دورية أكاديمية
Nivolumab versus everolimus in patients with advanced renal cell carcinoma:Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial
| العنوان: | Nivolumab versus everolimus in patients with advanced renal cell carcinoma:Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial |
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| المؤلفون: | Motzer, Robert J., Escudier, Bernard, George, Saby, Hammers, Hans J., Srinivas, Sandhya, Tykodi, Scott S., Sosman, Jeffrey A., Plimack, Elizabeth R., Procopio, Giuseppe, McDermott, David F., Castellano, Daniel, Choueiri, Toni K., Donskov, Frede, Gurney, Howard, Oudard, Stéphane, Richardet, Martin, Peltola, Katriina, Alva, Ajjai S., Carducci, Michael, Wagstaff, John, Chevreau, Christine, Fukasawa, Satoshi, Tomita, Yoshihiko, Gauler, Thomas C., Kollmannsberger, Christian K., Schutz, Fabio A., Larkin, James, Cella, David, McHenry, M. Brent, Saggi, Shruti Shally, Tannir, Nizar M. |
| المصدر: | Motzer , R J , Escudier , B , George , S , Hammers , H J , Srinivas , S , Tykodi , S S , Sosman , J A , Plimack , E R , Procopio , G , McDermott , D F , Castellano , D , Choueiri , T K , Donskov , F , Gurney , H , Oudard , S , Richardet , M , Peltola , K , Alva , A S , Carducci , M , Wagstaff , J , Chevreau , C , Fukasawa , S , Tomita , Y .... |
| سنة النشر: | 2020 |
| المجموعة: | Aarhus University: Research |
| مصطلحات موضوعية: | advanced renal cell carcinoma (aRCC), CheckMate 025, everolimus, immune checkpoint inhibitor, nivolumab, previously treated, SURVIVAL, SAFETY, DOSE RECOMBINANT INTERLEUKIN-2, LIFE, Kidney Neoplasms/drug therapy, Follow-Up Studies, Humans, Male, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols/pharmacology, Everolimus/pharmacology, Carcinoma, Renal Cell/drug therapy, Female, Nivolumab/pharmacology |
| الوصف: | Background: 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-term clinical benefits of nivolumab versus everolimus. Methods: The randomized, open-label, 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-free survival (PFS), safety, and health-related quality of life (HRQOL). Results: Eight hundred twenty-one patients were randomized to nivolumab (n = 410) or everolimus (n = 411); 803 patients were treated (406 with nivolumab and 397 with everolimus). With a minimum follow-up of 64 months (median, 72 months), nivolumab maintained an OS benefit in comparison with everolimus (median, 25.8 months [95% CI, 22.2-29.8 months] vs 19.7 months [95% CI, 17.6-22.1 months]; hazard ratio [HR], 0.73; 95% CI, 0.62-0.85) with 5-year OS probabilities of 26% and 18%, respectively. ORR was higher with nivolumab (94 of 410 [23%] vs 17 of 411 [4%]; P <.001). PFS also favored nivolumab (HR, 0.84; 95% CI, 0.72-0.99; P =.0331). The most common treatment-related 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. Conclusions: The superior efficacy of nivolumab over everolimus is maintained after extended follow-up with no new safety signals, and this supports the long-term benefits of nivolumab monotherapy in patients with previously treated aRCC. LAY SUMMARY: CheckMate 025 compared the effects of nivolumab (a novel immunotherapy) with those ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://pure.au.dk/portal/en/publications/5591d1af-cf99-4c16-9a03-79e66e2d789dTest |
| DOI: | 10.1002/cncr.33033 |
| الإتاحة: | https://doi.org/10.1002/cncr.33033Test https://pure.au.dk/portal/en/publications/5591d1af-cf99-4c16-9a03-79e66e2d789dTest http://www.scopus.com/inward/record.url?scp=85088021619&partnerID=8YFLogxKTest https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415096/pdf/nihms-1732721.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.BED84468 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/cncr.33033 |
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