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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2015, Vol. 09 ›› Issue (01) : 30 -34. doi: 10.3877/cma. j. issn.1674-0807.2015.01.007

论著

21 基因检测复发风险评分在早期乳腺癌中的临床分析
王文彦1, 王昕1, 王阳1, 高纪东1, 王靖1, 宣立学1, 方仪1, 王翔1,†()   
  1. 1.100021 北京,中国医学科学院北京协和医学院肿瘤医院乳腺外科
  • 收稿日期:2014-09-15 出版日期:2015-02-01
  • 通信作者: 王翔

Clinical analysis of 21-gene recurrence score assay applied in early-stage breast cancer patients

Wenyan Wang1, Xin Wang1, Yang Wang1, Jidong Gao1, Jing Wang1, Lixue Xuan1, Yi Fang1, Xiang Wang†,1()   

  1. 1.Department of Breast Surgery,Cancer Hospital and Institute,Peking Union Medical College,Chinese Academy of Medical Sciences,Beijing 100021,China
  • Received:2014-09-15 Published:2015-02-01
  • Corresponding author: Xiang Wang
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王文彦, 王昕, 王阳, 高纪东, 王靖, 宣立学, 方仪, 王翔. 21 基因检测复发风险评分在早期乳腺癌中的临床分析[J/OL]. 中华乳腺病杂志(电子版), 2015, 09(01): 30-34.

Wenyan Wang, Xin Wang, Yang Wang, Jidong Gao, Jing Wang, Lixue Xuan, Yi Fang, Xiang Wang. Clinical analysis of 21-gene recurrence score assay applied in early-stage breast cancer patients[J/OL]. Chinese Journal of Breast Disease(Electronic Edition), 2015, 09(01): 30-34.

目的

探讨ER 阳性、淋巴结无转移的早期乳腺癌患者21 基因检测复发风险评分与临床病理特征的相关性。

方法

2011 年12 月至2014年5 月在本院接受21 基因检测复发风险评分共86 例早期乳腺癌患者,回顾性分析其临床病理资料。 根据复发分数分为低复发风险组61 例(70.93%),中/高复发风险组25 例(29.07%,包括中复发风险23 例及高复发风险2 例)。 计数资料比较采用χ2 检验、Fisher 精确概率法及连续性校正χ2检验。 非参数检验采用独立样本Mann-Whitney U 检验。 多因素分析采用Logistic 回归分析。

结果

两组在肿瘤直径、Ki67、PR 表达上差异有统计学意义(χ2=3.167、8.167,P=0.075、0.004,P=0.022)。 差异性检验结果显示以PR、Ki67、p53 蛋白表达情况进行分组时,复发分数分布差异有统计学意义(Z=-2.671、-2.814、-2.168,P=0.004、0.005、0.030)。 多因素分析得出肿瘤直径(P=0.032,OR=3.834,95%CI=1.121 ～13.134)、Ki67(P=0.023,OR=4.598,95%CI=1.231 ～17.170)、p53 蛋白表达情况(P=0.006,OR=5.390,95%CI=1.635 ～17.167)是复发分数的独立影响因素。 19 例患者接受术后辅助化疗(22.1%,19/86),其中低风险组3 例(4.9%,3/61),中/高风险组16 例(60.9%,16/25)。 中位随访15.5 个月,1 例患者出现局部复发,无远处转移或死亡事件。

结论

在早期乳腺癌患者中,21 基因复发风险评分与肿瘤直径、Ki67、p53 等临床病理指标关系密切。

关键词: 乳腺癌, 化疗, 21 基因检测

Objective

To explore the correlation of 21-gene recurrence score assay with the clinicopathological characteristics in early-stage breast cancer patients with ER positive and axillary lymph node negative.

Methods

This study enrolled 81 early breast cancer patients who underwent 21-gene recurrence score assay in our hospital from December 2011 to May 2014,and their clinicopathological data were analyzed.According to their recurrence score,they were classified into low recurrence risk group (61 cases,70.93%) and moderate/high risk group (25 cases,29.07%,including 23 with moderate risk and 2 with high risk). Count data were compared with χ2 test,Fisher’s exact test and continuity correction.The independent sample Mann-Whitney U test was used for nonparametric test.Logistic regression was used for multivariate analysis.

