Efficacy And Influencing Factors Of Pertuzumab Combined With Trastuzumab In The Neoadjuvant Therapy Of HERT-2 Positive Breast Cancer

Obiectives: The inclusion of Pertuzumab in China’s medical insurance in 2020 has brought good news to patients with HER2-positive breast cancer.This study aims to investigate whether the pathological complete response(pCR)rate of HER-2 positive breast cancer trastuzumab and conventional chemotherapy combined with Pertuzumab(dual target combined chemotherapy)neoadjuvant treatment is further improved in the real world,and analyze the related factors that affect pCR and the occurrence of adverse reactions.Methods: This paper has retrospectively analyzed the complete case data of 83 patients with HER-2 positive breast cancer who received targeted combined chemotherapy during neoadjuvant from the First Hospital of Lanzhou University from January 1,2018 to March 5,2021.Among them,49 patients received trastuzumab and pertuzumab combined chemotherapy(dual target group),and 34 received trastuzumab combined chemotherapy(single target group).The Miler-Payne standard was used to evaluate the pathological efficacy,and the differences in pCR rates between the two groups under different definitions of pCR were compared.This paper has referred to Response Evaluation Criteriain Solid Tumours version 1.1 for clinical efficacy evaluation.At the same time,adverse reaction evaluations have been carried out in accordance with Common Terminology Criteria for Adverse Events version 5.0.Statistical methods use χ2 test or Fisher exact probability method to analyze the differences in pCR rates and adverse reactions between the two groups,and Logistic multivariate regression to analyze its influencing factors.Results:1.Evaluation of postoperative pathological efficacy after neoadjuvant treatment:The total efficacy rate of the dual target group was 93.9%,and that of the single target group was 88.2%.Regardless of the definition of pCR(tpCR:yp T0/is yp N0、GBGpCR:yp T0 yp N0、bpCR:yp T0/is),the pCR rate of the dual-target group was higher than that of the single-target group.In addition,after the pCR rates of the two groups with different definitions were compared,the differences were statistically significant(P=0.041,P=0.027,P=0.026).With tpCR as the main study endpoint,the tpCR rate of the dual target group was 55.1%,and that of the single target was 32.4%.Subgroup analysis:The tpCR of the dual-target group with positive preoperative lymph node was 48.5%,and the single-target group was 22.2%.The tpCR of the dual-target group with negative preoperative lymph node was 68.8%,and the single-target group was 43.8%.The tpCR of the HR-positive dual-target group was 41.7%,and the single-target group was15.0%.The tpCR of the HR-negative dual-target group was 68.0%,and the single-target group was 57.1%.Exploratory subgroup analysis:(1)Regardless of the definition of pCR,the pCR rate of the dual-target group in ER+ patients was significantly higher than that of the single-target group,and the difference between the two groups of tpCR and bpCR was statistically significant(P=0.048,P=0.027).However,the pCR rate of ER-patients was similar in the dual target group and the single target group,and the difference was not statistically significant.(2)The tpCR rate of the dual-target group with anthracycline-containing chemotherapy was higher than that without anthracycline(76.9% vs 47.2%),but the difference was not statistically significant.The tpCR rate of the single-target group with anthracycline-containing chemotherapy was lower than that without anthracycline(6.2% vs 55.6%),but the difference was statistically significant(P=0.002).(3)Comparison of the effects of neoadjuvant treatment cycles on tpCR was made in the dual-target group,but the difference was not statistically significant.Instead,the difference in the single-target group was statistically significant(P=0.002).(4)The effects of different chemotherapy regimens,primary tumor size,neoadjuvant therapy undergoing drug replacement and other factors on tpCR in the dual target group were studied,and no statistical difference in tpCR rate was observed in the results.2.Evaluation of preoperative clinical efficacy after neoadjuvant therapy: The overall efficacy rate of all patients was 96.4%,of which 100% was in the dual-target group and 91.2% in the single-target group.The preoperative clinical complete response(c CR)rate of the total population was 44.6%,61.2% in the dual-target group,and 20.6% in the single-target group.There was a statistical difference in the c CR rate between the two groups(P<0.001).3.Logistic multivariate regression analysis suggests that HR expression status is an independent factor influencing tpCR rate of targeted therapy combined with chemotherapy.4.Safety evaluation: The observations of this study have found that most of the adverse reactions of dual-target combined chemotherapy were grade 1 to 2.Only a few patients had a decrease in LVEF>10% after treatment.There were no cardiotoxic events above grade 3.Conclusion:1.Compared with single-target combined chemotherapy for HER-2 positive breast cancer,dual-target combined chemotherapy has a higher pCR rate in neoadjuvant therapy.2.Both dual-target combined chemotherapy and single-target combined chemotherapy with neoadjuvant therapy are well tolerated,and there is no significant difference in cardiotoxicity in particular.3.The neoadjuvant efficacy of HER-2 positive breast cancer is directly related to the dual-target therapy of sufficient course of treatment.However,different chemotherapy regimens,primary tumor size,and whether to remove anthracycline have no significant effect on tpCR.4.HR expression status is an independent factor influencing the tpCR rate of targeted therapy combined with chemotherapy.