Robert, Caroline ORCID: 0000-0002-9493-0238, Long, Georgina V., Brady, Benjamin, Dutriaux, Caroline, Maio, Michele ORCID: 0000-0002-0323-6321, Mortier, Laurent, Hassel, Jessica C., Rutkowski, Piotr ORCID: 0000-0002-8920-5429, McNeil, Catriona, Kalinka-Warzocha, Ewa, Savage, Kerry J., Hernberg, Micaela M., Lebbe, Celeste, Charles, Julie, Mihalcioiu, Catalin, Chiarion-Sileni, Vanna, Mauch, Cornelia, Cognetti, Francesco, Arance, Ana ORCID: 0000-0003-2896-1957, Schmidt, Henrik, Schadendorf, Dirk, Gogas, Helen, Lundgren-Eriksson, Lotta, Horak, Christine, Sharkey, Brian, Waxman, Ian M., Atkinson, Victoria and Ascierto, Paolo A. (2015). Nivolumab in Previously Untreated Melanoma without BRAF Mutation. N. Engl. J. Med., 372 (4). S. 320 - 331. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Robert, CarolineUNSPECIFIEDorcid.org/0000-0002-9493-0238UNSPECIFIED
Long, Georgina V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brady, BenjaminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dutriaux, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maio, MicheleUNSPECIFIEDorcid.org/0000-0002-0323-6321UNSPECIFIED
Mortier, LaurentUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hassel, Jessica C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rutkowski, PiotrUNSPECIFIEDorcid.org/0000-0002-8920-5429UNSPECIFIED
McNeil, CatrionaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalinka-Warzocha, EwaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Savage, Kerry J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hernberg, Micaela M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lebbe, CelesteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Charles, JulieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mihalcioiu, CatalinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chiarion-Sileni, VannaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mauch, CorneliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cognetti, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Arance, AnaUNSPECIFIEDorcid.org/0000-0003-2896-1957UNSPECIFIED
Schmidt, HenrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schadendorf, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gogas, HelenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lundgren-Eriksson, LottaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Horak, ChristineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sharkey, BrianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waxman, Ian M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Atkinson, VictoriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ascierto, Paolo A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-414454
DOI: 10.1056/NEJMoa1412082
Journal or Publication Title: N. Engl. J. Med.
Volume: 372
Number: 4
Page Range: S. 320 - 331
Date: 2015
Publisher: MASSACHUSETTS MEDICAL SOC
Place of Publication: WALTHAM
ISSN: 1533-4406
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
METASTATIC MELANOMA; ANTI-PD-1 ANTIBODY; IMPROVED SURVIVAL; MEK INHIBITION; OPEN-LABEL; VEMURAFENIB; SAFETY; IPILIMUMAB; EFFICACY; PHASE-3Multiple languages
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/41445

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