دورية أكاديمية
Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.
| العنوان: | 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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| المؤلفون: | Borghaei H; Fox Chase Cancer Center, Philadelphia, PA., Gettinger S; Yale Comprehensive Cancer Center, New Haven, CT., Vokes EE; Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL., Chow LQM; University of Washington, Seattle Cancer Care Alliance, Seattle, WA., Burgio MA; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., de Castro Carpeno J; Hospital De Madrid, Norte Sanchinarro, Madrid, Spain., Pluzanski A; Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland., Arrieta O; Instituto Nacional De Cancerología, Mexico City, Mexico., Frontera OA; Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile., Chiari R; Ospedale S. Maria Della Misericordia, Perugia, Italy., Butts C; Cross Cancer Institute, Edmonton, AB, Canada., Wójcik-Tomaszewska J; Provincial Center of Oncology in Gdańsk, Gdańsk, Poland., Coudert B; Centre Georges-François Leclerc, Dijon, France., Garassino MC; Instituto Nazionale per Lo Studio e La Cura, Milano, Italy., Ready N; Duke University Medical Center, Durham, NC., Felip E; Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain., García MA; Hospital Universitario Virgen Del Rocio, Sevilla, Spain., Waterhouse D; Oncology Hematology Care, Inc, Cincinnati, OH., Domine M; Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain., Barlesi F; Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France., Antonia S; H. Lee Moffitt Cancer Center, Tampa, FL., Wohlleber M; Robert Bosch Cancer Center, Gerlingen, Germany., Gerber DE; UT Southwestern Medical Center, Dallas, TX., Czyzewicz G; John Paul II Hospital, Kraków, Poland., Spigel DR; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN., Crino L; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy., Eberhardt WEE; Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany., Li A; Bristol Myers Squibb, Princeton, NJ., Marimuthu S; Bristol Myers Squibb, Princeton, NJ., Brahmer J; Johns Hopkins Kimmel Cancer Center, Baltimore, MD. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2021 Mar 01; Vol. 39 (7), pp. 723-733. Date of Electronic Publication: 2021 Jan 15. |
| نوع المنشور: | Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Immunotherapy*/adverse effects , Immunotherapy*/mortality, Carcinoma, Non-Small-Cell Lung/*drug therapy , Docetaxel/*therapeutic use , Immune Checkpoint Inhibitors/*therapeutic use , Lung Neoplasms/*drug therapy , Nivolumab/*therapeutic use , Tubulin Modulators/*therapeutic use, Adult ; Aged ; Aged, 80 and over ; Carcinoma, Non-Small-Cell Lung/immunology ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/pathology ; Clinical Trials, Phase III as Topic ; Disease Progression ; Docetaxel/adverse effects ; Female ; Humans ; Immune Checkpoint Inhibitors/adverse effects ; Lung Neoplasms/immunology ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Nivolumab/adverse effects ; Progression-Free Survival ; Randomized Controlled Trials as Topic ; Time Factors ; Tubulin Modulators/adverse effects ; Young Adult |
| مستخلص: | Purpose: 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. Methods: 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 2 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. Results: 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. Conclusion: 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. |
| التعليقات: | Erratum in: J Clin Oncol. 2021 Apr 1;39(10):1190. (PMID: 33780642) |
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| معلومات مُعتمدة: | UL1 TR001863 United States TR NCATS NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT01642004; NCT01673867 |
| المشرفين على المادة: | 0 (Immune Checkpoint Inhibitors) 0 (Tubulin Modulators) 15H5577CQD (Docetaxel) 31YO63LBSN (Nivolumab) |
| تواريخ الأحداث: | Date Created: 20210115 Date Completed: 20210920 Latest Revision: 20220302 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC8078445 |
| DOI: | 10.1200/JCO.20.01605 |
| PMID: | 33449799 |
| قاعدة البيانات: | MEDLINE |
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