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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front. Med.    2021, Vol. 15 Issue (4) : 621-628    https://doi.org/10.1007/s11684-020-0738-0
RESEARCH ARTICLE
Prognostic value of the 21-gene recurrence score in ER-positive, HER2-negative, node-positive breast cancer was similar in node-negative diseases: a single-center study of 800 patients
Jiayi Wu, Weiqi Gao, Xiaosong Chen, Chunxiao Fei, Lin Lin, Weiguo Chen, Ou Huang, Siji Zhu, Jianrong He, Yafen Li, Li Zhu, Kunwei Shen()
Comprehensive Breast Health Center, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
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Abstract

Multi-gene assays have emerged as crucial tools for risk stratification in early-stage breast cancer. This study aimed to evaluate the prognostic significance of the 21-gene recurrence score (RS) in Chinese patients with pN0-1, estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2) breast cancer. Among 800 patients recruited between 2009 and 2016, the median RS was 24 (0–69), with 27.4%, 46.8%, and 25.9% patients classified into low-, intermediate-, and high-risk groups. Cox regression analysis demonstrated that the high-risk category was associated with significantly higher odds of invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) events compared with the low-risk category (IDFS: HR= 2.450, 95% CI 1.017–5.902, P= 0.046; DDFS: HR= 2.829, 95% CI 1.013–7.901, P= 0.047). No significant association between RS category and overall survival (OS) was found (intermediate vs. low: HR= 1.244, 95% CI 0.292–5.297, P= 0.768; high vs. low: HR= 2.933, 95% CI 0.759–11.327, P= 0.119). RS, as a continuous variable, was a highly significant predictor for IDFS (HR= 1.028, 95% CI 1.010–1.047, P= 0.002), DDFS (HR= 1.030, 95% CI 1.010–1.051, P= 0.003), and OS (HR= 1.034, 95% CI 1.007–1.063, P= 0.014). Our findings suggested that RS may predict IDFS in Chinese patients with ER+/HER2 breast cancer with N0 or N1 disease.

Keywords early breast cancer      21-gene assay      recurrence score      prognosis     
Corresponding Author(s): Kunwei Shen   
Just Accepted Date: 27 September 2020   Online First Date: 07 December 2020    Issue Date: 23 September 2021
 Cite this article:   
Jiayi Wu,Weiqi Gao,Xiaosong Chen, et al. Prognostic value of the 21-gene recurrence score in ER-positive, HER2-negative, node-positive breast cancer was similar in node-negative diseases: a single-center study of 800 patients[J]. Front. Med., 2021, 15(4): 621-628.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-020-0738-0
https://academic.hep.com.cn/fmd/EN/Y2021/V15/I4/621
Pathologic type n %
Invasive ductal carcinoma 707 88.3
Mucinous carcinoma 43 5.4
Invasive lobular carcinoma 32 4.0
Invasive papillary carcinoma 7 0.9
Invasive micropapillary carcinoma 5 0.6
Neuroendocrine carcinoma 3 0.4
Tubular carcinoma 2 0.3
Medullary carcinoma 1 0.1
Total 800 100
Tab.1  Pathology of 800 eligible patients
Characteristics RS category, n (%) P
Low risk
(RS<18)
Intermediate risk
(RS 18−30)
High risk
(RS≥31)
Age 0.569
≤55 99 (25.6) 184 (47.7) 103 (26.7)
>55 120 (29.0) 190 (45.9) 104 (25.1)
Surgery 0.206
Mastectomy 140 (29.7) 216 (45.8) 116 (24.6)
BCS 79 (24.1) 158 (48.2) 91 (27.7)
Pathology 0.621
IDC 190 (26.9) 331 (46.8) 186 (26.3)
Others 29 (31.2) 43 (46.2) 21 (22.6)
Grade <0.001
I 54 (43.2) 60 (48.0) 11 (8.8)
II 113 (28.0) 203 (50.4) 87 (21.6)
III 25 (13.8) 71 (39.2) 85 (47.0)
Unknown 27 (29.7) 40 (44.0) 24 (26.4)
pT stage 0.015
T1 164 (29.9) 257 (46.8) 128 (23.3)
T2–3 55 (21.9) 117 (46.6) 79 (31.5)
pN stage 0.308
N0 198 (28.2) 322 (45.9) 182 (25.9)
N1 21 (21.4) 52 (53.1) 25 (25.5)
PR <0.001
Positive 205 (30.5) 318 (47.3) 150 (22.3)
Negative 14 (11.0) 56 (44.1) 57 (44.9)
Ki67 <0.001
<14% 155 (33.2) 231 (49.5) 81 (17.3)
14% 64 (19.2) 143 (42.9) 126 (37.8)
Subtype <0.001
Luminal A-like 129 (41.7) 144 (46.6) 36 (11.7)
Luminal B-like 90 (18.3) 230 (46.8) 171 (34.8)
Tab.2  Distribution of RS according to clinico-pathological factors
Characteristics IDFS DDFS OS
Survival rate (%) P Survival rate (%) P Survival rate (%) P
Age 0.877 0.991 0.048
?≤55 93.0 94.8 98.4
?>55 95.6 96.6 96.3
Surgery 0.857 0.782 0.234
?Mastectomy 94.0 95.3 96.6
?BCS 94.5 96.4 99.1
Pathology 0.887 0.483 0.472
?IDC 93.9 95.6 97.4
?Others 96.2 96.2 97.7
Grade 0.346 0.104 0.087
?I 98.4 99.2 100
?II 93.6 96.1 98.2
?III 92.1 92.7 94.5
?Unknown 95.0 95.0 96.6
pT stage 0.001 0.003 0.073
?T1 96.3 97.1 98.5
?T2–3 89.6 92.4 95.1
pN stage 0.367 0.271 0.952
?N0 94.1 95.5 97.5
?N1 94.5 97.7 96.9
PR 0.111 0.310 0.929
?Positive 94.8 96.1 97.6
?Negative 91.2 93.6 97.0
Ki67 0.008 0.032 0.148
?<14% 96.4 97.2 98.7
?≥14% 90.8 93.3 95.6
Subtype 0.017 0.077 0.756
?Luminal A-like 97.7 98.1 98.0
?Luminal B-like 91.8 94.0 97.1
RS category 0.002 0.012 0.093
?Low 97.3 98.6 98.7
?Intermediate 95.5 96.1 98.6
?High 89.5 92.6 95.3
Tab.3  Univariate prognostic analysis of 4-year IDFS, DDFS, and OS rates
Fig.1  Kaplan–Meier analysis of IDFS according to RS categories.
Characteristics IDFS DDFS OS
HR 95% CI P HR 95% CI P HR 95% CI P
pT stage
?T2–3 vs. T1 2.162 1.207–3.874 0.010 2.117 1.105–4.053 0.024 1.946 0.773–4.900 0.157
Subtype
?Luminal B-like vs. ??Luminal A-like 1.539 0.754–3.141 0.237 1.294 0.603–2.778 0.508 0.764 0.282–2.071 0.597
RS category
?Intermediate vs. low 1.285 0.518–3.189 0.589 1.696 0.597–4.815 0.321 1.244 0.292–5.297 0.768
?High vs. low 2.450 1.017–5.902 0.046 2.829 1.013–7.901 0.047 2.933 0.759–11.327 0.119
Tab.4  Multivariate prognostic analysis of IDFS, DDFS, and OS
Fig.2  Kaplan–Meier analysis of DDFS according to RS categories.
Fig.3  Kaplan–Meier analysis of OS according to RS categories.
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