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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2021, Vol. 15 ›› Issue (03) : 143 -151. doi: 10.3877/cma.j.issn.1674-0807.2021.03.003

论著

乳腺癌患者保留乳房手术后复发、转移危险因素分析
陈彦博1, 胡婷婷1, 陈凯1, 苏逢锡1,†()   
  1. 1. 510000　广州，中山大学孙逸仙纪念医院乳腺肿瘤中心
  • 收稿日期:2019-12-29 出版日期:2021-07-01
  • 通信作者: 苏逢锡
  • 基金资助:
    国家自然科学基金项目(81672619); 广东省医学科研基金项目(A2021280); 中山大学孙逸仙纪念医院临床研究培育项目(SYS-Q-202105)

Risk factors of breast cancer recurrence and metastasis after breast conserving surgery

Yanbo Chen1, Tingting Hu1, Kai Chen1, Fengxi Su1,†()   

  1. 1. Breast Tumor Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510000, China
  • Received:2019-12-29 Published:2021-07-01
  • Corresponding author: Fengxi Su
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引用本文：

陈彦博, 胡婷婷, 陈凯, 苏逢锡. 乳腺癌患者保留乳房手术后复发、转移危险因素分析[J/OL]. 中华乳腺病杂志(电子版), 2021, 15(03): 143-151.

Yanbo Chen, Tingting Hu, Kai Chen, Fengxi Su. Risk factors of breast cancer recurrence and metastasis after breast conserving surgery[J/OL]. Chinese Journal of Breast Disease(Electronic Edition), 2021, 15(03): 143-151.

目的

探讨乳腺癌患者行保留乳房(简称保乳)手术后复发和转移的危险因素。

方法

本研究为回顾性队列研究。依据纳入、排除标准，选取2000年1月至2018年12月在中山大学孙逸仙纪念医院行保乳手术的2 167例乳腺癌患者的临床及病理资料进行分析。采用Kaplan-Meier法分析患者的无复发生存和无远处转移生存情况，用Cox比例风险回归模型研究患者保乳术后复发和远处转移的危险因素。

结果

2 167例保乳患者中，新辅助化疗者320例，辅助化疗者1 847例；中位随访时间60个月，复发105例，远处转移137例。患者5年无复发生存率和无远处转移生存率分别为95%和93%，10年无复发生存率和无远处转移生存率分别为91%和89%。新辅助化疗患者5年和10年无复发生存率分别为91%和85%，辅助化疗患者5年和10年无复发生存率分别为95%和92%。新辅助化疗患者5年和10年无转移生存率分别为88%和74%，辅助化疗患者5年和10年无转移生存率分别为94%和91%。影响患者术后复发的因素包括淋巴结病理分期(pN)和ER状态(pN3期比pN0期：HR＝4.773，95%CI：1.614～14.116，P＝0.005；ER阴性组比ER阳性组：HR＝2.302，95%CI：1.095～4.841，P＝0.028)。影响患者远处转移的因素有淋巴结临床分期(cN)和pN(cN1期比cN0期：HR＝1.799，95%CI：1.154～2.805，P＝0.010；pN2、pN3期分别比pN0期：HR＝2.304，95%CI：1.148～4.624，P＝0.019; HR＝8.156，95%CI：4.433～15.007，P<0.001)。

结论

淋巴结病理阳性和ER阴性的乳腺癌保乳术后患者，其复发率更高；淋巴结临床阳性、病理阳性的乳腺癌保乳术后患者更容易发生远处转移。

关键词: 乳腺肿瘤, 复发, 肿瘤转移, 危险因素, 保留乳房手术
Objective

To investigate the risk factors of recurrence and metastasis in breast cancer patients after breast conserving surgery.

Methods

This was a retrospective cohort study. According to inclusion and exclusion criteria, clinical and pathological data of 2 167 breast cancer patients who underwent breast conserving surgery in the Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University from January 2000 to December 2018 were analyzed. The Kaplan-Meier method was used to analyze recurrence-free survival and distant metastasis-free survival. Cox proportional risk regression models were used to study the risk factors of recurrence and metastasis after breast conserving surgery.

