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Five-Year Outcomes ...
Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma.
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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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Di Giacomo, Anna Maria (author)
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Mortier, Laurent (author)
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Rutkowski, Piotr (author)
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Hassel, Jessica C (author)
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McNeil, Catriona M (author)
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Kalinka, Ewa Anna (author)
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Lebbé, Céleste (author)
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Charles, Julie (author)
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Hernberg, Micaela M (author)
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Savage, Kerry J (author)
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Chiarion-Sileni, Vanna (author)
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Mihalcioiu, Catalin (author)
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Mauch, Cornelia (author)
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Arance, Ana (author)
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Cognetti, Francesco (author)
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- Ny, Lars, 1967 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology
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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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Zoco, Jesús (author)
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Re, Sandra (author)
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Ascierto, Paolo A (author)
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Atkinson, Victoria (author)
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(creator_code:org_t)
- 2020
- 2020
- English.
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In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 1527-7755. ; 38:33, s. 3937-3946
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Abstract
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- The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated BRAF wild-type advanced melanoma. Five-year results are presented herein.In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type BRAF melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m2 every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n = 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report.Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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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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Di Giacomo, Anna ...
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Mortier, Laurent
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show more...
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Rutkowski, Piotr
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Hassel, Jessica ...
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McNeil, Catriona ...
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Kalinka, Ewa Ann ...
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Lebbé, Céleste
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Charles, Julie
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Hernberg, Micael ...
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Savage, Kerry J
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Chiarion-Sileni, ...
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Mihalcioiu, Cata ...
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Mauch, Cornelia
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Arance, Ana
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Cognetti, France ...
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Ny, Lars, 1967
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Schmidt, Henrik
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Schadendorf, Dir ...
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Gogas, Helen
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Zoco, Jesús
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Re, Sandra
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Ascierto, Paolo ...
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Atkinson, Victor ...
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show less...
- 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 ...
- Articles in the publication
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Journal of clini ...
- By the university
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University of Gothenburg