The main objective of this report was to detail the long-term follow-up data from the REMORA study, which investigated the safety and efficacy of lenvatinib in patients with thymic carcinoma. In addition, an exploratory analysis of the association between relative dose intensity (RDI) and the efficacy of lenvatinib is presented. The single-arm, open-label, phase 2 REMORA study was conducted at eight Japanese institutions. Forty-two patients received oral lenvatinib 24 mg once daily in 4-week cycles until the occurrence of intolerable adverse events or disease progression. The REMORA long-term follow-up data were evaluated, including overall survival (OS). RDI was calculated by dividing the actual dose administered to the patient by the standard recommended dose. This trial is registered on JMACCT (JMA-IIA00285) and on UMIN-CTR (UMIN000026777). The updated median OS was 28.3 months (95 % confidence interval [CI]: 17.1–34.0 months), and the OS rate at 36 months was 35.7 % (95 % CI: 21.7 %–49.9 %). When grouped by RDI of lenvatinib, the median OS was 38.5 months (95 % CI: 31.2–not estimable) in patients with ≥ 75 % RDI and 17.3 months (95 % CI: 13.4–26.2 months) in patients with < 75 % RDI (hazard ratio 0.46 [95 % CI: 0.22–0.98]; = 0.0406) at 8 weeks. Patients who maintained their lenvatinib dose over 8 weeks had a higher objective response rate than patients whose doses were reduced (75.0 % vs 29.4 %; = 0.0379). No new safety concerns or treatment-related deaths were reported, and lenvatinib had a tolerable safety profile. This follow-up report updated OS in patients with metastatic or recurrent thymic carcinoma. A higher RDI of lenvatinib at 8 weeks could be associated with improved outcomes.

中文翻译：

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乐伐替尼治疗转移性或复发性胸腺癌患者的长期随访和探索性分析：多中心、2 期 REMORA 试验的结果

本报告的主要目的是详细介绍 REMORA 研究的长期随访数据，该研究调查了仑伐替尼在胸腺癌患者中的安全性和有效性。此外，还对相对剂量强度（RDI）与乐伐替尼疗效之间的关联进行了探索性分析。这项单臂、开放标签、2 期 REMORA 研究是在八家日本机构进行的。 42 名患者接受口服仑伐替尼 24 mg，每日一次，周期为 4 周，直至出现无法耐受的不良事件或疾病进展。对 REMORA 长期随访数据进行了评估，包括总生存期 (OS)。 RDI 的计算方法是将给予患者的实际剂量除以标准推荐剂量。该试验已在 JMACCT (JMA-IIA00285) 和 UMIN-CTR (UMIN000026777) 上注册。更新后的中位 OS 为 28.3 个月（95% 置信区间 [CI]：17.1–34.0 个月），36 个月时的 OS 率为 35.7%（95% CI：21.7%–49.9%）。按乐伐替尼 RDI 分组时，RDI ≥ 75 % 的患者中位 OS 为 38.5 个月（95 % CI：31.2 - 不可估计），RDI < 75 % 的患者中位 OS 为 17.3 个月（95 % CI：13.4 - 26.2 个月）第 8 周时（风险比 0.46 [95% CI：0.22–0.98]；= 0.0406）。维持乐伐替尼剂量超过 8 周的患者比减少剂量的患者具有更高的客观缓解率（75.0 % vs 29.4 %；= 0.0379）。没有新的安全问题或与治疗相关的死亡报告，乐伐替尼的安全性尚可。该随访报告更新了转移性或复发性胸腺癌患者的 OS。 8 周时更高的乐伐替尼每日推荐摄入量可能与改善结果相关。