Proliferation determined by Ki-67 immunohistochemistry has been proposed as a useful prognostic and predictive marker in breast cancer. However, the clinical validity of Ki-67 is questionable. In this study, Ki-67 was retrospectively evaluated by three pathologists using two methods: a visual assessment of the entire slide and a quantitative assessment of the tumour margin in 411 early-stage breast cancer patients with a median follow-up of 26.8 years. We found excellent agreement between the three pathologists for both methods. The risk of recurrence for Ki-67 was time-dependent, as the high proliferation group (Ki-67 ≥ 30%) had a higher risk of recurrence initially, but after 4.5 years the risk was higher in the low proliferation group. In estrogen receptor (ER)-positive patients, the intermediate Ki-67 group initially followed the high Ki-67 group, but eventually followed the low Ki-67 group. ER-positive pN0-1 patients with intermediate Ki-67 treated with endocrine therapy alone had a similar outcome to patients treated with chemotherapy. A cut-off value of 20% appeared to be most appropriate for distinguishing between the high and low Ki-67 groups. To summarize, a simple visual whole slide Ki-67 assessment turned out to be a reliable method for clinical decision-making in early breast cancer patients. We confirmed Ki-67 as an important prognostic and predictive biomarker.
Ki-67免疫组化检测所确定的增殖指数已被提出作为乳腺癌有用的预后和预测标志物。然而，Ki-67的临床有效性仍存争议。本研究回顾性评估了411例早期乳腺癌患者的Ki-67表达情况，中位随访时间为26.8年，由三位病理学家采用两种方法进行评估：全切片视觉评估和肿瘤边缘定量评估。我们发现两种方法在三位病理学家间均具有极佳的一致性。Ki-67的复发风险呈时间依赖性，高增殖组（Ki-67 ≥ 30%）初期复发风险较高，但4.5年后低增殖组的复发风险更高。在雌激素受体阳性患者中，中等Ki-67组初期与高Ki-67组趋势相似，但最终与低Ki-67组趋势一致。对于接受单纯内分泌治疗的中等Ki-67表达的ER阳性pN0-1期患者，其预后与接受化疗的患者相似。20%的截断值似乎最适合区分高、低Ki-67组。总之，简单的全切片视觉Ki-67评估被证明是早期乳腺癌患者临床决策的可靠方法。我们证实Ki-67是一个重要的预后和预测生物标志物。
肿瘤(癌症)患者之家