天津医药

天津医药 ›› 2021, Vol. 49 ›› Issue (12): 1319-1323.doi: 10.11958/20210930

• 临床研究 • 上一篇    下一篇

HR+/HER2-乳腺癌患者Ki-67临界值的确定及表达对早期复发转移的影响

马琴 1，厚玉瑾 1，高旭彤 2，刘新兰 1△   

  1. 目的 确定激素受体阳性和人表皮生长因子受体2阴性（HR+/HER2-）乳腺癌患者Ki-67表达高低的临界 值，探讨不同Ki-67表达水平对HR+/HER2-乳腺癌早期复发转移的影响。方法 回顾性分析我院近5年经手术病理 确诊的956例HR+/HER2-乳腺癌患者的病历资料，以中位数作为HR+/HER2-乳腺癌Ki-67表达高低的临界值，分析 Ki-67表达水平对HR+/HER2-乳腺癌早期复发转移的影响。结果 956例HR+/HER2-乳腺癌患者Ki-67表达的中 位数为20%，5年间Ki-67值分布差异无统计学意义（χ2=16.010，P＞0.05）。以20%作为区分Ki-67表达高低的临界 值，与国际通用的Ki-67临界值（14%）相比，2种方法判断一致性较好（Kappa值=0.846）。956例患者经4~71个月的 随访，共56例出现复发或转移。单因素分析发现，Ki-67表达水平、T分期、N分期、组织学分级、脉管/神经侵犯是 HR+/HER2-乳腺癌患者出现早期复发转移的影响因素。多因素分析发现，淋巴结N1~N3分期（HR=2.130，95%CI： 1.200~3.781）、Ki-67≥20%（HR=3.271，95%CI：1.441~7.421）是HR+/HER2-乳腺癌无病生存时间（DFS）的独立危险因 素。进一步将Ki-67≥20%的患者分层为20%~＜30%、30%~＜50%和≥50%共3个亚组。与Ki-67＜20%患者相比， 随着Ki-67表达水平的增高，患者早期复发转移风险比增加（HR分别为2.784、4.409、6.168），5年DFS降低（分别为 94.9%、91.3%、87.5%）。结论 本中心HR+/HER2-乳腺癌Ki-67表达高低的临界值为20%；随着Ki-67表达水平的 增高，患者早期复发转移风险增加，DFS降低。
  • 收稿日期:2021-04-19 修回日期:2021-08-10 出版日期:2021-12-15 发布日期:2021-12-27
  • 通讯作者: △通信作者 E-mail：nxliuxinlan@163.com E-mail:liuxinlan@csco.org.cn
  • 作者简介:马琴（1993），女，硕士，住院医师，主要从事实体肿瘤的治疗方面研究。E-mail：1310115008@qq.com

Determination of the cut-off value of Ki-67 and its effect on the early recurrence and metastasis in patients with HR+/HER2- breast cancer

MA Qin1, HOU Yu-jin1, GAO Xu-tong2, LIU Xin-lan1△   

  1. Objective To determine the cut-off value of Ki-67 expression in hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer patients, and to explore the effect of different Ki-67 expression levels on the early recurrence and metastasis of breast cancer. Methods Data of 956 patients with HR+/HER2- breast cancer diagnosed by operation and pathology in our hospital for recent 5 years were retrospectively analyzed. The median was used to determine the cut-off value of Ki-67 expression in HR+/HER2- breast cancer. The effect of Ki-67 expression on the early recurrence and metastasis of HR+/HER2- breast cancer were analyzed. Results The median expression of Ki-67 in 956 patients with HR+/HER2- breast cancer was 20%. There were no significant differences in the shape and position of Ki- 67 distribution curve between different years (χ2=16.010, P＞0.05). Using 20% as the cut off value for distinguishing the expression of Ki-67, compared with the internationally accepted cut off value of Ki-67 (14%), the consistency of the two methods was better (Kappa value = 0.846). A total of 956 patients were followed up for 4 to 71 months, and 56 patients had recurrence or metastasis. Univariate analysis showed that Ki-67 expression level, T stage, N stage, histological grade and vascular / nerve invasion were the influencing factors for the early recurrence and metastasis in patients with breast cancer. Multivariate analysis showed that lymph node stage N1-N3 (HR=2.130, 95%CI: 1.200-3.781) and Ki-67 ≥20% (HR=3.271, 95%CI: 1.441-7.421) were independent risk factors for disease-free survival (DFS) of HR+/ HER2- breast cancer. The patients with Ki-67 ≥20% will be further divided into 3 subgroup and ≥50%. Compared with <20% patients, the risk ratio of the early recurrence and metastasis increased with the increase of Ki-67 expression level (HR=2.784, 4.409 and 6.168), and 5-year DFS decreased (94.9%, 91.3% and 87.5%). Conclusion The cut-off value of Ki-67 expression in HR+/HER2- breast cancer is 20% in our hospital. With the increase of Ki-67 expression level, the risk ratio of early recurrence and metastasis is increased, DFS is decreased in patients with HR+/ HER2- breast cancer.
  • Received:2021-04-19 Revised:2021-08-10 Published:2021-12-15 Online:2021-12-27
  • Contact: LIU Xinlan E-mail:liuxinlan@csco.org.cn

