在早期三阴性乳腺癌中使用 pembrolizumab 的整体存活率
Peter Schmid1, Javier Cortes1, Rebecca Dent1
1From the Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, and Medical Scientia Innovation Research, Barcelona, and IOB Madrid, Institute of Oncology, Hospital Beata María Ana, and the Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid - all in Spain (J.C.); National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); University of Texas Southwestern Medical Center (H.M.) and Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute (J.O.) - both in Dallas; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); the Breast Unit, Department of Gynecology with Breast Center, Kliniken Essen-Mitte, Essen (S.K.), Charité-Universitätsmedizin Berlin (S.K.) and the Breast Cancer Center, Helios Klinikum Berlin-Buch (M.U.), Berlin, the Institute of Pathology, Philipps University of Marburg and University Hospital Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich, LMU University Hospital, Munich (N.H.), and University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.) - all in Germany; Samsung Medical Center, Sungkyunkwan University School of Medicine (Y.H.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University (S.-A.I.) - both in Seoul, South Korea; Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); the Center of Cancer Medicine, School of Clinical Medicine, University of Hong Kong, Hong Kong (R.H.); Hokkaido University Hospital, Sapporo, Japan (M.T.); Centre Jean-Perrin, Clermont-Ferrand, France (M.-A.M.-R.); the Department of Oncology-Pathology, Karolinska Institutet, and Breast Center, Theme Cancer, Karolinska University Hospital, Stockholm (T.F.); Instituto Português de Oncologia do Porto Francisco Gentil, Porto (M.F.), and the Breast Unit, Champalimaud Clinical Center-Champalimaud Foundation, Lisbon (F.C.) - both in Portugal; and the Department of Oncology, Merck, Rahway, NJ (X.Z., V.K., K.T., G.A.).
在早期三阴性乳腺癌患者中,添加 pembrolizumab 于化疗显著改善了整体存活率. 在KEYNOTE-522试验的最终分析中,这种免疫疗法组合显示出显著的生存益处.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 三阴性乳腺癌 (TNBC) 是一种具有有限治疗选择的侵袭性亚型.
- 此前,KEYNOTE-522试验已经在早期TNBC中证明了pembrolizumab加化疗的好处.
- 本研究报告了来自KEYNOTE-522试验的最终整体生存数据.
研究的目的:
- 评估新辅助剂和辅助剂布罗利祖马布与早期TNBC的化疗相结合的长期整体生存益处.
- 报告最终的整体生存结果作为KEYNOTE-522试验的次要终点.
主要方法:
- 第三阶段,随机,双盲试验,比较pembrolizumab加化疗与安慰剂加化疗.
- 患者接受了新辅助 pembrolizumab 或安慰剂与帕克利塔塞尔/卡博普拉丁,其次是多克索鲁比辛/cyclophosphamide,然后辅助 pembrolizumab 或安慰剂.
- 总体存活率是次要终点,随访时间中位数为75.1个月.
主要成果:
- 在60个月后, pembrolizumab - 化疗组的总生存率为86.6%,而安慰剂 - 化疗组的总生存率为81.7%.
- 添加 pembrolizumab 于化疗导致总体存活率的统计学上显著改善 (P=0.002).
- 副作用与已知的pembrolizumab和化疗的安全概况一致.
结论:
- 新辅助剂和辅助剂 pembrolizumab 结合化疗显著改善了早期TNBC的整体存活率.
- 布罗利祖马布加化学疗法代表了早期三阴性乳腺癌治疗的重大进展.
- 这些发现支持在这种患者群体中将布罗利祖马布与化疗结合使用.


