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Consensus of the Spanish Society of Medical Oncology (SEOM) and Spanish Society of Pathology (SEAP) for HER2 testing in gastric carcinoma

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Abstract

The identification of HER2 alterations in advanced gastric carcinomas is of critical importance in daily clinical practice as such neoplasms require specific treatment with trastuzumab. For these reasons, pathologists and oncologists with expertise in gastric carcinomas and HER2 testing from both organisations (SEAP and SEOM) have endeavoured to discuss and agree on national guidelines for HER2 testing in gastric carcinomas. These guidelines are based on the experience of those who participated in the discussions and also on experience published internationally. These agreed guidelines give the minimum requirements that a pathological anatomy laboratory must fulfil in order to guarantee adequate HER2 testing in daily practice. Any laboratories which do not meet the minimum standards set out in the guidelines must make every effort to achieve compliance.

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References

  1. Bang YJ, Van Cutsem E, Feyereislova A et al (2010) Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastrooesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 376:687–697

    Article  PubMed  CAS  Google Scholar 

  2. Allison M (2010) The HER2 testing conundrum. Nat Biotechnol 28:117–119

    Article  PubMed  CAS  Google Scholar 

  3. Yamamoto T, Ikawa S, Akiyama T et al (1986) Similarity of protein encoded by the human cerb-B-2 gene to epidermal growth factor receptor. Nature 319:230–234

    Article  PubMed  CAS  Google Scholar 

  4. Cortés-Funes H, Rivera F, Alés I et al (2007) Phase II of trastuzumab and cisplatin in patients (pts) with advanced gastric cancer (AGC) with HER2/neu overexpression/amplification. J Clin Oncol 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement): 4613

    Google Scholar 

  5. Hofmann M, Stoss O, Shi D et al (2008) Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology 52: 797–805

    Article  PubMed  CAS  Google Scholar 

  6. Van Cutsem E, Kang Y, Chung H et al (2009) Efficacy results from the ToGA trial: a phase III study of trastuzumab added to standard chemotherapy (CT) in first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC). J Clin Oncol 27:18s (suppl; abstr LBA4509)

    Article  Google Scholar 

  7. Bang Y, Chung H, Xu J et al (2009) Pathological features of advanced gastric cancer (GC): Relationship to human epidermal growth factor receptor 2 (HER2) positivity in the global screening programme of the ToGA trial. J Clin Oncol 27:15s (suppl; abstr 4556)

    Article  Google Scholar 

  8. Ruschoff J, Dietel M, Baretton G et al (2010) HER2 diagnostics in gastric cancer-guideline validation and development of standardized immunohistochemical testing. Virchows Arch 457:299–307

    Article  PubMed  Google Scholar 

  9. García-García E, Gómez-Martín C, Angulo A et al. Hybridization for HER2 testing in gastric carcinoma: a comparison of fluorescence in situ hybridization with a novel fully automated dualcolor silver in situ hybridization. Histopathology (in press)

  10. Gómez Martín C (2010) Importancia pronóstica y predictiva del estudio del oncogen HER2 en adenocarcinomas gástricos. Doctoral thesis, Universidad Autónoma de Madrid

  11. Zuo T, Wang L, Morrison C et al (2007) FOXP3 is an X-linked breast cancer suppressor gene and an important repressor of the HER-2/ErbB2 oncogene. Cell 129:1275–1286

    Article  PubMed  CAS  Google Scholar 

  12. Cappuzzo F, Bemis L, Varella-Garcia M (2006) HER2 mutation and response to trastuzumab therapy in non-small-cell lung cancer. N Engl J Med 354:2619–2621

    Article  PubMed  CAS  Google Scholar 

  13. Wang SE, Narasanna A, Perez-Torres M et al (2006) HER2 kinase domain mutation results in constitutive phosphorylation and activation of HER2 and EGFR and resistance to EGFR tyrosine kinase inhibitors. Cancer Cell 10:25–38

