{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T16:27:39Z","timestamp":1791822459951,"version":"4.3.4"},"reference-count":25,"publisher":"Wiley","issue":"18","license":[{"start":{"date-parts":[[2020,7,16]],"date-time":"2020-07-16T00:00:00Z","timestamp":1594857600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["P30 CA016672"],"award-info":[{"award-number":["P30 CA016672"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2020,9,15]]},"abstract":"\n Background<\/jats:title>\n CheckMate 025 has shown superior efficacy for nivolumab over everolimus in patients with advanced renal cell carcinoma (aRCC) along with improved safety and tolerability. This analysis assesses the long\u2010term clinical benefits of nivolumab versus everolimus.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The randomized, open\u2010label, phase 3 CheckMate 025 trial (NCT01668784) included patients with clear cell aRCC previously treated with 1 or 2 antiangiogenic regimens. Patients were randomized to nivolumab (3 mg\/kg every 2 weeks) or everolimus (10 mg once a day) until progression or unacceptable toxicity. The primary endpoint was overall survival (OS). The secondary endpoints were the confirmed objective response rate (ORR), progression\u2010free survival (PFS), safety, and health\u2010related quality of life (HRQOL).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Eight hundred twenty\u2010one patients were randomized to nivolumab (n\u00a0=\u00a0410) or everolimus (n\u00a0=\u00a0411); 803 patients were treated (406 with nivolumab and 397 with everolimus). With a minimum follow\u2010up of 64 months (median, 72 months), nivolumab maintained an OS benefit in comparison with everolimus (median, 25.8 months [95% CI, 22.2\u201029.8 months] vs 19.7 months [95% CI, 17.6\u201022.1 months]; hazard ratio [HR], 0.73; 95% CI, 0.62\u20100.85) with 5\u2010year OS probabilities of 26% and 18%, respectively. ORR was higher with nivolumab (94 of 410 [23%] vs 17 of 411 [4%];\n P<\/jats:italic>\n \u00a0<\u00a0.001). PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72\u20100.99;\n P<\/jats:italic>\n \u00a0=\u00a0.0331). The most common treatment\u2010related adverse events of any grade were fatigue (34.7%) and pruritus (15.5%) with nivolumab and fatigue (34.5%) and stomatitis (29.5%) with everolimus. HRQOL improved from baseline with nivolumab but remained the same or deteriorated with everolimus.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The superior efficacy of nivolumab over everolimus is maintained after extended follow\u2010up with no new safety signals, and this supports the long\u2010term benefits of nivolumab monotherapy in patients with previously treated aRCC.<\/jats:p>\n <\/jats:sec>\n \n LAY SUMMARY<\/jats:title>\n \n \n \n CheckMate 025 compared the effects of nivolumab (a novel immunotherapy) with those of everolimus (an older standard\u2010of\u2010care therapy) for the treatment of advanced kidney cancer in patients who had progressed on antiangiogenic therapy.<\/jats:p>\n <\/jats:list-item>\n \n After 5 years of study, nivolumab continues to be better than everolimus in extending the lives of patients, providing a long\u2010lasting response to treatment, and improving quality of life with a manageable safety profile. The results demonstrate that the clinical benefits of nivolumab versus everolimus in previously treated patients with advanced kidney cancer continue in the long term.<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/cncr.33033","type":"journal-article","created":{"date-parts":[[2020,7,16]],"date-time":"2020-07-16T15:45:06Z","timestamp":1594914306000},"page":"4156-4167","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":305,"title":["Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long\u2010term follow\u2010up of the randomized, open\u2010label, phase 3 CheckMate 025 trial"],"prefix":"10.1002","volume":"126","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6925-2327","authenticated-orcid":false,"given":"Robert J.","family":"Motzer","sequence":"first","affiliation":[{"name":"Department of Medicine Memorial Sloan Kettering Cancer Center New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Escudier","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Gustave Roussy Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saby","family":"George","sequence":"additional","affiliation":[{"name":"Department of Medicine Roswell Park Cancer Institute Buffalo New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans J.","family":"Hammers","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology UT Southwestern Kidney Cancer Program Dallas Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandhya","family":"Srinivas","sequence":"additional","affiliation":[{"name":"Stanford Cancer Institute Stanford University Medical Center Stanford California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott S.","family":"Tykodi","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Washington and Fred Hutchinson Cancer Research Center Seattle Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey A.","family":"Sosman","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology Northwestern University Medical Center Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth R.","family":"Plimack","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology Fox Chase Cancer Center Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2498-402X","authenticated-orcid":false,"given":"Giuseppe","family":"Procopio","sequence":"additional","affiliation":[{"name":"Fondazione Istituto Nazionale Tumori Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F.","family":"McDermott","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Dana\u2010Farber\/Harvard Cancer Center Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Castellano","sequence":"additional","affiliation":[{"name":"Oncologia Medica Hospital Universitario 12 De Octubre Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9201-3217","authenticated-orcid":false,"given":"Toni K.","family":"Choueiri","sequence":"additional","affiliation":[{"name":"Lank Center for Genitourinary Oncology Dana\u2010Farber Cancer Institute Boston Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frede","family":"Donskov","sequence":"additional","affiliation":[{"name":"Department of Oncology Aarhus University Hospital Aarhus 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Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajjai S.","family":"Alva","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of Michigan Ann Arbor Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Carducci","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine Baltimore Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1140-5981","authenticated-orcid":false,"given":"John","family":"Wagstaff","sequence":"additional","affiliation":[{"name":"South West Wales Cancer Institute and Swansea University College of Medicine Swansea United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9866-913X","authenticated-orcid":false,"given":"Christine","family":"Chevreau","sequence":"additional","affiliation":[{"name":"Institut 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Lurie Comprehensive Cancer Center, Feinberg School of Medicine Northwestern University Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Brent","family":"McHenry","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Bristol Myers Squibb Princeton New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti Shally","family":"Saggi","sequence":"additional","affiliation":[{"name":"Department of Clinical Trials Bristol Myers Squibb Princeton New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nizar M.","family":"Tannir","sequence":"additional","affiliation":[{"name":"Department of Genitourinary Medical Oncology The University of Texas MD Anderson Cancer Center Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,7,16]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Opdivo (nivolumab) [package insert]","year":"2019"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.26.7609"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.192461099"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1510665"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30125-5"},{"key":"e_1_2_9_7_1","unstructured":"National Cancer Institute.Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 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