甲磺酸阿帕替尼治疗进展性碘难治性甲状腺癌的短期疗效及安全性初步报告

发布时间：2018-04-08 13:13

本文选题：阿帕替尼　切入点：酪氨酸激酶抑制剂　出处：《中国癌症杂志》2016年09期

【摘要】：背景与目的:碘难治性甲状腺癌(radioactive iodine-refractory differentiated thyroid cancer,RAIRDTC)是目前临床诊疗的难点与热点,目前国际指南中推荐的靶向治疗药物仅有索拉非尼及乐伐替尼。该研究报告具有我国自主知识产权的靶向药物甲磺酸阿帕替尼治疗进展性碘RAIR-DTC 8周后的短期疗效及安全性。方法:纳入10例进展性RAIR-DTC患者予阿帕替尼治疗(750 mg,每天1次,口服)。每2周复查甲状腺球蛋白(thyroglobulin,Tg),每4周CT监测靶病灶(target lesions,TL)。观察甲状腺癌血清标志物Tg水平变化,采用实体瘤疗效评价标准1.1(response evaluation criteria in solid tumors,RECIST 1.1)评估疗效。初步评估患者经药物治疗的短期不良事件(adverse event,AE)以评估安全性。结果:8例Tg可评价的患者,在治疗2周后Tg即出现下降,在治疗8周后较基线平均降幅达68%,达到"生化部分缓解"。10例患者共18个TL,治疗4周后即出现缩小,在8周后较基线平均缩小达40%,9例患者(9/10,90%)达到部分缓解,1例(1/10,10%)呈疾病稳定,客观缓解率及疾病控制率分别达90%和100%。最常见的3级以上AE主要包括手足皮肤反应、高血压和低钙血症,分别占50%、30%和20%,未观察到与药物相关的严重AE。结论:甲磺酸阿帕替尼可安全用于RAIR-DTC治疗,且在8周治疗中从血清学及结构影像学角度证实快速有效,客观缓解率高。
[Abstract]:Background & objective: radioactive iodine-refractory differentiated thyroid cancer RAIRDTC is a difficult and hot point in clinical diagnosis and treatment. Only Solafenib and Lovatinib are recommended in international guidelines.This study reported the short-term efficacy and safety of Apatinib mesylate as a target of intellectual property rights in the treatment of progressive iodine RAIR-DTC for 8 weeks.Methods: ten patients with progressive RAIR-DTC were treated with apatinib 750 mg once a day.The thyroid globulins were examined every 2 weeks, and the target lesions were monitored by CT every 4 weeks.To observe the changes of serum TG level in thyroid carcinoma and evaluate the therapeutic effect by 1.1(response evaluation criteria in solid tumor RECIST 1.1).A preliminary assessment of short-term adverse events in patients undergoing drug therapy was conducted to assess safety.Results Twenty eight patients with evaluable TG showed a decrease after 2 weeks of treatment. After 8 weeks of treatment, the mean decrease of TG was 68, reaching "biochemical partial remission" .10 patients with 18 TLs. After 4 weeks of treatment, there was a decrease in TG.After 8 weeks, the average reduction from the baseline was 40% (9 / 10 / 90) and 1 case (1 / 10 / 10) was stable. The objective remission rate and the disease control rate were 90% and 100%, respectively.The most common grade 3 or above AE mainly included skin reaction of hands and feet, hypertension and hypocalcemia, accounting for 50% and 20%, respectively. No serious AEE associated with drugs was observed.Conclusion: Apatinib mesylate was used safely in RAIR-DTC, and it was proved to be rapid and effective by serological and structural imaging in 8-week treatment, and the objective remission rate was high.
【作者单位】：中国医学科学院北京协和医学院核医学科;北京大学国际医院肿瘤内科;
【基金】：国家自然科学基金(81571714)
【分类号】：R736.1

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