术期间使用杜尔瓦卢马布治疗可切除的非小细胞肺癌
John V Heymach1, David Harpole1, Tetsuya Mitsudomi1
1From the Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (J.V.H.), and US Oncology Research, the Woodlands (A.S.) - both in Texas; the Department of Surgery, Duke University Medical Center (D.H.), and Duke Cancer Institute (J.C.) - both in Durham, NC; the Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama (T.M.), the Department of Thoracic Surgery, Aichi Cancer Center Hospital, Aichi (H.K.), and Internal Medicine III, Wakayama Medical University, Wakayama (H.A.) - all in Japan; the Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins Kimmel Cancer Center, Baltimore (J.M.T.); Törökbalint Institute of Pulmonology, Törökbálint (G. Galffy), Koranyi National Institute for TB and Pulmonology, Budapest (G.O.), and the University Teaching Hospital of Fejér County, Székesfehérvár (Z.P.-S.) - all in Hungary; the Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna (M.H.), and the Department of Hematology, Oncology, Gastroenterology and Infectiology, Landeskrankenhaus Feldkirch, Feldkirch (T.W.) - both in Austria; Krasnoyarsk State Medical University, Krasnoyarsk, Russia (R.Z.); Fundación Estudios Clínicos, Santa Fe, Argentina (G. Garbaos); the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (S.G.), and the Department of Lung Cancer, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin (J.Y.) - both in China; the Oncology and Chemotherapy Department, University Medical Center of Ho Chi Minh City, Ho Chi Minh City (T.V.T.), and No. 1 Medical Oncology Department, Hanoi Oncology Hospital, Hanoi (H.T.L.) - both in Vietnam; the Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan (K.-Y.L.); the Clinical Oncology Unit, Careggi University Hospital, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy (L.A.); Tata Medical Center, Kolkata, India (B.B.); Virginia Cancer Specialists Research Institute, Fairfax (A.S.); AstraZeneca, Cambridge, United Kingdom (M.A., G.J.D., H.M.); AstraZeneca, New York (T.M.F.); and Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany (M.R.).
术后的杜尔瓦卢马布与化疗相结合,显著改善了可切除非小细胞肺癌 (NSCLC) 患者的无事件生存率和病理完整反应. 这种免疫疗法方法显示出良好的安全性,为患者提供了新的治疗选择.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胸部外科手术 胸部外科手术
背景情况:
- 新辅助或辅助免疫疗法增强了可切除的非小细胞肺癌 (NSCLC) 的结果.
- 周术期免疫疗法方案旨在结合新辅助剂和辅助剂的益处,以改善患者的长期结果.
- 研究术前期杜瓦卢马布与可切除NSCLC的化疗联合治疗的疗效.
研究的目的:
- 评估术后杜尔瓦卢马布加化疗对可切除NSCLC患者无事件生存期 (EFS) 的影响.
- 评估与安慰剂相比,接受术后杜尔瓦卢马布的患者的病理完整响应 (pCR) 率.
- 为了确定外科手术期间的杜尔瓦卢马布治疗方案的安全性和耐受性.
主要方法:
- 一项随机试验分配了802名可切除NSCLC (II-IIIB阶段) 的患者,接受基于的化疗加上杜尔瓦卢马布或安慰剂.
- 治疗包括4个周期的新辅助疗法,其次是12个周期的辅助疗法,随机分层根据阶段和PD-L1表达.
- 主要终点包括无事件生存率和病理完整反应,并分析了疗效和安全性数据.
主要成果:
- 杜尔瓦卢马布显著改善了EFS,疾病进展,复发或死亡的危险比为0.68 (P=0.004).
- 在12个月后,Durvalumab的EFS为73.4%,而安慰剂为64.5%;pCR显著更高 (17.2%对4.3%,P<0.001).
- 在不同阶段和PD-L1表达水平中观察到益处,与类似的3/4级不良事件率 (42.4%与43.2%) 相似.
结论:
- 与单独的化疗相比,外科术期间的杜尔瓦卢马布加上新辅助化疗显著增强了可切除NSCLC的EFS和pCR.
- 术后杜尔瓦卢马布的安全性概况与其单个药物一致,支持其临床实用性.
- 这种术后免疫疗法策略对可切除的NSCLC患者来说是一个有前途的进步.
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