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Published on: February 12, 2022
复发性扩散性大B细胞淋巴瘤的组合向疗法
Christopher Melani1, Rahul Lakhotia1, Stefania Pittaluga1
1From the Lymphoid Malignancies Branch (C. Melani, R.L., J.D.P., D.W.H., J.S., J.M., Y.Y., W.X., A.P., C. Morrison, A.T., A.M.J., M.R., L.M.S., W.H.W.), the Clinical Pharmacology Program (C.J.P., O.A., W.D.F.), the Molecular Imaging Branch (E.M., L.L., E.B.), and the Biostatistics and Data Management Section (S.M.S.), Center for Cancer Research, the Laboratory of Pathology, Clinical Center (S.P., T.D.-H., S.D.P., E.S.J.), and the Biometric Research Program, Division of Cancer Treatment and Diagnosis (G.W.), National Cancer Institute, the Division of Pre-Clinical Innovation Chemistry Technologies, National Center for Advancing Translational Sciences (C.J.T., M.C., F.A.T.), and the Clinical Center Pharmacy Department (C.L.), National Institutes of Health, Bethesda, and Greenebaum Comprehensive Cancer Center, University of Maryland Medical Center, Baltimore (S.T.L.) - all in Maryland; the Division of Hematology and Oncology, University of Virginia, Charlottesville (C.A.P.); Mario Lemieux Center for Blood Cancers, University of Pittsburgh School of Medicine, Pittsburgh (R.J.F.); and Adaptive Biotechnologies, Seattle (A.J., H.S.).
ViPOR疗法在特定的扩散性大B细胞淋巴瘤 (DLBCL) 亚型中显示出持久的缓解. 这种组合疗法,包括venetoclax,在复发或耐药DLBCL患者中显示出可管理的不良事件.
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科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 临床药理学 临床药理学
背景情况:
- 向扩散型大B细胞淋巴瘤 (DLBCL) 的瘤突变导致了特定途径的药物.
- 通过针对DLBCL多重生存途径进行治愈治疗的潜力仍然是未知的.
研究的目的:
- 评估一种新型组合治疗方案ViPOR的安全性和有效性,用于复发性或耐药性DLBCL的患者.
- 在ViPOR疗法中确定推的2期venetoclax剂量.
主要方法:
- 进行了一项单中心的1b-2期研究,对venetoclax,ibrutinib,prednisone,obinutuzumab和lenalidomide (ViPOR) 进行了研究.
- 第1b阶段确定了venetoclax (800毫克) 的推剂量,第二阶段评估了DLBCL患者的疗效.
- 维波尔每21天进行一次,持续6个周期.
主要成果:
- 3级内出血的剂量限制性毒性确定了venetoclax的第二阶段剂量.
- 在48名可评估的DLBCL患者中,客观反应为54%,完全反应为38%.
- 在非GCB DLBCL和具有特定基因重组的高度B细胞淋巴瘤中观察到完全反应;无进展的2年生存率为34%,总生存率为36%.
结论:
- 在具有特定分子DLBCL亚型的患者中,ViPOR疗法实现了持久的缓解.
- 与ViPOR相关的不良事件主要是可逆的.
- 这项研究由国家癌症研究所和其他机构 (ClinicalTrials.gov NCT03223610) 资助.