多克索鲁比辛-特拉贝克丁与特拉贝克丁在莱奥米奥萨尔科马中进行维护
Patricia Pautier1, Antoine Italiano1, Sophie Piperno-Neumann1
1From the Departments of Medical Oncology (P.P., A.L.C.), Radiology (C.B.), and Biostatistics and Epidemiology (B.A.), Institut Gustave-Roussy, and Oncostat, INSERM Unité 1018, Labeled Ligue Contre le Cancer (B.A.), Villejuif, the Department of Medical Oncology, Institut Bergonié, and the Faculty of Medicine, University of Bordeaux, Bordeaux (A.I.), the Department of Medical Oncology, Institut Curie (S.P.-N.), and the Department of Medical Oncology, Hôpital Cochin-Port Royal (P.B.-R.), Paris, the Department of Medical Oncology, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse (C.C.), Lille University, and the Department of Medical Oncology, Centre Oscar Lambret, Lille (N.P.), the Department of Medical Oncology, Institut Régional du Cancer, INSERM Unité 1194, Institut de Recherche en Cancérologie de Montpellier, and the University of Montpellier, Montpellier (N.F.), the Department of Medical Oncology, Institut Paoli-Calmettes (F.B.), the Department of Medical Oncology, La Timone University Hospital (F.D.), and Aix-Marseille Université (F.B., F.D.), Marseille, the Department of Medical Oncology, Centre Hospitalo-Universitaire Dupuytren, Limoges (V.L.-L.), the Department of Medical Oncology, Centre Léon Bérard, and University Claude-Bernard Lyon 1, Lyon (I.R.-C.), the Department of Medical Oncology, Centre Hospitalier Universitaire de Besançon-Hôpital Jean-Minjoz, Besançon (E.K.), Institut de Cancérologie de l'Ouest, Angers-Nantes (E.B.), Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez (O.C.), Centre Georges-François Leclerc, Dijon (N.I.), the Department of Medical Oncology, Centre Paul Papin, Rouen (C.G.), and Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy (M.R.) - all in France.
将特拉贝克丁添加到多克索鲁比辛化疗中,显著改善了晚期乳腺神经瘤患者的生存结果. 与单独使用多克索鲁比辛相比,这种联合治疗提供了更好的无进展和整体存活率.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 临床试验 临床试验
背景情况:
- 晚期乳腺肌肉瘤是一种罕见的软组织肉瘤,治疗选择有限.
- 多克索鲁比是一种标准的第一线化疗,但它的疗效可以得到改善.
研究的目的:
- 为了评估添加trabectedin到doxorubicin作为先进的乳腺神经瘤的第一线治疗的疗效.
- 为了比较组合治疗和单独使用多克索鲁比之间的整体存活率 (OS) 和无进展存活率 (PFS).
主要方法:
- 进行了一项3期随机试验,其中150名患有转移性或不可切除的乳腺神经瘤的患者.
- 患者接受了单剂多克索鲁比辛或多克索鲁比辛加上特拉贝克丁,随后如果适用,则进行特拉贝克丁的维持治疗.
- 无进展生存率和总生存率分别是主要和次要终点.
主要成果:
- 多克索鲁比-特拉贝克丁组的平均整体存活时间 (33个月 vs. 24个月) 和无进展存活时间 (12个月 vs. 6个月) 显着更长.
- 对死亡的调整风险比为0.65,对进展或死亡的风险比为0.37,有利于组合治疗.
- 在组合手臂中观察到更高的不良事件发生率和剂量减少.
结论:
- 与多克索鲁比辛和特拉贝克丁的联合治疗,随后是特拉贝克丁的维持治疗,显著改善了晚期雷奥米奥萨尔科马的存活率.
- 与单独使用多克索鲁比辛相比,这种治疗方案对于患有子宫或软组织乳腺肌肉瘤的患者来说是一种优越的第一线治疗选择.
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