两种不同新辅助化疗方案联合双靶对HER-2阳性乳腺癌病理完全缓解率的影响

Effect of Two Different Neoadjuvant Chemotherapy Regimens Combined with Dual-Target on Pathological Complete Response Rate of HER-2 Positive Breast Cancer and Its Influencing Factors

目的探讨不同新辅助化疗方案联合曲妥珠单抗(H)和帕妥珠单抗(P)对HER-2阳性乳腺癌病理完全缓解(pCR)率的影响及安全性并分析获得pCR的影响因素。方法回顾性分析2019年5月至2021年5月我院使用AC-THP或TCbHP新辅助治疗(NAT)且完成手术的HER-2阳性乳腺癌患者临床病理资料,主要研究终点是总病理完全缓解(tpCR)率及不良反应,次要终点是乳房病理完全缓解(bpCR)率和腋窝病理完全缓解(apCR)率,并分析影响tpCR的因素。结果128例患者纳入分析,其中75例使用TCbHP方案,53例使用AC-THP方案。总tpCR率为60.9%,其中TCbHP为62.7%,AC-THP为58.5%(χ^(2)=0.228,P=0.633);总bpCR率为64.1%,TCbHP为65.3%,AC-THP为62.3%(χ^(2)=0.127,P=0.721);总apCR率为70.3%,TCbHP为78.7%,AC-THP为58.5%,差异有统计学意义(χ^(2)=6.009,P=0.014)。单因素分析显示,激素受体(HR)状态、雌激素受体(ER)表达、孕激素受体(PR)表达、HER-2状态、腋窝淋巴结状态、临床分期及紫杉类药物种类是影响tpCR的相关因素。多因素分析发现,ER表达情况、HER-2状态、腋窝淋巴结状态是预测tpCR的独立因素。两方案总体不良反应可控,但TCbHP方案的3~4级血液毒性反应更高。结论TCbHP方案的tpCR率、apCR率、bpCR率均要高于AC-THP方案,但仅在apCR上观察到统计学差异。两种方案的安全性良好。ER阴性、HER-2(3+)、腋窝淋巴结阴性患者的tpCR率更高。

Objective To investigate the effect and safety of different neoadjuvant chemotherapy regimens combined with trastuzumab(H)and pertuzumab(P)on pathological complete response(pCR)of HER-2 positive breast cancer,and to analyze the influencing factors of pCR.Methods The clinicopathological data of HER-2 positive breast cancer patients who underwent neoadjuvant treatment(NAT)with AC-THP or TCbHP and completed surgery in the Breast Disease Treatment Center of the Affiliated Hospital of Southwest Medical University from May 2019 to May 2021 were retrospectively collected.The main endpoints were the total pathological complete remission rate(tpCR)and the adverse reactions.The secondary endpoints were the breast pathological complete response rate(bpCR)and the axillary pathological complete response rate(apCR),and the factors affecting tpCR were analyzed.Results A total of 128 patients were included in the analysis,75 of whom received TCbHP regimen and 53 received AC-THP regimen.The total tpCR rate was 60.9%,of which TCbHP was 62.7%and AC-THP was 58.5%(χ^(2)=0.228,P=0.633).The total bpCR rate was 64.1%,TCbHP was 65.3%,AC-THP was 62.3%(χ^(2)=0.127,P=0.721).The total apCR rate was 70.3%,TCbHP was 78.7%,and AC-THP was 58.5%,and the difference was statistically significant(χ^(2)=6.009,P=0.014).Univariate analysis showed that the hormone receptor(HR)status,estrogen receptor(ER)expression,progestrone receptor(PR)expression,HER-2 status,axillary lymph node status,clinical stage and taxane type were related factors affecting tpCR.The multiple factors in univariate analysis were brought into multivariate analysis,and it was found that ER expression,HER-2 status and axillary lymph node status were independent factors for predicting tpCR.The overall adverse reactions of the two regimens were controllable,but the grade 3~4 hematologic toxicity of the TCbHP regimen was higher.Conclusion The tpCR rate,apCR rate and bpCR rate of TCbHP are higher than those of AC-THP,but the statistical difference is only observed on apCR.The security of the two schemes is good.The tpCR rate of ER negative,HER-2(3+),axillary lymph node negative patients is higher.