Department of Clinical Trial, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, 310022, Zhejiang, China.
Department of Medical Oncology, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, 310022, Zhejiang, China.
BMC Med. 2022 May 10;20(1):154. doi: 10.1186/s12916-022-02361-w.
Thymic epithelial tumors (TETs) are rare malignancies and the treatment options are limited. We aimed to evaluate the efficacy and safety of apatinib, an angiogenesis inhibitor, in advanced TETs.
This was an open-label, single-arm, phase II trial at three centers in China. Patients with TET who had progressed after failure of at least one line of platinum-based chemotherapy were enrolled. Patients received apatinib 500 mg orally per day. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety.
From June 29, 2017, to April 18, 2019, 25 patients were enrolled. At data cut off (September 30, 2021), one patient achieved complete response, nine achieved partial response, and 11 achieved stable disease, with an ORR of 40% (95% CI 21-61%) and DCR of 84% (95% CI 64-95%). The median PFS was 9.0 (95% CI 5.4-12.6) months. The median OS was 24.0 (95% CI 8.2-39.8) months. All patients reported treatment-related adverse events (TRAEs). Grade 3 TRAEs occurred 26 times in 15 patients. No grade 4 or 5 toxicities occurred.
This is the first trial of apatinib for the treatment of TETs. Apatinib showed promising antitumor activity and the toxicities were tolerable and manageable.
胸腺瘤（TET）是一种罕见的恶性肿瘤，治疗选择有限。我们旨在评估血管生成抑制剂阿帕替尼在晚期 TET 中的疗效和安全性。
这是在中国三个中心进行的一项开放标签、单臂、二期试验。招募了至少一线铂类化疗失败后进展的 TET 患者。患者每天口服阿帕替尼 500mg。主要终点是客观缓解率（ORR）。次要终点包括无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）和安全性。
从 2017 年 6 月 29 日至 2019 年 4 月 18 日，共招募了 25 名患者。在数据截止日期（2021 年 9 月 30 日），1 名患者完全缓解，9 名患者部分缓解，11 名患者疾病稳定，ORR 为 40%（95%CI 21-61%），DCR 为 84%（95%CI 64-95%）。中位 PFS 为 9.0 个月（95%CI 5.4-12.6）。中位 OS 为 24.0 个月（95%CI 8.2-39.8）。所有患者均报告了治疗相关的不良事件（TRAEs）。15 名患者中有 26 次出现 3 级 TRAEs。无 4 级或 5 级毒性。
这是阿帕替尼治疗 TET 的首次试验。阿帕替尼显示出有希望的抗肿瘤活性，且毒性可耐受和可控。
