| Objective In this study,the clinicopathological data of patients with early hormone receptor(Hormonereceptor)positive breast cancer in a single center after 5 years of endocrine therapy were retrospectively analyzed to verify the clinical value of CTS5(Clinical Treatment Scorepost-5years)score model in predicting the risk of late recurrence,and to screen the beneficiaries of prolonged endocrine therapy.To explore the risk factors affecting the late recurrence of patients with early HR+ breast cancer,and to provide a convenient,practical and economical screening tool for clinicians to evaluate the prognosis of patients with HR+ breast cancer and guide treatment.Methods A total of 2678 patients with I-III stage HR+ breast cancer diagnosed by operation or puncture pathology in the Cancer Hospital of Ningxia Medical University from January 1,2011 to January 1,2017 were collected.2678 patients who were still alive after 5years of endocrine therapy were retrospectively analyzed.The end point of the study was late recurrence(>5 years).The clinical value of CTS5 in predicting the risk of late recurrence was verified.CTS5 score = 0.438 × number of lymph node metastasis + 0.988 ×(0.093 × tumor size-0.001 × tumor size square + 0.375 × tumor grade + 0.017 × age).The scores of 3.13,3.86 were used as low-risk,medium-risk and high-risk cut-off.Statistical analysis and data processing were performed by SPSS26.0 and Graphpadprism9.0.0software,chi-square test was used to compare the differences of clinicopathological features among different groups,survival analysis was performed by Kaplan Meier method,and Cox proportional hazard regression model was used to determine the prognostic value of CTS5.Univariate and multivariate Cox regression analysis of factors affecting the late recurrence of HR+ breast cancer.It was considered statistically significant to draw the subject working characteristic curve(Receiver Operating Characteristic Curve,ROC)to evaluate the predictive efficiency.Results 1.Clinicopathological features of 516 patients with early HR+ breast cancer:All the 516 HR+ breast cancer patients were female,with a median age of 48 years(42-56 years),a median follow-up period of 7 years(6-9 years),64% of premenopausal patients(330/516),and 36% of postmenopausal patients(186/516).Postoperative adjuvant chemotherapy was 86.8%,postoperative adjuvant radiotherapy was 46.5%,and oral endocrine drugs AI,TAM and TAM-AI were 56.2%(290/516),41.9%(216/516)and 1.9%(10/516)respectively.The proportions of tumor size <10 mm,10-20 mm and >20 mm were7.2%(37/516),61.6%(318/516)and 31.2%(161/516)respectively.The proportions of tumor grade I,II and III were 15.5%(80/516),68%(351/516)and 16.5%(85/516)respectively.The percentages of 0,1,2-3,4-9 and >9 lymph node metastases were 63.8%(329/516),11%(57/516),13.8%(71/516),8.1%(42/516)and 3.3%(17/516)respectively.The rates of HER2 negative,positive and unknown were 73.4%(379/516),12.4%(64/516)and 14.1%(73/516)respectively.The percentages of ki-67 expression<20% and≥20% were37.2%(192/516)and 62.8%(324/516)respectively.The proportion of TNM stage I,II and III stage was 47.7%(246/516),40.7%(210/516)and 11.6%(60/516)respectively.There was no significant difference in tumor size,tumor grade,number of lymph node metastasis and HER2 status between postmenopausal and postmenopausal patients,but there were significant differences in Ki-67 expression level and different endocrine drugs.2.CTS5 scoring model predictive value2.1 CTS5 score model predicts the risk of long-term recurrence of patients with HR+early breast cancer after 5 years of endocrine therapy(Late recurrence risk,LDR): the results of Cox multivariate analysis showed that the group with high CTS5 score had the highest LDR.