Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies

Comprehensive genomic profiling enables genomic biomarker detection in advanced solid tumors. Here, to evaluate the utility of circulating tumor DNA (ctDNA) genotyping, we compare trial enrollment using ctDNA sequencing in 1,687 patients with advanced gastrointestinal (GI) cancer in SCRUM-Japan GOZI...

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Bibliographic Details
Published in:Nature medicine Vol. 26; no. 12; pp. 1859 - 1864
Main Authors: Nakamura, Yoshiaki, Taniguchi, Hiroya, Ikeda, Masafumi, Bando, Hideaki, Kato, Ken, Morizane, Chigusa, Esaki, Taito, Komatsu, Yoshito, Kawamoto, Yasuyuki, Takahashi, Naoki, Ueno, Makoto, Kagawa, Yoshinori, Nishina, Tomohiro, Kato, Takeshi, Yamamoto, Yoshiyuki, Furuse, Junji, Denda, Tadamichi, Kawakami, Hisato, Oki, Eiji, Nakajima, Takako, Nishida, Naohiro, Yamaguchi, Kensei, Yasui, Hisateru, Goto, Masahiro, Matsuhashi, Nobuhisa, Ohtsubo, Koushiro, Yamazaki, Kentaro, Tsuji, Akihito, Okamoto, Wataru, Tsuchihara, Katsuya, Yamanaka, Takeharu, Miki, Izumi, Sakamoto, Yasutoshi, Ichiki, Hiroko, Hata, Masayuki, Yamashita, Riu, Ohtsu, Atsushi, Odegaard, Justin I., Yoshino, Takayuki
Format: Journal Article
Language:English
Published: New York Nature Publishing Group US 01.12.2020
Nature Publishing Group
Subjects:
631/67/69
692/308/153
692/53/2423
Adult
Biomarkers
Biomarkers, Tumor - blood
Biomedical and Life Sciences
Biomedicine
Cancer
Cancer Research
Care and treatment
Circulating Tumor DNA - blood
Circulating Tumor DNA - genetics
Clinical trials
Deoxyribonucleic acid
Diagnosis
DNA
DNA sequencing
DNA, Neoplasm - blood
Gastrointestinal cancer
Gastrointestinal Neoplasms - blood
Gastrointestinal Neoplasms - genetics
Gastrointestinal Neoplasms - pathology
Genetic aspects
Genotype
Genotyping
Health aspects
High-Throughput Nucleotide Sequencing
Humans
Infectious Diseases
Japan - epidemiology
Letter
Male
Metabolic Diseases
Middle Aged
Molecular Medicine
Mutation - genetics
Neurosciences
Nucleotide sequence
Nucleotide sequencing
Observational studies
Oncology, Experimental
Patients
Precision Medicine
Solid tumors
Tumors
Japan
ISSN:1078-8956, 1546-170X, 1546-170X
Online Access:Get full text
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Summary:Comprehensive genomic profiling enables genomic biomarker detection in advanced solid tumors. Here, to evaluate the utility of circulating tumor DNA (ctDNA) genotyping, we compare trial enrollment using ctDNA sequencing in 1,687 patients with advanced gastrointestinal (GI) cancer in SCRUM-Japan GOZILA (no. UMIN000016343), an observational ctDNA-based screening study, to enrollment using tumor tissue sequencing in the same centers and network (GI-SCREEN, 5,621 patients). ctDNA genotyping significantly shortened the screening duration (11 versus 33 days, P  < 0.0001) and improved the trial enrollment rate (9.5 versus 4.1%, P  < 0.0001) without compromising treatment efficacy compared to tissue genotyping. We also describe the clonal architecture of ctDNA profiles in ~2,000 patients with advanced GI cancer, which reinforces the relevance of many targetable oncogenic drivers and highlights multiple new drivers as candidates for clinical development. ctDNA genotyping has the potential to accelerate innovation in precision medicine and its delivery to individual patients. An observational study on a large cohort of patients with gastrointestinal cancer demonstrates the utility of ctDNA analysis for accelerating the enrollment of patients in clinical trials with no accompanying deterioration in treatment efficacy.
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ISSN:1078-8956
1546-170X
1546-170X
DOI:10.1038/s41591-020-1063-5