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Title: Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma
Author: Eggermont, Alexander Maximiliaan
Blank, C.U.
Mandala, Mario
Long, Georgina V.
Atkinson, Victoria
Dalle, Stéphane
Haydon, Andrew
Lichinitser, Mikhail
Khattak, Adnan
Carlino, Matteo S.
Sandhu, Shahneen
Larkin, James
Puig i Sardà, Susana
Ascierto, Paolo Antonio
Rutkowski, Piotr
Schadendorf, Dirk
Koornstra, Rutger
Hernandez Aya, Leonel
Maio, Michele
Eertwegh, Alfonsus J.M. van den
Grob, Jean Jacques
Gutzmer, Ralf
Jamal, Rahima
Lorigan, Paul
Ibrahim, Nageatte
Marreaud, Sandrine
Akkooi, Alexander Christopher Jonathan van
Suciu, Stefan
Robert, Caroline
Keywords: Melanoma
Tractament adjuvant del càncer
Placebos (Medicine)
Adjuvant treatment of cancer
Issue Date: 10-May-2018
Publisher: Massachusetts Medical Society
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 recurrencefree survival than placebo, with no new toxic effects identified. (
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It is part of: New England Journal of Medicine, 2018, vol. 378, num. 19, p. 1789-1801
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ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Medicina)

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