(HR=6.585;95%CI:2.996-14.473;P<0.001).There was no significant difference in CTS5 score between the risk group and the low risk group(HR=1.923;95%CI :0.822-4.499;P=0.132).2.2 CTS5 score model predicts LDR in premenopausal HR+ patients with early breast cancer 5 years after endocrine therapy: Cox multifactorial analysis showed that the group with high CTS5 score had the highest LDR(HR=7.006;95%CI:2.792-17.578;P<0.001).There was no significant difference in CTS5 score between the risk group and the low risk group(HR=1.796;95%CI:0.651-4.953;P=0.258).2.2.1 CTS5 scoring model predicts LDR of premenopausal HR+ early breast cancer patients with different HER2 status 5 years after endocrine therapy: Cox single factor analysis results show that CTS5 scoring model can predict LDR of premenopausal HR+/HER2 early breast cancer patients(HR=2.852;95%CI:1.706-4.768;P<0.001).The CTS5 scoring model had no predictive value for LDR in premenopausal patients with HR+/HER2+ early breast cancer(HR=0.615;95% CI:0.093-4.070;P=0.614).2.2.2 CTS5 scoring model predicts LDR of premenopausal HR+ early breast cancer patients with different Ki-67 expression levels 5 years after endocrine therapy:Cox single factor analysis showed that the CTS5 scoring model had no predictive value for the LDR of premenopausal patients with HR+/Ki-67<20%(HR=1.579;95%CI:0.383-6.500;P=0.527).CTS5 scoring model can predict LDR of premenopausal patients with HR+/Ki67≥20%early breast cancer(HR=2.656;95% CI:1.608-4.388;P<0.001).2.3 CTS5 score model predicts LDR in postmenopausal HR+ patients with early breast cancer after 5 years of endocrine therapy: Cox multifactorial analysis shows that the group with high CTS5 score has the highest LDR(HR=7.345;95%CI:1.523-35.416;P=0.013).There was no significant difference in CTS5 score between the risk group and the low risk group(HR=2.471;95% CI:0.479-12.740;P=0.28).2.3.1 CTS5 scoring model predicts LDR in postmenopausal HR+early breast cancer patients with different HER2 status 5 years after endocrine therapy: Cox single factor analysis results show that CTS5 scoring model has no predictive value for LDR in postmenopausal HR+/HER2-early breast cancer patients(HR=1.740;95%CI:0.696-4.350;P=0.236).CTS5 scoring model can predict LDR of postmenopausal patients with HR+/HER2+ early breast cancer(HR=4.325;95%CI:1.232-15.182;P=0.022).2.3.2 CTS5 scoring model predicts LDR of postmenopausal HR+ early breast cancer patients with different Ki-67 expression levels 5 years after endocrine therapy:Cox showed that CTS5 score model had no predictive value for LDR in postmenopausal patients with HR+/Ki-67<20%(HR=1.087;95%CI:0.340-3.474;P=0.888).The CTS5 score model can predict the LDR of postmenopausal patients with early breast cancer with HR+/Ki-67≥ 20%(HR=5.279;95% CI:2.274-12.258;P<0.001).3.Prognostic factors of late recurrence in patients with early HR+ breast cancer:The results of Cox univariate test showed that tumor grade(HR=2.682;95% CI:1.550-4.639;P<0.001),number of metastatic lymph nodes(HR=1.603;95% CI : 1.299-1.978;P<0.001),postoperative adjuvant radiotherapy(HR=2.154;95%CI : 1.145-4.050;P=0.017),Ki-67 expression level(HR=2.532;95%CI : 1.172-5.470;P=0.018)and CTS5(HR=2.679;95% CI:1.788-4.014;P<0.001)is associated with the prognosis of late recurrence in patients with early HR+ breast cancer.4.Prediction of performance by CTS5 scoring model:AUC=0.720(95%CI :0.636-0.804;P<0.001),indicating that the CTS5 score model had a good efficacy in predicting late recurrence.Conclusion 1.Early HR+ breast cancer patients are mainly premenopausal women.The patients with tumor size of 10-20 mm and without lymph node metastasis accounted for a higher proportion.2.CTS5 score model can effectively predict the risk of late recurrence of unscreened premenopausal and early postmenopausal HR+ breast cancer patients in the real world.Prolonged endocrine therapy should be given to early HR+ breast cancer patients with premenopausal HER2-,Ki-67≥20% and postmenopausal HER2+,Ki-67≥20% CTS5 score high risk patients.For patients with low risk of CTS5 score,prolonged endocrine therapy may not be needed.3.Tumor grade,number of metastatic lymph nodes,postoperative adjuvant radiotherapy and Ki-67 expression were associated with late recurrence in patients with early HR+ breast cancer. |
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