在微卫星-不稳定性-高转移性结肠直肠癌中,尼沃卢马布加上伊皮利穆马布
Thierry Andre1, Elena Elez1, Eric Van Cutsem1
1From Sorbonne Université, Hôpital Saint Antoine, Assistance Publique-Hôpitaux de Paris, Unité Mixte de Recherche Scientifique 938, and SIRIC CURAMUS, Paris (T.A.), Hopital Foch, Suresnes (J.B.), and Institut Paoli-Calmettes (C.F.), and La Timone, Aix Marseille Université (L.D.), Marseille - all in France; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona (E.E.), Hospital Universitario Virgen del Rocío, Seville (M.L.L.), Institut Català d'Oncologia, Hospital Universitario Germans Trias i Pujol, Badalona (J.L.M.M.), and Hospital Universitario 12 de Octubre, Imas12, Medicine Department-UCM, Madrid (R.G.-C.) - all in Spain; University Hospitals Gasthuisberg and University of Leuven (KU Leuven), Leuven, Belgium (E.V.C.); the University Hospital of Southern Denmark, Vejle Hospital, Vejle (L.H.J.); Hospital Universitario Fundacion Favaloro, Buenos Aires (G.M.); Centrul de Oncologie Sf Nectarie, Craiova, Romania (M.S.); the National Cancer Center Hospital East, Chiba, Japan (T.Y.); Shanghai East Hospital, Shanghai, China (J.L.); the University of Southern California Norris Comprehensive Cancer Center, Los Angeles (H.-J.L.); Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome (G.T.), and Veneto Institute of Oncology IOV-IRCCS, Padua (S.L.) - both in Italy; the Netherlands Cancer Institute, Amsterdam (M.C.); Cancer Research SA, Adelaide, SA, Australia (R.J.); Hematology-Oncology Practice Eppendorf (HOPE) and University Cancer Center Hamburg (UCCH), Hamburg, Germany (E.G.); the Institute of Cancer of São Paulo, São Paulo (M.I.B.); Adana City Education and Research Hospital, Adana, Turkey (T. Cil); and Bristol Myers Squibb, Princeton, NJ (E.C., T. Chen, M.L., M.D., S.A.).
与化疗相比,尼沃卢马布加上伊皮利穆马布显著改善了微卫星不稳定性高 (MSI-H) 或不匹配修复缺陷 (dMMR) 的转移性结直肠癌患者的无进展生存期. 这种免疫疗法组合为这种患者群体提供了优越的第一线治疗选择.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠道癌症 胃肠道癌症
背景情况:
- 具有MSI-H或dMMR状态的转移性结直肠癌 (mCRC) 历史上对标准化疗反应不佳.
- 在MSI-H/dMMRmCRC之前的非随机研究中,尼沃卢马布加上伊皮利马布已经证明了潜在的临床益处.
研究的目的:
- 为了评估nivolumab加上ipilimumab的疗效,与化疗相比,作为MSI-H或dMMR状态的不可切除或转移性结直肠癌的第一线治疗.
主要方法:
- 第3期,开放标签试验,随机分配MSI-H/dMMRmCRC患者接受尼沃卢马布加上伊皮利穆马布,单独尼沃卢马布或化疗 (2:2:1比率).
- 主要终点侧重于无进展生存期 (PFS),比较一线治疗中nivolumab加上ipilimumab与化疗.
- 临时分析评估了nivolumab加上ipilimumab与化疗的PFS主要终点.
主要成果:
- 在中心确诊的MSI-H/dMMR瘤的255名患者中,尼沃卢马布加上伊皮利穆马布比化疗显著改善了PFS (P<0.001).
- 24个月的PFS为nivolumab和ipilimumab的72%,与化疗的14%相比.
- 与化学疗法 (48%) 相比,尼沃卢马布加上伊皮利穆马布 (23%) 的3/4级不良事件较低.
结论:
- 与MSI-H/dMMR转移性结直肠癌的第一线治疗化学疗法相比,尼沃卢马布加上伊皮利穆马布的无进展生存率更高.
- 组合免疫疗法对这种特定结直肠癌亚型的患者来说是一个显著的进步.
相关概念视频
Tumor Immunotherapy
Drugs that Stabilize Microtubules


