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.
Liver Cancer

中文翻译：

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不可切除肝细胞癌患者的 3 期 REFLECT 研究中的基线肝功能和后续结果

简介：开始治疗不可切除的肝细胞癌 (uHCC) 的患者的基线肝功能会影响生存率，并可能影响治疗的疗效结果和安全性。这项对 3 期 REFLECT 研究的事后分析通过 Child-Pugh 评分 (CPS) 和白蛋白-胆红素 (ALBI) 分级评估了 lenvatinib 和索拉非尼在 uHCC 患者中的疗效和安全性结果。方法：根据研究进入基线 ALBI 等级和 CPS，在 REFLECT 的患者队列中评估疗效和安全性。结果：Lenvatinib 治疗通常在所有组中提供生存益处。对于乐伐替尼和索拉非尼组，ALBI 1 级患者的中位总生存期 (OS) 始终高于 ALBI 2 级患者（乐伐替尼：17.4 对 8.6 个月；索拉非尼：14.6 对 7.7 个月，分别）。CPS 为 5 的患者的中位 OS 始终高于 CPS 为 6 的患者（乐伐替尼：15.3 个月对 9.4 个月；索拉非尼：14.2 个月对 7.9 个月）。这些 ALBI 等级和 CPS 的无进展生存率和客观反应率表现出相似的模式。在接受乐伐替尼并经历与治疗相关的治疗相关不良事件导致退出的患者中，6.6% 的 ALBI 等级为 1，而 13.3% 的 ALBI 等级为 2，7.9% 的 CPS 为 5，结论：通过 ALBI 分级或 CPS 测量的基线时更好的肝功能可能预示接受乐伐替尼或索拉非尼治疗的 uHCC 患者更好的生存结果。
肝癌