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

doi:10.3877/cma. j. issn.1674-0807.2015.01.007

Abstract

Abstract:

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

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]. Chinese Journal of Breast Disease(Electronic Edition), 2015, 09(01): 30-34.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhrxbzz.cma-cmc.com.cn/EN/10.3877/cma. j. issn.1674-0807.2015.01.007

https://zhrxbzz.cma-cmc.com.cn/EN/Y2015/V09/I01/30

Figures/Tables 4

References 16

[1]	Paik S,Shak S,Tang G,et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer[J].N Engl J Med,2004,351(27): 2817-2826.
[2]	Paik S,Tang G,Shak S,et al. Gene expression and benefit of chemotherapy in women with node-negative,estrogen receptorpositive breast cancer[J].J Clin Oncol,2006,24(23): 3726-3734.
[3]	Paik S.Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen[J].Oncologist,2007,12(6): 631-635.
[4]	Mamounas EP,Tang G,Fisher B,et al.Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative,estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20[J]. J Clin Oncol,2010,28(10): 1677-1683.
[5]	Toi M,Iwata H,Yamanaka T,et al. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population[J].Cancer,2010,116(13): 3112-3118.
[6]	Goldstein LJ,Gray R,Badve S,et al.Prognostic utility of the 21-gene assay in hormone receptor-positive operable breast cancer compared with classical clinicopathologic features[J]. J Clin Oncol,2008,26(25): 4063-4071.
[7]	Williams DJ,Cohen C,Darrow M,et al. Proliferation (Ki-67 and phosphohistone H3) and oncotype DX recurrence score in estrogen receptor-positive breast cancer [ J ]. Appl Immunohistochem Mol Morphol,2011,19(5): 431-436.
[8]	Schneider JG,Khiali D. Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use[J].Breast Cancer Res Treat,2012,134(3): 1125-1132.
[9]	Dowsett M,Cuzick J,Wale C. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study[J].J Clin Oncol,2010,28(11): 1829-1834.
[10]	Albain KS,Barlow WE,Shak S,et al.Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial[J].Lancet Oncol,2010,11(1): 55-65.
[11]	Gianni L,Zambetti M,Clark K,et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer[J].J Clin Oncol,2005,23(29): 7265-7277.
[12]	Chang JC,Makris A,Gutierrez MC.Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients[J]. Breast Cancer Res Treat,2008,108(2): 233-240.
[13]	Tang G,Cuzick J,Costantino JP,et al. Risk of recurrence and chemotherapy benefit for patients with node-negative,estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors[J].J Clin Oncol,2011,29(33): 4365-4372.
[14]	Albanell J, González A, Ruiz-Borrego M, et al. Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer[J]. Ann Oncol,2012,23(3): 625-631.
[15]	Lo SS,Mumby PB,Norton J. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection[J].J Clin Oncol,2010,28(10): 1671-1676.
[16]	Geffen DB,Abu-Ghanem S,Sion-Vardy N,et al. The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy[J].Ann Oncol,2011,22(11): 2381-2386.

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

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

组别	例数	年龄			肿瘤直径		病理类型			组织学分级			脉管瘤栓		PR
组别	例数	＜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		0.800^a			0.156			0.620^b		0.022^a
组别	例数	Ki67		p53		TOPⅡɑ		EGFR		CK5/6		手术方式
组别	例数	≤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		0.739^b		0.203^b		1.000^b		0.759

组别	例数	年龄			肿瘤直径		病理类型			组织学分级			脉管瘤栓		PR
组别	例数	＜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		0.800^a			0.156			0.620^b		0.022^a
组别	例数	Ki67		p53		TOPⅡɑ		EGFR		CK5/6		手术方式
组别	例数	≤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		0.739^b		0.203^b		1.000^b		0.759

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)	-0.352	0.725
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)	-1.107	0.268
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)	-0.136	0.892
PR
阴性	3	14.00(10.00,18.00)	-2.671	0.004
阳性	83	24.00(10.00,48.25)	-2.671	0.004
Ki67
≤14%	34	12.00(9.00,16.25)	-2.814	0.005
＞14%	52	15.00(11.50,22.75)	-2.814	0.005
p53
阴性	52	13.00(10.00,16.00)	-2.168	0.030
阳性	34	17.50(10.50,26.25)	-2.168	0.030
TOP IIɑ
阴性	17	14.00(9.50,23.50)	-0.163	0.871
阳性	69	14.00(10.00,18.50)	-0.163	0.871
EGFR
阴性	79	14.00(10.00,18.00)	-0.380	0.704
阳性	7	11.00(6.00,28.00)	-0.380	0.704
CK5/6
阴性	77	14.00(10.00,18.50)	-0.565	0.572
阳性	9	13.00(7.00,20.00)	-0.565	0.572

Please choose a citation manager

Content to export