Results

There was a significant difference in the tumor diameter, Ki67, PR expression between two groups(χ2=3.167,8.167;P=0.075,0.004,P=0.022).There was a significant difference in RS distribution in patients groups divided by PR,Ki67 and p53 protein expression(Z=-2.671,-2.814,-2.168;P=0.004,0.005,0.030).Multivariate analysis showed that diameter,Ki67 and p53 protein expression were independent influencing factors for RS(P=0.032,OR=3.834,95%CI=1.121-13.134;P=0.023,OR=4.598,95%CI=1.231-17.170;P=0.006,OR=5.390,95%CI=1.635-17.167).Among all the patients,19 patients(22.1%,19/86)received postoperative adjuvant chemotherapy,including 3 cases (4. 9%,3/61) in low risk group and 16(60.9%,16/25) in moderate/high risk group. The median follow-up time was 15. 5 months. One case had recurrence.No distal metastasis or death was reported.

Conclusion

The 21-gene recurrence score is closely related to the clinicopathological characteristics of the patients with early breast cancer,including tumor diameter,Ki67,p53,etc.

Key words: Breast neoplasms, Chemotherapy, 21-gene assay
表1 乳腺癌患者的临床病理特征与复发分数的多因素分析变量赋值量表
变量 量化赋值
年龄 ＜45岁=0,≥45岁=1
肿瘤直径 ≤2 cm=0,＞2 cm=1
组织学分级 1 级=0,2 级=1,3 级=2
脉管瘤栓 无=0,有=1
PR 阴性=0,阳性=1
Ki67 ≤14%=0,＞14%=1
p53 阴性=0,阳性=1
TOP Ⅱɑ 阴性=0,阳性=1
EGFR 阴性=0,阳性=1
CK5/6 阴性=0,阳性=1
复发风险分组 低风险=0,中、高风险=1
表2 各组乳腺癌患者的不同临床病理特征(例)
组别 例数 年龄 肿瘤直径 病理类型 组织学分级 脉管瘤栓 PR
＜45岁 45～59岁 ≥60岁 ≤2 cm ＞2 cm 浸润性导管癌 浸润性小叶癌 其他类型c 1级 2级 3级 有 无 阴性 阳性
低风险 61 20 34 7 46 15 56 3 2 15 46 0 9 52 0 61
中/高风险 25 9 13 3 14 11 24 0 1 4 19 2 2 23 3 22
检验值 Z=-0.202 χ2=3.167 χ2=1.045 Z=-1.420 χ2=0.246
P值 0.840 0.075 0.800a 0.156 0.620b 0.022a
组别 例数 Ki67 p53 TOPⅡɑ EGFR CK5/6 手术方式
≤14% ＞14% 阴性 阳性 阴性 阳性 阴性 阳性 阴性 阳性 保留乳房+前哨淋巴结活组织检查 单纯切除+前哨淋巴结活组织检查 改良根治术
低风险 61 30 31 37 24 11 50 58 3 55 6 24 15 22
中/高风险 25 4 21 15 10 6 19 21 4 22 3 8 6 11
检验值 χ2=8.167 χ2=0.003 χ2=0.111 χ2=1.619 χ2=0.000 χ2=0.551
P值 0.004 0.995 0.739b 0.203b 1.000b 0.759
表3 乳腺癌患者临床病理特征与复发分数的差异性检验
临床病理特征 例数 M(P25,P75) Z值 P值
年龄
＜45岁 29 15.00(9.00,23.50) -0.352 0.725
≥45岁 57 14.00(10.50,18.00)
肿瘤直径
≤2 cm 60 14.00(10.00,17.75) -1.107 0.268
＞2 cm 26 15.00(10.75,25.25)
组织学分级
1级 19 13.00(10.00,18.00) 5.391 0.068
2级 65 14.00(10.50,19.00)
3级 2 39.00(23.00,55.00)
脉管瘤栓
有 11 15.00(10.00,19.00) -0.136 0.892
无 75 14.00(11.00,17.00)
PR
阴性 3 14.00(10.00,18.00) -2.671 0.004
阳性 83 24.00(10.00,48.25)
Ki67
≤14% 34 12.00(9.00,16.25) -2.814 0.005
＞14% 52 15.00(11.50,22.75)
p53
阴性 52 13.00(10.00,16.00) -2.168 0.030
阳性 34 17.50(10.50,26.25)
TOP IIɑ
阴性 17 14.00(9.50,23.50) -0.163 0.871
阳性 69 14.00(10.00,18.50)
EGFR
阴性 79 14.00(10.00,18.00) -0.380 0.704
阳性 7 11.00(6.00,28.00)
CK5/6
阴性 77 14.00(10.00,18.50) -0.565 0.572
阳性 9 13.00(7.00,20.00)
表4 乳腺癌复发分数的多因素分析结果
影响因素 B值 SE Wald值 P值 OR值 95%CI
肿瘤直径 1.334 0.627 4.587 0.032 3.834 1.121～13.134
Ki67 1.526 0.672 5.150 0.023 4.598 1.231～17.170
p53 1.685 0.609 7.664 0.006 5.390 1.635～17.167
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