Prognostic and Predictive Markers in Primary Breast Cancer - Quality Assurance and Long-term Effects of Adjuvant tamoxifen Treatment
Abstract
Breast cancer is the most common cancer among women in Sweden and worldwide.When a patient is diagnosed with breast cancer, prognostic and predictive factors are used to estimate the prognosis and the likely benefit from different kinds of adjuvant therapy.A challenge in this setting is to identify patients with oestrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancers, for whom adjuvant endocrine therapy is sufficient and chemotherapy can be omitted.One of the most important markers used for this decision is Ki67, which reflects the degree of proliferation within the tumour.However, there are concerns about the reproducibility of Ki67 results between different laboratories as well as between different assessors.It is therefore important to continuously evaluate the laboratories' performance by participation in quality assurance schemes and to strive to improve all steps in the Ki67 analysis. Study I:We evaluated a new rabbit monoclonal antibody (SP6) for immuohistochemical staining of Ki67, but in comparison with the gold standard antibody (MIB1), the agreement between assessors was not improved, nor was the prognostic value. Study II:We investigated the quality of Swedish breast cancer biomarker analyses (ER, PR, HER2, and Ki67) in terms of agreement by using a well-known reference laboratory in Milan, Italy for comparison.We found very good agreement for ER, PR, and HER2.Agreement for Ki67 was good, which was better than…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 564 participants or records.
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