Results

Among 2 167 patients receiving breast conserving surgery, there were 320 patients with neoadjuvant chemotherapy and 1 847 patients with adjuvant chemotherapy. During the follow-up of median 60 months, there were 105 cases of recurrence and 137 cases of distant metastasis. In all patients, the 5-year recurrence-free survival and distant metastasis-free survival were 95% and 93%, respectively and the 10-year recurrence-free survival and distant metastasis-free survival were 91% and 89%, respectively. The 5-year and 10-year recurrence-free survival was 91% and 85% in patients with neoadjuvant chemotherapy, 95% and 92% in patients with adjuvant chemotherapy. The 5-year and 10-year metastasis-free survival of was 88% and 74% in patients with neoadjuvant chemotherapy, 94% and 91% in patients with adjuvant chemotherapy. The factors affecting postoperative recurrence included pathological stage of lymph nodes (pN) (pN3 vs pN0, HR=4.773, 95%CI: 1.614-14.116, P=0.005) and ER status (ER-negative vs ER-positive, HR=2.302, 95%CI: 1.095-4.841, P=0.028). Factors affecting distant metastasis included clinical stage of lymph nodes (cN) (cN1 vs cN0: HR=1.799, 95%CI: 1.154-2.805, P=0.010) and pathological stage of lymph nodes (pN2 vs pN0: HR=2.304, 95%CI: 1.148-4.624, P=0.019; pN3 vs pN0: HR=8.156, 95%CI: 4.433-15.007, P<0.001).

Conclusions

The breast cancer patients with pathologically positive lymph nodes and ER negative after breast conserving surgery show a higher recurrence rate. Patients with clinically positive and pathologically positive lymph nodes are more likely to have distant metastasis after breast conserving surgery.

