【佳學基因檢測】評估腫瘤學中的許多治療方法和生物標志物：一種新設計

品牌基因檢測價格表2022年合理性

學習腫瘤基因組學個性化藥物選擇知悉《J Clin Oncol》在.?2013 Dec 20;31(36):4562-8.發(fā)表了一篇題目為《評估腫瘤學中的許多治療方法和生物標志物：一種新設計》腫瘤靶向藥物治療基因檢測臨床研究文章。該研究由Richard Kaplan?,?Timothy Maughan,?Angela Crook,?David Fisher,?Richard Wilson,?Louise Brown,?Mahesh Parmar等完成。促進了腫瘤的正確治療與個性化用藥的發(fā)展，進一步強調(diào)了基因信息檢測與分析的重要性。

腫瘤全國篩查臨床研究內(nèi)容關鍵詞：

生物標志物,分層,試驗設計,靶向療法,AKT,PTEN,缺失

腫瘤靶向治療基因檢測臨床應用結(jié)果

生物標志物分層臨床試驗迫切需要更有效的試驗設計。我們建議采用一種新的試驗設計方法，將新的治療評估與驗證性 II/III 期試驗環(huán)境中生物標志物的同時評估聯(lián)系起來。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志物的三個研究問題：（1）經(jīng)過一段時間的一線化療后，靶向新療法是否在不同的生物標志物定義的人群中提供活動信號？ (2) 如果是這樣，這些是否確實改善了結(jié)果？ (3) 活動證據(jù)是否僅限于生物標志物定義的組？該方案在許多不同的生物標志物定義的人群豐富隊列中同時隨機化新藥與安慰劑： BRAF 突變；激活的 AKT 通路：PI3K 突變/先進 PTEN 缺失腫瘤； KRAS 和 NRAS 突變；和所有提到的基因的野生型。在每個生物標志物定義的人群中，該試驗使用多階段方法，靈活地適應計劃中的缺乏活動的中期分析。 FOCUS4 是一項協(xié)議的先進個測試，該協(xié)議將所有轉(zhuǎn)移性結(jié)直腸癌患者分配到多個平行的人群豐富、生物標志物分層的隨機試驗中的一個。使用這種方法可以以相對快速和有效的方式回答有關多種新療法的功效和安全性的問題，同時還可以評估生物標志物以幫助靶向治療。

腫瘤發(fā)生與反復轉(zhuǎn)移國際數(shù)據(jù)庫描述：

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.