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Nivolumab in Previo...
Nivolumab in Previously Untreated Melanoma without BRAF Mutation
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Robert, Caroline (author)
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Long, Georgina V. (author)
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Brady, Benjamin (author)
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Dutriaux, Caroline (author)
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Maio, Michele (author)
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Mortier, Laurent (author)
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Hassel, Jessica C. (author)
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Rutkowski, Piotr (author)
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McNeil, Catriona (author)
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Kalinka-Warzocha, Ewa (author)
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Savage, Kerry J. (author)
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Hernberg, Micaela M. (author)
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Lebbe, Celeste (author)
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Charles, Julie (author)
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Mihalcioiu, Catalin (author)
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Chiarion-Sileni, Vanna (author)
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Mauch, Cornelia (author)
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Cognetti, Francesco (author)
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Arance, Ana (author)
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Schmidt, Henrik (author)
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Schadendorf, Dirk (author)
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Gogas, Helen (author)
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- Lundgren, Lotta (author)
- Lund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine
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Horak, Christine (author)
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Sharkey, Brian (author)
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Waxman, Ian M. (author)
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Atkinson, Victoria (author)
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Ascierto, Paolo A. (author)
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(creator_code:org_t)
- 2015
- 2015
- English.
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In: New England Journal of Medicine. - 0028-4793. ; 372:4, s. 320-330
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http://dx.doi.org/10...
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https://doi.org/10.1...
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Abstract
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- 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 < 0.001). The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group (hazard ratio for death or progression of disease, 0.43; 95% CI, 0.34 to 0.56; P < 0.001). The objective response rate was 40.0% (95% CI, 33.3 to 47.0) in the nivolumab group versus 13.9% (95% CI, 9.5 to 19.4) in the dacarbazine group (odds ratio, 4.06; P < 0.001). The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups, including subgroups defined by status regarding the programmed death ligand 1 (PD-L1). Common adverse events associated with nivolumab included fatigue, pruritus, and nausea. Drug-related adverse events of grade 3 or 4 occurred in 11.7% of the patients treated with nivolumab and 17.6% of those treated with dacarbazine. CONCLUSIONS Nivolumab was associated with significant improvements in overall survival and progression-free survival, as compared with dacarbazine, among previously untreated patients who had metastatic melanoma without a BRAF mutation.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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- By the author/editor
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Robert, Caroline
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Long, Georgina V ...
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Brady, Benjamin
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Dutriaux, Caroli ...
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Maio, Michele
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Mortier, Laurent
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show more...
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Hassel, Jessica ...
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Rutkowski, Piotr
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McNeil, Catriona
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Kalinka-Warzocha ...
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Savage, Kerry J.
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Hernberg, Micael ...
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Lebbe, Celeste
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Charles, Julie
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Mihalcioiu, Cata ...
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Chiarion-Sileni, ...
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Mauch, Cornelia
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Cognetti, France ...
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Arance, Ana
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Schmidt, Henrik
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Schadendorf, Dir ...
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Gogas, Helen
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Lundgren, Lotta
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Horak, Christine
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Sharkey, Brian
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Waxman, Ian M.
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Atkinson, Victor ...
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Ascierto, Paolo ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
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New England Jour ...
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Lund University