Regorafenib Versus Nivolumab After Sorafenib Failure: Real-World Data in Patients With Hepatocellular Carcinoma
Regorafenib Versus Nivolumab After Sorafenib Failure: Real-World Data in Patients With Hepatocellular Carcinoma
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DOI：
10.1002/hep4.1523
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发表时间：
2020-06-16
影响因子：
5.1
通讯作者：
Kim, Kang Mo
中科院分区：
文献类型：
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作者：
Choi, Won-Mook;Choi, Jonggi;Kim, Kang Mo
瑞戈非尼和纳武利尤单抗是索拉非尼治疗失败后被批准用于肝细胞癌（HCC）患者二线治疗的药物。然而，瑞戈非尼和纳武利尤单抗在索拉非尼之后的有效性尚未直接比较。该研究回顾性评估了373例HCC患者，这些患者在2017年7月至2019年2月期间接受索拉非尼治疗失败后接受了瑞格非尼（n = 223）或纳武利尤单抗（n = 150）治疗。无进展生存期（PFS;风险比[HR]，0.85; 95%置信区间[CI]，0.69-1.06;P = 0.150），至进展时间（TTP; HR，0.95; 95% CI，0.77-1.19;P = 0.680）和总生存期（OS; HR，0.83; 95% CI，0.64-1.07; P = 0.154）在接受瑞格非尼和纳武利尤单抗治疗的患者组之间无显著差异，通过多变量校正，倾向评分匹配和逆概率治疗加权（IPTW）分析。然而，纳武利尤单抗组的客观缓解率显著高于瑞格非尼组（13.3% vs. 4.0%;P = 0.002）。当在治疗后无进展者（定义为首次缓解评估后达到完全缓解、部分缓解或疾病稳定的患者）中比较瑞戈非尼和纳武单抗的有效性时，PFS（HR，0.50; 95% CI，0.33-0.75;P = 0.001），TTP（HR，0.48; 95% CI，0.31-0.73;P < 0.001），OS（HR，0.51; 95%CI，0.31-0.87;P = 0.013）在59名nivolumab非进展者中比在104名regorafenib非进展者中显著更长，通过多变量调整和IPTW分析也观察到了结果。索拉非尼治疗失败后接受瑞格非尼和纳武单抗治疗的患者的生存结局无显著差异。然而，nivolumab在非进展者中可能比regorafenib更有效。
Regorafenib and nivolumab are drugs approved for second-line treatment of patients with hepatocellular carcinoma (HCC) after sorafenib failure. However, the effectiveness of regorafenib and nivolumab following sorafenib has not been directly compared. This study retrospectively evaluated 373 patients with HCC who were treated with regorafenib (n = 223) or nivolumab (n = 150) after sorafenib failure between July 2017 and February 2019. Progression-free survival (PFS; hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.69-1.06;P = 0.150), time to progression (TTP; HR, 0.95; 95% CI, 0.77-1.19;P = 0.680), and overall survival (OS; HR, 0.83; 95% CI, 0.64-1.07;P = 0.154) did not differ significantly between groups of patients treated with regorafenib and nivolumab, findings consistently observed by multivariable-adjusted, propensity score-matched, and inverse probability treatment weighting (IPTW) analyses. However, the objective response rate was significantly higher in the nivolumab than in the regorafenib group (13.3% vs. 4.0%;P = 0.002). When the effectiveness of regorafenib and nivolumab was compared in nonprogressors to treatment, defined as patients who achieved complete response, partial response, or stable disease after first response evaluation, PFS (HR, 0.50; 95% CI, 0.33-0.75;P = 0.001), TTP (HR, 0.48; 95% CI, 0.31-0.73;P < 0.001), and OS (HR, 0.51; 95% CI, 0.31-0.87;P = 0.013) were significantly longer in the 59 nonprogressors to nivolumab than in the 104 nonprogressors to regorafenib, findings also observed by multivariable-adjusted and IPTW analyses.Conclusion:Survival outcomes in patients treated with regorafenib and nivolumab after sorafenib failure did not differ significantly. However, nivolumab may be more effective than regorafenib in nonprogressors.