    Article  PubMed  Google Scholar 

  14. Sauter G, Simon R, Hillan K (2003) Tissue microarrays in drug discovery. Nat Rev Drug Discov 2:962–972

    Article  PubMed  CAS  Google Scholar 

  15. Zhang XL, Yang YS, Xu DP et al (2009) Comparative study on overexpression of HER2/neu and HER3 in gastric cancer. World J Surg 33:2112–2118

    Article  PubMed  Google Scholar 

  16. Takehana T, Kunitomo K, Kono K et al (2002) Status of c-erbB-2 in gastric adenocarcinoma: a comparative study of immunohistochemistry, fluorescence in situ hybridization and enzyme-linked immunosorbent assay. Int J Cancer 98:833–837

    Article  PubMed  CAS  Google Scholar 

  17. Allgayer H, Babic R, Gruetzner KU et al (2000) c-erbB-2 is of independent prognostic relevance in gastric cancer and is associated with the expression of tumor-associated protease systems. J Clin Oncol 18:2201–2209

    PubMed  CAS  Google Scholar 

  18. Marx AH, Tharun L, Muth J et al (2009) HER-2 amplification is highly homogenous in gastric cancer. Hum Pathol 40:769–777

    Article  PubMed  CAS  Google Scholar 

  19. Yano T, Doi T, Ohtsu A et al (2006) Comparison of HER2 gene amplification assessed by fluorescence in situ hybridization and HER2 protein expression assessed by immunohistochemistry in gastric cancer. Oncol Rep 15:65–71

    PubMed  Google Scholar 

  20. Lottner C, Schwarz S, Diermeier S et al (2005) Simultaneous detection of HER2/neu gene amplification and protein overexpression in paraffinembedded breast cancer. J Pathol 205:577–584

    Article  PubMed  CAS  Google Scholar 

  21. Park DI, Yun JW, Park JH et al (2006) HER-2/neu amplification is an independent prognostic factor in gastric cancer. Dig Dis Sci 51:1371–1379

    Article  PubMed  CAS  Google Scholar 

  22. Nakajima M, Sawada H, Yamada Y et al (1999) The prognostic significance of amplification and overexpression of c-met and c-erb B-2 in human gastric carcinomas. Cancer 85:1894–1902

    PubMed  CAS  Google Scholar 

  23. Tanner M, Hollmén M, Junttila TT et al (2005) Amplification of HER-2 in gastric carcinoma: association with Topoisomerase IIalpha gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann Oncol 16:273–278

    Article  PubMed  CAS  Google Scholar 

  24. Grabsch H, Sivakumar S, Gray S et al (2010) HER2 expression in gastric cancer: Rare, heterogeneous and of no prognostic value: conclusions from 924 cases of two independent series. Cell Oncol 32:57–65

    PubMed  Google Scholar 

  25. Matsui Y, Inomata M, Tojigamori M et al (2005) Suppression of tumor growth in human gastric cancer with HER2 overexpression by an anti-HER2 antibody in a murine model. Int J Oncol 27:681–685

    PubMed  CAS  Google Scholar 

  26. Rebischung C, Barnoud R, Stéfani L et al (2005) The effectiveness of trastuzumab (Herceptin) combined with chemotherapy for gastric carcinoma with overexpression of the c-erbB-2 protein. Gastric Cancer 8:249–252

    Article  PubMed  Google Scholar 

  27. Inui T, Asakawa A, Morita Y et al (2006) HER-2 overexpression and targeted treatment by trastuzumab in a very old patient with gastric cancer. J Intern Med 260:484–487

    Article  PubMed  CAS  Google Scholar 

  28. Rech J, Arnld D, Folprecht G et al (2006) A pilot study of Trastuzumab monotherapy in patients who progressed while on chemotherapy for metastatic or locally advanced HER positive gastric cancer. Ann Oncol 17[Suppl 9]:314 (abstract 1096P)

