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甲磺酸阿帕替尼治療進(jìn)展性碘難治性甲狀腺癌的短期療效及安全性初步報(bào)告

發(fā)布時(shí)間:2018-04-08 13:13

  本文選題:阿帕替尼 切入點(diǎn):酪氨酸激酶抑制劑 出處:《中國(guó)癌癥雜志》2016年09期


【摘要】:背景與目的:碘難治性甲狀腺癌(radioactive iodine-refractory differentiated thyroid cancer,RAIRDTC)是目前臨床診療的難點(diǎn)與熱點(diǎn),目前國(guó)際指南中推薦的靶向治療藥物僅有索拉非尼及樂(lè)伐替尼。該研究報(bào)告具有我國(guó)自主知識(shí)產(chǎn)權(quán)的靶向藥物甲磺酸阿帕替尼治療進(jìn)展性碘RAIR-DTC 8周后的短期療效及安全性。方法:納入10例進(jìn)展性RAIR-DTC患者予阿帕替尼治療(750 mg,每天1次,口服)。每2周復(fù)查甲狀腺球蛋白(thyroglobulin,Tg),每4周CT監(jiān)測(cè)靶病灶(target lesions,TL)。觀察甲狀腺癌血清標(biāo)志物Tg水平變化,采用實(shí)體瘤療效評(píng)價(jià)標(biāo)準(zhǔn)1.1(response evaluation criteria in solid tumors,RECIST 1.1)評(píng)估療效。初步評(píng)估患者經(jīng)藥物治療的短期不良事件(adverse event,AE)以評(píng)估安全性。結(jié)果:8例Tg可評(píng)價(jià)的患者,在治療2周后Tg即出現(xiàn)下降,在治療8周后較基線平均降幅達(dá)68%,達(dá)到"生化部分緩解"。10例患者共18個(gè)TL,治療4周后即出現(xiàn)縮小,在8周后較基線平均縮小達(dá)40%,9例患者(9/10,90%)達(dá)到部分緩解,1例(1/10,10%)呈疾病穩(wěn)定,客觀緩解率及疾病控制率分別達(dá)90%和100%。最常見的3級(jí)以上AE主要包括手足皮膚反應(yīng)、高血壓和低鈣血癥,分別占50%、30%和20%,未觀察到與藥物相關(guān)的嚴(yán)重AE。結(jié)論:甲磺酸阿帕替尼可安全用于RAIR-DTC治療,且在8周治療中從血清學(xué)及結(jié)構(gòu)影像學(xué)角度證實(shí)快速有效,客觀緩解率高。
[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.
【作者單位】: 中國(guó)醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院核醫(yī)學(xué)科;北京大學(xué)國(guó)際醫(yī)院腫瘤內(nèi)科;
【基金】:國(guó)家自然科學(xué)基金(81571714)
【分類號(hào)】:R736.1

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