在激素受体阳性晚期乳腺癌中的capivasertib
Nicholas C Turner1, Mafalda Oliveira1, Sacha J Howell1
1From the Royal Marsden Hospital, Institute of Cancer Research, London (N.C.T.), the Christie NHS Foundation Trust, Manchester (S.J.H.), and Oncology Research and Development, AstraZeneca, Cambridge (E.C.B., L.G., G.S., A.F.) - all in the United Kingdom; the Department of Medical Oncology, Vall d'Hebron University Hospital (M. Oliveira), the Breast Cancer Unit, Vall d'Hebron Institute of Oncology (M. Oliveira), the Department of Oncology, International Breast Cancer Center, Pangaea Oncology, Quiron Group, Medica Scientia Innovation Research (J.C.), and Institut de Recerca Biomèdica (S.M.M.), Barcelona, and the Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid (J.C.) - all in Spain; Institut Claudius Regaud, Institut Universitaire du Cancer-Oncopole Toulouse, Toulouse, France (F.D.); Departamento de Oncología Médica, Instituto Nacional de Enfermedades Neoplásicas, and Universidad Ricardo Palma - both in Lima, Peru (H.L.G.M.); Shanghai Cancer Center, Fudan University, Shanghai, China (X.H.); Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College - both in New York (K.J.); Petrov Research Institute of Oncology, St. Petersburg (P.K.), and Loginov Moscow Clinical Scientific Center, Moscow (L.Z.) - both in Russia; GBG Forschungs, Neu-Isenburg, and the Center for Hematology and Oncology, Bethanien, Frankfurt - both in Germany (S.L.); Icon Cancer Centre, Adelaide, SA, Australia (M. Okera); Sungkyunkwan University School of Medicine, Samsung Medical Center (Y.H.P.), and Yonsei University College of Medicine, Yonsei Cancer Center (J.S.) - both in Seoul; Kyoto University Hospital, Kyoto (M.T.), and National Hospital Organization Kyushu Cancer Center, Fukuoka (E.T.) - both in Japan; Emek Medical Center, Afula, Israel (S.Y.); and the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco (H.S.R.).
将capivasertib添加到fulvestrant显著改善了晚期激素受体阳性乳腺癌患者的无进展生存率. 这种组合疗法为那些对内分泌疗法耐药的人提供了一个新的选择.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- AKT通路的激活与乳腺癌中的内分泌疗法抵抗有关.
- 有限的数据存在于capivasertib的疗效和安全性与富尔韦斯特兰特相结合,用于激素受体阳性乳腺癌的晚期.
研究的目的:
- 为了评估capivasertib加富尔韦斯特兰特与安慰剂加富尔韦斯特兰特在患有激素受体阳性,HER2阴性晚期乳腺癌的患者的疗效和安全性.
- 评估总人口和AKT途径改变瘤患者的无进展生存率.
主要方法:
- 一个第三阶段,随机,双盲试验 (CAPItello-291) 涉及708名患有晚期乳腺癌的患者.
- 患者接受了capivasertib加富勒弗兰特或安慰剂加富勒弗兰特.
- 主要终点是研究人员评估的无进展生存期.
主要成果:
- 在总体人群中,无进展生存时间的中位数为7.2个月,与capivasertib-fulvestrant相比,与安慰剂-fulvestrant相比为3.6个月 (HR,0.60;P<0.001).
- 在AKT途径改变的患者中,无进展生存时间的中位数为7.3个月,而无进展生存时间为3.1个月 (HR,0.50;P<0.001).
- 3级或更高的皮疹和腹是用capivasertib-fulvestrant最常见的不良事件.
结论:
- 与单独使用富勒弗兰特相比,capivasertib加上富勒弗兰特显著改善了无进展生存率.
- 这种组合疗法在激素受体阳性晚期乳腺癌患者中表现出有效性,包括那些AKT通路改变的患者.
- 这项研究提供了证据,证明capivasertib-fulvestrant作为这种患者群体的潜在治疗选择.
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