Clinical utility study of 21-gene assay in 927 Chinese patients with early breast cancer

Jiayi WU; Yan Fang; Lin Lin; Yu Zong; Xiaosong Chen; Ou Huang; Jianrong HE; Li Zhu; Weiguo Chen; Yafen LI; Kunwei Shen

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Clinical utility study of 21-gene assay in 927 Chinese patients with early breast cancer

VernacularTitle: 927例早期乳腺癌患者中21基因复发风险评分的临床应用
Author: Jiayi WU ¹ ; Yan FANG ¹ ; Lin LIN ² ; Yu ZONG ¹ ; Xiaosong CHEN ¹ ; Ou HUANG ¹ ; Jianrong HE ¹ ; Li ZHU ¹ ; Weiguo CHEN ¹ ; Yafen LI ¹ ; Kunwei SHEN ¹
Author Information

1. Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
2. Department of Clinical Laboratory, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
Publication Type:Clinical Trail
Keywords: Breast neoplasms; 21-gene; Risk Score; Clinicopathological factors
From: Chinese Journal of Oncology 2017;39(9):668-675
CountryChina
Language:Chinese
Abstract: Objective:To investigate the distribution patterns of 21-gene assay and its influencing factors in Chinese patients with early breast cancer.
Methods:Nine hundred and twenty-seven early breast cancer patients were retrospectively recruited from January 2009 to December 2015 at Ruijin Hospital, Shanghai Jiaotong University School of Medicine. The 21-gene reverse transcriptase-polymerase chain reaction(RT-PCR) assay were conducted in paraffin-embedded tumor tissues to calculate the Recurrence Score(RS). Immunohistochemistry(IHC) assay was used to measure the expression levels of estrogen receptor(ER), progesterone receptor(PR) and Ki-67. Concordances of RT-PCR and IHC results were assessed. Correlations of RS and classical clinicopathological factors were evaluated, and logistic regression were applied to determine independent predictive factors for RS.
Results:The median RS of 927 patients was 23(range: 0~90), and the proportions of patients categorized as having a low, intermediate, or high risk were 26.5%, 47.7% and 25.8%, respectively. The distribution of RS varied significantly according to different tumor grade, T stage, PR status, Ki-67 index and molecular subtypes(P<0.05 for all). Grade, PR status and Ki-67 index were independent predictive factors for RS. ER, PR status and Ki-67 index showed significantly correlation between RT-PCR and IHC assays, and the concordance rates for ER and PR status were 98.7% and 87.8%, respectively.
Conclusions:RS significantly correlated with tumor grade, T stage, PR status, Ki-67 index and subtypes. Grade, PR status and Ki-67 index can independently predict RS. Remarkable concordances of ER, PR status and Ki-67 index are found between RT-PCR and IHC assays.