K药-三阴性乳腺癌.pptxVIP

KEYNOTE系列研究: 从晚期到早期，步步为营;Keynote-012：Pembrolizumab在TNBC后线治疗中安全性与疗效;Keynote-012：客观缓解率 18.5%;KEYNOTE系列研究: 从晚期到早期，步步为营;KEYNOTE系列研究: 从晚期到早期，步步为营;KEYNOTE 119：研究设计;Overall survival;KEYNOTE系列研究: 从晚期到早期，步步为营;KEYNOTE系列研究: 从晚期到早期，步步为营;TNBC新辅助——KEYNOTE-173;KEYNOTE-173获得较高的pCR及ORR;aMust consist of at least 2 separate tumor cores from the primary tumor. bCarboplatin dose was AUC 5 Q3W or AUC 1.5 QW. cPaclitaxel dose was 80 mg/m2 QW.;KEYNOTE-522：研究终点;aPD-L1 assessed at a central laboratory using the PD-L1 IHC 22C3 pharmDx assay and measured using the combined positive score (CPS; number of PD-L1–positive tumor cells, lymphocytes, and macrophages divided by total number of tumor cells x 100); PD-L1–positive = CPS ≥1. Data cutoff date: April 24, 2019.;PD-L1分层的pCR;For the overall population, analysis is based on Miettinen and Nurminen method stratified by nodal status (positive versus negative), tumor size (T1/T2 versus T3/T4), and frequency of carboplatin administration (once weekly versus once every 3 weeks). For other subgroups, analysis is based on unstratified Miettinen and Nurminen method.;;aPrespecified P value boundary of 0.000051 not reached at this analysis (the first interim analysis of EFS). Hazard ratio (CI) analyzed based on a Cox regression model with treatment as a covariate stratified by the randomization stra tification factors. Data cutoff April 24, 2019.;帕博利珠单抗是目前唯一在TNBC新辅助化疗中取得阳性结果的免疫检查点抑制剂 在无铂的新辅助化疗中加入帕博利珠单抗，可显著增加pCR率I-SPY2(60% vs 20%) 在含铂的新辅助化疗中加入帕博利珠单抗，可显著增加pCR率KEYNOTE-522(64.8% vs 51.2%)(P=0.00055) ，包括PD-L1表达低的亚组，副作用已知且可控，与淋巴结侵犯和更晚的肿瘤分期正相关； 2年随访数据提示，帕博利珠单抗组的EFS有获益趋势(HR 0.63)； Atezolizumab及Durvalumab在TNBC新辅助临床研究中未获得具有统计学意义的pCR获益。