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    Adjuvant pembrolizumab versus placebo in resected stage III melanoma.

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    Authors
    Eggermont, A
    Blank, C
    Mandala, M
    Long, G
    Atkinson, V
    Dalle, S
    Haydon, A
    Lichinitser, M
    Khattak, A
    Carlino, M
    Sandhu, S
    Larkin, J
    Puig, S
    Ascierto, P
    Rutkowski, P
    Schadendorf, D
    Koornstra, R
    Hernandez-Aya, L
    Maio, M
    van den Eertwegh, A
    Grob, J
    Gutzmer, R
    Jamal, R
    Lorigan, Paul C
    Ibrahim, N
    Marreaud, S
    van Akkooi, ACJ
    Suciu, S
    Robert, C
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    Affiliation
    Gustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuif
    Issue Date
    2018-04-15
    
    Metadata
    Show full item record
    Abstract
    Background The programmed death 1 (PD-1) inhibitor pembrolizumab has been found to prolong progression-free and overall survival among patients with advanced melanoma. We conducted a phase 3 double-blind trial to evaluate pembrolizumab as adjuvant therapy in patients with resected, high-risk stage III melanoma. Methods Patients with completely resected stage III melanoma were randomly assigned (with stratification according to cancer stage and geographic region) to receive 200 mg of pembrolizumab (514 patients) or placebo (505 patients) intravenously every 3 weeks for a total of 18 doses (approximately 1 year) or until disease recurrence or unacceptable toxic effects occurred. Recurrence-free survival in the overall intention-to-treat population and in the subgroup of patients with cancer that was positive for the PD-1 ligand (PD-L1) were the primary end points. Safety was also evaluated. Results At a median follow-up of 15 months, pembrolizumab was associated with significantly longer recurrence-free survival than placebo in the overall intention-to-treat population (1-year rate of recurrence-free survival, 75.4% [95% confidence interval {CI}, 71.3 to 78.9] vs. 61.0% [95% CI, 56.5 to 65.1]; hazard ratio for recurrence or death, 0.57; 98.4% CI, 0.43 to 0.74; P<0.001) and in the subgroup of 853 patients with PD-L1-positive tumors (1-year rate of recurrence-free survival, 77.1% [95% CI, 72.7 to 80.9] in the pembrolizumab group and 62.6% [95% CI, 57.7 to 67.0] in the placebo group; hazard ratio, 0.54; 95% CI, 0.42 to 0.69; P<0.001). Adverse events of grades 3 to 5 that were related to the trial regimen were reported in 14.7% of the patients in the pembrolizumab group and in 3.4% of patients in the placebo group. There was one treatment-related death due to myositis in the pembrolizumab group. Conclusions As adjuvant therapy for high-risk stage III melanoma, 200 mg of pembrolizumab administered every 3 weeks for up to 1 year resulted in significantly longer recurrence-free survival than placebo, with no new toxic effects identified. (Funded by Merck; ClinicalTrials.gov number, NCT02362594 ; EudraCT number, 2014-004944-37 .).
    Citation
    Adjuvant pembrolizumab versus placebo in resected stage III melanoma. 2018 N Engl J Med
    Journal
    The New England Journal of Medicine
    URI
    http://hdl.handle.net/10541/621024
    DOI
    10.1056/NEJMoa1802357
    PubMed ID
    29658430
    Type
    Article
    Language
    en
    ISSN
    1533-4406
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa1802357
    Scopus Count
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