| Autor: |
Robert, C. Long, G.V. Brady, B. Dutriaux, C. Maio, M. Mortier, L. Hassel, J.C. Rutkowski, P. McNeil, C. Kalinka-Warzocha, E. Savage, K.J. Hernberg, M.M. Lebbé, C. Charles, J. Mihalcioiu, C. Chiarion-Sileni, V. Mauch, C. Cognetti, F. Arance, A. Schmidt, H. Schadendorf, D. Gogas, H. Lundgren-Eriksson, L. Horak, C. Sharkey, B. Waxman, I.M. Atkinson, V. Ascierto, P.A. |
| Jazyk: |
angličtina |
| Rok vydání: |
2015 |
| Popis: |
BACKGROUND: Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma. The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study. METHODS: We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab (at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks) or dacarbazine (at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks). The primary end point was overall survival. RESULTS: At 1 year, the overall rate of survival was 72.9% (95% confidence interval [CI], 65.5 to 78.9) in the nivolumab group, as compared with 42.1% (95% CI, 33.0 to 50.9) in the dacarbazine group (hazard ratio for death, 0.42; 99.79% CI, 0.25 to 0.73; P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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