Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
| Autor: | Sabeen Mekan, Philippe Barthélémy, Marc-Oliver Grimm, Bohuslav Melichar, Allen C. Chen, Robert E. Hawkins, David F. McDermott, Christian Kollmannsberger, Brian I. Rini, M. Brent McHenry, Megan Wind-Rotolo, Sergio Bracarda, Nizar M. Tannir, Carlos H. Barrios, Toni K. Choueiri, Camillo Porta, Osvaldo Arén Frontera, Bernard Escudier, Robert J. Motzer, Yoshihiko Tomita, Justin Doan, Howard Gurney, V. Neiman, Frede Donskov, Alain Ravaud, Pamela Salman, Hans J. Hammers, Daniel Castellano, Thomas Powles, Saby George, Elizabeth R. Plimack, Padmanee Sharma |
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| Přispěvatelé: | Hospital Universitario 12 de Octubre, Lääketieteen ja biotieteiden tiedekunta - Faculty of Medicine and Life Sciences, Tampere University |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Anticuerpos Monoclonales Male Indoles MULTICENTER Supervivencia sin Enfermedad urologic and male genital diseases THERAPY 0302 clinical medicine Antineoplastic Agents Immunological Renal cell carcinoma Antineoplastic Combined Chemotherapy Protocols Medicine and Health Sciences Sunitinib Tasa de Supervivencia Ipilimumab/administration & dosage Masculino Aged 80 and over Persona de Mediana Edad KIDNEY CANCER Adulto Antibodies Monoclonal PHASE-III TRIAL General Medicine Indoles/administration & dosage Middle Aged OPEN-LABEL Kidney Neoplasms Humanos Axitinib Survival Rate Kidney Neoplasms/drug therapy Nivolumab 030220 oncology & carcinogenesis Antineoplásicos Inmunológicos medicine.drug Protocolos de Quimioterapia Combinada Antineoplásica Adult Risk medicine.medical_specialty Análisis de Supervivencia Anciano Urology Ipilimumab Riesgo Antibodies Monoclonal/administration & dosage Disease-Free Survival PAZOPANIB 03 medical and health sciences Antineoplastic Agents Immunological/administration & dosage Syöpätaudit - Cancers medicine Carcinoma Humans Pyrroles SYMPTOM INDEX Carcinoma de Células Renales Survival rate Carcinoma Renal Cell Survival analysis Aged business.industry Antineoplastic Combined Chemotherapy Protocols/adverse effects Pyrroles/administration & dosage UNTREATED MELANOMA medicine.disease Pirroles Survival Analysis Anciano de 80 o más Años 1ST-LINE TREATMENT 030104 developmental biology Carcinoma Renal Cell/drug therapy Quality of Life Calidad de Vida INTERFERON-ALPHA business Neoplasias Renales |
| Zdroj: | CheckMate 214 Investigators 2018, ' Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma ', The New England Journal of Medicine, vol. 378, no. 14, pp. 1277-1290 . https://doi.org/10.1056/NEJMoa1712126 Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid NEW ENGLAND JOURNAL OF MEDICINE |
| ISSN: | 0028-4793 1533-4406 |
| Popis: | 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; PCONCLUSIONS: Overall survival and objective response rates were significantly higher with nivolumab plus ipilimumab than with sunitinib among intermediate- and poor-risk patients with previously untreated advanced renal-cell carcinoma. (Funded by Bristol-Myers Squibb and Ono Pharmaceutical; CheckMate 214 ClinicalTrials.gov number, NCT02231749 .). |
| Databáze: | OpenAIRE |
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