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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2022, Vol. 16 ›› Issue (03) : 138 -146. doi: 10.3877/cma.j.issn.1674-0807.2022.03.002

论著

T1~3N0M0期激素受体阳性、人表皮生长因子受体2阴性浸润性乳腺癌复发、转移风险因素分析
郭丽丽1, 侯牛牛2, 肖晶晶1, 王哲1, 王亚萍1, 易军1, 凌瑞1,†()   
  1. 1. 710032　西安，空军军医大学西京医院甲乳血管外科
    2. 210001　南京，中国人民解放军东部战区空军医院普外科
  • 收稿日期:2022-02-18 出版日期:2022-06-01
  • 通信作者: 凌瑞

Risk factors of recurrence and metastasis in patients with hormonal receptor-positive and HER-2-negative T1-3N0M0 invasive breast cancer

Lili Guo1, Niuniu Hou2, Jingjing Xiao1, Zhe Wang1, Yaping Wang1, Jun Yi1, Rui Ling1,†()   

  1. 1. Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Air Force Medical University, Xi’an 710032, China
    2. Department of General Surgery, Air Force Hospital of Eastern Theater Command of PLA, Nanjing 210001, China
  • Received:2022-02-18 Published:2022-06-01
  • Corresponding author: Rui Ling
  • About author:
    Guo Lili and Hou Niuniu are co-first authors
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引用本文：

郭丽丽, 侯牛牛, 肖晶晶, 王哲, 王亚萍, 易军, 凌瑞. T1~3N0M0期激素受体阳性、人表皮生长因子受体2阴性浸润性乳腺癌复发、转移风险因素分析[J]. 中华乳腺病杂志(电子版), 2022, 16(03): 138-146.

Lili Guo, Niuniu Hou, Jingjing Xiao, Zhe Wang, Yaping Wang, Jun Yi, Rui Ling. Risk factors of recurrence and metastasis in patients with hormonal receptor-positive and HER-2-negative T1-3N0M0 invasive breast cancer[J]. Chinese Journal of Breast Disease(Electronic Edition), 2022, 16(03): 138-146.

目的

分析T1~3N0M0期激素受体阳性、人表皮生长因子受体2阴性[HR(+)/HER-2(-)]乳腺癌患者复发、转移风险因素。

方法

回顾性分析2008年1月1日至2017年12月31日在空军军医大学西京医院诊治的1 064例T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者的临床病理资料。运用Kaplan-Meier法进行生存分析，使用Cox比例风险回归模型筛选复发、转移的独立预测因素。绘制受试者操作特征(ROC)曲线并计算ROC曲线下面积(AUC)，检验独立危险因素预测无复发生存的准确度。

结果

本组患者5年、10年无复发生存率分别为93.90% (95%CI: 92.30%~95.40%)和87.10% (95%CI: 84.00%~90.20%)。单因素Cox比例风险回归模型显示：是否接受内分泌治疗、肿瘤最大径及Ki-67水平是复发、转移的影响因素(HR＝5.39, 95%CI: 3.25~8.94, P<0.001；HR＝1.28, 95%CI: 1.11~1.48, P＝0.001；HR＝1.92, 95%CI: 1.24~2.96, P＝0.003)。多因素Cox比例风险回归分析表明：是否接受内分泌治疗、肿瘤最大径及Ki-67水平是患者术后复发、转移的独立预测因素(HR＝4.76, 95%CI: 2.83~8.02, P<0.001；HR＝1.17, 95%CI: 1.01~1.37, P＝0.043；HR＝1.79, 95%CI: 1.16~2.76, P＝0.009);未接受内分泌治疗者术后复发、转移的风险是接受内分泌治疗者的4.76倍；Ki-67水平>20%者术后出现复发、转移的风险是Ki-67水平≤20%者的1.79倍。AUC显示，以上3个变量预测T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者术后无复发生存的准确度较好，3、5、10年AUC分别为0.73 (95%CI: 0.67~0.80, P<0.001)、0.72 (95%CI: 0.66~0.78, P<0.001)和0.68 (95%CI: 0.62~0.75, P<0.001)。

结论

在T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者中，是否接受内分泌治疗、肿瘤最大径和Ki-67水平3个因素联合能够较准确地预测患者术后无复发生存情况，可能会为指导个体化治疗提供一定帮助。

关键词: 乳腺肿瘤, 受体，雌激素, 人类, 受体，表皮生长因子, 复发
Objective

To analyze the risk factors of recurrence and metastasis in female patients with hormone receptor(HR)-positive/HER-2-negative T1-3N0M0 invasive breast cancer.

Methods

The clinicopathological data of 1 064 patients with HR-positive/HER-2-negative T1-3N0M0 invasive breast cancer in the Xijing Hospital of Air Force Medical University from January 1, 2008 to December 31, 2017 were retrospectively analyzed. Kaplan-Meier method was used to make survival analysis. The Cox proportional risk regression model was used to explore independent prognostic factors for recurrence and metastasis. Receiver operating characteristic (ROC) curve was drawn and area under the curve (AUC) was calculated to assess the accuracy of independent factors in predicting the recurrence-free survival.

