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WFRF:(Chiarion Sileni Vanna)
 

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FältnamnIndikatorerMetadata
00004989naa a2200601 4500
001oai:gup.ub.gu.se/274918
003SwePub
008240528s2019 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/2749182 URI
0247 a https://doi.org/10.1001/jamaoncol.2018.45142 DOI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Ascierto, Paolo A4 aut
2451 0a 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.
264 1b American Medical Association (AMA),c 2019
520 a 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.To compare the 3-year survival with nivolumab vs that with dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma.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.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/m2 every 3 weeks plus nivolumab-matched placebo every 2 weeks).Overall survival.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.Nivolumab led to improved 3-year overall survival vs dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma.ClinicalTrials.gov identifier: NCT01721772.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
7001 a Long, Georgina V4 aut
7001 a Robert, Caroline4 aut
7001 a Brady, Benjamin4 aut
7001 a Dutriaux, Caroline4 aut
7001 a Di Giacomo, Anna Maria4 aut
7001 a Mortier, Laurent4 aut
7001 a Hassel, Jessica C4 aut
7001 a Rutkowski, Piotr4 aut
7001 a McNeil, Catriona4 aut
7001 a Kalinka-Warzocha, Ewa4 aut
7001 a Savage, Kerry J4 aut
7001 a Hernberg, Micaela M4 aut
7001 a Lebbé, Celeste4 aut
7001 a Charles, Julie4 aut
7001 a Mihalcioiu, Catalin4 aut
7001 a Chiarion-Sileni, Vanna4 aut
7001 a Mauch, Cornelia4 aut
7001 a Cognetti, Francesco4 aut
7001 a Ny, Lars,d 1967u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology4 aut0 (Swepub:gu)xnylai
7001 a Arance, Ana4 aut
7001 a Svane, Inge Marie4 aut
7001 a Schadendorf, Dirk4 aut
7001 a Gogas, Helen4 aut
7001 a Saci, Abdel4 aut
7001 a Jiang, Joel4 aut
7001 a Rizzo, Jasmine4 aut
7001 a Atkinson, Victoria4 aut
7102 a Göteborgs universitetb Institutionen för kliniska vetenskaper, Avdelningen för onkologi4 org
7730 t JAMA oncologyd : American Medical Association (AMA)g 5:2, s. 187-194q 5:2<187-194x 2374-2445x 2374-2437
8564 u https://jamanetwork.com/journals/jamaoncology/articlepdf/2707224/jamaoncology_ascierto_2018_oi_180086.pdf
8564 8u https://gup.ub.gu.se/publication/274918
8564 8u https://doi.org/10.1001/jamaoncol.2018.4514

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