Study on the state of implementation of HER2 testing and positive ratios in patients with breast cancer in the Kyushu-Okinawa region of Japan

Yasuaki Sagara, Yoshihiko Kamada, Yutaka Yamamoto, Maki Tanaka, Makoto Kubo, Rin Yamaguchi, Reiki Nishimura, Shoshu Mitsuyama

Research output: Contribution to journalArticle

Abstract

Background: The development of molecular-targeted agents has improved the recovery rate for cancer. In Japan, trastuzumab has been approved as an adjuvant treatment for human epidermal growth factor receptor-2 (HER2)-positive breast cancer; therefore, accurate management of HER2 testing has become more important. In addition, proper patient selection is required from the viewpoint of health care economics. Methods: The current situation of HER2 testing in patients with infiltrating breast cancer from April 2008 to March 2009 was evaluated in 49 institutions (50 departments) treating breast cancer in the Kyushu-Okinawa region. Results: In a total of 5286 samples, HER2-positive ratio was 14.2%, which may reasonably reflect the current state of HER2 testing for breast cancer in the Kyushu-Okinawa region. There was a moderate discrepancy in HER2-positive ratio between institutions. Immunohistochemistry (IHC) analysis was outsourced in 15 institutions, and fluorescence in situ hybridization (FISH) analysis was outsourced in 23 institutions. The ratio of retesting by FISH analysis for samples judged as 2+ on IHC was 86.1%. There was no correlation between HER2-positive ratio and the number of HER2 tests at the institution. However, a high percentage of HER2 IHC 0-1+ results and a low percentage of HER2 2+ and 3+ results at the institution were significantly correlated with a high percentage of HER2 FISH-positive results for HER2 IHC 2+ cases. Conclusions: There is a moderate discrepancy in HER2-positive ratio between institutions. Institutions with a high percentage of HER2 IHC 0-1+ and a low percentage of HER2 2+ and 3+ may have more false negative cases. These institutions should perform internal accuracy evaluations in order to maintain proper diagnostic judgment.

Original languageEnglish
Pages (from-to)315-320
Number of pages6
JournalBreast Cancer
Volume19
Issue number4
DOIs
Publication statusPublished - Oct 1 2012

Fingerprint

Japan
Breast Neoplasms
Immunohistochemistry
Fluorescence In Situ Hybridization
human ERBB2 protein
Patient Selection
Economics
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Pharmacology (medical)

Cite this

Study on the state of implementation of HER2 testing and positive ratios in patients with breast cancer in the Kyushu-Okinawa region of Japan. / Sagara, Yasuaki; Kamada, Yoshihiko; Yamamoto, Yutaka; Tanaka, Maki; Kubo, Makoto; Yamaguchi, Rin; Nishimura, Reiki; Mitsuyama, Shoshu.

In: Breast Cancer, Vol. 19, No. 4, 01.10.2012, p. 315-320.

Research output: Contribution to journalArticle

Sagara, Yasuaki ; Kamada, Yoshihiko ; Yamamoto, Yutaka ; Tanaka, Maki ; Kubo, Makoto ; Yamaguchi, Rin ; Nishimura, Reiki ; Mitsuyama, Shoshu. / Study on the state of implementation of HER2 testing and positive ratios in patients with breast cancer in the Kyushu-Okinawa region of Japan. In: Breast Cancer. 2012 ; Vol. 19, No. 4. pp. 315-320.
@article{76b4dcc959224582923330be198639a0,
title = "Study on the state of implementation of HER2 testing and positive ratios in patients with breast cancer in the Kyushu-Okinawa region of Japan",
abstract = "Background: The development of molecular-targeted agents has improved the recovery rate for cancer. In Japan, trastuzumab has been approved as an adjuvant treatment for human epidermal growth factor receptor-2 (HER2)-positive breast cancer; therefore, accurate management of HER2 testing has become more important. In addition, proper patient selection is required from the viewpoint of health care economics. Methods: The current situation of HER2 testing in patients with infiltrating breast cancer from April 2008 to March 2009 was evaluated in 49 institutions (50 departments) treating breast cancer in the Kyushu-Okinawa region. Results: In a total of 5286 samples, HER2-positive ratio was 14.2{\%}, which may reasonably reflect the current state of HER2 testing for breast cancer in the Kyushu-Okinawa region. There was a moderate discrepancy in HER2-positive ratio between institutions. Immunohistochemistry (IHC) analysis was outsourced in 15 institutions, and fluorescence in situ hybridization (FISH) analysis was outsourced in 23 institutions. The ratio of retesting by FISH analysis for samples judged as 2+ on IHC was 86.1{\%}. There was no correlation between HER2-positive ratio and the number of HER2 tests at the institution. However, a high percentage of HER2 IHC 0-1+ results and a low percentage of HER2 2+ and 3+ results at the institution were significantly correlated with a high percentage of HER2 FISH-positive results for HER2 IHC 2+ cases. Conclusions: There is a moderate discrepancy in HER2-positive ratio between institutions. Institutions with a high percentage of HER2 IHC 0-1+ and a low percentage of HER2 2+ and 3+ may have more false negative cases. These institutions should perform internal accuracy evaluations in order to maintain proper diagnostic judgment.",
author = "Yasuaki Sagara and Yoshihiko Kamada and Yutaka Yamamoto and Maki Tanaka and Makoto Kubo and Rin Yamaguchi and Reiki Nishimura and Shoshu Mitsuyama",
year = "2012",
month = "10",
day = "1",
doi = "10.1007/s12282-011-0295-0",
language = "English",
volume = "19",
pages = "315--320",
journal = "Breast Cancer",
issn = "1340-6868",
publisher = "Springer Japan",
number = "4",

