PMID- 19657709 OWN - NLM STAT- MEDLINE DCOM- 20091229 LR - 20151119 IS - 1880-4233 (Electronic) IS - 1340-6868 (Linking) VI - 16 IP - 4 DP - 2009 TI - Recent trends of HER-2 testing and trastuzumab therapy for breast cancer. PG - 284-7 LID - 10.1007/s12282-009-0159-z [doi] AB - Molecular-targeted therapy using trastuzumab, a humanized monoclonal antibody against human epidermal growth factor receptor type-2 (HER-2), is considered to be effective for metastatic as well as primary breast cancer and has already become a worldwide standard therapy for patients with HER-2 protein over-expression and gene amplification. Pretreatment evaluation of HER-2 status is considered to be essential for selection of patients, and according to the generally used algorithm, cases with an immunohistochemistry (IHC) score of 3+ and positivity upon fluorescence in situ hybridization (FISH) are thought to be eligible for trastuzumab therapy. In order to develop an appropriate domestic HER-2 testing system in Japan, the Trastuzumab Pathology Committee was established in 2000 and has been used as a forum for active discussions of policies related to HER-2 testing. After trastuzumab therapy and HER-2 testing had become widely adopted internationally, new guidelines for HER-2 testing were proposed by the ASCO/CAP group in 2007. Since then, these guidelines have gradually become accepted and used in many large-scale clinical studies of HER-2-targeting agents. On the other hand, new ISH methods have been introduced, such as bright-field HER-2 and chromosome 17 centromere double in situ hybridization (BDISH) and dual color-chromogenic in situ hybridization (dc-CISH). These methods make it possible to examine HER-2 gene amplification using only one paraffin section like the dc-FISH method, and to observe grains on the HER-2 gene and centrosome-17 by conventional microscopy. These approaches are considered to be reliable and equally as effective as the dc-FISH method. Accurate evaluation of HER-2 status is thought to be most important for appropriate selection of breast cancer patients who will obtain genuine benefit from trastuzumab treatment. In order to perform effective evaluation of HER-2 status, it is necessary to establish a reliable HER-2 examination system and to maintain its quality at a high level. FAU - Kurosumi, Masafumi AU - Kurosumi M AD - Department of Pathology, Saitama Cancer Center, 818 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan. mkurosumi@cancer-c.pref.saitama.jp LA - eng PT - Journal Article PT - Review DEP - 20090806 PL - Japan TA - Breast Cancer JT - Breast cancer (Tokyo, Japan) JID - 100888201 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Antibodies, Monoclonal/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Agents/*therapeutic use MH - Breast Neoplasms/*chemistry/*drug therapy MH - Female MH - Gene Amplification MH - Humans MH - Receptor, ErbB-2/*analysis MH - Trastuzumab RF - 11 EDAT- 2009/08/07 09:00 MHDA- 2009/12/30 06:00 CRDT- 2009/08/07 09:00 PHST- 2009/06/07 00:00 [received] PHST- 2009/06/22 00:00 [accepted] PHST- 2009/08/07 09:00 [entrez] PHST- 2009/08/07 09:00 [pubmed] PHST- 2009/12/30 06:00 [medline] AID - 10.1007/s12282-009-0159-z [doi] PST - ppublish SO - Breast Cancer. 2009;16(4):284-7. doi: 10.1007/s12282-009-0159-z. Epub 2009 Aug 6.