Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function.
Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function.
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DOI：
10.1177/17588359221116608
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发表时间：
2022
影响因子：
4.9
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中科院分区：
文献类型：
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乐伐替尼是一种获批的不可切除肝细胞癌（uHCC）的一线治疗药物。我们评价了乐伐替尼与索拉非尼B在治疗期间恶化至Child-Pugh分级B（CP-B）的uHCC患者中的安全性和疗效。我们回顾性评价了REFLECT中随机分组后8周内恶化为CP-B级的患者与Child-Pugh A级（CP-A）的患者。根据改良的实体瘤疗效评价标准（mRECIST），从基线评估最佳总体缓解和客观缓解率（ORR）。从第8周开始评估mRECIST评估的无进展生存期（PFS）和总生存期（OS）。接受乐伐替尼治疗的CP-B与CP-A分级患者的ORR分别为28.3%和42.9%;接受索拉非尼治疗的CP-B与CP-A分级患者的ORR分别为8.5%和12.9%。中位PFS和OS（从第8周开始的里程碑分析）分别为3.7个月[95%置信区间（CI）：1.8-7.4]和6.8个月（95% CI：2.6-10.3），而CP-A亚组分别为6.5个月（95% CI：5.6-7.4）和13.3个月（95% CI：11.6-16.1）。CP-B亚组中接受索拉非尼治疗的患者的中位PFS和OS分别为0.5个月（95% CI：0.1-3.6）和4.5个月（95% CI：2.9-6.1），而CP-A亚组分别为3.6个月（95% CI：2.7-3.7）和12.0个月（95% CI：10.2-14.0）。乐伐替尼队列中最常见的治疗后出现的不良事件为高血压（两个亚组）和食欲下降（CP-B亚组）。结果表明，开始治疗后肝功能恶化至CP-B的uHCC患者可继续接受乐伐替尼治疗。ClinicalTrials.gov、NCT 01761266、https://clinicaltrials.gov/ct2/show/NCT01761266。
Lenvatinib is an approved first-line treatment for unresectable hepatocellular carcinoma (uHCC). We evaluated the safety and efficacy of lenvatinib versus sorafenib in patients with uHCC who deteriorated to Child-Pugh class B (CP-B) on treatment. We retrospectively evaluated patients from REFLECT who deteriorated to CP-B versus those who remained Child-Pugh class A (CP-A) within 8 weeks after randomization. Best overall response and objective response rate (ORR) per modified Response Evaluation Criteria In Solid Tumors (mRECIST) were assessed from baseline. Progression-free survival (PFS) per mRECIST and overall survival (OS) were assessed beginning at week 8. Patients with CP-B versus CP-A classification receiving lenvatinib had ORRs of 28.3 and 42.9%, respectively; patients with CP-B versus CP-A classification receiving sorafenib had ORRs of 8.5 and 12.9%, respectively. Median PFS and OS (landmark analyses beginning at week 8) in patients receiving lenvatinib were 3.7 months [95% confidence interval (CI): 1.8–7.4] and 6.8 months (95% CI: 2.6–10.3) in the CP-B subgroup versus 6.5 months (95% CI: 5.6–7.4) and 13.3 months (95% CI: 11.6–16.1) in the CP-A subgroup, respectively. Median PFS and OS in patients receiving sorafenib were 0.5 months (95% CI: 0.1–3.6) and 4.5 months (95% CI: 2.9–6.1) in the CP-B subgroup versus 3.6 months (95% CI: 2.7–3.7) and 12.0 months (95% CI: 10.2–14.0) in the CP-A subgroup, respectively. The most common treatment-emergent adverse events in the lenvatinib cohort were hypertension (both subgroups) and decreased appetite (CP-B subgroup). Results suggest that patients with uHCC whose liver function deteriorates to CP-B after initiation of therapy may continue to receive lenvatinib. ClinicalTrials.gov, NCT01761266, https://clinicaltrials.gov/ct2/show/NCT01761266.
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影响因子：
2.1
作者：
Tohyama O;Matsui J;Kodama K;Hata-Sugi N;Kimura T;Okamoto K;Minoshima Y;Iwata M;Funahashi Y
通讯作者：
Funahashi Y
影响因子：
3.8
作者：
Miksad, Rebecca A.;Ogasawara, Sadahisa;Piscaglia, Fabio
通讯作者：
Piscaglia, Fabio
影响因子：
13.8
作者：
Vogel, Arndt;Frenette, Catherine;Kudo, Masatoshi
通讯作者：
Kudo, Masatoshi
影响因子：
6.4
作者：
Matsui, Junji;Yamamoto, Yuji;Asada, Makoto
通讯作者：
Asada, Makoto
影响因子：
11.5
作者：
Matsui, Junji;Funahashi, Yasuhiro;Asada, Makoto
通讯作者：
Asada, Makoto