吡柔比星和表柔比星在三阴性乳腺癌新辅助化疗中的疗效及安全性对比  

Comparison of efficacy and safety of Pirarubicin and Epirubicin in neoadjuvant chemotherapy of triple negative breast cancer

作　　者：殷晨燕 唐杰 YIN Chenyan;TANG Jie(Pharmacy Department,Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;Oncology Department,Jiangsu Second Traditional Chinese Medicine Hospital,Nanjing 210017,China)

机构地区：[1]江苏省中医院药学部,江苏南京210029 [2]江苏省第二中医院<南京中医药大学第二附属医院>肿瘤科,江苏南京210017

出　　处：《药学研究》2025年第1期85-88,99,共5页Journal of Pharmaceutical Research

基　　金：江苏省中医药科技发展计划项目(No.YB2020023)。

摘　　要：目的比较吡柔比星及表柔比星在三阴性乳腺癌新辅助化疗中的疗效及安全性。方法回顾性分析2019年1月至2023年9月就诊于江苏省中医院,接受完整新辅助化疗并行手术治疗的三阴性乳腺癌患者的临床资料。患者根据用药不同分为吡柔比星组(n=91)及表柔比星组(n=95)。比较两组患者的病理完全缓解率(pathological complete response,pCR)、客观缓解率(objective remission rate,ORR)、Ki-67变化、Miller-Payne分级及不良事件发生率。结果吡柔比星组的总体ORR高于表柔比星组(89.0%VS 77.9%,P=0.042),且在Ⅰ~Ⅱ期肿瘤亚组(91.4%VS 78.5%,P=0.048)、>2 cm肿瘤亚组(92.5%VS 78.5%,P=0.012)及有淋巴结转移亚组(90.0%VS 76.3%,P=0.028)中,吡柔比星组的ORR均高于表柔比星组,且差异有统计学意义。吡柔比星组骨髓抑制发生率(27.5%VS 12.6%,P=0.011)高于表柔比星组,而胃肠道反应(16.5%VS 29.5%,P=0.036)及脱发(19.8%VS 32.6%,P=0.047)均低于表柔比星。结论吡柔比星相较于表柔比星可提高三阴性乳腺癌新辅助化疗的客观缓解率,并可减少胃肠道及脱发不良事件的发生,但骨髓抑制发生率更高。Objective To compare the efficacy and safety of Pirarubicin and Epirubicin in neoadjuvant chemotherapy for triple-negative breast cancer.Methods A retrospective analysis was conducted on the clinical data of triple-negative breast cancer patients who received complete neoadjuvant chemotherapy followed by surgery at Jiangsu Province Hospital of Chinese Medicine from January 2019 to September 2023.Patients were divided into two groups based on the drug used:the Pirarubicin group(n=91)and the Epirubicin group(n=95).The pathological complete response(pCR)rate,objective remission rate(ORR),Ki-67 index reduction,Miller-Payne grading,and incidence of adverse events were compared between the two groups.Results The overall ORR in the Pirarubicin group was significantly higher than that in the Epirubicin group(89.0%VS 77.9%,P=0.042).In the subgroups withⅠ~Ⅱstage tumors(91.4%VS 78.5%,P=0.048),tumors>2 cm(92.5%VS 78.5%,P=0.012),and patients with lymph node metastasis(90.0%VS 76.3%,P=0.028),the ORR was also higher in the Pirarubicin group,respectively,with statistically significant differences.Additionally,the incidence of bone marrow suppression was higher in the Pirarubicin group(27.5%VS 12.6%,P=0.011),while gastrointestinal reactions(16.5%VS 29.5%,P=0.036)and hair loss(19.8%VS 32.6%,P=0.047)were lower compared to the Epirubicin group.Conclusion Pirarubicin can improve the ORR in neoadjuvant chemotherapy for triple-negative breast cancer compared to Epirubicin,and it reduces the incidence of gastrointestinal reactions and hair loss.However,it is associated with a higher rate of bone marrow suppression.

关 键 词：三阴性乳腺癌 新辅助化疗 吡柔比星 表柔比星 疗效 安全性 

分 类 号：R737.9[医药卫生—肿瘤]