【佳学基因检测】评估肿瘤学中的许多治疗方法和生物标志物：一种新设计

品牌基因检测价格表2022年合理性

学习肿瘤基因组学个性化药物选择知悉《J Clin Oncol》在. 2013 Dec 20;31(36):4562-8.发表了一篇题目为《评估肿瘤学中的许多治疗方法和生物标志物：一种新设计》肿瘤靶向药物治疗基因检测临床研究文章。该研究由Richard Kaplan , Timothy Maughan, Angela Crook, David Fisher, Richard Wilson, Louise Brown, Mahesh Parmar等完成。促进了肿瘤的精准治疗与个性化用药的发展，进一步强调了基因信息检测与分析的重要性。

肿瘤全国筛查临床研究内容关键词：

生物标志物,分层,试验设计,靶向疗法,AKT,PTEN,缺失

肿瘤靶向治疗基因检测临床应用结果

生物标志物分层临床试验迫切需要更有效的试验设计。我们建议采用一种新的试验设计方法，将新的治疗评估与验证性 II/III 期试验环境中生物标志物的同时评估联系起来。我们描述了一种在晚期结直肠癌中使用这种方法的新方案，称为 FOCUS4。该方案最终将回答许多治疗和生物标志物的三个研究问题：（1）经过一段时间的一线化疗后，靶向新疗法是否在不同的生物标志物定义的人群中提供活动信号？ (2) 如果是这样，这些是否确实改善了结果？ (3) 活动证据是否仅限于生物标志物定义的组？该方案在许多不同的生物标志物定义的人群丰富队列中同时随机化新药与安慰剂： BRAF 突变；激活的 AKT 通路：PI3K 突变/绝对 PTEN 缺失肿瘤； KRAS 和 NRAS 突变；和所有提到的基因的野生型。在每个生物标志物定义的人群中，该试验使用多阶段方法，灵活地适应计划中的缺乏活动的中期分析。 FOCUS4 是一项协议的第一个测试，该协议将所有转移性结直肠癌患者分配到多个平行的人群丰富、生物标志物分层的随机试验中的一个。使用这种方法可以以相对快速和有效的方式回答有关多种新疗法的功效和安全性的问题，同时还可以评估生物标志物以帮助靶向治疗。

肿瘤发生与复发转移国际数据库描述：

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.