【佳學基因檢測】比較 GOZILA 和 COLOMATE：胃腸道惡性腫瘤的基因檢測

腫瘤基因檢測公司關(guān)注的原因

比較《腫瘤基因易感位點列表及發(fā)生率分析》《Oncology (Williston Park)》在 2021 Jul 17;35(7):382-389發(fā)表了一篇題目為《比較 GOZILA 和 COLOMATE：正在進行的傘/籃子試驗檢查胃腸道惡性腫瘤的基因檢測》腫瘤靶向藥物治療基因檢測臨床研究文章。該研究由Hideaki Bando, Yoshiaki Nakamura, Daisuke Kotani, Yoshino Yoshino 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。

腫瘤靶向藥物及正確治療臨床研究內(nèi)容關(guān)鍵詞：

COLOMATE,哥斯拉,循環(huán)腫瘤DNA,結(jié)直腸癌,伴隨試驗,靶向治療。

腫瘤靶向治療基因檢測臨床應(yīng)用結(jié)果

基于循環(huán)腫瘤 DNA (ctDNA) 的下一代測序 (NGS) 分析由于其低侵入性和重復采樣的可用性而比經(jīng)典的基于組織的分析具有優(yōu)勢。由于胃腸癌中 HER2 或 BRAF V600E 等靶基因改變的發(fā)生率較低，因此需要非常大的篩選平臺來開發(fā)基于基因組的臨床試驗。出于這些原因，正在積極開展基于 ctDNA 的基因檢測篩查研究,其中包括日本的 GOZILA (Guardant Originates in Zipangu Liquid biopsy Arrival) 研究和美國的 COLOMATE (COlorectal Cancer Liquid BiOpsy Screening Protocol for Molecularly Assigned Therapy) 研究。雖然只有以前接受過標準化療的轉(zhuǎn)移性結(jié)直腸癌（mCRC）患者才有資格參加 COLOMATE 研究，但任何治療線的各種類型實體瘤患者都有資格接受 GOZILA。這種對合格人群的廣泛覆使得超過 5000 名患者的大人群基因檢測研究成為可能。相比之下，使用基于 ctDNA 的 NGS 檢測的快速周轉(zhuǎn)時間有效篩選選定的候選患者進行伴隨試驗是 COLOMATE 的關(guān)鍵。 GOZILA 和 COLOMATE 對 mCRC 靶向治療的伴隨試驗相似。這兩項研究都通過檢查 ERBB2 (HER2)、BRAF V600E、BRAF non-V600E 和 FGFR 改變，以及 MET 擴增和抗 EGFR 抗體再次攻擊，確定了符合研究條件的患者。對于可能成為兩個平臺上潛在治療目標的常見改變的各種伴隨試驗的存在，可能會導致未來的國際合作。

腫瘤發(fā)生與反復轉(zhuǎn)移國際數(shù)據(jù)庫描述：

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.