Background

For advanced tumors that lack specific oncogenic alteration and are resistant to chemotherapy, anti-angiogenesis therapy or immunotherapy or a combination of the two are the most important treatments. Anlotinib is a newly developed oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis. This was an open-label, single-arm, phase 2 study to validate the efficacy and safety of anlotinib in patients with various cancer types.

Methods

Patients with advanced malignancy who have failed previous therapies or lack effective treatment choices received daily oral administration of 12 mg anlotinib on days 1–14 every 3 weeks until disease progression, intolerable toxicity or physician decision. The primary endpoint was objective response rate (ORR).

Results

A total of 93 eligible patients with 26 different cancer types were enrolled. The overall ORR was 21.5%. The median PFS was 5.7 months and median OS was 12.0 months. The most common treatment-related AE of all grades and of grade 3 was both hypertriglyceridemia at an incidence of 40.9% and 5.4%, respectively.

Conclusions

Anlotinib exhibits objective efficacy and safety in advanced malignancy and might be a possible treatment option for many types of cancer patients who have failed prior treatment and with no optimal therapy regimen.

中文翻译：

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安罗替尼在晚期恶性肿瘤患者中的疗效和安全性：单中心、单臂、2 期试验

背景

对于缺乏特异性致癌改变且对化疗耐药的晚期肿瘤，抗血管生成疗法或免疫疗法或两者的组合是最重要的治疗方法。安罗替尼是一种新开发的口服小分子受体酪氨酸激酶抑制剂，具有抑制肿瘤血管生成的功效。这是一项开放标签、单臂、2 期研究，旨在验证安罗替尼对各种癌症类型患者的疗效和安全性。

方法

先前治疗失败或缺乏有效治疗选择的晚期恶性肿瘤患者每 3 周在第 1-14 天每天口服 12 毫克安罗替尼，直至疾病进展、出现无法耐受的毒性或医生决定。主要终点是客观反应率（ORR）。

结果

共有 93 名符合条件的患者参与了 26 种不同的癌症类型。总体 ORR 为 21.5%。中位 PFS 为 5.7 个月，中位 OS 为 12.0 个月。所有级别和 3 级最常见的治疗相关 AE 均为高甘油三酯血症，发生率分别为 40.9% 和 5.4%。

结论

安罗替尼在晚期恶性肿瘤中表现出客观的疗效和安全性，可能是许多先前治疗失败且没有最佳治疗方案的癌症患者的一种可能的治疗选择。