Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non–Small-Cell Lung Cancer in CheckMate 227
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- Julie R. Brahmer
- Johns Hopkins Kimmel Cancer Center, Baltimore, MD
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- Jong-Seok Lee
- National University Bundang Hospital, Seongnam, Republic of Korea
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- Tudor-Eliade Ciuleanu
- Institutul Oncologic Prof Dr Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania
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- Reyes Bernabe Caro
- Hospital Universitario Virgen Del Rocio, Instituto de Biomedicina de Seville, Seville, Spain
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- Makoto Nishio
- Department of Thoracic Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
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- Laszlo Urban
- Matrai Gyogyintezet, Mátraháza, Hungary
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- Clarisse Audigier-Valette
- Orientation Oncologique, Hôpital Sainte Musse, Toulon, France
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- Lorena Lupinacci
- Hospital Italiano De Buenos Aires, Buenos Aires, Argentina
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- Randeep Sangha
- Cross Cancer Institute, Edmonton, AB, Canada
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- Adam Pluzanski
- Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
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- Jacobus Burgers
- Netherlands Cancer Institute, Amsterdam, the Netherlands
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- Mauricio Mahave
- Instituto Oncológico Fundación Arturo López Pérez, Santiago, Chile
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- Samreen Ahmed
- University Hospitals of Leicester NHS Trust, Infirmary Square, Leicester, United Kingdom
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- Adam J. Schoenfeld
- Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY
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- Luis G. Paz-Ares
- Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain
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- Martin Reck
- Airway Research Center North, German Center for Lung Research, Lung Clinic, Grosshansdorf, Germany
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- Hossein Borghaei
- Fox Chase Cancer Center, Philadelphia, PA
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- Kenneth J. O'Byrne
- Princess Alexandra Hospital, Translational Research Institute and Queensland University of Technology, Brisbane, Queensland, Australia
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- Ravi G. Gupta
- Bristol Myers Squibb, Princeton, NJ
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- Judith Bushong
- Bristol Myers Squibb, Princeton, NJ
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- Li Li
- Bristol Myers Squibb, Princeton, NJ
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- Steven I. Blum
- Bristol Myers Squibb, Princeton, NJ
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- Laura J. Eccles
- Bristol Myers Squibb, Princeton, NJ
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- Suresh S. Ramalingam
- Winship Cancer Institute, Emory University, Atlanta, GA
説明
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> We present 5-year results from CheckMate 227 Part 1, in which nivolumab plus ipilimumab improved overall survival (OS) versus chemotherapy in patients with metastatic non–small-cell lung cancer, regardless of tumor programmed death ligand 1 (PD-L1) status. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Adults with stage IV/recurrent non–small-cell lung cancer without EGFR mutations or ALK alterations and with tumor PD-L1 ≥ 1% or < 1% (n = 1739) were randomly assigned. Patients with tumor PD-L1 ≥ 1% were randomly assigned to first-line nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. Patients with tumor PD-L1 < 1% were randomly assigned to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy. End points included exploratory 5-year results for efficacy, safety, and quality of life. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> At a minimum follow-up of 61.3 months, 5-year OS rates were 24% versus 14% for nivolumab plus ipilimumab versus chemotherapy (PD-L1 ≥ 1%) and 19% versus 7% (PD-L1 < 1%). The median duration of response was 24.5 versus 6.7 months (PD-L1 ≥ 1%) and 19.4 versus 4.8 months (PD-L1 < 1%). Among patients surviving 5 years, 66% (PD-L1 ≥ 1%) and 64% (PD-L1 < 1%) were off nivolumab plus ipilimumab without initiating subsequent systemic anticancer treatment by the 5-year time point. Survival benefit continued after nivolumab plus ipilimumab discontinuation because of treatment-related adverse events, with a 5-year OS rate of 39% (combined PD-L1 ≥ 1% and < 1% populations). Quality of life in 5-year survivors treated with nivolumab plus ipilimumab was similar to that in the general US population through the 5-year follow-up. No new safety signals were observed. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> With all patients off immunotherapy treatment for ≥ 3 years, nivolumab plus ipilimumab increased 5-year survivorship versus chemotherapy, including long-term, durable clinical benefit regardless of tumor PD-L1 expression. These data support nivolumab plus ipilimumab as an effective first-line treatment for patients with metastatic non–small-cell lung cancer. </jats:p></jats:sec><jats:sec><jats:title /><jats:p> [Media: see text] </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 41 (6), 1200-1212, 2023-02-20
American Society of Clinical Oncology (ASCO)