PMID- 34281885 OWN - NLM STAT- MEDLINE DCOM- 20210729 LR - 20210729 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 41 IP - 8 DP - 2021 Aug TI - Effect of the 2013 ASCO-CAP HER2 Testing Guideline on the Management of IHC/HER2 2+ Invasive Breast Cancer. PG - 4143-4149 LID - 10.21873/anticanres.15217 [doi] AB - BACKGROUND/AIM: With advances in anti-HER2 treatment and improved prognoses of HER2-positive breast cancer, the American Society of Clinical Oncology and the American Society of Pathologists (ASCO/CAP) have revised the HER2 diagnostic guidelines several times. We examined how to respond clinically to the revisions of the interpretation of the immunohistochemistry (IHC) method. PATIENTS AND METHODS: We re-evaluated 254 patients diagnosed as HER2 IHC equivocal, who underwent fluorescence in situ hybridization (FISH) before and after the IHC diagnostic criteria update in 2013. RESULTS: Twenty of 131 (15.3%) IHC equivocal cases by the ASCO/CAP 2007 guideline were IHC score 3+ and one of 20 (0.76%) was negative for FISH. Five of 123 (4.1%) IHC equivocal cases by the ASCO/CAP 2013 guideline were negative for IHC as per the 2007 guideline and four were positive for FISH. CONCLUSION: After revision of the ASCO/CAP 2013 guideline, 3.3% of HER2-negative cases before the revision should have received anti-HER2 treatment. CI - Copyright (c) 2021 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved. FAU - Yamada, Mai AU - Yamada M AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Kubo, Makoto AU - Kubo M AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan mkubo@surg1.med.kyushu-u.ac.jp. FAU - Yamamoto, Hidetaka AU - Yamamoto H AD - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Yamashita, Nami AU - Yamashita N AD - Department of Surgery and Science, Kyushu University, Fukuoka, Japan. FAU - Kai, Masaya AU - Kai M AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Zaguirre, Karen AU - Zaguirre K AD - Institute of Surgery, St. Luke's Medical Center, Quezon, Philippines. FAU - Kaneshiro, Kazuhisa AU - Kaneshiro K AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Shimazaki, Akiko AU - Shimazaki A AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Hayashi, Saori AU - Hayashi S AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Kawaji, Hitomi AU - Kawaji H AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Mori, Masaki AU - Mori M AD - Department of Surgery and Science, Kyushu University, Fukuoka, Japan. FAU - Oda, Yoshinao AU - Oda Y AD - Department of Anatomic Pathology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Nakamura, Masafumi AU - Nakamura M AD - Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. LA - eng PT - Journal Article PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - 0 (Antineoplastic Agents) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Antineoplastic Agents/therapeutic use MH - Breast Neoplasms/*diagnosis/drug therapy/metabolism/surgery MH - Female MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Practice Guidelines as Topic MH - Receptor, ErbB-2/antagonists & inhibitors/*metabolism OTO - NOTNLM OT - HER2 diagnosis OT - IHC/HER2 equivocal OT - revision of ASCO/CAP guideline EDAT- 2021/07/21 06:00 MHDA- 2021/07/30 06:00 CRDT- 2021/07/20 06:09 PHST- 2021/05/22 00:00 [received] PHST- 2021/06/12 00:00 [revised] PHST- 2021/06/17 00:00 [accepted] PHST- 2021/07/20 06:09 [entrez] PHST- 2021/07/21 06:00 [pubmed] PHST- 2021/07/30 06:00 [medline] AID - 41/8/4143 [pii] AID - 10.21873/anticanres.15217 [doi] PST - ppublish SO - Anticancer Res. 2021 Aug;41(8):4143-4149. doi: 10.21873/anticanres.15217.