首页|Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer:A phase Ⅱ single-arm study
Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer:A phase Ⅱ single-arm study
扫码查看
点击上方二维码区域，可以放大扫码查看
原文链接
NETL
NSTL
万方数据
Objective:Despite cardiotoxicity overlap,the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits.Pegylated liposomal doxorubicin(PLD),a less cardiotoxic anthracycline,was evaluated for efficacy and cardiac safety when combined with cyclophosphamide and followed by taxanes with trastuzumab/pertuzumab in human epidermal growth factor receptor-2(HER2)-positive early breast cancer(BC).Methods:In this multicenter,phase Ⅱ study,patients with confirmed HER2-positive early BC received four cycles of PLD(30-35 mg/m2)and cyclophosphamide(600 mg/m2),followed by four cycles of taxanes(docetaxel,90-100 mg/m2 or nab-paclitaxel,260 mg/m2),concomitant with eight cycles of trastuzumab(8 mg/kg loading dose,then 6 mg/kg)and pertuzumab(840 mg loading dose,then 420 mg)every 3 weeks.The primary endpoint was total pathological complete response(tpCR,ypT0/is ypN0).Secondary endpoints included breast pCR(bpCR),objective response rate(ORR),disease control rate,rate of breast-conserving surgery(BCS),and safety(with a focus on cardiotoxicity).Results:Between May 27,2020 and May 11,2022,78 patients were treated with surgery,42(53.8％)of whom had BCS.After neoadjuvant therapy,47[60.3％,95％confidence interval(95％CI),48.5％-71.2％]patients achieved tpCR,and 49(62.8％)achieved bpCR.ORRs were 76.9％(95％CI,66.0％-85.7％)and 93.6％(95％CI,85.7％-97.9％)after 4-cycle and 8-cycle neoadjuvant therapy,respectively.Nine(11.5％)patients experienced asymptomatic left ventricular ejection fraction(LVEF)reductions of ≥10％from baseline,all with a minimum value of＞55％.No treatment-related abnormal cardiac function changes were observed in mean N-terminal pro-BNP(NT-proBNP),troponin I,or high-sensitivity troponin.Concluslons:This dual HER2-blockade with sequential polychemotherapy showed promising activity with rapid tumor regression in HER2-positive BC.Importantly,this regimen showed an acceptable safety profile,especially a low risk of cardiac events,suggesting it as an attractive treatment approach with a favorable risk-benefit balance.
Breast cancerHER2-positive breast cancerdual HER2 blockadeneoadjuvant therapysequential therapy
Breast Tumor Center,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation,Guangzhou 510120,China
Department of Thyroid and Breast Surgery,Shenzhen Qianhai Shekou Free Trade Zone Hospital,Shenzhen 518000,China
Breast and Thyroid Surgery,Guilin Medical College Second Affiliated Hospital,Guilin 541199,China
Department of Breast Disease,Henan Breast Cancer Center,the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital,Zhengzhou 450008,China
展开 >
National Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaNational Key R&D Program of ChinaSun Yat-Sen Clinical Research Cultivating ProgramBeijing Medical Award FoundationGuangzhou Science and Technology ProgramGuangzhou Science and Technology Program
NETL
NSTL
万方数据
