The fourth edition of the European guidelines for quality assurance in breast cancer screening and diagnosis was published by the European Commission in 2006. The present supplements to the fourth edition have been produced by the same groups of experts originally established under the Europe Against Cancer programme that have developed and updated the guidelines since the early 1990s. Over the years, the scope and the depth of the multidisciplinary guidelines have expanded, and recommendations and protocols have been updated to keep pace with developments in the field. The present supplements lay a cornerstone for a new, completely revised fifth edition of the guidelines

/pdf/european-guidelines-for-quality-assurance-in-breast-cancer-34igkumbby.pdf

European guidelines for quality assurance in breast cancer screening and diagnosis

Rak piersi jest najczestszą przyczyna zgonu wśrod kobiet i stanowi istotny problem kliniczny. Wczesne
wykrycie raka piersi dzieki regularnie prowadzonym badaniom przesiewowym za pomocą mammografii
umozliwia rozpoznanie choroby w stadium, w ktorym leczenie jest skuteczniejsze i zazwyczaj wiąze sie
z lepszą jakością zycia. Jednakze mammografia moze byc przyczyną niepotrzebnego stresu, dolegliwości,
kosztow finansowych oraz narazenia na promieniowanie jonizujące. Z tego powodu nalezy polozyc
mozliwie najwiekszy nacisk na kontrole jakości. Opracowanie Europejskich zalecen dotyczących kontroli
jakości badan przesiewowych i rozpoznawania raka piersi bylo inicjatywą programu Europa przeciwko
rakowi . Czwartą edycje interdyscyplinarnych zalecen opublikowano w 2006 roku. Sklada sie z okolo 400
stron podzielonych na 12 rozdzialow przygotowanych przez ponad 200 autorow i wspolautorow. Interdyscyplinarna
rada wydawnicza przygotowala streszczenie dokumentu w celu przedstawienia podstawowych
zasad i zalozen, na ktorych powinny opierac sie badania przesiewowe oraz diagnostyka raka piersi.
Opracowanie zawiera takze tabele podsumowującą wskaźniki wydajności, aby szersze grono naukowcow
moglo sie z nią zapoznac.

/pdf/european-guidelines-for-quality-assurance-in-breast-cancer-2ik5vahzpv.pdf

European guidelines for quality assurance in breast cancer screening and diagnosis. Fourth edition - summary document

Breast cancer is the leading cause of death among solid tumours in women, and its incidence is increasing in the West. Adjuvant chemotherapy and hormonal treatment improve survival but have potentially serious side effects, and are costly. Because adjuvant treatment should be given to high risk patients only, and traditional prognostic factors (lymph node status, tumour size) are insufficiently accurate, better predictors of high risk and treatment response are needed. Invasive breast cancer metastasises haematogenously very early on, so many breast cancer prognosticators are directly or indirectly related to proliferation. Although studies evaluating the role of individual proliferation regulating genes have greatly increased our knowledge of this complex process, the functional end result-cells dividing-has remained the most important prognostic factor. This article reviews the prognostic value of different proliferation assays in invasive breast cancer, and concludes that increased proliferation correlates strongly with poor prognosis, irrespective of the methodology used. Mitosis counting provides the most reproducible and independent prognostic value, and Ki67/MIB1 labelling and cyclin A index are promising alternatives that need methodological fine tuning.

https://jcp.bmj.com/content/jclinpath/57/7/675.full.pdf

Prognostic value of proliferation in invasive breast cancer: a review

Current Perspectives on HER2 Testing: A Review of National Testing Guidelines

The development of Herceptin (Trazumatab) makes testing for HER2 status important for choosing optimal therapy in breast cancer. This study addresses the precision, accuracy, and reproducibility of HER2 assays. HER2 was assessed retrospectively by immunohistochemistry (IHC) with Dako 'Herceptest', by IHC with the monoclonal antibody CB11, and by fluorescence in situ hybridization (FISH, PathVysion), in a series of 216 formalin-fixed breast carcinomas including 191 for which quantitative HER2 data from radioimmunohistochemistry (Q-IHC) were available. All tests were scored independently by two observers. Positivity rates varied between Herceptest (12.6%), FISH (19.4%), and CB11 IHC (28.5%). Kappa values showed that IHC-based tests were more susceptible to inter-observer variation (kappa=0.67 and 0.74 for Herceptest and CB11, respectively) than FISH (kappa=0.973). Overall test accuracy (see the Materials and methods section) for CB11 IHC (83.8%) was lower than Herceptest (87.4%) or FISH (93.2%). FISH predicted p185 HER2 overexpression (determined by Q-IHC) better (concordance index C.Ind. 0.90) than CB11 IHC (C.Ind.=0.85) or Herceptest (C.Ind.=0.81). Of 42 cases with gene amplification by FISH, 67% were positive in the Herceptest (2+ or 3+) vs. 83% with CB11. Of 174 cases negative by FISH, 96% were negative in the Herceptest and 68% with CB11. In conclusion, FISH is the most accurate, reproducible, and precise predictor of HER2 overexpression in routine diagnostic laboratories.

Evaluating HER2 amplification and overexpression in breast cancer.

Determining the HER2 status of breast carcinomas is a prerequisite for the use of the monoclonal antibody trastuzumab (Herceptin®), which has recently been licensed for the treatment of metastatic disease. This necessitates a test based on archival material. The preferred analyses are immunohistochemistry with fluorescent in situ hybridisation (FISH) as a follow up test for ambiguous results. Guidelines have been developed for standardised, well controlled procedures for the provision of reliable results. A group of three reference laboratories has been established to provide advice, quality assurance, and materials, where needed.

https://jcp.bmj.com/content/jclinpath/53/12/890.full.pdf

P. Barrett Lee

Papers

Recommendations for HER2 testing in the UK