Department of Pathology, Michigan Medicine, Ann Arbor.
Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor.
Am J Clin Pathol. 2019 Nov 4;152(6):766-774. doi: 10.1093/ajcp/aqz105.
Current College of American Pathologists/American Society of Clinical Oncology guidelines recommend cold ischemic time (CIT) of 1 hour or less for breast specimens to preserve biomarker expression, although some publications support an acceptable CIT of 4 hours or less. We retrospectively evaluated changes in estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) from biopsy to resection specimens that were triaged to optimize CIT.
We identified breast resection specimens collected after institutional implementation of a triage protocol. Clinicopathologic features were assessed.
In total, 295 excisions had a prior malignant diagnosis, with CIT of 4 hours or less and repeat ER, PR, and/or HER2; 230 (78%) had CIT of 1 hour or less, and 65 (22%) had CIT of more than 1 hour but 4 hours or less. Categorical change was seen in 10 (17.9%) of 56 with repeated ER/PR and 38 (13.3%) of 285 with repeated HER2 (of which five [1.8%] had meaningful change).
When CIT is optimized, a meaningful change in biomarker expression is infrequent. This study supports that when specimens are appropriately triaged, CIT of 4 hours or less may be acceptable.
目前，美国病理学家学会/美国临床肿瘤学会的指南建议，为了保持生物标志物的表达，乳房标本的冷缺血时间（CIT）应在 1 小时或更短时间内，尽管一些出版物支持 CIT 可接受的时间为 4 小时或更短。我们回顾性评估了经过优先处理方案的活检和切除标本中雌激素受体（ER）、孕激素受体（PR）和人表皮生长因子受体 2（HER2）的变化，以优化 CIT。
我们确定了在机构实施分诊方案后收集的乳房切除标本。评估了临床病理特征。
总共 295 例切除标本均有恶性诊断，CIT 为 4 小时或更短，且重复进行 ER、PR 和/或 HER2 检测；230 例（78%）的 CIT 为 1 小时或更短，65 例（22%）的 CIT 超过 1 小时但不超过 4 小时。在 56 例重复 ER/PR 的患者中，有 10 例（17.9%）出现了分类变化，在 285 例重复 HER2 的患者中，有 38 例（13.3%）出现了变化（其中 5 例[1.8%]出现了有意义的变化）。
当 CIT 得到优化时，生物标志物表达的显著变化并不常见。本研究支持在适当进行标本分类时，CIT 可接受的时间为 4 小时或更短。