Results

The 5-year and 10-year recurrence-free survival in these patients were 93.90% (95%CI: 92.30%-95.40%) and 87.10% (95%CI: 84.00%-90.20%), respectively. Univariate Cox proportional risk regression analysis showed that endocrine therapy, maximum diameter of the tumor and Ki-67 expression were affecting factors for recurrence and metastasis (HR=5.39, 95%CI: 3.25-8.94, P<0.001; HR=1.28, 95%CI: 1.11-1.48, P=0.001; HR=1.92, 95%CI: 1.24-2.96, P=0.003). Multivariate Cox proportional risk regression analysis showed that endocrine therapy, maximum diameter of the tumor and Ki-67 expression were independent prognostic factors of recurrence and metastasis (HR=4.76, 95%CI: 2.83-8.02, P<0.001; HR=1.17, 95%CI: 1.01-1.37, P=0.043; HR=1.79, 95%CI: 1.16-2.76, P=0.009). The risk of postoperative recurrence and metastasis in patients who did not receive endocrine therapy was 4.76 times as high as that in patients with endocrine therapy; the risk of postoperative recurrence and metastasis in patients with Ki-67 level >20% was 1.79 times as high as that in patients with Ki-67 level ≤20%. The AUC indicated that the above-mentioned three variables had high accuracy in predicting postoperative recurrence-free survival in HR-positive/HER-2-negative T1-3N0M0 invasive breast cancer. The 3-year, 5-year, and 10-year AUC was 0.73 (95%CI: 0.67-0.80, P<0.001), 0.72 (95%CI: 0.66-0.78, P<0.001), 0.68 (95%CI: 0.62-0.75, P<0.001), respectively.

Conclusion

In patients with HR-positive/ HER-2-negative T1-3N0M0 invasivebreast cancer, the combination of these three factors (endocrine therapy, maximum diameter of the tumor and Ki-67 expression)can predict postoperative recurrence-free survival and provide guidance for individualized treatment.

