Jong, Yoon Jung-Hwan, Kim Tae-You, Kim Yoon Jun
机构信息
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
出版信息
Clin Mol Hepatol. 2020 Jul;26(3):328-339. doi: 10.3350/cmh.2019.0049n. Epub 2020 May 28.
BACKGROUND/AIMS: Several treatment options are currently available for patients with hepatocellular carcinoma (HCC) failing previous sorafenib treatment. We aimed to compare the effectiveness of regorafenib and nivolumab in these patients.
METHODS
Consecutive HCC patients who received regorafenib or nivolumab after failure of sorafenib treatment were included. Primary endpoint was overall survival (OS) and secondary endpoints were time to progression, tumor response rate, and adverse events. Inverse probability of treatment weighting (IPTW) using the propensity score was conducted to reduce treatment selection bias.
RESULTS
Among 150 study patients, 102 patients received regorafenib and 48 patients received nivolumab. Median OS was 6.9 (95% confidence interval [CI], 3.0-10.8) months for regorafenib and 5.9 (95% CI, 3.7-8.1) months for nivolumab (P=0.77 by log-rank test). In multivariable analysis, nivolumab was associated with prolonged OS (vs. regorafenib: adjusted hazard ratio [aHR], 0.54; 95% CI, 0.30-0.96; P=0.04). Time to progression was not significantly different between groups (nivolumab vs. regorafenib: aHR, 0.82; 95% CI, 0.51-1.30; P=0.48). HRs were maintained after IPTW. Objective response rates were 5.9% and 16.7% in patients treated with regorafenib and nivolumab, respectively (P=0.04).
CONCLUSION
After sorafenib failure, the use of nivolumab may be associated with improved OS and better objective response rate as compared to using regorafenib.
背景/目的：目前，对于既往索拉非尼治疗失败的肝细胞癌（HCC）患者有多种治疗选择。我们旨在比较瑞戈非尼和纳武单抗在这些患者中的疗效。
方法
纳入索拉非尼治疗失败后接受瑞戈非尼或纳武单抗治疗的连续性HCC患者。主要终点为总生存期（OS），次要终点为疾病进展时间、肿瘤缓解率和不良事件。采用倾向评分进行治疗权重逆概率（IPTW）以减少治疗选择偏倚。
结果
150例研究患者中，102例接受瑞戈非尼治疗，48例接受纳武单抗治疗。瑞戈非尼组的中位OS为6.9（95%置信区间[CI]，3.0 - 10.8）个月，纳武单抗组为5.9（95%CI，3.7 - 8.1）个月（对数秩检验P = 0.77）。在多变量分析中，纳武单抗与更长的OS相关（与瑞戈非尼相比：调整后风险比[aHR]，0.54；95%CI，0.30 - 0.96；P = 0.04）。两组间疾病进展时间无显著差异（纳武单抗与瑞戈非尼相比：aHR，0.82；95%CI，0.51 - 1.30；P = 0.48）。IPTW后风险比保持不变。接受瑞戈非尼和纳武单抗治疗的患者客观缓解率分别为5.9%和16.7%（P = 0.04）。
结论
索拉非尼治疗失败后，与使用瑞戈非尼相比，使用纳武单抗可能与改善OS和更好的客观缓解率相关。
Zotero 插件