【佳學(xué)基因檢測(cè)】2 型神經(jīng)纖維瘤病相關(guān)前庭神經(jīng)鞘瘤 II 期抗腫瘤藥物研究的建議反應(yīng)標(biāo)準(zhǔn)
1年靶向藥物要多少錢(qián)評(píng)價(jià)
探索明白《J Neurooncol》在?2009 May;93(1):61-77發(fā)表了一篇題目為《2 型神經(jīng)纖維瘤病相關(guān)前庭神經(jīng)鞘瘤 II 期抗腫瘤藥物研究的建議反應(yīng)標(biāo)準(zhǔn)》腫瘤靶向藥物治療基因檢測(cè)臨床研究文章。該研究由Scott R Plotkin,?Chris Halpin,?Jaishri O Blakeley,?William H Slattery rd,?D Bradley Welling,?Susan M Chang,?Jay S Loeffler,?Gordon J Harris,?A Gregory Sorensen,?Michael J McKenna,?Fred G Barker nd等完成。促進(jìn)了腫瘤的正確治療與個(gè)性化用藥的發(fā)展,進(jìn)一步強(qiáng)調(diào)了基因信息檢測(cè)與分析的重要性。
腫瘤靶向藥物及正確治療臨床研究?jī)?nèi)容關(guān)鍵詞:
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腫瘤靶向治療基因檢測(cè)臨床應(yīng)用結(jié)果
2型神經(jīng)纖維瘤?。∟F2)是一種以多發(fā)性神經(jīng)鞘瘤,尤其是前庭神經(jīng)鞘瘤(VS)和腦膜瘤為特征的抑癌基因綜合征。目前正在探索抗癌藥物試驗(yàn),但 NF2 沒(méi)有標(biāo)準(zhǔn)化的終點(diǎn)。我們回顧了 NF2 臨床試驗(yàn)的挑戰(zhàn),并提出了用于初始 II 期研究的可能反應(yīng)標(biāo)準(zhǔn)。我們建議在此類試驗(yàn)中使用兩個(gè)主要的反應(yīng)標(biāo)準(zhǔn)??陀^放射學(xué)反應(yīng)定義為 VS 體積持久減少 20% 或更多,基于通過(guò)內(nèi)耳道收集 3 毫米或更細(xì)切口的增強(qiáng)后 T1 加權(quán) MRI 圖像。聽(tīng)力反應(yīng)被定義為在聽(tīng)力學(xué)中使用 50 個(gè)單詞的記錄列表在單詞識(shí)別分?jǐn)?shù)方面的統(tǒng)計(jì)顯著改善。概述了結(jié)合放射學(xué)反應(yīng)和聽(tīng)力反應(yīng)的可能復(fù)合終點(diǎn)。我們強(qiáng)調(diào)應(yīng)對(duì)評(píng)估中的陷阱,并提出指導(dǎo)方針,以盡量減少對(duì)應(yīng)對(duì)的誤解。我們還確定了 NF2 的研究目標(biāo),以促進(jìn)未來(lái)的試驗(yàn)進(jìn)行,例如確定對(duì)未經(jīng)治療的 NF2 相關(guān) VS 的腫瘤進(jìn)展時(shí)間和可測(cè)量聽(tīng)力損失時(shí)間的預(yù)期,以及這兩個(gè)終點(diǎn)與患者預(yù)后因素(如年齡)的關(guān)系、基線腫瘤體積和疾病嚴(yán)重程度的測(cè)量)。這些數(shù)據(jù)將有助于未來(lái)使用基于腫瘤大小和聽(tīng)力穩(wěn)定性的端點(diǎn),這可能更適合測(cè)試某些藥物。我們鼓勵(lì)在為該人群開(kāi)發(fā) II 期試驗(yàn)的早期采用標(biāo)準(zhǔn)化終點(diǎn),以促進(jìn)不同藥物試驗(yàn)之間結(jié)果的比較。
腫瘤發(fā)生與反復(fù)轉(zhuǎn)移國(guó)際數(shù)據(jù)庫(kù)描述:
Neurofibromatosis type 2 (NF2) is a tumor suppressor gene syndrome characterized by multiple schwannomas, especially vestibular schwannomas (VS), and meningiomas. Anticancer drug trials are now being explored, but there are no standardized endpoints in NF2. We review the challenges of NF2 clinical trials and suggest possible response criteria for use in initial phase II studies. We suggest two main response criteria in such trials. Objective radiographic response is defined as a durable 20% or greater reduction in VS volume based on post-contrast T1-weighted MRI images collected with 3 mm or finer cuts through the internal auditory canal. Hearing response is defined as a statistically significant improvement in word recognition scores using 50-word recorded lists in audiology. A possible composite endpoint incorporating both radiographic response and hearing response is outlined. We emphasize pitfalls in response assessment and suggest guidelines to minimize misinterpretations of response. We also identify research goals in NF2 to facilitate future trial conduct, such as identifying the expectations for time to tumor progression and time to measurable hearing loss in untreated NF2-related VS, and the relation of both endpoints to patient prognostic factors (such as age, baseline tumor volume, and measures of disease severity). These data would facilitate future use of endpoints based on stability of tumor size and hearing, which might be more appropriate for testing certain drugs. We encourage adoption of standardized endpoints early in the development of phase II trials for this population to facilitate comparison of results across trials of different agents.
(責(zé)任編輯:佳學(xué)基因)