Department of Nuclear Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Department of Ultrasound Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
Front Endocrinol (Lausanne). 2023 Jul 18;14:1200932. doi: 10.3389/fendo.2023.1200932. eCollection 2023.
Sorafenib included in Chinese medical insurance is the earliest targeted drug for radioactive iodine refractory differentiated thyroid cancer (RR-DTC). This study is to further demonstrate the clinical efficacy and safety of sorafenib used in Zhujiang Hospital of Southern Medical University.
RR-DTC patients treated at our Department of Nuclear Medicine in Zhujiang Hospital of Southern Medical University (October 2017-May 2020) were retrospectively analyzed. Treatment effects, progression-free survival (PFS), and adverse effects (AEs) during medication were evaluated.
Of the 31 patients included, 26 patients were evaluated for efficacy with a median follow-up time of 17.5 months (4.0-51.0 months). The disease control rate (DCR) was 57.7% ( = 15) and the objective response rate (ORR) was 26.9% ( = 7). Most patients with disease control had thyroglobulin decreases of more than 60% ( = 0.004), ORRs were favorable in patients with lung metastasis and lung-only metastasis ( = 0.010 and 0.001, respectively). The PFS of the 26 patients analyzed was 16.5 months (95%CI: 14.41 -23.90 months). In the subgroup analysis, female, patients with lung-only metastasis, hand-foot skin syndrome (HFS), and thyroglobulin response ≥ 60% observed longer PFS ( = 0.038, 0.045, 0.035, and 0.000, respectively), while patients with bone metastasis had lower PFS ( = 0.035). The most common toxicity profile was HFS (93.5%), followed by diarrhea (83.9%), alopecia (74.2%). All the side effects were mainly grade 1-2. Grade 3-4 adverse reactions were more common in diarrhea and HFS.
Sorafenib has promising efficacy in RR-DTC, especially in patients with lung metastasis and lung-only metastasis. The AEs of sorafenib were generally mild, and the main AE was HFS.
纳入中国医保的索拉非尼是分化型甲状腺癌（DTC）碘难治性复发（RR-DTC）的最早靶向药物。本研究旨在进一步证实南方医科大学珠江医院核医学科使用索拉非尼的临床疗效和安全性。
回顾性分析 2017 年 10 月至 2020 年 5 月在南方医科大学珠江医院核医学科治疗的 RR-DTC 患者。评估治疗效果、无进展生存期（PFS）和药物治疗期间的不良反应（AE）。
31 例患者中，26 例患者进行了疗效评估，中位随访时间为 17.5 个月（4.0-51.0 个月）。疾病控制率（DCR）为 57.7%（=15），客观缓解率（ORR）为 26.9%（=7）。大多数疾病控制的患者甲状腺球蛋白下降超过 60%（=0.004），肺转移和肺转移患者的 ORR 较好（=0.010 和 0.001）。分析的 26 例患者的 PFS 为 16.5 个月（95%CI：14.41-23.90 个月）。在亚组分析中，女性、肺转移患者、手足皮肤综合征（HFS）和甲状腺球蛋白反应≥60%的患者观察到更长的 PFS（=0.038、0.045、0.035 和 0.000），而骨转移患者的 PFS 较低（=0.035）。最常见的毒性谱是 HFS（93.5%），其次是腹泻（83.9%）、脱发（74.2%）。所有副作用主要为 1-2 级。腹泻和 HFS 更常见 3-4 级不良反应。
索拉非尼在 RR-DTC 中具有良好的疗效，尤其是在肺转移和肺转移患者中。索拉非尼的不良反应通常较轻，主要的不良反应是 HFS。
