External quality assurance of breast cancer pathologic reporting in Kenya

Background: Eighty percent of women diagnosed with breast cancer (BC) in East Africa present with advanced disease; current literature suggests a preponderance of triple negative/basal like breast cancer in this subset of African women. These studies are limited by their retrospective nature, small numbers, and unclear quality of pathologic specimen reporting. The objective of this study is to provide external quality assurance (EQA), quality control, and validation of hormone receptor and Her2 status of breast cancer specimens from Kenya. Methods: 108 retrospectively identified BC tumour blocks from the Aga Khan University Hospital (Nairobi, Kenya) during 2006–2008 will undergo repeat pathologic assessment for estrogen receptor (ER), progesterone receptor (PR), and Her2 status at Sunnybrook Health Sciences Center (Toronto, Canada).Currently at the Aga Khan University Pathology Lab, ER,PR and Her2 testing is performed manually once every two weeks using Heat Induced Antigen Retrieval and Dako reagents including the ENVISION detection system. Parallel controls of known tissue reactivity are also run; however there is currently no formal EQA. Results: Results will be used to identify areas of improvement in specimen handling and pathology reporting. Conclusions: Standardized and accurate pathologic assessment of BC specimens in East Africa is essential for establishing centres of excellence in Kenya and the wider East African region for hormone receptor and Her2 neu analysis. Results would contribute to understanding the prevalence of triple negative disease in East Africa, lead to improved treatment recommendations and patient outcomes, and serve as a foundation for prospective studies in East Africa