}

TY - JOUR

T1 - Study on the state of implementation of HER2 testing and positive ratios in patients with breast cancer in the Kyushu-Okinawa region of Japan

AU - Sagara, Yasuaki

AU - Kamada, Yoshihiko

AU - Yamamoto, Yutaka

AU - Tanaka, Maki

AU - Kubo, Makoto

AU - Yamaguchi, Rin

AU - Nishimura, Reiki

AU - Mitsuyama, Shoshu

PY - 2012/10/1

Y1 - 2012/10/1

N2 - Background: The development of molecular-targeted agents has improved the recovery rate for cancer. In Japan, trastuzumab has been approved as an adjuvant treatment for human epidermal growth factor receptor-2 (HER2)-positive breast cancer; therefore, accurate management of HER2 testing has become more important. In addition, proper patient selection is required from the viewpoint of health care economics. Methods: The current situation of HER2 testing in patients with infiltrating breast cancer from April 2008 to March 2009 was evaluated in 49 institutions (50 departments) treating breast cancer in the Kyushu-Okinawa region. Results: In a total of 5286 samples, HER2-positive ratio was 14.2%, which may reasonably reflect the current state of HER2 testing for breast cancer in the Kyushu-Okinawa region. There was a moderate discrepancy in HER2-positive ratio between institutions. Immunohistochemistry (IHC) analysis was outsourced in 15 institutions, and fluorescence in situ hybridization (FISH) analysis was outsourced in 23 institutions. The ratio of retesting by FISH analysis for samples judged as 2+ on IHC was 86.1%. There was no correlation between HER2-positive ratio and the number of HER2 tests at the institution. However, a high percentage of HER2 IHC 0-1+ results and a low percentage of HER2 2+ and 3+ results at the institution were significantly correlated with a high percentage of HER2 FISH-positive results for HER2 IHC 2+ cases. Conclusions: There is a moderate discrepancy in HER2-positive ratio between institutions. Institutions with a high percentage of HER2 IHC 0-1+ and a low percentage of HER2 2+ and 3+ may have more false negative cases. These institutions should perform internal accuracy evaluations in order to maintain proper diagnostic judgment.

AB - Background: The development of molecular-targeted agents has improved the recovery rate for cancer. In Japan, trastuzumab has been approved as an adjuvant treatment for human epidermal growth factor receptor-2 (HER2)-positive breast cancer; therefore, accurate management of HER2 testing has become more important. In addition, proper patient selection is required from the viewpoint of health care economics. Methods: The current situation of HER2 testing in patients with infiltrating breast cancer from April 2008 to March 2009 was evaluated in 49 institutions (50 departments) treating breast cancer in the Kyushu-Okinawa region. Results: In a total of 5286 samples, HER2-positive ratio was 14.2%, which may reasonably reflect the current state of HER2 testing for breast cancer in the Kyushu-Okinawa region. There was a moderate discrepancy in HER2-positive ratio between institutions. Immunohistochemistry (IHC) analysis was outsourced in 15 institutions, and fluorescence in situ hybridization (FISH) analysis was outsourced in 23 institutions. The ratio of retesting by FISH analysis for samples judged as 2+ on IHC was 86.1%. There was no correlation between HER2-positive ratio and the number of HER2 tests at the institution. However, a high percentage of HER2 IHC 0-1+ results and a low percentage of HER2 2+ and 3+ results at the institution were significantly correlated with a high percentage of HER2 FISH-positive results for HER2 IHC 2+ cases. Conclusions: There is a moderate discrepancy in HER2-positive ratio between institutions. Institutions with a high percentage of HER2 IHC 0-1+ and a low percentage of HER2 2+ and 3+ may have more false negative cases. These institutions should perform internal accuracy evaluations in order to maintain proper diagnostic judgment.

UR - http://www.scopus.com/inward/record.url?scp=84876449578&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84876449578&partnerID=8YFLogxK

U2 - 10.1007/s12282-011-0295-0

DO - 10.1007/s12282-011-0295-0

M3 - Article

C2 - 21814842

AN - SCOPUS:84876449578

VL - 19

SP - 315

EP - 320

JO - Breast Cancer

JF - Breast Cancer

SN - 1340-6868

IS - 4

ER -