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dc.contributor.authorEggermont, Aen
dc.contributor.authorBlank, Cen
dc.contributor.authorMandala, Men
dc.contributor.authorLong, Gen
dc.contributor.authorAtkinson, Ven
dc.contributor.authorDalle, Sen
dc.contributor.authorHaydon, Aen
dc.contributor.authorLichinitser, Men
dc.contributor.authorKhattak, Aen
dc.contributor.authorCarlino, Men
dc.contributor.authorSandhu, Sen
dc.contributor.authorLarkin, Jen
dc.contributor.authorPuig, Sen
dc.contributor.authorAscierto, Pen
dc.contributor.authorRutkowski, Pen
dc.contributor.authorSchadendorf, Den
dc.contributor.authorKoornstra, Ren
dc.contributor.authorHernandez-Aya, Len
dc.contributor.authorMaio, Men
dc.contributor.authorvan den Eertwegh, Aen
dc.contributor.authorGrob, Jen
dc.contributor.authorGutzmer, Ren
dc.contributor.authorJamal, Ren
dc.contributor.authorLorigan, Paul Cen
dc.contributor.authorIbrahim, Nen
dc.contributor.authorMarreaud, Sen
dc.contributor.authorvan Akkooi, Aen
dc.contributor.authorSuciu, Sen
dc.contributor.authorRobert, Cen
dc.date.accessioned2018-06-04T09:31:39Z
dc.date.available2018-06-04T09:31:39Z
dc.date.issued2018-04-15
dc.identifier.citationAdjuvant pembrolizumab versus placebo in resected stage III melanoma. 2018 N Engl J Meden
dc.identifier.issn1533-4406
dc.identifier.pmid29658430
dc.identifier.doi10.1056/NEJMoa1802357
dc.identifier.urihttp://hdl.handle.net/10541/621024
dc.description.abstractBackground 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 .).
dc.language.isoenen
dc.rightsArchived with thanks to The New England journal of medicineen
dc.titleAdjuvant pembrolizumab versus placebo in resected stage III melanoma.en
dc.typeArticleen
dc.contributor.departmentGustave Roussy Cancer Campus Grand Paris and University Paris-Saclay, Villejuifen
dc.identifier.journalThe New England Journal of Medicineen
dc.internal.reviewer-noteThis needs to be deleted -sorry it got through JOen
html.description.abstractBackground 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 .).


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