【佳學(xué)基因檢測(cè)】評(píng)估腫瘤學(xué)中的許多治療方法和生物標(biāo)志物：一種新設(shè)計(jì)

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學(xué)習(xí)腫瘤基因組學(xué)個(gè)性化藥物選擇知悉《J Clin Oncol》在.?2013 Dec 20;31(36):4562-8.發(fā)表了一篇題目為《評(píng)估腫瘤學(xué)中的許多治療方法和生物標(biāo)志物：一種新設(shè)計(jì)》腫瘤靶向藥物治療基因檢測(cè)臨床研究文章。該研究由Richard Kaplan?,?Timothy Maughan,?Angela Crook,?David Fisher,?Richard Wilson,?Louise Brown,?Mahesh Parmar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。

腫瘤全國(guó)篩查臨床研究?jī)?nèi)容關(guān)鍵詞：

生物標(biāo)志物,分層,試驗(yàn)設(shè)計(jì),靶向療法,AKT,PTEN,缺失

腫瘤靶向治療基因檢測(cè)臨床應(yīng)用結(jié)果

生物標(biāo)志物分層臨床試驗(yàn)迫切需要更有效的試驗(yàn)設(shè)計(jì)。我們建議采用一種新的試驗(yàn)設(shè)計(jì)方法，將新的治療評(píng)估與驗(yàn)證性 II/III 期試驗(yàn)環(huán)境中生物標(biāo)志物的同時(shí)評(píng)估聯(lián)系起來(lái)。我們描述了一種在晚期結(jié)直腸癌中使用這種方法的新方案，稱為 FOCUS4。該方案賊終將回答許多治療和生物標(biāo)志物的三個(gè)研究問(wèn)題：（1）經(jīng)過(guò)一段時(shí)間的一線化療后，靶向新療法是否在不同的生物標(biāo)志物定義的人群中提供活動(dòng)信號(hào)？ (2) 如果是這樣，這些是否確實(shí)改善了結(jié)果？ (3) 活動(dòng)證據(jù)是否僅限于生物標(biāo)志物定義的組？該方案在許多不同的生物標(biāo)志物定義的人群豐富隊(duì)列中同時(shí)隨機(jī)化新藥與安慰劑： BRAF 突變；激活的 AKT 通路：PI3K 突變/先進(jìn) PTEN 缺失腫瘤； KRAS 和 NRAS 突變；和所有提到的基因的野生型。在每個(gè)生物標(biāo)志物定義的人群中，該試驗(yàn)使用多階段方法，靈活地適應(yīng)計(jì)劃中的缺乏活動(dòng)的中期分析。 FOCUS4 是一項(xiàng)協(xié)議的先進(jìn)個(gè)測(cè)試，該協(xié)議將所有轉(zhuǎn)移性結(jié)直腸癌患者分配到多個(gè)平行的人群豐富、生物標(biāo)志物分層的隨機(jī)試驗(yàn)中的一個(gè)。使用這種方法可以以相對(duì)快速和有效的方式回答有關(guān)多種新療法的功效和安全性的問(wèn)題，同時(shí)還可以評(píng)估生物標(biāo)志物以幫助靶向治療。

腫瘤發(fā)生與反復(fù)轉(zhuǎn)移國(guó)際數(shù)據(jù)庫(kù)描述：

There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concurrently across a number of different biomarker-defined population-enriched cohorts: BRAF mutation; activated AKT pathway: PI3K mutation/absolute PTEN loss tumors; KRAS and NRAS mutations; and wild type at all the mentioned genes. Within each biomarker-defined population, the trial uses a multistaged approach with flexibility to adapt in response to planned interim analyses for lack of activity. FOCUS4 is the first test of a protocol that assigns all patients with metastatic colorectal cancer to one of a number of parallel population-enriched, biomarker-stratified randomized trials. Using this approach allows questions regarding efficacy and safety of multiple novel therapies to be answered in a relatively quick and efficient manner, while also allowing for the assessment of biomarkers to help target treatment.