Key words: Breast neoplasms, Recurrence, Neoplasm metastasis, Risk factors, Breast conserving surgery
图1 改良的乳腺癌保留乳房手术后残腔边缘评估法示意图[10]
表1 乳腺癌患者复发、转移影响因素的Cox比例风险回归模型变量赋值表
临床因素 变量类型 变量分类及赋值
年龄 X1 <35岁＝0，35～50岁＝1，>50岁＝2
乳腺癌家族史 X2 无＝0，有＝1
月经状况 X3 已停经＝0，未停经＝1
生育情况 X4 已生育＝0，未生育＝1
体质指数 X5 <18.5 kg/m2＝0，18.5～23.9 kg/m2＝1，24.0～27.0 kg/m2＝2，>27.0 kg/m2＝3
肿瘤临床分期(cT) X6 cT1＝0，cT2＝1，cT3＝2
淋巴结临床分期(cN) X7 cN0＝0，cN1＝1
术中是否再切 X8 未再切＝0，再切＝1
肿瘤病理分期(pT) X9 pT0＝0，pT1＝1，pT2＝2，pT3＝3
淋巴结病理分期(pN) X10 pN0＝0，pN1＝1，pN2＝2，pN3＝3
ER状态 X11 ER阳性＝0，ER阴性＝1
PR状态 X12 PR阳性＝0，PR阴性＝1
HER-2状态 X13 HER-2阳性＝0，HER-2阴性＝1
Ki-67 X14 <15%＝0，15%～50%＝1，>50%＝2
组织学分级 X15 1级＝0，2级＝1，3级＝2
化疗类型 X16 辅助化疗＝0，新辅助化疗＝1
无复发生存 Y1 无复发＝0，有复发＝1
无远处转移生存 Y2 无远处转移＝0，有远处转移＝1
表2 2 167例乳腺癌保留乳房手术患者临床资料[例(%)]
临床资料 新辅助化疗(n＝320) 辅助化疗(n＝1 847) 检验值 P值 临床资料 新辅助化疗(n＝320) 辅助化疗(n＝1 847) 检验值 P值
年龄         淋巴结病理分期(pN)        
  <35岁 58(18.1) 188(10.2) Z＝7.081 <0.001   pN0 168(52.5) 1 258(68.1) Z＝-6.053 <0.001
  35～50岁 175(54.7) 973(52.7)   pN1 99(30.9) 424(23.0)
  >50岁 87(27.2) 686(37.1)   pN2 36(11.2) 100(5.4)
乳腺癌家族史           pN3 15(4.7) 45(2.4)
  无 310(96.9) 1 767(95.7) χ2＝0.880 0.348   pNx 2(0.6) 20(1.1)
  有 8(2.5) 65(3.5) ER状态        
  不详 2(0.6) 15(0.8)   阳性 192(60.0) 708(38.3) χ2＝1.031 0.310
月经状况           阴性 98(30.6) 416(22.5)
  已停经 60(18.8) 530(28.7) χ2＝14.302 <0.001   不详 30(9.4) 723(39.1)
  未停经 242(75.6) 1 204(65.2) PR状态        
  不详 18(5.6) 113(6.1)   阳性 178(55.6) 766(41.5) χ2＝26.163 <0.001
生育情况           阴性 132(41.2) 288(15.6)
  已生育 281(87.8) 1 692(91.6) χ2＝10.661 0.001   不详 10(3.1) 793(42.9)
  未生育 31(9.7) 93(5.0) HER-2状态        
  不详 8(2.5) 62(3.4)   阳性 101(31.6) 404(21.9) χ2＝20.100 <0.001
体质指数           阴性 164(51.2) 1 215(65.8)
  <18.5 kg/m2 14(4.4) 93(5.0) Z＝-0.672 0.725   不详 55(17.2) 228(12.3)
  18.5～23.9 kg/m2 185(57.8) 982(53.2) Ki-67        
  24.0～27.0 kg/m2 54(16.9) 363(19.7)   <15% 129(40.3) 488(26.4) Z＝-7.784 <0.001
  >27.0 kg/m2 31(9.7) 154(8.3)   15%～50% 72(22.5) 799(43.3)
  不详 36(11.2) 255(13.8)   >50% 40(12.5) 310(16.8)
肿瘤临床分期(cT)           不详 79(24.7) 250(13.5)
  cT1 57(17.8) 861(46.6)     组织学分级        
  cT2 215(67.2) 754(40.8) Z＝16.102 <0.001   1级 8(2.5) 93(5.0) Z＝-5.103 0.007
  cT3 35(10.9) 15(0.8)       2级 90(28.1) 638(34.5)
  cTx 13(4.1) 217(11.7)       3级 51(15.9) 670(36.3)
淋巴结临床分期(cN)           不详 171(53.4) 446(24.1)
  cN0 184(57.5) 1 579(85.5) Z＝14.524 <0.001 是否复发        
  cN1 130(40.6) 234(12.7)   是 25(7.8) 80(4.3) χ2＝7.169 0.007
  cNx 6(1.9) 34(1.8)   否 295(92.2) 1 767(95.7)
肿瘤病理分期(pT)         是否远处转移        
  pT0 36(11.2) 6(0.3) Z＝-8.912 <0.001   是 39(12.2) 98(5.3) χ2＝21.809 <0.001
  pT1 167(52.2) 947(51.3)   否 281(87.8) 1 749(94.7)
  pT2 67(20.9) 465(25.2)            
  pT3 1(0.3) 12(0.6)            
  pTx 49(15.3) 417(22.6)            
图2 乳腺癌患者行保留乳房手术后的生存曲线　a、b图分别所示全部患者的无复发生存和无转移生存曲线；c、d图分别所示新辅助化疗与辅助化疗患者的无复发和无远处转移生存曲线
表3 乳腺癌患者保留乳房手术后复发的单因素Cox比例风险回归模型分析(n＝2 167)
临床因素 HR值 95%CI P值 临床因素 HR值 95%CI P值
年龄       肿瘤病理分期(pT)      
  <35岁 1.000       pT0 1.000    
  35～50岁 0.453 0.274～0.748 0.002   pT1 0.278 0.110～0.703 0.007