Key words: Breast neoplasms, Receptors, estrogen, Humans, Receptor, epidermal growth factor, Recurrence
表1 T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者无复生存的Cox比例风险回归分析变量赋值表
因素 变量 赋值
确诊时年龄 X1 ≤40＝0，41~50岁＝1，51~60岁＝2，61~70岁＝3，>70岁＝4
确诊时月经状态 X2 绝经后＝0，绝经前＝1
肿瘤最大径 X4 连续变量
肿瘤位置 X3 左侧＝0，右侧＝1
组织学类型 X5 预后良好型a＝0，IDC/NST＝1，浸润性小叶癌＝2，其他b＝3
组织学分级 X6 1级＝0，2级＝1，3级＝2
雌激素受体状态 X7 阳性＝0,阴性＝1
孕激素受体状态 X8 阳性＝0,阴性＝1
HR状态 X9 ER(+)、PR(+)＝0，ER(+)、PR(-)＝1，ER(-)、PR(+)＝2
Ki-67水平 X10 ≤20%＝0，>20%＝1
脉管癌栓 X11 阴性＝0，阳性＝1
镜下软组织侵犯 X12 阴性＝0，阳性＝1
术中切缘状态 X13 阴性＝0，阳性＝1
手术方式 X14 乳房切除手术＝0，保留乳房手术＝1
内分泌治疗 X15 是＝0，否＝1
化疗 X16 是＝0，否＝1
放射治疗 X17 是＝0，否＝1
生存状态 Y 无复发、转移＝0，复发、转移＝1
表2 T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者的复发、转移情况[例(%)]
临床特征 无复发、转移(n＝982) 复发、转移(n＝82) 检验值 P值
确诊时年龄        
  ≤40岁 160(16.3) 19(23.2) Z＝-0.391 0.696
  41~50岁 406(41.3) 27(32.9)
  51~60岁 229(23.3) 18(22.0)
  61~70岁 133(13.5) 16(19.5)
  >70岁 54(5.5) 2(2.4)
确诊时月经状态        
  绝经后 390(39.7) 36(43.9) χ2＝0.553 0.457
  绝经前 592(60.3) 46(56.1)
肿瘤最大径[cm，M(P25，P75)]        
    1.6(1.2，2.1) 1.9(1.5，2.5) Z＝-2.925 0.003
肿瘤位置        
  左侧 485(49.4) 35(42.7) χ2＝1.362 0.243
  右侧 497(50.6) 47(57.3)
组织学类型        
  预后良好型a 72(7.3) 3(3.7) χ2＝1.617 0.656
  IDC/NST 822(83.7) 72(87.8)
  浸润性小叶癌 37(3.8) 3(3.7)
  其他b 51(5.2) 4(4.9)
组织学分级        
  1级 129(13.1) 8(9.8) Z＝-1.153 0.249
  2级 772(78.6) 65(79.3)
  3级 81(8.2) 9(11.0)
雌激素受体状态        
  阳性 965(98.3) 78(95.1)   0.072c
  阴性 17(1.7) 4(4.9)  
孕激素受体状态        
  阳性 867(88.3) 74(90.2) χ2＝0.283 0.595
  阴性 115(11.7) 8(9.8)
HR状态        
  ER(+)、PR(-) 115(11.7) 8(9.8) χ2＝4.060 0.131
  ER(+)、PR(+) 850(86.6) 70(85.4)
  ER(-)、PR(+) 17(1.7) 4(4.9)
Ki-67水平        
  ≤20% 657(66.9) 43(52.4) χ2＝7.036 0.008
  >20% 325(33.1) 39(47.6)
脉管癌栓        
  阴性 970(98.8) 80(97.6)   0.294c
  阳性 12(1.2) 2(2.4)  
镜下软组织侵犯        
  阴性 946(96.3) 79(96.3)   1.000c
  阳性 36(3.7) 3(3.7)  
术中切缘状态        
  阴性 965(98.3) 80(97.6)   0.653c
  阳性 17(1.7) 2(2.4)  
手术方式        
  乳房切除手术 644(65.6) 58(70.7) χ2＝0.895 0.344
  保留乳房手术 338(34.4) 24(29.3)
内分泌治疗        
  是 937(95.4) 62(75.6) χ2＝51.768 <0.001
  否 45(4.6) 20(24.4)
化疗        
  是 618(62.9) 62(75.6) χ2＝5.273 0.022
  否 364(37.1) 20(24.4)
放射治疗        
  是 296(30.1) 21(25.6) χ2＝0.743 0.389
  否 686(69.9) 61(74.4)
图1 1 064例T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者的无复发生存曲线 注：HR为激素受体；HER-2为人表皮生长因子受体2
表3 T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者无复发生存的单因素Cox比例风险回归分析
因素 HR值 95%CI P值
确诊时年龄      
  ≤40岁 1.00    
  41~50岁 0.59 0.33~1.06 0.080
  51~60岁 0.70 0.37~1.33 0.278
  61~70岁 1.15 0.59~2.24 0.675
  >70岁 0.44 0.10~1.89 0.270
确诊时月经状态      
  绝经后 1.00    
  绝经前 0.79 0.51~1.23 0.296
肿瘤最大径 1.28 1.11~1.48 0.001
肿瘤位置      
  左侧 1.00    
  右侧 1.33 0.86~2.06 0.204
组织学类型      
  预后良好型a 1.00    
  IDC/NST 2.05 0.64~6.50 0.224
  浸润性小叶癌 1.83 0.37~9.05 0.461
  其他b 2.11 0.47~9.43 0.328
组织学分级      
  1级 1.00    
  2级 1.24 0.560~2.59 0.561
  3级 1.60 0.62~4.16 0.331
雌激素受体状态      
  阳性 1.00    
  阴性 2.49 0.91~6.82 0.075
孕激素受体状态      
  阳性 1.00    
  阴性 0.74 0.36~1.54 0.427
HR状态      
  ER(+)、PR(-) 1.00    
  ER(+)、PR(+) 1.30 0.62~2.70 0.482
  ER(-)、PR(+) 3.14 0.95~10.45 0.061
Ki-67水平      
  ≤20% 1.00    
  >20% 1.92 1.24~2.96 0.003
脉管癌栓      
  阴性 1.00    
  阳性 2.35 0.58~9.58 0.232
镜下软组织侵犯      
  阴性 1.00    
  阳性 0.85 0.28~2.77 0.819
术中切缘状态      
  阴性 1.00    
  阳性 2.14 0.52~8.77 0.288
手术方式      
  乳房切除手术 1.00    
  保留乳房手术 0.93 0.58~1.51 0.779
内分泌治疗      
  是 1.00    
  否 5.39 3.25~8.94 <0.001
化疗      
  是 1.00    
  否 0.76 0.46~1.27 0.298
放射治疗      
  是 1.00    
  否 1.16 0.71~1.91 0.555
图2 肿瘤最大径、Ki-67水平及是否接受内分泌治疗3个独立预测因素共同预测T1~3N0M0期HR(+)/HER-2(-)浸润性乳腺癌患者无复发生存的ROC曲线　a、b、c图分别为患者3、5、10年无复发生存的ROC曲线 注：预测患者3、5、10年无复发生存的ROC曲线下面积及其95%CI分别为0.73 (95%CI：0.67~0.80)、0.72 (95%CI: 0.66~0.78)和0.68 (95%CI: 0.62~0.75), P均<0.001；HR为激素受体；HER-2为人表皮生长因子受体2；ROC为受试者操作特征
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