【佳学基因检测】比较 GOZILA 和 COLOMATE：胃肠道恶性肿瘤的基因检测

肿瘤基因检测公司关注的原因

比较《肿瘤基因易感位点列表及发生率分析》《Oncology (Williston Park)》在 2021 Jul 17;35(7):382-389发表了一篇题目为《比较 GOZILA 和 COLOMATE：正在进行的伞/篮子试验检查胃肠道恶性肿瘤的基因检测》肿瘤靶向药物治疗基因检测临床研究文章。该研究由Hideaki Bando, Yoshiaki Nakamura, Daisuke Kotani, Yoshino Yoshino 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。

肿瘤靶向药物及精准治疗临床研究内容关键词：

COLOMATE,哥斯拉,循环肿瘤DNA,结直肠癌,伴随试验,靶向治疗。

肿瘤靶向治疗基因检测临床应用结果

基于循环肿瘤 DNA (ctDNA) 的下一代测序 (NGS) 分析由于其低侵入性和重复采样的可用性而比经典的基于组织的分析具有优势。由于胃肠癌中 HER2 或 BRAF V600E 等靶基因改变的发生率较低，因此需要非常大的筛选平台来开发基于基因组的临床试验。出于这些原因，正在积极开展基于 ctDNA 的基因检测筛查研究,其中包括日本的 GOZILA (Guardant Originates in Zipangu Liquid biopsy Arrival) 研究和美国的 COLOMATE (COlorectal Cancer Liquid BiOpsy Screening Protocol for Molecularly Assigned Therapy) 研究。虽然只有以前接受过标准化疗的转移性结直肠癌（mCRC）患者才有资格参加 COLOMATE 研究，但任何治疗线的各种类型实体瘤患者都有资格接受 GOZILA。这种对合格人群的广泛覆使得超过 5000 名患者的大人群基因检测研究成为可能。相比之下，使用基于 ctDNA 的 NGS 检测的快速周转时间有效筛选选定的候选患者进行伴随试验是 COLOMATE 的关键。 GOZILA 和 COLOMATE 对 mCRC 靶向治疗的伴随试验相似。这两项研究都通过检查 ERBB2 (HER2)、BRAF V600E、BRAF non-V600E 和 FGFR 改变，以及 MET 扩增和抗 EGFR 抗体再次攻击，确定了符合研究条件的患者。对于可能成为两个平台上潜在治疗目标的常见改变的各种伴随试验的存在，可能会导致未来的国际合作。

肿瘤发生与复发转移国际数据库描述：

Circulating tumor DNA (ctDNA)-based next-generation sequencing (NGS) assays have advantages over classic tissue-based analyses because of their low invasiveness and availability of repeated sampling. Because of the low incidence of target gene alterations such as HER2 or BRAF V600E in gastrointestinal cancers, very large screening platforms are needed to develop genome-based clinical trials. For those reasons, ctDNA-based screening studies are being actively conducted; among them are the GOZILA (Guardant Originates in Zipangu Liquid biopsy Arrival) study in Japan and the COLOMATE (COlorectal Cancer Liquid BiOpsy Screening Protocol for Molecularly Assigned ThErapy) study in the United States. Although only patients with metastatic colorectal cancer (mCRC) who had previously received standard chemotherapies are eligible for the COLOMATE study, patients with various types of solid tumors at any line of treatment are eligible for GOZILA. This broad coverage of the eligible population allows a target of 5000 patients. By contrast, effective screening of selected candidate patients for companion trials using rapid turnaround time by ctDNA-based NGS assay is the key for COLOMATE. The companion trials of targeted therapies in mCRC are similar between GOZILA and COLOMATE. Both studies have identified patients eligible for studies by examining ERBB2 (HER2), BRAF V600E, BRAF non-V600E, and FGFR alterations, as well as MET amplification and rechallenge with anti-EGFR antibodies. The existence of various companion trials for common alterations that can be potential therapy targets on the 2 platforms can lead to future international collaboration.