دورية أكاديمية
Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma
| العنوان: | Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma |
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| المؤلفون: | Motzer, Robert J., Tannir, Nizar M., McDermott, David F., Arén Frontera, Osvaldo, Melichar, Bohuslav, Choueiri, Toni K., Plimack, Elizabeth R., Barthélémy, Philippe, Porta, Camillo, George, Saby, Powles, Thomas, Donskov, Frede, Neiman, Victoria, Kollmannsberger, Christian K., Salman, Pamela, Gurney, Howard, Hawkins, Robert, Ravaud, Alain, Grimm, Marc-Oliver, Bracarda, Sergio, Barrios, Carlos H., Tomita, Yoshihiko, Castellano, Daniel, Rini, Brian I., Chen, Allen C., Mekan, Sabeen, McHenry, M. Brent, Wind-Rotolo, Megan, Doan, Justin, Sharma, Padmanee, Hammers, Hans J., Escudier, Bernard, CheckMate 214 Investigators, missing, Rottey, Sylvie |
| المصدر: | NEW ENGLAND JOURNAL OF MEDICINE ; ISSN: 0028-4793 ; ISSN: 1533-4406 |
| سنة النشر: | 2018 |
| المجموعة: | Ghent University Academic Bibliography |
| مصطلحات موضوعية: | Medicine and Health Sciences, General Medicine, PHASE-III TRIAL, INTERFERON-ALPHA, UNTREATED MELANOMA, 1ST-LINE TREATMENT, SYMPTOM INDEX, KIDNEY CANCER, OPEN-LABEL, PAZOPANIB, THERAPY, MULTICENTER |
| الوصف: | BACKGROUND Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma. METHODS We randomly assigned adults in a 1:1 ratio to receive either nivolumab (3 mg per kilogram of body weight) plus ipilimumab (1 mg per kilogram) intravenously every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram) every 2 weeks, or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The coprimary end points were overall survival (alpha level, 0.04), objective response rate (alpha level, 0.001), and progression-free survival (alpha level, 0.009) among patients with intermediate or poor prognostic risk. RESULTS A total of 1096 patients were assigned to receive nivolumab plus ipilimumab (550 patients) or sunitinib (546 patients); 425 and 422, respectively, had intermediate or poor risk. At a median follow-up of 25.2 months in intermediate-and poor-risk patients, the 18-month overall survival rate was 75% (95% confidence interval [CI], 70 to 78) with nivolumab plus ipilimumab and 60% (95% CI, 55 to 65) with sunitinib; the median overall survival was not reached with nivolumab plus ipilimumab versus 26.0 months with sunitinib (hazard ratio for death, 0.63; P<0.001). The objective response rate was 42% versus 27% (P<0.001), and the complete response rate was 9% versus 1%. The median progression-free survival was 11.6 months and 8.4 months, respectively (hazard ratio for disease progression or death, 0.82; P = 0.03, not significant per the prespecified 0.009 threshold). Treatment-related adverse events occurred in 509 of 547 patients (93%) in the nivolumab-plus-ipilimumab group and 521 of 535 patients (97%) in the sunitinib group; grade 3 or 4 events occurred in 250 patients (46%) and 335 patients (63%), respectively. Treatment- related adverse events leading to discontinuation occurred in 22% and 12% of the patients ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://biblio.ugent.be/publication/8730625Test; http://hdl.handle.net/1854/LU-8730625Test; http://dx.doi.org/10.1056/nejmoa1712126Test; https://biblio.ugent.be/publication/8730625/file/8730628Test |
| DOI: | 10.1056/nejmoa1712126 |
| الإتاحة: | https://doi.org/10.1056/nejmoa1712126Test https://biblio.ugent.be/publication/8730625Test http://hdl.handle.net/1854/LU-8730625Test https://biblio.ugent.be/publication/8730625/file/8730628Test |
| حقوق: | No license (in copyright) ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.7FFDBE90 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/nejmoa1712126 |
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