Department of Medical Oncology, Affiliated Hospital of Guilin Medical University, Guangxi Guilin, China.
Radiol Oncol. 2023 Jul 26;57(3):405-410. doi: 10.2478/raon-2023-0036. eCollection 2023 Sep 1.
The aim of the study was to observe the safety and efficacy of anlotinib (ANL) alone or combined with S-1 in the first-line treatment of advanced hepatocellular carcinoma (HCC).
Fifty-four patients with untreated advanced HCC who could not be resected were randomly divided into the ANL group (n = 27) and ANL+S-1 group (n = 27). The ANL group was given 10 mg ANL orally once a day for 14 consecutive days, stopped for 1 week, and repeated every 21 days. The ANL+S-1 group was given 10 mg ANL once a day orally and 40 mg S-1 twice a day orally for 14 consecutive days, stopped for 1 week, repeated every 21 days. All patients were treated until the disease progressed or toxicity became unacceptable. For patients who could not tolerate adverse reactions, the ANL dose should be reduced to 8 mg per day. CT or MRI was reviewed every 6 weeks to evaluate the efficacy.
A total of 44 patients were included in the results analysis, including 22 patients in the ANL group and 22 patients in the ANL+S-1 group. In the ANL group, the objective response rate (ORR) was 4.5% (1/22), the disease control rate (DCR) was 77.3% (17/22), the median progression-free survival (PFS) was 4.2 months (95% CI: 3.6-6.0) and the median overall survival (mOS) was 7.0 months (95% CI: 6.3-9.0). In the ANL+S-1 group, the ORR was 18.2% (4/22), the DCR was 59.1% (13/22), the median PFS was 4.0 months (95% CI: 3.6-5.4) and the mOS was 6.0 months (95% CI: 5.5-7.4). There was no significant difference in ORR ( = 0.345) or DCR ( = 0.195) between the two groups. Adverse reactions were mainly hypertension, anorexia, fatigue, liver transaminase heightened and hand and foot skin reaction.
ANL monotherapy was effective in the treatment of advanced HCC, and adverse reactions have been able to tolerated.
本研究旨在观察安罗替尼（ANL）单药或联合替吉奥（S-1）一线治疗晚期肝细胞癌（HCC）的安全性和疗效。
54 例不可切除的晚期 HCC 患者随机分为 ANL 组（n=27）和 ANL+S-1 组（n=27）。ANL 组给予 10mg ANL 口服，每日 1 次，连用 14 天，停药 1 周，每 21 天重复 1 次。ANL+S-1 组给予 10mg ANL 口服，每日 1 次，40mg S-1 口服，每日 2 次，连用 14 天，停药 1 周，每 21 天重复 1 次。所有患者均接受治疗，直至疾病进展或毒性不可耐受。对于不能耐受不良反应的患者，应将 ANL 剂量减少至 8mg/d。每 6 周进行 CT 或 MRI 复查以评估疗效。
共 44 例患者纳入结果分析，其中 ANL 组 22 例，ANL+S-1 组 22 例。在 ANL 组中，客观缓解率（ORR）为 4.5%（1/22），疾病控制率（DCR）为 77.3%（17/22），中位无进展生存期（PFS）为 4.2 个月（95%CI：3.6-6.0），中位总生存期（mOS）为 7.0 个月（95%CI：6.3-9.0）。在 ANL+S-1 组中，ORR 为 18.2%（4/22），DCR 为 59.1%（13/22），中位 PFS 为 4.0 个月（95%CI：3.6-5.4），mOS 为 6.0 个月（95%CI：5.5-7.4）。两组 ORR（ = 0.345）或 DCR（ = 0.195）差异均无统计学意义。不良反应主要为高血压、厌食、乏力、肝转氨酶升高和手足皮肤反应。
安罗替尼单药治疗晚期 HCC 有效，不良反应可耐受。
