在多发性骨髓瘤治疗中使用Belantamab Mafodotin,Bortezomib和Dexamethasone
Vania Hungria1, Pawel Robak1, Marek Hus1
1From Clinica São Germano (V.H.) and Hospital das Clínicas and Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo (G.A.M.), São Paulo, Centro de Pesquisa e Ensino em Saúde de Santa Catarin, Florianópolis (A.C.R.A.), and Universidade da Região de Joinville and Centro de Hematologia e Oncologia, Joinville (M.P.L.) - all in Brazil; Medical University of Lodz, Lodz (P.R.), Medical University of Lublin, Lublin (M.H., M.M.), and the Medical University of Silesia, Katowice (S.G.) - all in Poland; Gorodskaya Klinicheskaya Bol'nitsa Imeni Saint Petersburg Botkina, Moscow (V.Z.); the Royal North Shore Hospital (C.W.) and Liverpool Hospital (A.B.), Sydney, Royal Prince Alfred Hospital and University of Sydney, Camperdown, NSW (P.J.H.), and Pindara Private Hospital, Gold Coast, QLD (H.S.) - all in Australia; the Department of Hematooncology, University Hospital Ostrava, and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic (R.H.); Sungkyunkwan University and Samsung Medical Center, Seoul, South Korea (K.K.); Institut Català d'Oncologia-L'Hospitalet de Llobregat-Barcelona, Barcelona (A.M.S.B.), Institut Català d'Oncologia and Josep Carreras Research Institute, Hospital Germans Trias i Pujol, Badalona (A.O.), and Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer, Ciberonc, Salamanca (M.-V.M.) - all in Spain; Cross Cancer Institute, Edmonton (I.S.), and GSK, Mississauga (H.B.) - both in Canada; the Hematology Unit, Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori," IRST IRCCS, Meldola (C.C.), and IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna (M.C.) - both in Italy; Christchurch Hospital, Christchurch, New Zealand (P.G.); National and Kapodistrian University of Athens, Athens (M.D.); the First Affiliated Hospital of Soochow University, Suzhou, China (C.F.); University Hospitals of Leicester NHS Trust, Leicester (M.G.), GSK, Stevenage (A.M., S.M.), and GSK, London (L.E.) - all in the United Kingdom; University of Kansas Cancer Center, Fairway (A.-O.A.); the Department of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel (M.E.G.); Rocky Mountain Cancer Centers-Denver-Midtown, Denver (R. Rifkin); Matsuyama Red Cross Hospital, Matsuyama, Japan (T.F.); GSK, Upper Providence, PA (N.P., X.Z., R. Rogers, S.R.-G., J.O.); and GSK, Durham (M.N.), and GSK, Research Triangle Park (E.L.) - both in North Carolina.
在复发性或耐火性多发性骨髓瘤患者中,贝兰他马布 (Belantamab mafodotin),博尔特佐米布 (Bortezomib) 和德克萨米萨 (DVd) 与达拉图穆巴 (daratumumab),博尔特佐米布 (Bortezomib) 和德克萨米萨 (DVd) 相比,显著改善了无进展的生存期. 虽然BVd显示出更高的疗效,但它也呈现出更多的3级+不良事件,特别是眼部.
科学领域:
- 血液学 血液学 血液学
- 临床瘤学临床瘤学
- 药理学 药理学是指药理学的学科.
背景情况:
- 贝兰他马布 (Belantamab mafodotin) 在复发性或耐火性多发性髓瘤中表现出单剂活性.
- 这一发现支持进一步调查结合疗法中的贝兰他马布 (belantamab mafodotin).
研究的目的:
- 评估贝兰他马布 (Belantamab) 对多发性骨髓瘤患者的有效性和安全性,比较贝兰他马布 (Belantamab),博尔特佐米布 (Bortezomib) 和德克萨米松 (Dexamethasone) 在多发性骨髓瘤患者中的有效性和安全性.
- 为了比较两种治疗手臂之间的无进展生存率 (PFS),总生存率 (OS),响应持续时间和最小残留疾病 (MRD) - 阴性状态.
主要方法:
- 第3期,开放标签,随机试验,涉及494名多发性骨髓瘤患者,至少接受过一次先前治疗.
- 患者被分配给接受BVd或DVd.
- 主要终点是无进展的生存期;次要终点包括OS,响应持续时间和MRD阴性状态.
主要成果:
- 与DVd组 (13.4个月) 相比,BVd组的PFS中位数显著更长 (36.6个月) (HR,0.41;P<0.001).
- 18个月的总生存率在BVd组 (84%) 与DVd组 (73%) 相比更高.
- 在BVd组中观察到3级或更高的不良事件 (95%与78%) 和眼部事件 (79%与29%) 的更高率,尽管眼部事件是可以管理的.
结论:
- 在复发性或耐药性多发性骨髓瘤患者中,BVD疗法比DVd疗法提供了显著的无进展生存益处.
- BVd疗法与3级或更高的不良事件的高发病率有关,包括需要谨慎管理的眼部毒性.
- 这项名为DREAMM-7的研究是由GSK资助的,注册号为NCT04246047,EudraCT号为2018-003993-29.
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