  >50岁 0.455 0.266～0.781 0.004   pT2 0.596 0.234～1.520 0.279
乳腺癌家族史         pT3 <0.001 - 0.953
  无 1.000     淋巴结病理分期(pN)      
  有 0.896 0.330～2.433 0.830   pN0 1.000    
月经状况         pN1 1.126 0.715～1.772 0.610
  已停经 1.000       pN2 0.967 0.419～2.230 0.936
  未停经 1.211 0.769～1.939 0.398   pN3 2.713 1.175～6.264 0.019
生育情况       ER状态      
  已生育 1.000       阳性 1.000    
  未生育 1.653 0.861～3.175 0.131   阴性 1.731 1.011～2.962 0.045
体质指数       PR状态      
  <18.5 kg/m2 1.000       阳性 1.000    
  18.5～23.9 kg/m2 0.511 0.260～1.005 0.052   阴性 1.492 0.947～2.353 0.085
  24.0～27.0 kg/m2 0.403 0.181～0.896 0.026 HER-2状态      
  >27.0 kg/m2 0.405 0.154～1.065 0.067   阳性 1.000    
肿瘤临床分期(cT)         阴性 1.344 0.859～2.104 0.195
  cT1 1.000     Ki-67      
  cT2 1.203 0.801～1.805 0.373   <15% 1.000    
  cT3 1.079 0.262～4.446 0.916   15%～50% 1.870 1.078～3.244 0.026
淋巴结临床分期(cN)         >50% 1.833 0.934～3.598 0.078
  cN0 1.000     组织学分级      
  cN1 1.798 1.170～2.761 0.007   1级 1.000    
术中是否再切         2级 1.072 0.411～2.797 0.888
  否 1.000       3级 1.542 0.597～3.983 0.371
  是 0.668 0.433～1.031 0.069 化疗类型      
            新辅助 1.000    
            辅助 0.506 0.322～0.793 0.003
表4 乳腺癌患者保留乳房手术后复发的多因素Cox比例风险回归模型分析(n＝2 167)
临床因素 HR值 95%CI P值
淋巴结病理分期(pN)      
  pN0 1.000    
  pN1 1.034 0.428～2.497 0.941
  pN2 <0.001 - 0.975
  pN3 4.773 1.614～14.116 0.005
ER状态      
  阳性 1.000    
  阴性 2.302 1.095～4.841 0.028
表5 乳腺癌患者保留乳房手术后远处转移的单因素Cox比例风险回归模型分析(n＝2 167)
临床因素 HR值 95%CI P值 临床因素 HR值 95%CI P值
年龄       肿瘤病理分期(pT)      
  <35岁 1.000       pT0 1.000    
  35～50岁 0.538 0.339～0.853 0.008   pT1 0.529 0.192～1.455 0.217
  >50岁 0.583 0.359～0.948 0.030   pT2 0.842 0.301～2.353 0.743
乳腺癌家族史         pT3 <0.001 - 0.947
  无 1.000     淋巴结病理分期( pN)      
  有 0.645 0.205～2.024 0.452   pN0 1.000    
月经状况         pN1 1.698 1.138～2.525 0.010
  已停经 1.000       pN2 2.798 1.641～4.773 <0.001
  未停经 1.201 0.808～1.784 0.365   pN3 9.222 5.392～15.773 <0.001
生育情况       ER状态      
  已生育 1.000       阳性 1.000    
  未生育 1.249 0.655～2.381 0.499   阴性 1.053 0.678～1.634 0.818
体质指数       PR状态      
  <18.5 kg/m2 1.000       阳性 1.000    
  18.5～23.9 kg/m2 2.069 0.650～6.587 0.219   阴性 1.207 0.808～1.803 0.358
  24.0～27.0 kg/m2 2.362 0.713～7.825 0.159 HER-2状态      
  >27.0 kg/m2 2.626 0.748～9.217 0.132   阳性 1.000    
肿瘤临床分期(cT)         阴性 1.086 0.718～1.643 0.695
  cT1 1.000     Ki-67      
  cT2 1.583 1.106～2.265 0.012   <15% 1.000    
  cT3 1.859 0.672～5.141 0.232   15～50% 1.350 0.842～1.163 0.213
淋巴结临床分期(cN)         >50% 2.030 1.183～3.481 0.010
  cN0 1.000     组织学分级      
  cN1 2.518 1.765～3.591 <0.001   1级 1.000    
术中是否再切         2级 2.115 0.758～5.905 0.153
  否 1.000       3级 2.638 0.947～7.350 0.063
  是 1.193 0.839～1.698 0.325 化疗类型      
            新辅助 1.000    
            辅助 0.397 0.274～0.575 <0.001
表6 乳腺癌患者保留乳房手术后远处转移的多因素Cox比例风险回归模型分析(n＝2 167)
临床因素 HR值 95%CI P值
淋巴结临床分期(cN)      
  cN0 1.000    
  cN1 1.799 1.154～2.805 0.010
淋巴结病理分期(pN)      
  pN0 1.000    
  pN1 1.484 0.905～2.433 0.118
  pN2 2.304 1.148～4.624 0.019
  pN3 8.156 4.433～15.007 <0.001
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