    Google Scholar 

  29. Nicholas G, Cripps C, Heather-Jane A et al (2006) Early results of a trial of trastuzumab, cisplatin and docetaxel (TCD) for the treatment of metastatic gastric cancer overexpressing HER2. Ann Oncol 17[Suppl 9]:316 (abstract 1105P)

    Google Scholar 

  30. Satoh T, Leon J, Lopez RI et al (2010) Quality of life results from a phase III trial of trastuzumab plus chemotherapy in first-line HER2-positive advanced gastric and GE junction cancer. 2010 Gastrointestinal Cancers Symposium, Abstract 7

  31. Wainberg ZA, Anghel A, Desai AJ et al (2010) Lapatinib, a dual EGFR and HER2 kinase inhibitor, selectively inhibits HER2-amplified human gastric cancer cells and is synergistic with trastuzumab in vitro and in vivo. Clin Cancer Res 16:1509–1519

    Article  PubMed  CAS  Google Scholar 

  32. Wolff AC, Hammond ME, Schwartz JN et al; American Society of Clinical Oncology; College of American Pathologists (2007) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 25:118–145

    Article  PubMed  CAS  Google Scholar 

  33. Risio M, De Rosa G, Sarotto L et al (2003) HER2 testing in gastric cancer: molecular morphology and storage time-related changes in archival samples. Int J Oncol 23:1381–1387

    PubMed  CAS  Google Scholar 

  34. Werner M, Chott A, Fabiano A, Battifora H (2000) Effect of formalin tissue fixation and processing on immunohistochemistry. Am J Surg Pathol 24:1016–1019

    Article  PubMed  CAS  Google Scholar 

  35. Goldstein NS, Hewitt SM, Taylor CR et al; members of Ad-Hoc Committee on Immunohistochemistry Standardization (2007) Recommendations for improved standardization of immunohistochemistry. Appl Immunohistochem Mol Morphol 15:124–133

    Article  PubMed  CAS  Google Scholar 

  36. Burnett MG (1982) The mechanism of the formaldehyde clock reaction. J Chem Educ 59:160–162

    Article  CAS  Google Scholar 

  37. Grace-Jones W (2008) Tissue microarray. In: Bancroft JD, Gamble M (eds) Theory and practice of histological techniques, 6th edn. Churchill Livingstone, Elsevier, Philadelphia, pp 527–535

    Google Scholar 

  38. Blind C, Koepenik A, Pacyna-Gengelbach M et al (2008) Antigenicity testing by immunohistochemistry after tissue oxidation. J Clin Pathol 61:79–83

    Article  PubMed  CAS  Google Scholar 

  39. Hatanaka Y, Hashizume K, Kamihara Y et al (2001) Quantitative immunohistochemical evaluation of HER2/neu expression with HerceptestTM in breast carcinoma by image analysis. Pathol Int 51:33–36

    Article  PubMed  CAS  Google Scholar 

  40. Mulrane L, Rexhepaj E, Penney S et al (2008) Automated image analysis in histopathology: a valuable tool in medical diagnostics. Exp Rev Mol Diagn 8:707–725

    Article  Google Scholar 

  41. Persons DL, Tubbs RR, Cooley LD et al (2006) HER-2 fluorescence in situ hybridization. Results from the Survey Program of the College of American Pathologists. Arch Pathol Lab Med 130:325–331

    Google Scholar 

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Correspondence to Carlos Gómez-Martín.

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Gómez-Martín, C., Concha, Á., Corominas, J.M. et al. Consensus of the Spanish Society of Medical Oncology (SEOM) and Spanish Society of Pathology (SEAP) for HER2 testing in gastric carcinoma. Clin Transl Oncol 13, 636–651 (2011). https://doi.org/10.1007/s12094-011-0709-7

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  • DOI: https://doi.org/10.1007/s12094-011-0709-7

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