Jiang He-Jiun, Chang Yen-Hsiang, Chen Yen-Hao, Wu Che-Wei, Wang Pei-Wen, Hsiao Pi-Jung
Division of Endocrinology and Metabolism, Department of Internal Medicine, E-DA DaChang Hospital, Kaohsiung, Taiwan.
Department of Nuclear Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
Cancer Manag Res. 2021 Sep 14;13:7139-7148. doi: 10.2147/CMAR.S326255. eCollection 2021.
Lenvatinib treatment of 24 mg/day for radioiodine-refractory differentiated thyroid carcinoma (RRDTC) patients was almost intolerable, with high rates of dose reduction, interruption and discontinuation. Balancing treatment safety with disease risks remains challenging, and the appropriate dosage remains unclear in Asia.
A total of 65 RRDTC patients treated with lenvatinib were retrospectively collected from Oct. 2015 to Jun. 2020 from two medical centers of South Taiwan. The drug tolerability, treatment efficacy and clinical outcomes were analyzed.
Different doses of lenvatinib were initiated but ultimately maintained with a median dose of 10 mg/day within the first 3 months. The disease control rate reached 89.2%, including 24.6% partial response and 64.6% stable disease. Disease progression occurred in 10.8% of patients and increased to 40.0% at the end. Eventually, the treatment dose achieved a median progression-free survival (PFS) of 26.1 months (95% CI: 17.1-NA) with overall survival (OS) not reached yet (24.1~NA). Overall, the 48-month PFS rate was 35.6% (95% CI: 18.5-68.4) and 48-month OS was 54.3% (95% CI: 41.2-71.7). The dose was tolerable with a dose reduction rate of 44.6%, dose interruption rate of 40.0% and fewer high-graded adverse events. The drug discontinuation rate was only 3.1%. However, RRDTC patients with bone metastasis or maximal dose exposure to RAI (≥600 mCi) may have less efficacy to the low maintenance dose treatment.
Assessing treatment intensity, safety and efficacy, low-dose lenvatinib treatment was well tolerated by RRDTC patients and displayed acceptable drug efficacy and outcomes.
对于放射性碘难治性分化型甲状腺癌（RRDTC）患者，每天24毫克的乐伐替尼治疗几乎难以耐受，剂量减少、中断和停药率很高。在治疗安全性与疾病风险之间取得平衡仍然具有挑战性，而且在亚洲合适的剂量仍不明确。
回顾性收集了2015年10月至2020年6月期间来自台湾南部两个医疗中心的65例接受乐伐替尼治疗的RRDTC患者。分析了药物耐受性、治疗效果和临床结局。
起始使用了不同剂量的乐伐替尼，但在前3个月内最终维持的中位剂量为每天10毫克。疾病控制率达到89.2%，包括24.6%的部分缓解和64.6%的病情稳定。10.8%的患者出现疾病进展，到最后增至40.0%。最终，治疗剂量实现了中位无进展生存期（PFS）为26.1个月（95%置信区间：17.1 - 未达到），总生存期（OS）尚未达到（24.1~未达到）。总体而言，48个月的PFS率为35.6%（95%置信区间：18.5 - 68.4），48个月的OS率为54.3%（95%置信区间：41.2 - 71.7）。该剂量耐受性良好，剂量减少率为44.6%，剂量中断率为40.0%，且高级别不良事件较少。药物停药率仅为3.1%。然而，有骨转移或最大剂量暴露于放射性碘（≥600毫居里）的RRDTC患者可能对低维持剂量治疗的疗效较差。
评估治疗强度、安全性和疗效后，低剂量乐伐替尼治疗RRDTC患者耐受性良好，且显示出可接受的药物疗效和结局。
