PMID- 35050726
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220210
IS  - 2473-4284 (Electronic)
IS  - 2473-4284 (Linking)
VI  - 4
DP  - 2020 Nov
TI  - International Harmonization of Provisional Diagnostic Criteria for 
      ERBB2-Amplified Metastatic Colorectal Cancer Allowing for Screening by 
      Next-Generation Sequencing Panel.
PG  - 6-19
LID - 10.1200/PO.19.00154 [doi]
AB  - PURPOSE: ERBB2 amplification (human epidermal growth factor receptor 2 positivity 
      [HER2(+)]) in metastatic colorectal cancer (mCRC) has important therapeutic 
      implications that necessitate the need for accurate diagnostics. The study 
      purpose was to establish and validate harmonized diagnostic criteria for HER2(+) 
      mCRC among 3 groups (GI-SCREEN-Japan, NCTN-SWOG-USA, and Korea). PATIENTS AND 
      METHODS: We assessed HER2 status by immunohistochemistry (IHC), ERBB2/CEP17 
      ratio, gene copy number (GCN) by fluorescence in situ hybridization (FISH), and 
      copy number variation (CNV) using two targeted next-generation sequencing (NGS) 
      panels. Tumor samples from 475 and 16 patients with mCRC in exploratory and 
      validation cohorts, respectively, were used for cross-validation of the NGS 
      panels. RESULTS: Consensus diagnostic criteria among the 3 groups for HER2(+) 
      mCRC were established as follows: IHC 3+ or IHC 2+ and ERBB2/CEP17 ratio by FISH 
      >/= 2.0, tumor content > 10% for surgically resected specimens, and necessary tumor 
      content not defined for biopsy specimens. The median GCN and CNV for HER2(+) 
      patients were 10.9 and 27.7 compared with 2.5 (P < .0001) and 3.5 (P < .0001), 
      respectively, in HER2-negative patients. These findings were validated in a 
      validation cohort (GCN, 16.2 v 2.4 [P = .0002]; CNV, 42.5 v 2.0 [P = .0003]). GCN 
      correlated with CNV in both cohorts (exploratory, r = 0.90; validation, r = 0.97; 
      P < .0001). CNV in cross-validation of the 2 NGS panels also showed a strong 
      correlation (r = 0.98; P < .0001). CNV in patients who fulfilled the consensus 
      criteria was > 4.0 in all, which demonstrates the accuracy of the IHC/FISH 
      criteria and cross-validation of NGS panels. CONCLUSION: We have established and 
      verified harmonized diagnostic criteria for HER2(+) and demonstrated consistency 
      between IHC/FISH and CNV determined by NGS in mCRC.
FAU - Fujii, Satoshi
AU  - Fujii S
AD  - Division of Pathology, Exploratory Oncology Research & Clinical Trial Center, 
      National Cancer Center, Kashiwa, Japan.
FAU - Magliocco, Anthony M
AU  - Magliocco AM
AD  - Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, FL.
FAU - Kim, Jihun
AU  - Kim J
AD  - Department of Pathology, University of Ulsan College of Medicine, Asan Medical 
      Center, Seoul, South Korea.
FAU - Okamoto, Wataru
AU  - Okamoto W
AD  - Biobank Translational Research Support Section, Translational Research Management 
      Division, Clinical Research Support Office, National Cancer Center Hospital East, 
      Kashiwa, Japan.
FAU - Kim, Jeong Eun
AU  - Kim JE
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, South Korea.
FAU - Sawada, Kentaro
AU  - Sawada K
AD  - Department of Gastroenterology and Gastrointestinal Oncology, National Cancer 
      Center Hospital East, Kashiwa, Japan.
FAU - Nakamura, Yoshiaki
AU  - Nakamura Y
AD  - Department of Gastroenterology and Gastrointestinal Oncology, National Cancer 
      Center Hospital East, Kashiwa, Japan.
FAU - Kopetz, Scott
AU  - Kopetz S
AD  - Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Park, Woong-Yang
AU  - Park WY
AD  - Samsung Genome Institute, Samsung Medical Center, Seoul, South Korea.
FAU - Tsuchihara, Katsuya
AU  - Tsuchihara K
AD  - Division of Translational Informatics, Exploratory Oncology Research & Clinical 
      Trial Center, National Cancer Center, Kashiwa, Japan.
FAU - Kim, Tae Won
AU  - Kim TW
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, South Korea.
FAU - Raghav, Kanwal
AU  - Raghav K
AD  - Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The 
      University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Yoshino, Takayuki
AU  - Yoshino T
AD  - Department of Gastroenterology and Gastrointestinal Oncology, National Cancer 
      Center Hospital East, Kashiwa, Japan.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JCO Precis Oncol
JT  - JCO precision oncology
JID - 101705370
SB  - IM
EDAT- 2020/11/01 00:00
MHDA- 2020/11/01 00:01
CRDT- 2022/01/20 17:38
PHST- 2022/01/20 17:38 [entrez]
PHST- 2020/11/01 00:00 [pubmed]
PHST- 2020/11/01 00:01 [medline]
AID - 10.1200/PO.19.00154 [doi]
PST - ppublish
SO  - JCO Precis Oncol. 2020 Nov;4:6-19. doi: 10.1200/PO.19.00154.