TY - JOUR
T1 - A multicentre, prospective study of plasma circulating tumour DNA test for detecting RAS mutation in patients with metastatic colorectal cancer
AU - Bando, Hideaki
AU - Kagawa, Yoshinori
AU - Kato, Takeshi
AU - Akagi, Kiwamu
AU - Denda, Tadamichi
AU - Nishina, Tomohiro
AU - Komatsu, Yoshito
AU - Oki, Eiji
AU - Kudo, Toshihiro
AU - Kumamoto, Hiroshi
AU - Yamanaka, Takeharu
AU - Yoshino, Takayuki
N1 - Funding Information:
Competing interests: H.B. reports research funding from AstraZeneca; T.D. reports research funding from Sanofi, Boehringer Ingelheim and MSD and honoraria from Chugai Pharmaceutical, Yakult Honsha, and Taiho Pharmaceutical; Y.K. reports the research funds from Merck Serono, Takeda, Chugai Pharmaceutical, Eli Lilly, Sanofi, Yakut Honsha, Taiho Pharmaceutical, Daiichi-Sankyo, Ono, MSD, Kyowa-kirin, Shionogi, Nipro, Dainihon, Eisai, BMS, Bayer Japan, and Pfizer; E.O. has received honoraria for lecturing from Taiho Pharmaceutical, Eli Lilly, Bayer Japan, Yakult Honsha, Merck Serono, Takeda, and Chugai Pharmaceutical; T.K. reports research funding from Yakult Honsha, Chugai Pharmaceutical, and Ono; H.K. reports employment by Sysmex Corporation during the conduct of the study; T.Y. reports research funding from Taiho Pharmaceutical and Takeda, honoraria from Taiho Pharmaceutical, Takeda, Chugai Pharmaceutical, and Boehringer Ingelheim, and advisory role from AstraZeneca, Daiichi-Sankyo, Gilead Sciences, Sysmex, and HUYA Bioscience, and reports research funding from GlaxoSmithKline and Nippon Boehringer Ingelheim and honoraria from Taiho Pharmaceutical, Eli Lilly Japan, and Chugai Pharmaceutical; and Y.K., T.K., T.N., and K.A. report no competing interest.
Funding Information:
Funding: This work was funded and sponsored by Sysmex Corporation.
PY - 2019/5/14
Y1 - 2019/5/14
N2 - Background: OncoBEAMTM RAS CRC kit using BEAMing technology is a circulating tumour DNA (ctDNA) test for detecting plasma RAS mutational status in metastatic colorectal cancer (mCRC). We conducted a multicentre, prospective study to investigate the concordance of the RAS mutational status between plasma ctDNA and tumour tissue DNA. Methods: mCRC patients without prior anti-EGFR antibodies or regorafenib treatment were enroled. Plasma- and tissue-based RAS mutational status were determined by BEAMing, respectively. Results: A total of 280 patients from eight institutions were eligible. The overall agreement between plasma- and tissue-based analyses was 86.4%, with a positive percent agreement of 82.1% and negative percent agreement of 90.4%. From logistic regression analysis, lung metastasis alone indicated the most significant factor associated with discordance. The agreement between plasma- and tissue-based analyses was 64.5% in patients with lung metastasis alone (n = 31) indicating lower amount of ctDNA. Among the cases with lung metastasis alone, all plasma- and tissue-based analyses were perfectly concordant in cases with ≥20 mm of maximum lesion diameter or ≥10 lesions. Conclusion: The clinical validity of OncoBEAMTM RAS CRC kit was confirmed. Careful attention should be paid for mCRC patients with lung metastases alone having fewer metastases or smaller diameter lesions.
AB - Background: OncoBEAMTM RAS CRC kit using BEAMing technology is a circulating tumour DNA (ctDNA) test for detecting plasma RAS mutational status in metastatic colorectal cancer (mCRC). We conducted a multicentre, prospective study to investigate the concordance of the RAS mutational status between plasma ctDNA and tumour tissue DNA. Methods: mCRC patients without prior anti-EGFR antibodies or regorafenib treatment were enroled. Plasma- and tissue-based RAS mutational status were determined by BEAMing, respectively. Results: A total of 280 patients from eight institutions were eligible. The overall agreement between plasma- and tissue-based analyses was 86.4%, with a positive percent agreement of 82.1% and negative percent agreement of 90.4%. From logistic regression analysis, lung metastasis alone indicated the most significant factor associated with discordance. The agreement between plasma- and tissue-based analyses was 64.5% in patients with lung metastasis alone (n = 31) indicating lower amount of ctDNA. Among the cases with lung metastasis alone, all plasma- and tissue-based analyses were perfectly concordant in cases with ≥20 mm of maximum lesion diameter or ≥10 lesions. Conclusion: The clinical validity of OncoBEAMTM RAS CRC kit was confirmed. Careful attention should be paid for mCRC patients with lung metastases alone having fewer metastases or smaller diameter lesions.
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U2 - 10.1038/s41416-019-0457-y
DO - 10.1038/s41416-019-0457-y
M3 - Article
C2 - 31015557
AN - SCOPUS:85064753831
VL - 120
SP - 982
EP - 986
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 10
ER -