Human epidermal growth factor receptor 2 (HER2) protein overexpression and/or HER2 gene amplification is found in about 20% of invasive breast cancers. It is a sole predictive marker for treatment benefits from HER2 targeted therapy and thus, HER2 testing is a routine practice for newly diagnosed breast cancer in pathology. Currently, HER2 immunohistochemistry (IHC) is used for a screening test, and in situ hybridization is used as a confirmation test for HER2 IHC equivocal cases. Since the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines on HER2 testing was first released in 2007, it has been updated to provide clear instructions for HER2 testing and accurate determination of HER2 status in breast cancer. During HER2 interpretation, some pitfalls such as intratumoral HER2 heterogeneity and increase in chromosome enumeration probe 17 signals may lead to inaccurate assessment of HER2 status. Moreover, HER2 status can be altered after neoadjuvant chemotherapy or during metastatic progression, due to biologic or methodologic issues. This review addresses recent updates of ASCO/CAP guidelines and factors complicating in the interpretation of HER2 status in breast cancers.
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J Pathol Transl Med. 2017;51(3):191-204. Published online May 10, 2017
Next-generation sequencing (NGS) has recently emerged as an essential component of personalized cancer medicine due to its high throughput and low per-base cost. However, no sufficient guidelines for implementing NGS as a clinical molecular pathology test are established in Korea. To ensure clinical grade quality without inhibiting adoption of NGS, a taskforce team assembled by the Korean Society of Pathologists developed laboratory guidelines for NGS cancer panel testing procedures and requirements for clinical implementation of NGS. This consensus standard proposal consists of two parts: laboratory guidelines and requirements for clinical NGS laboratories. The laboratory guidelines part addressed several important issues across multistep NGS cancer panel tests including choice of gene panel and platform, sample handling, nucleic acid management, sample identity tracking, library preparation, sequencing, analysis and reporting. Requirements for clinical NGS tests were summarized in terms of documentation, validation, quality management, and other required written policies. Together with appropriate pathologist training and international laboratory standards, these laboratory standards would help molecular pathology laboratories to successfully implement NGS cancer panel tests in clinic. In this way, the oncology community would be able to help patients to benefit more from personalized cancer medicine.
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Gastric cancer is the most common malignant neoplasm among Koreans, and the pathologists's daily diagnostic competency on gastric cancer at any hospital setting plays a critical implication not only in the quality of clinical service but also to the determination of patient's prognosis. Thus, adoption of a unified assessment system based on comprehensive understanding of pathologic features together with their active participation has been crucially demanded.
Nevertheless, a considerable difference in handling procedures and diagnostic approach on gastric cancer among institutions apparently resulted in an extreme difficulty in exchange of clinicopathologic informations and in the nationwide survey. It is, therefore, essential and be the first step to develop a practical but scientific and reproducible classification of gastric cancer with its diverse gross and histologic findings. Based on the following basic principles, the Subcommittee on Gastric Cancer under the Gastrointestinal Study Group of the Korean Society of Pathologists has been requested to develop the guidelines of future pathologic study of gastric cancer to meet the above needs and be efficiently used with ease among the society members. 1) The prerequisite for pathologic classification of gastric cancer starts with consistency in handling of the resected stomach before its further examination. Thus, the guideline shall limits its scope only with the minimum agreement. 2) The classification should be simple and practical so that all pathologists can use with ease and with high reproducibility. 3) All the gross and microscopic findings which have been considered to be the prognosis-related factors should be included in every pathologic procedures to help future information exchange among pathologists and clinicians and to provide a meaningful role in determination of patient's prognosis. 4) The classification should be interchangeable and stand with compatibility among WHO and other internationally accepted classifications. 5) The guideline accepts in part the staging system of American Joint Commitee on Cancer, classification of early gastric cancer proposed by the Japanese Society of Gastrointestinal Endoscopy, and the General Rules of Stomach Cancer Study by Japanese Research Society of Gastric Cancer, until otherwise developed and accepted by the Korean Society of Pathologists. 6) The guideline should not interfere with each institution-based special study. The details of the handling procedures of the resected stomach cancer, its gross and histologic classifications and descriptive methods of prognostic factors are supplemented with illustrations.