作者
Jason J Luke, Piotr Rutkowski, Paola Queirolo, Michele Del Vecchio, Jacek Mackiewicz, Vanna Chiarion-Sileni, Luis de la Cruz Merino, Muhammad A Khattak, Dirk Schadendorf, Georgina V Long, Paolo A Ascierto, Mario Mandala, Federica De Galitiis, Andrew Haydon, Reinhard Dummer, Jean-Jacques Grob, Caroline Robert, Matteo S Carlino, Peter Mohr, Andrew Poklepovic, Vernon K Sondak, Richard A Scolyer, John M Kirkwood, Ke Chen, Scott J Diede, Sama Ahsan, Nageatte Ibrahim, Alexander MM Eggermont
发表日期
2022/4/30
期刊
The Lancet
卷号
399
期号
10336
页码范围
1718-1729
出版商
Elsevier
简介
Background
Pembrolizumab prolongs progression-free and overall survival among patients with advanced melanoma and recurrence-free survival in resected stage III disease. KEYNOTE-716 assessed pembrolizumab as adjuvant therapy in patients with completely resected, high-risk, stage II melanoma. We report results from the planned first and second interim analyses for recurrence-free survival.
Methods
In this double-blind, randomised, placebo-controlled phase 3 study, involving 160 academic medical centres and hospitals in 16 countries (Australia, Belgium, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Poland, South Africa, Spain, Switzerland, the UK, and the USA), patients aged 12 years or older with newly diagnosed, completely resected stage IIB or IIC melanoma (TNM stage T3b or T4 with a negative sentinel lymph node biopsy) were recruited. Eligible patients were randomly assigned (1 …
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JJ Luke, P Rutkowski, P Queirolo, M Del Vecchio… - The Lancet, 2022
