Miller R T, Hapke M R, Greene G L
Department of Pathology, Clarkson Hospital, Omaha, Nebraska 68105.
Cancer. 1993 Jun 1;71(11):3541-6. doi: 10.1002/1097-0142(19930601)71:11<3541::aid-cncr2820711113>3.0.co;2-x.
Estrogen receptor (ER) immunocytochemical assay (ICA) can be a useful procedure in patients with breast cancer. The authors sought to study the utility of monoclonal antibody D75P3 gamma (D75) in paraffin-embedded sections of breast cancers.
Sixty-seven cases of breast cancer were studied by ICA for ER using monoclonal antibody D75 in routinely processed formaldehyde-fixed paraffin-embedded tissue, employing ficin predigestion of sections before application of D75. The results were tabulated using a modified histochemical score (HS). In 59 cases, frozen sections of tumors were also studied with D75. In 40 cases, paraffin-embedded sections were stained with both D75 and monoclonal antibody H222 (which is commercially available). Quantitative biochemical ER assays were performed by the standard dextran-coated charcoal method.
Statistical analysis of the data showed a highly significant correlation (P < 0.0001) between biochemical ER and paraffin-embedded section HS using D75. The results of frozen section assay and paraffin-embedded section assay using D75 were also highly correlated (P < 0.0001). In addition, paraffin-embedded section HS using D75 correlated well with paraffin-embedded section HS using H222 (P < 0.0001). However, D75 HS generally were higher than H222 HS because of the more intense staining with D75, and this difference was statistically significant (P < 0.0001). Assuming that the biochemical ER data were "true," paraffin-embedded section ICA with D75 had a diagnostic sensitivity of 100%, a diagnostic specificity of 70%, a positive predictive value of 89%, and a negative predictive value of 100%. The results of biochemical ER status and paraffin-embedded section D75 ICA ER status agreed in 61 of 67 cases (91%). In all six cases where the ER status differed, the biochemical ER status was negative, and the ER status by ICA with D75 was positive, leading the authors to suspect that some of these cases may have been biochemical false-negative findings.
It was concluded that ICA for ER with D75 using a 2-minute ficin predigestion of formaldehyde-fixed paraffin-embedded tissue is an acceptable alternative to frozen section ICA. In addition, paraffin-embedded section ICA with D75 is easier to interpret than frozen section ICA, and the results are superior to ICA with H222 on paraffin-embedded sections.
雌激素受体（ER）免疫细胞化学检测（ICA）对于乳腺癌患者可能是一种有用的方法。作者旨在研究单克隆抗体D75P3γ（D75）在乳腺癌石蜡包埋切片中的应用价值。
采用ficin对甲醛固定石蜡包埋组织切片进行预消化后，使用单克隆抗体D75对67例乳腺癌患者进行ER的ICA检测，切片在常规处理的甲醛固定石蜡包埋组织中进行检测。结果采用改良组织化学评分（HS）进行列表分析。在59例患者中，还使用D75对肿瘤冰冻切片进行了研究。在40例患者中，石蜡包埋切片同时用D75和单克隆抗体H222（市售）进行染色。通过标准葡聚糖包被活性炭法进行定量生化ER检测。
数据统计分析显示，生化ER与使用D75的石蜡包埋切片HS之间存在高度显著相关性（P < 0.0001）。使用D75的冰冻切片检测结果与石蜡包埋切片检测结果也高度相关（P < 0.0001）。此外，使用D75的石蜡包埋切片HS与使用H222的石蜡包埋切片HS相关性良好（P < 0.0001）。然而，由于D75染色更强，D75的HS通常高于H222的HS，且这种差异具有统计学意义（P < 0.0001）。假设生化ER数据是“真实的”，使用D75的石蜡包埋切片ICA诊断敏感性为100%，诊断特异性为70%，阳性预测值为89%，阴性预测值为100%。67例中有61例（91%）生化ER状态与石蜡包埋切片D75 ICA ER状态一致。在所有6例ER状态不同的病例中，生化ER状态为阴性，而使用D75的ICA ER状态为阳性，这使得作者怀疑其中一些病例可能是生化假阴性结果。
得出结论，使用ficin对甲醛固定石蜡包埋组织进行2分钟预消化后用D75进行ER的ICA检测是冰冻切片ICA的一种可接受的替代方法。此外，使用D75的石蜡包埋切片ICA比冰冻切片ICA更易于解读，且结果优于石蜡包埋切片上使用H222的ICA检测。
