Baseline Liver Function and Subsequent Outcomes in the Phase 3 REFLECT Study of Patients with Unresectable Hepatocellular Carcinoma
Baseline Liver Function and Subsequent Outcomes in the Phase 3 REFLECT Study of Patients with Unresectable Hepatocellular Carcinoma
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DOI：
10.1159/000516490
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发表时间：
2021-07-15
期刊：
影响因子：
13.8
通讯作者：
Kudo, Masatoshi
中科院分区：
文献类型：
--
作者：
Vogel, Arndt;Frenette, Catherine;Kudo, Masatoshi
导言：不能切除的肝细胞癌(UHCC)患者开始治疗时的基线肝功能会影响存活率，并可能影响疗效和治疗的安全性。这项3期Reflect研究的特别分析通过Child-Pugh评分(CPS)和白蛋白-胆红素(ALBI)分级评估了lenvatinib和sorafenib在uHCC患者中的疗效和安全性结果。方法：根据研究开始时的基线、白蛋白分级和CPS，用Reflect对患者队列进行疗效和安全性评估。结果：Lenvatinib治疗总体上为所有组的患者提供了生存益处。白蛋白评分为1的患者的中位总存活率(OS)始终高于白蛋白评分为2的患者(分别为17.4个月和14.6个月；索拉非尼分别为8.6个月和7.7个月)。CPS为5的患者的中位OS持续高于CPS为6的患者(Lenvatinib：15.3个月对9.4个月；索拉非尼：14.2对7.9个月)。这些ALBI分级和CPS的无进展存活率和客观应答率显示出相似的模式。在接受Lenvatinib治疗并经历与治疗相关的紧急不良事件导致停药的患者中，6.6%的患者Albi分级为1，13.3%的患者Albi分级为2，7.9%的患者CPS为5，12.1%的患者CPS为6。结论：以Albi分级或CPS衡量，基线时肝功能的改善可能是接受Lenvatinib或Sorafenib治疗的UHCC患者更好的生存结果的预后。
Introduction: Baseline liver function among patients starting treatment for unresectable hepatocellular carcinoma (uHCC) impacts survival and could impact efficacy outcomes and safety profiles of treatments. This post hoc analysis of the phase 3 REFLECT study examined the efficacy and safety outcomes for lenvatinib and for sorafenib in patients with uHCC, assessed by Child-Pugh score (CPS) and albumin-bilirubin (ALBI) grade. Methods: Efficacy and safety were assessed in patient cohorts from REFLECT according to study entry baseline ALBI grade and CPS. Results: Lenvatinib treatment generally provided survival benefits in all groups. Median overall survival (OS) among patients with an ALBI grade of 1 was consistently higher than among patients with an ALBI grade of 2 for both the lenvatinib and sorafenib arms (lenvatinib: 17.4 vs. 8.6 months; sorafenib: 14.6 vs. 7.7 months, respectively). Median OS among patients with a CPS of 5 was consistently higher than among patients with a CPS of 6 (lenvatinib: 15.3 vs. 9.4 months; sorafenib: 14.2 vs. 7.9 months, respectively). Progression-free survival and objective response rates for these ALBI grades and CPS demonstrated similar patterns. Among patients who received lenvatinib and experienced a treatment-related treatment-emergent adverse event leading to withdrawal, 6.6% had an ALBI grade of 1, while 13.3% had an ALBI grade of 2, and 7.9% had a CPS of 5, while 12.1% had a CPS of 6. Conclusions: Better liver function at baseline, as measured by ALBI grade or CPS, may be prognostic for better survival outcomes in patients with uHCC undergoing treatment with lenvatinib or sorafenib.