Clinical Analysis Of Recurrence Risk Evaluation Of 28-Gene Test In Patients With Early-Stage Breast Cancer

Objective: Due to the individual differences in breast cancer patients,there are differences in efficacy even when patients have the same disease phenotype and the same treatment.The adjuvant treatment decision for early-stage breast cancer(EBC)patients with Hormone Receptor(HR)positive and Human Epidermal Growth Factor Receptor 2(HER-2)negative also has a significant impact on their prognosis and life quality.The 28-gene test has been developed and applied to evaluate the local recurrence risk(RI-LR)and the distant recurrence risk(RI-DR)in the EBC patients with HR positive and HER-2 negative in the Asian population.The aim of this study was to retrospectively analyze the consistency of the 28-gene test with the clinicopathological data of EBC patients with HR positive and HER-2 negative,and to provide a reference for clinical research data on multigene testing for breast cancer,with the purpose of improving the treatment decision and prognosis of the EBC population in China.Methods: 1.The study included 44 EBC patients with HR positive and HER-2 negative and 0-3 lymph node metastasis who underwent surgery and had 28-gene test,and all patients met the inclusion and exclusion criteria.Clinical data and pathological diagnosis of all patients were collected,including age,histological grading,vascular cancer embolism,clinical stage,Estrogen Receptor(ER)、Progesterone Receptor(PR),HER-2,Ki-67,molecular typing,etc.2.The distribution of 28-gene test RI-LR and RIDR with clinicopathological characteristics of the enrolled patients was demonstrated by statistical graphs and tables.The differences in the distribution of each clinicopathological feature in different risk groups were compared by χ2 test.Independent influences of each risk group were explored by logistic regression analysis.Kappa analysis was used to analyze the concordance between the indices detected by Immunohistochemistry(IHC)and Quantitative Real-time Polymerase Chain Reaction(RT-PCR).P < 0.05 was considered a statistically significant difference.Results: 1.28-gene test at the mRNA level was fully consistent with conventional pathology test for ER and HER-2,and has a fair degree of agreement for PR.(κ = 0.421,P < 0.001).2.There was a significant difference between the distribution of lymph node metastasis and vascular cancer embolism in both risk group of RI-LR(P < 0.05)and clinical stage,lymph node metastasis and vascular cancer embolism in both risk group of RI-DR(P < 0.05),but no independent influencing factors were observed.3.The overall shift in adjuvant chemotherapy regimens after 28-gene test was 38.6%,with a statistically significant change in treatment decision making(P < 0.001).The change in treatment decision for adjuvant radiotherapy has no statistical significance.Conclusion: This study confirms that 28-gene test at the mRNA level agrees well with ER,PR,and HER-2 in compared with conventional pathology test.Patient lymph node metastasis and vascular tumor embolism can predict the RI-LR,and patient lymph node metastasis,vascular cancer embolism and clinical stage can predict the RI-DR.In terms of treatment decision,28-gene test does not significantly alter adjuvant radiotherapy regimen,but it is meaningful for guidance of adjuvant chemotherapy regimen.28-gene test helps to provide patients with individualized treatment decisions and prognostic information,and has a wide range of application scenarios in individualized precision therapy.