Introduction In REFLECT, lenvatinib was noninferior to sorafenib in terms of overall survival (OS) in patients with unresectable hepatocellular carcinoma (uHCC; median 13.6 vs. 12.3 months; HR 0.92, 95% CI 0.79-1.06). The objective response rate (ORR) with lenvatinib was 18.8% by blinded independent imaging review (IIR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); per modified RECIST (mRECIST), the ORR was 40.6%. We sought to further characterize these tumor responses and explore ORR's importance among outcomes for patients with HCC. Methods Efficacy assessments included all patients randomly assigned to receive lenvatinib treatment (if bodyweight ≥60 kg, 12 mg/day; if <60 kg, 8 mg/day). Time to first objective response (TTR) and duration of response (DOR) included patients who achieved a partial or complete tumor response. Tumors were assessed by IIR per RECIST v1.1 or mRECIST. Results Four hundred seventy-eight patients were randomly assigned to receive lenvatinib. By IIR, 90 patients (18.8%) achieved an objective response per RECIST v1.1, and 194 (40.6%) had an objective response per mRECIST. Median TTR/DOR were 2.8 months/7.4 months in responders per RECIST v1.1, and 1.9 months/7.3 months in responders per mRECIST, respectively. Per baseline disease characteristics, ORRs by Child-Pugh score (A5/A6) were 21.2%/11.2% per RECIST v1.1 and 42.9%/33.6% per mRECIST, respectively. By baseline alpha-fetoprotein level (<400/≥400 ng/mL), ORRs were 21.4%/15.4% per RECIST v1.1 and 45.6%/33.8% per mRECIST, respectively. Incidences of treatment-related treatment-emergent adverse events were 98.9% in responders per RECIST v1.1 and 97.9% in responders per mRECIST. Conclusions Responses were seen even in those patients with more severe disease at baseline. Tumor responses occurred early and were durable.

中文翻译：

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在 3 期随机试验中接受 Lenvatinib 治疗的不可切除肝细胞癌患者的肿瘤反应特征：REFLECT。


引言 在 REFLECT 中，仑伐替尼在不可切除肝细胞癌 （uHCC） 患者的总生存期 （OS） 方面不劣于索拉非尼;中位生存期分别为 13.6 个月和 12.3 个月;HR 0.92,95% CI 0.79-1.06）。根据实体瘤反应评估标准 1.1 版 （RECIST v1.1），盲法独立影像学审查 （IIR） 对 lenvatinib 的客观缓解率 （ORR） 为 18.8%;根据修改后的 RECIST （mRECIST），ORR 为 40.6%。我们试图进一步描述这些肿瘤反应，并探讨 ORR 在 HCC 患者结局中的重要性。方法 疗效评估包括所有随机分配接受 lenvatinib 治疗的患者 （如果体重 ≥60 kg，12 mg/天;如果 <60 kg，8 mg/天）。首次客观缓解时间 （TTR） 和缓解持续时间 （DOR） 包括达到部分或完全肿瘤缓解的患者。根据 RECIST v1.1 或 mRECIST 通过 IIR 评估肿瘤。结果 478 例患者被随机分配接受 lenvatinib 治疗。到 IIR，90 名患者 （18.8%） 达到 RECIST v1.1 的客观缓解，194 名患者 （40.6%） 达到 mRECIST 的客观缓解。根据 RECIST v1.1，应答者的中位 TTR/DOR 分别为 2.8 个月/7.4 个月，根据 mRECIST 应答者的中位 TTR/DOR 分别为 1.9 个月/7.3 个月。根据基线疾病特征，Child-Pugh 评分 （A5/A6） 的 ORR 分别为 RECIST v1.1 的 21.2%/11.2% 和 mRECIST 的 42.9%/33.6%。根据基线甲胎蛋白水平 （<400/≥400 ng/mL），ORR 分别为 21.4%/15.4%（RECIST v1.1）和 45.6%/33.8%（mRECIST）。根据 RECIST v1.1，反应者中与治疗相关的治疗中出现的不良事件的发生率为 98.9%，根据 mRECIST 的反应者为 97.9%。 结论 即使在基线时病情更严重的患者中也观察到反应。肿瘤反应发生较早且持久。