TY - JOUR
T1 - Combined analysis of concordance between liquid and tumor tissue biopsies for RAS mutations in colorectal cancer with a single metastasis site
T2 - The METABEAM study
AU - Kagawa, Yoshinori
AU - Elez, Elena
AU - García-Foncillas, Jesus
AU - Bando, Hideaki
AU - Taniguchi, Hiroya
AU - Vivancos, Ana
AU - Akagi, Kiwamu
AU - García, Ariadna
AU - Denda, Tadamichi
AU - Ros, Javier
AU - Nishina, Tomohiro
AU - Baraibar, Iosune
AU - Komatsu, Yoshito
AU - Ciardiello, Davide
AU - Oki, Eiji
AU - Kudo, Toshihiro
AU - Kato, Takeshi
AU - Yamanaka, Takeharu
AU - Tabernero, Josep
AU - Yoshino, Takayuki
N1 - Funding Information:
We would like to express our special gratitude to all participating patients, their families, and all participating investigators. The authors thank P4 Statistics Co. Ltd. for providing support during the statistical analyses, and Celestina Chin and Yen May Ong of MIMS Pte Ltd. for providing medical writing support/editorial support. We also thank Editage (www.editage.com) for English language editing, which was funded by Sysmex Corporation, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). This work was funded and sponsored by Sysmex Corporation.
Funding Information:
Y. Kagawa reports personal fees from Bayer, Chugai, Eli Lilly, Merck, Ono, Taiho, and Yakult Honsha, and grants and personal fees from Takeda outside the submitted work. E. Elez reports personal fees from AbbVie, Amgen, Array BioPharma, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Roche, Merck Serono, MSD, Pierre-Fabre, Sanofi-Aventis, and Servier outside the submitted work. H. Bando reports grants from AstraZeneca and Sysmex and personal fees from Taiho Pharmaceutical and Eli Lilly outside the submitted work. H. Taniguchi reports grants from Sysnex, Takeda, Taiho, and Daiichi Sankyo, and personal fees from Chugai, Lilly, Takeda, and Taiho outside the submitted work. A. Vivancos reports consultancy for Sysmex Inostics. T. Denda reports personal fees from Sysmex and SAWAI Pharmaceutical Co and grants from MSD and ONO Pharmaceutical outside the submitted work. T. Nishina reports grants and personal fees from ONO Pharmaceutical, Taiho, Chugai, Merck Serono, and Lilly, and grants from Takeda, Daiichi Sankyo, and MSD during the conduct of the study. Y. Komatsu reports grants and personal fees from Takeda and Merck during the conduct of the study. Y. Komatsu also reports grants and personal fees from Daiichi Sankyo, ONO Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, Nipro, and Eli Lilly; grants from MSD; and personal fees from Yakult outside the submitted work. D. Ciardiello reports other from Sanofi during the conduct of the study. E. Oki reports personal fees from Taiho Pharmaceutical, Eli Lilly, Bayer, Takeda Pharmaceutical, Chugai Pharmaceutical, and ONO Pharmaceutical outside the submitted work. T. Yamanaka reports grants and personal fees from Chugai Pharmaceuticals and Bayer, personal fees from Takeda, and grants from Taiho during the conduct of the study. J. Tabernero reports personal fees from Array Biopharma, AstraZeneca, Bayer, BeiGene, Biocartis, Boehringer Ingelheim, Chugai Pharmaceuticals, Foundation Medicine, Roche, Genentech, Genmab, HalioDX SAS, Halozyme, Imugene, Inflection Biosciences, Ipsen, Kura, Eli Lilly, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, MSD, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, Roche Diagnostics, Sanofi, Seagen, Seattle Genetics, Servier, Symphogen, Taiho Pharmaceuticals, and VCN Biosciences outside the submitted work. T. Yoshino reports grants from Taiho Pharmaceutical, Sumitomo Dainippon Pharmaceutical, ONO Pharmaceutical, Chugai Pharmaceutical, Amgen, Parexel International, MSD, Daiichi San-kyo, and Sanofi outside the submitted work. No disclosures were reported by the other authors.
Publisher Copyright:
2021 American Association for Cancer Research.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - Purpose: OncoBEAM is a circulating tumor DNA (ctDNA) test that uses the BEAMing digital PCR technology. We clarified the association between the baseline tumor burden and discordance in the RAS status by metastatic sites in patients with a single metastatic site. Experimental Design: Data from previous Spanish and Japanese studies investigating the concordance of the RAS status between OncoBEAM and tissue biopsy in 221 patients with metastatic colorectal cancer (mCRC) were used. We collected data from patients with liver, peritoneal, or lung metastases and evaluated the concordance rates according to the metastatic site and the association between the concordance rate and tumor burden. Results: Patients had metastases in the liver (n ¼ 151), peritoneum (n ¼ 25), or lung (n ¼ 45) with concordance rates of 91% (95% confidence interval, 85%–95%), 88% (68%–97%), and 64% (49%–78%), respectively. Factors associated with concordance included the baseline longest diameter and lesion number (P ¼ 0.004), and sample collection interval (P ¼ 0.036). Concordance rates ≥90% were observed in the following groups: liver metastases alone, regardless of the baseline longest diameter and lesion number; peritoneal metastases alone in patients with a baseline longest diameter ≥20 mm; and lung metastases alone in patients with a baseline longest diameter ≥20 mm and/or number of lesions ≥10. Conclusions: Plasma ctDNA-based liquid biopsy in patients with mCRC may be useful depending on the metastatic site. The maximum diameter and lesion number should be carefully considered when determining patients’ RAS status with only peritoneal or lung metastases.
AB - Purpose: OncoBEAM is a circulating tumor DNA (ctDNA) test that uses the BEAMing digital PCR technology. We clarified the association between the baseline tumor burden and discordance in the RAS status by metastatic sites in patients with a single metastatic site. Experimental Design: Data from previous Spanish and Japanese studies investigating the concordance of the RAS status between OncoBEAM and tissue biopsy in 221 patients with metastatic colorectal cancer (mCRC) were used. We collected data from patients with liver, peritoneal, or lung metastases and evaluated the concordance rates according to the metastatic site and the association between the concordance rate and tumor burden. Results: Patients had metastases in the liver (n ¼ 151), peritoneum (n ¼ 25), or lung (n ¼ 45) with concordance rates of 91% (95% confidence interval, 85%–95%), 88% (68%–97%), and 64% (49%–78%), respectively. Factors associated with concordance included the baseline longest diameter and lesion number (P ¼ 0.004), and sample collection interval (P ¼ 0.036). Concordance rates ≥90% were observed in the following groups: liver metastases alone, regardless of the baseline longest diameter and lesion number; peritoneal metastases alone in patients with a baseline longest diameter ≥20 mm; and lung metastases alone in patients with a baseline longest diameter ≥20 mm and/or number of lesions ≥10. Conclusions: Plasma ctDNA-based liquid biopsy in patients with mCRC may be useful depending on the metastatic site. The maximum diameter and lesion number should be carefully considered when determining patients’ RAS status with only peritoneal or lung metastases.
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U2 - 10.1158/1078-0432.CCR-20-3677
DO - 10.1158/1078-0432.CCR-20-3677
M3 - Article
C2 - 33602686
AN - SCOPUS:85105344934
SN - 1078-0432
VL - 27
SP - 2515
EP - 2522
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 9
ER -