Limited human epidermal growth factor receptor 2 discordance in metastatic breast cancer patients treated with trastuzumab,a population based study |
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| Affiliation: | 1. Department of Internal Medicine, Martini Hospital, Groningen, The Netherlands;2. Department of Research, Comprehensive Cancer Centre the Netherlands, Utrecht, The Netherlands;3. Department of Internal Medicine, Isala Klinieken Zwolle, Zwolle, The Netherlands;4. MIRA Institute, Health Technology and Services Research, University of Twente, Enschede, The Netherlands;5. Department of Medical Oncology, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands;6. Department of Pathology, Isala Klinieken Zwolle, Zwolle, The Netherlands;1. Department of Surgery, Washington University School of Medicine, St Louis, MO;2. Department of Medicine, Washington University School of Medicine, St Louis, MO;3. Department of Radiology, Washington University School of Medicine, St Louis, MO;4. Department of Radiation Oncology, Washington University School of Medicine, St Louis, MO;5. Division of Biostatistics, Washington University School of Medicine, St Louis, MO;1. Liverpool Hepatobiliary Centre, University Hospital Aintree, Liverpool L9 7AL, UK;2. University of Liverpool Management School, Chatham Street, Liverpool L69 7ZH, UK;3. Department of Radiology, University Hospital Aintree, Liverpool L9 7AL, UK;1. Department of Environmental Science, College of Tourism and Environment, Shaanxi Normal University, Xi''an, Shaanxi 710062, PR China;2. Department of Law and Foreign Language, Shaanxi Police Professional College, Xi''an, Shaanxi 710043, PR China;3. College of Chemistry and Engineering, Shaanxi Normal University, Xi''an, Shaanxi 710062, PR China;1. Department of Gynecology and Obstetrics, Interdisciplinary Breast Center, University of Rostock, Südring 81, 18059 Rostock, Germany;2. Institute for Biostatistics and Informatics in Medicine and Ageing Research, Rostock University Medical Center, Ernst-Heydemann-Str. 8, 18057 Rostock, Germany;1. Neuroendocrine Tumour Unit, The Royal Free Hospital, Pond Street, London, UK;2. UCL Cancer Institute, London, UK;3. Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit – Cancer Theme, Addenbrooke’s Hospital, Cambridge, UK;4. Medical Research Council Biostatistics Unit Hub for Trials Methodology, Cambridge, UK;5. Department of Medical Oncology, The Christie, Manchester, UK;6. Oxford Neuroendocrine Tumour Centre, Churchill Hospital, Oxford, UK;7. Gastrointestinal Unit, The Royal Marsden, London, UK;8. Beatson Oncology Centre, Glasgow, UK;9. Oncology Centre, Addenbrooke’s Hospital, Cambridge, UK |
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| Abstract: | BackgroundAccurate assessment of the human epidermal growth factor receptor 2 (HER2) in breast cancer is essential for proper treatment decisions. HER2 positivity confirmation rates in breast cancer trials by central testing pathology laboratories were reported to be approximately 85%. The aim of our study was to assess in a population based sample concordance of HER2 status in metastatic breast cancer (MBC) patients locally tested HER2 positive and treated with trastuzumab. Moreover cost-effectiveness of in situ hybridisation (ISH) in patients with an immunohistochemical score 3+ (IHC3+) was explored.MethodsMBC patients treated between 2005 and 2009 with trastuzumab-based therapy in North East Netherlands were identified by a survey of hospital pharmacies. Primary tumour samples were retested centrally for HER2 status using 1 immunohistochemical (IHC) method and two methods using ISH on tissue micro-arrays. Potential discordant patients were retested on whole tumour slides. HER2 positivity was defined as: (1) ISH amplification (according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) clinical practice Guideline Update) and (2) when ISH failed an IHC score of 3+. Cost-effectiveness was estimated using potential ISH and treatment costs.ResultsHER2 status could be retested in 174 of 194 (90%) patients. The HER2 concordance rate was 87%. The 21 discordant patients were in the 67% due to primary HER2 testing with only IHC. Overall survival of HER2 discordant and concordant patients was not significantly different (18 versus 25 months, p = 0.131). Structural ISH in the case of IHC3+ has an estimated potential saving of €87,710 per 100 patients.ConclusionHER2 concordance in a population based study is comparable to those described in selected populations. Discordance is mostly due to testing with only IHC. ISH in the case of IHC3+ is cost-effective. |
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| Keywords: | HER2 positive breast cancer Trastuzumab HER2 testing HER2 concordance Immunohistochemistry |
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