Efficacy and Safety of Ramucirumab in Patients with Unresectable Hepatocellular Carcinoma with Progression after Treatment with Lenvatinib.
Efficacy and Safety of Ramucirumab in Patients with Unresectable Hepatocellular Carcinoma with Progression after Treatment with Lenvatinib.
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DOI：
10.2169/internalmedicine.5185-20
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发表时间：
2021-02-01
期刊：
影响因子：
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通讯作者：
Kumada H
中科院分区：
文献类型：
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作者：
Kasuya K;Kawamura Y;Kobayashi M;Shindoh J;Kobayashi Y;Kajiwara A;Iritani S;Fujiyama S;Hosaka T;Saitoh S;Sezaki H;Akuta N;Suzuki F;Suzuki Y;Ikeda K;Arase Y;Eguchi Y;Hashimoto M;Kumada H
在既往接受过索拉非尼（SOR）治疗的不可切除肝细胞癌（uHCC）和甲胎蛋白（AFP）浓度≥400 ng/mL的患者中，证明了雷莫芦单抗（RAM）的生存获益。然而，目前尚不清楚RAM是否在乐伐替尼（LEN）治疗后进展的uHCC患者中具有相似的疗效。本研究旨在评估RAM作为LEN治疗后晚期uHCC的二线治疗的早期抗肿瘤反应。 我们在开始后6周回顾性评估了RAM的有效性和安全性。根据实体瘤疗效评价标准第1.1版评价疗效。 我们评估了7例在LEN失败后接受RAM作为二线或三线治疗的uHCC患者。 疾病控制率（DCR）为28.6%（2/7例患者）。在开始RAM后，快速疾病进展导致1例患者在19天后死亡。中位无进展生存期（PFS）为41天。未发生3级或4级治疗相关不良事件。第6周时，改良白蛋白-胆红素（mALBI）分级未恶化。在具有稳定疾病（SD）的成像反应的患者中，AFP产生速率从基线降低。 RAM可能具有抑制先前用LEN治疗的患者的uHCC进展以及在治疗期间维持肝功能的治疗潜力。因此，评估AFP趋势可能有助于预测RAM的有效性。
A survival benefit was demonstrated for ramucirumab (RAM) in patients with unresectable hepatocellular carcinoma (uHCC) and α-fetoprotein (AFP) concentrations ≥400 ng/mL who had previously received sorafenib (SOR). However, it is unclear whether RAM has a similar efficacy in patients with uHCC that progresses after lenvatinib (LEN) treatment. This study aimed to evaluate the early anti-tumor response to RAM as a second-line treatment for advanced uHCC after LEN treatment. We retrospectively assessed the efficacy and safety of RAM at 6 weeks after initiation. The therapeutic effects were evaluated according to the Response Evaluation Criteria in Solid Tumors version 1.1. We evaluated 7 patients with uHCC who received RAM as a second- or third-line treatment after LEN failure. The disease control rate (DCR) was 28.6% (2 of 7 patients). After the initiation of RAM, a rapid disease progression resulted in 1 patient death after 19 days. The median progression-free survival (PFS) was 41 days. There were no grade 3 or 4 treatment-related adverse events. At 6 weeks, there was no deterioration in the modified albumin-bilirubin (mALBI) grade. In patients with an imaging response of stable disease (SD), the rate of AFP production decreased from the baseline. RAM may have a therapeutic potential for the suppression of uHCC progression in patients previously treated with LEN, as well as for maintaining the liver function during treatment. Evaluating the AFP trends may therefore be useful for predicting RAM effectiveness.