Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer
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- Hossein Borghaei
- Fox Chase Cancer Center, Philadelphia, PA
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- Scott Gettinger
- Yale Comprehensive Cancer Center, New Haven, CT
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- Everett E. Vokes
- Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL
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- Laura Q. M. Chow
- University of Washington, Seattle Cancer Care Alliance, Seattle, WA
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- Marco Angelo Burgio
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy
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- Javier de Castro Carpeno
- Hospital De Madrid, Norte Sanchinarro, Madrid, Spain
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- Adam Pluzanski
- Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland
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- Oscar Arrieta
- Instituto Nacional De Cancerología, Mexico City, Mexico
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- Osvaldo Arén Frontera
- Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile
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- Rita Chiari
- Ospedale S. Maria Della Misericordia, Perugia, Italy
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- Charles Butts
- Cross Cancer Institute, Edmonton, AB, Canada
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- Joanna Wójcik-Tomaszewska
- Provincial Center of Oncology in Gdańsk, Gdańsk, Poland
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- Bruno Coudert
- Centre Georges-François Leclerc, Dijon, France
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- Marina Chiara Garassino
- Instituto Nazionale per Lo Studio e La Cura, Milano, Italy
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- Neal Ready
- Duke University Medical Center, Durham, NC
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- Enriqueta Felip
- Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain
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- Miriam Alonso García
- Hospital Universitario Virgen Del Rocio, Sevilla, Spain
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- David Waterhouse
- Oncology Hematology Care, Inc, Cincinnati, OH
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- Manuel Domine
- Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain
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- Fabrice Barlesi
- Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France
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- Scott Antonia
- H. Lee Moffitt Cancer Center, Tampa, FL
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- Markus Wohlleber
- Robert Bosch Cancer Center, Gerlingen, Germany
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- David E. Gerber
- UT Southwestern Medical Center, Dallas, TX
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- Grzegorz Czyzewicz
- John Paul II Hospital, Kraków, Poland
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- David R. Spigel
- Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN
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- Lucio Crino
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy
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- Wilfried Enst Erich Eberhardt
- Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany
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- Ang Li
- Bristol Myers Squibb, Princeton, NJ
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- Sathiya Marimuthu
- Bristol Myers Squibb, Princeton, NJ
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- Julie Brahmer
- Johns Hopkins Kimmel Cancer Center, Baltimore, MD
Description
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m<jats:sup>2</jats:sup> once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3–5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC. </jats:p></jats:sec>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 39 (7), 723-733, 2021-03-01
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1360013171182497408
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref