Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mod Pathol. 2013 Jan;26(1):71-8. doi: 10.1038/modpathol.2012.135. Epub 2012 Aug 17.
To facilitate accurate detection of estrogen receptor (ER) expression in breast tumors, the American Society of Clinical Oncology/College of American Pathologists recommends that cold ischemia time be kept under 1 h. However, data to address the upper threshold of cold ischemia time are limited. Although it is our routine practice to keep cold ischemia time under 1 h for breast core biopsy specimens, this is difficult for surgical specimens because of the comprehensive intraoperative assessment performed at our institution. In this retrospective study, we compared ER immunohistochemical staining results in paired breast tumor core biopsy specimens and resection specimens with cold ischemia times ranging from 64 to 357 min in 97 patients. The staining category (≥10%, positive; 1-9%, low positive; <1%, negative) between the core biopsy and resection specimens changed for five patients (5%). The weighted Kappa statistic for ER staining category between the two specimen types was 0.86 (95% confidence interval, 0.74-0.99), indicating good concordance. The difference in the percentage of ER staining between core biopsy and resection was not significantly associated with cold ischemia time (P=0.81, Spearman correlation). Although we did not observe significant associations between the difference in ER staining in the two specimen types and cold ischemia time after placing the patients in three groups of 'increase', 'decrease' and 'no change' using a difference of 25% in ER staining percentage as the cutoff, a trend of decreased ER staining with cold ischemia time >2 h was detected. No statistically significant association was found between the change of ER staining and the history of neoadjuvant chemotherapy. Our findings indicate that prolonged cold ischemia time up to 4 h (97% of our cohort) in the practice setting of our institution has minimal clinical impact on ER immunohistochemical expression in breast tumors.
为了准确检测乳腺癌中的雌激素受体 (ER) 表达，美国临床肿瘤学会/美国病理学家学院建议将冷缺血时间保持在 1 小时以内。然而，关于冷缺血时间上限的数据有限。虽然我们的常规做法是将乳腺癌核心活检标本的冷缺血时间保持在 1 小时以内，但由于我们机构进行的全面术中评估，对于手术标本来说这很难做到。在这项回顾性研究中，我们比较了 97 名患者的配对乳腺癌肿瘤核心活检标本和切除标本的 ER 免疫组织化学染色结果，这些标本的冷缺血时间范围为 64 至 357 分钟。5 名患者（5%）的核心活检和切除标本之间的染色类别（≥10%，阳性；1-9%，低阳性；<1%，阴性）发生变化。两种标本类型之间 ER 染色类别的加权 Kappa 统计量为 0.86（95%置信区间，0.74-0.99），表明具有良好的一致性。核心活检和切除标本之间 ER 染色百分比的差异与冷缺血时间无显著相关性（P=0.81，Spearman 相关）。尽管我们没有观察到两种标本类型之间 ER 染色差异与冷缺血时间之间存在显著关联，将患者分为“增加”、“减少”和“无变化”三组后，使用 ER 染色百分比差异 25%作为截止值，随着冷缺血时间超过 2 小时，ER 染色呈下降趋势。ER 染色变化与新辅助化疗史之间也未发现统计学显著关联。我们的研究结果表明，在我们机构的实践设置中，冷缺血时间延长至 4 小时（我们队列的 97%）对乳腺癌肿瘤中 ER 免疫组织化学表达的临床影响最小。
