First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen(IPSOS):a phase 3,global,multicentre,open-label,randomised controlled study
作者机构:[a]Department of Oncology University College London Hospitals NHS Foundation Trust CRUK Lung Cancer Centre of Excellence and UCL Cancer Institute London UK [b]Bereich Pneumologie Klinik und Poliklinik für Innere Medizin II University Hospital Regensburg Regensburg Germany [c]Department of Medical Oncology Tata Memorial Hospital Mumbai India [d]Department of Lung Cancer and Thoracic Tumors Maria Sklodowska-Curie National Research Institute of Oncology Warsaw Poland [e]Department of Lung Diseases Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Otwock Poland [f]Department of Pulmonary Medicine Shanghai Chest Hospital Shanghai Jiao Tong University Shanghai China [g]Department of Thoracic Oncology LKI Lungenfachklinik Immenhausen Immenhausen Germany [h]Department of Oncology Royal Cornwall Hospitals NHS Trust Truro UK [i]Medical Oncology Department Hospital Universitario Virgen Macarena Seville Spain [j]Department of Medical Oncology The Christie NHS Foundation Trust and Division of Cancer Sciences University of Manchester Manchester UK [k]Department of Medical Oncology AAST H S Gerardo Monza Monza Italy [l]Cho Ray Cancer Centre Cho Ray Hospital Ho Chi Minh City Viet Nam [m]Department of Thoracic Oncology National Clinical Research Centre for Cancer Tianjin Medical University Cancer Institute & Hospital Tianjin China [n]Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada [o]Department of Oncology National Cancer Institute IRCCS Regina Elena Rome Italy [p]Oncologico Potosino San Luis Potosí Mexico [q]Department of Thoracic Oncology Lungen Clinic Grosshansdorf Airway Research Centre North German Centre for Lung Research Grosshansdorf Germany [r]Department of Medical Oncology Catalan Institute of Oncology Hospital Duran i Reynals L'Hospitalet Barcelona Spain [s]Department of Medical Oncology Instituto do Cancer do Estado de Sao Paulo Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo Brazil [t]F Hoffmann-La Roche Basel Switzerland [u]Genentech San Francisco CA USA [v]Centre Hospitalier Universitaire Vaudois Lausanne University Lausanne Switzerland [w]Pfizer Kent UK
出 版 物:《四川生理科学杂志》 (Sichuan Journal of Physiological Sciences)
年 卷 期:2023年第45卷第8期
页 面:1332-1332页
核心收录:
学科分类:1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金:University College London Biochemical Research Centre Genentech F. Hoffmann-La Roche UCLH Biomedical Research Centre, NIHR BRC
摘 要:Background:Despite immunotherapy advancements for patients with advanced or metastatic non-small-cell lung cancer(NSCLC),pivotal first-line trials were limited to patients with an Eastern Cooperative Oncology Group performance status(ECOG PS)0-1 and a median age of 65 years or *** aimed to compare the efficacy and safety of first-line atezolizumab monotherapy with single-agent chemotherapy in patients ineligible for platinum-based ***:This trial was a phase 3,open-label,randomised controlled study conducted at 91 sites in 23 countries across Asia,Europe,North America,and South *** patients had stage IIIB or IV NSCLC in whom platinum-doublet chemotherapy was deemed unsuitable by the investigator due to an ECOG PS 2 or 3,or alternatively,being 70 years or older with an ECOG PS 0-1 with substantial comorbidities or contraindications for platinum-doublet *** were randomised 2:1 by permuted-block randomisation(block size of six)to receive 1200 mg of atezolizumab given intravenously every 3 weeks or single-agent chemotherapy(vinorelbine[oral or intravenous]or gemcitabine[intravenous];dosing per local label)at 3-weekly or 4-weekly *** primary endpoint was overall survival assessed in the intention-to-treat *** analyses were conducted in the safety-evaluable population,which included all randomised patients who received any amount of atezolizumab or *** trial is registered with ***,NCT03191786.