| BackgroundPyrotinib is a new small-molecule tyrosine kinase inhibitor(TKI),has shown good antitumor effects in metastatic breast cancer with HER2-positive.However,the efficacy of pyrotinib in neoadjuvant therapy(NAT)for HER2-positive breast cancer is unknown.This paper is a population-based cohort study,and the purpose is to evaluate the efficacy and safety of pyrotinib plus trastuzumab in a neoadjuvant setting for HER2-positive early or locally advanced breast cancers,and to compare it with that of pertuzumab plus trastuzumab.In order to provide data support for the application of Pyrotinib in NAT.MehodsRetrospective analysis of 190 patients with early or locally advanced HER-2 positive breast cancer who received NT with pyrotinib plus trastuzumab and pertuzumab plus trastuzumab at the First Affiliated Hospital of Zhengzhou University from March 2019 to June 2021.Three groups were divided according to the targeted agents used in NAT.Case groups:Group Ⅰ:Patients received pyrotinib+trastuzumab combined with neoadjuvant chemotherapy(NAC);Group Ⅱ:Patients received pertuzumab+trastuzumab combined withNAC.The control group consisted of patients treated with trastuzumab alone in combination with NAC.The primary endpoint was total pathologicalal complete response(tpCR)and secondary endpoint was breast pathological complete response(bpCR)、objective response rate(ORR)and clinical complete response(cCR).Univariate logistic regression analysis was applied.Enumeration data were processed by Fisher’s exact test.A P value of<0.05 was considered statistically significant.Results1.Evaluation of preoperative clinical efficacy after NAT:Preoperative ORR of the overall patients was 96.84%,of which the ORR of the two dual-target groups Ⅰand Ⅱ were 100%,and the clinical Complete response(cCR)rates were 46.03%and 36.92%.The cCR rate of group Ⅲ was 22.58%.The cCR rate of group Ⅰ and Ⅱ was significantly higher than group Ⅲ(P=0.006,P=0.015).Evaluation of postoperative pathological efficacy after NAT:The tpCR rate of group Ⅰ was 63.49%(40/63);the bpCR rate was 76.19%(48/63);the effective rate of pathological evaluation was 96.83%.Significantly higher than the tpCR rate in single target group Ⅲ(63.49%vs.29.03%,P<0.001).Although there was no significant difference in tpCR rate between group Ⅰ and group Ⅱ(P=0.350),the bpCR rate in group Ⅰ was significantly higher than that in group Ⅱ(P=0.039).2.Regarding adverse events(AEs),diarrhea(n=56,88.89%)was the most frequent in the group Ⅰ,including 7 participants who developed grade 3 diarrhea(11.11%),followed by leukopenia(n=48,76.19%).In the meantime,there was only 1 patient experienced grade Ⅳ thrombocytopenia.3.Hormone receptor(HR)-negative patients were more likely to reach tpCR as compared to HR-positive patients(62.92%vs.37.62%,P=0.001,95%CI:1.561 to 5.071),and the tpCR rate of tumor,node,metastasis(TNM)stage Ⅲ 39.39%(26/66)was significantly lower than that of stage Ⅱ 56.67%(68/124),which was statistically significant(P=0.043,95%CI:0.292 to 0.983).No recurrence or metastasis was found during short-term follow-up.4.The Positive Predictive Value(PPV)of pCR based Radiographic complete response(rCR)was 85.07%.The negative predictive value(NPV)was 69.92%.Conclusion1.Pyrotinib plus trastuzumab combined with neoadjuvant chemotherapy showed good short-term efficacy with a high pCR rate in HER2-positive breast cancer.The AEs with the highest incidence rate was diarrhea,which may be related to pyrotinib but controllable.2.The bpCR rate of the neoadjuvant pyrotinib plus trastuzumab was higher than that of trastuzumab plus pertuzumab group.3.For patients with HER2-positive breast cancer who received NAT,HR status and cTNM stage were closely related to the acquisition of pCR. |
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