Ascierto, Paolo A., Long, Georgina V., Robert, Caroline ORCID: 0000-0002-9493-0238, Brady, Benjamin, Dutriaux, Caroline, Di Giacomo, Anna Maria, 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, Ny, Lars ORCID: 0000-0003-3864-5958, Arance, Ana, Svane, Inge Marie ORCID: 0000-0002-9451-6037, Schadendorf, Dirk, Gogas, Helen, Saci, Abdel, Jiang, Joel, Rizzo, Jasmine and Atkinson, Victoria (2019). Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy Three-Year Follow-up of a Randomized Phase 3 Trial. JAMA Oncol., 5 (2). S. 187 - 195. CHICAGO: AMER MEDICAL ASSOC. ISSN 2374-2445

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Abstract

IMPORTANCE This analysis provides long-term follow-up in patients with BRAF wild-type advanced melanoma receiving first-line therapy based on anti-programmed cell death 1 receptor inhibitors. OBJECTIVE To compare the 3-year survival with nivolumab vs that with dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma. DESIGN, SETTING, AND PARTICIPANTS This follow-up of a randomized phase 3 trial analyzed 3-year overall survival data from the randomized, controlled, double-blind CheckMate 066 phase 3 clinical trial. For this ongoing, multicenter academic institution trial, patients were enrolled from January 2013 through February 2014. Eligible patients were 18 years or older with confirmed unresectable previously untreated stage III or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 but without a BRAF mutation. INTERVENTIONS Patients were treated until progression or unacceptable toxic events with nivolumab (3 mg/kg every 2 weeks plus dacarbazine-matched placebo every 3 weeks) or dacarbazine (1000 mg/m(2) every 3 weeks plus nivolumab-matched placebo every 2 weeks). MAIN OUTCOME AND MEASURE Overall survival. RESULTS At minimum follow-ups of 38.4 months among 210 participants in the nivolumab group (median age, 64 years [range, 18-86 years]; 57.6% male) and 38.5 months among 208 participants in the dacarbazine group (median age, 66 years [range, 25-87 years]; 60.1% male), 3-year overall survival rates were 51.2% (95% CI, 44.1%-57.9%) and 21.6% (95% CI, 16.1%-27.6%), respectively. The median overall survival was 37.5 months (95% CI, 25.5 months-not reached) in the nivolumab group and 11.2 months (95% CI, 9.6-13.0 months) in the dacarbazine group (hazard ratio, 0.46; 95% CI, 0.36-0.59; P < .001). Complete and partial responses, respectively, were reported for 19.0% (40 of 210) and 23.8% (50 of 210) of patients in the nivolumab group compared with 1.4% (3 of 208) and 13.0% (27 of 208) of patients in the dacarbazine group. Additional analyses were performed on outcomes with subsequent therapies. Treatment-related grade 3/4 adverse events occurred in 15.0% (31 of 206) of nivolumab-treated patients and in 17.6% (36 of 205) of dacarbazine-treated patients. There were no deaths due to study drug toxic effects. CONCLUSIONS AND RELEVANCE Nivolumab led to improved 3-year overall survival vs dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Ascierto, Paolo A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Long, Georgina V.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robert, CarolineUNSPECIFIEDorcid.org/0000-0002-9493-0238UNSPECIFIED
Brady, BenjaminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dutriaux, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Giacomo, Anna MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
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
Ny, LarsUNSPECIFIEDorcid.org/0000-0003-3864-5958UNSPECIFIED
Arance, AnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Svane, Inge MarieUNSPECIFIEDorcid.org/0000-0002-9451-6037UNSPECIFIED
Schadendorf, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gogas, HelenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Saci, AbdelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jiang, JoelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rizzo, JasmineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Atkinson, VictoriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-157845
DOI: 10.1001/jamaoncol.2018.4514
Journal or Publication Title: JAMA Oncol.
Volume: 5
Number: 2
Page Range: S. 187 - 195
Date: 2019
Publisher: AMER MEDICAL ASSOC
Place of Publication: CHICAGO
ISSN: 2374-2445
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
OPEN-LABEL; IPILIMUMAB; PEMBROLIZUMAB; CHEMOTHERAPY; MULTICENTERMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/15784

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