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Multicenter Study
. 2019 May;120(10):982-986.
doi: 10.1038/s41416-019-0457-y. Epub 2019 Apr 24.

A multicentre, prospective study of plasma circulating tumour DNA test for detecting RAS mutation in patients with metastatic colorectal cancer

Hideaki Bando  1 , Yoshinori Kagawa  2 , Takeshi Kato  3 , Kiwamu Akagi  4 , Tadamichi Denda  5 , Tomohiro Nishina  6 , Yoshito Komatsu  7 , Eiji Oki  8 , Toshihiro Kudo  9 , Hiroshi Kumamoto  10 , Takeharu Yamanaka  11 , Takayuki Yoshino  12
Affiliations
Multicenter Study

A multicentre, prospective study of plasma circulating tumour DNA test for detecting RAS mutation in patients with metastatic colorectal cancer

Hideaki Bando et al. Br J Cancer. 2019 May.

Erratum in

Abstract

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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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Analysis of mutation allele frequency and lesion volume. Mutation allele frequency (MAF) in cases with metastatic site (a) and the longest diameter of lesion and number of lesions with concordant and discordant cases (b). *Derived from Steel test with control of group of lung metastasis alone
See this image and copyright information in PMC

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