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摘要： 目的 确定激素受体阳性和人表皮生长因子受体2阴性（HR+/HER2-）乳腺癌患者Ki-67表达高低的临界 值，探讨不同Ki-67表达水平对HR+/HER2-乳腺癌早期复发转移的影响。方法 回顾性分析我院近5年经手术病理 确诊的956例HR+/HER2-乳腺癌患者的病历资料，以中位数作为HR+/HER2-乳腺癌Ki-67表达高低的临界值，分析 Ki-67表达水平对HR+/HER2-乳腺癌早期复发转移的影响。结果 956例HR+/HER2-乳腺癌患者Ki-67表达的中 位数为20%，5年间Ki-67值分布差异无统计学意义（χ2=16.010，P＞0.05）。以20%作为区分Ki-67表达高低的临界 值，与国际通用的Ki-67临界值（14%）相比，2种方法判断一致性较好（Kappa值=0.846）。956例患者经4~71个月的 随访，共56例出现复发或转移。单因素分析发现，Ki-67表达水平、T分期、N分期、组织学分级、脉管/神经侵犯是 HR+/HER2-乳腺癌患者出现早期复发转移的影响因素。多因素分析发现，淋巴结N1~N3分期（HR=2.130，95%CI： 1.200~3.781）、Ki-67≥20%（HR=3.271，95%CI：1.441~7.421）是HR+/HER2-乳腺癌无病生存时间（DFS）的独立危险因 素。进一步将Ki-67≥20%的患者分层为20%~＜30%、30%~＜50%和≥50%共3个亚组。与Ki-67＜20%患者相比， 随着Ki-67表达水平的增高，患者早期复发转移风险比增加（HR分别为2.784、4.409、6.168），5年DFS降低（分别为 94.9%、91.3%、87.5%）。结论 本中心HR+/HER2-乳腺癌Ki-67表达高低的临界值为20%；随着Ki-67表达水平的 增高，患者早期复发转移风险增加，DFS降低。

关键词: 乳腺肿瘤, Ki-67抗原, 实验室临界值, 复发, 肿瘤转移, 受体, 表皮生长因子, 受体, 类固醇

Abstract: Abstract：Objective To determine the Cut-off value of Ki-67 expression in hormone receptor positive and human epidermal growth factor receptor 2 negative（HR+/HER2-） breast cancer, to explore the effect of different Ki-67 expression levels on early recurrence and metastasis of breast cancer. Methods We retrospectively analyzed 956 patients with HR+/HER2- breast cancer diagnosed by operation and pathology in our hospital from January 1, 2015 to December 31, 2019. The median was used to determine the Cut-off value of Ki-67 expression in HR+/HER2- breast cancer. Analysis the effect of Ki-67 expression on early recurrence and metastasis of HR+/HER2- breast cancer. Results The median expression of Ki-67 in 956 patients with HR+/HER2- breast cancer was 20%, There was no significant difference in the shape and position of Ki- 67 distribution curve among different years.20% was used as the cut off value for distinguishing the high and low expression of Ki-67 in our center. Compared with the international cut off value of Ki-67 (14%), the consistency of the two methods was better (Kappa = 0.846).956 patients were followed up for 4 to 71 months, a total of 56 patients had recurrence or metastasis. Univariate analysis showed that Ki-67 expression level, T stage, N stage, histological grade and vascular / nerve invasion were the influencing factors of early recurrence and metastasis in patients with breast cancer. Multivariate analysis showed that N stage (HR=2.130,95%CI:1.200~3.781) and Ki-67 ≥ 20% (HR=3.271,95%CI:1.441~7.421) were independent risk factors for disease-free survival (DFS) of HR+/HER2- breast cancer. The patients with Ki-67 ≥ 20% will be further divided into 3 subgroups: 20% ~ < 30%, 30% ~ < 50% and ≥ 50%. Compared with < 20% patients, with the increase of Ki-67 expression level, the risk ratio of early recurrence and metastasis increased (HR was 2.784, 4.409, 6.168), and 5-year DFS decreased (94.9%, 91.3%, 87.5%). Conclusion The Cut-off value of Ki-67 expression in HR+/HER2- breast cancer is 20% in our hospital. with the increase of Ki-67 expression, the risk ratio of early recurrence and metastasis with HR+/HER2- breast cancer was increased, DFS was decreased.

Key words: breast neoplasms, Ki-67 antigen, laboratory critical values, recurrence, neoplasm metastasis, receptor, epidermal growth factor, receptors, steroid

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