Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial

Systemic therapies have improved the management of hepatocellular carcinoma, but there is still a need to further enhance overall survival in first-line advanced stages. This study aimed to evaluate the addition of pembrolizumab to lenvatinib versus lenvatinib plus placebo in the first-line setting...

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Veröffentlicht in:	The lancet oncology 2023-12, Vol.24 (12), p.1399-1410
Hauptverfasser:	Llovet, Josep M, Kudo, Masatoshi, Meyer, Tim, Qin, Shukui, Ikeda, Masafumi, Ren, Zhenggang, Lim, Ho Yeong, Cheng, Ann-Lii, Galle, Peter R, Wang, Anran, Mody, Kalgi, Dutcus, Corina, Siegel, Abby B, Thompson, Alexander, Andelkovic, Vladimir, Knox, Jennifer, Davies, Janine, Asselah, Jamil, Brahmania, Mayur, Xu, Ruocai, Pan, Hongming, Gu, Kangsheng, Hao, Chunyi, Cao, Peiguo, Xiao, Juxiang, Bai, Yuxian, Chen, Xiaoming, Yan, Dong, Zhao, Hong, Bonilla, Carlos, Zambrano, Angela, Lema, Mauricio, Restrepo Gutierrez, Juan Carlos, Ramos, Victor, LeSourd, Samuel, Edeline, Julien, Bourliere, Marc, Regnault, Helene, Dauvois, Barbara, Schulze, Kornelius, Waidmann, Oliver, Berres, Marie-Luise, Berg, Thomas, Waldschmidt, Dirk T, Bitzer, Michael, Duffy, Austin, Tonini, Giuseppe, Rizzo, Mimma, Biscaldi, Elisa, Numata, Kazushi, Marusawa, Hiroyuki, Kato, Naoya, Morimoto, Manabu, Yamashita, Tatsuya, Koga, Hironori, Masaki, Tsutomu, Tateishi, Ryosuke, Inaba, Yoshitaka, Arakawa, Tomohiro, Suzuki, Yoshiyuki, Hosaka, Tetsuya, Ryoo, Baek-Yeol, Kim, Tae-You, Hernandez Hernandez, Carlos, Motola Kuba, Daniel, Segura Gonzalez, Manuel, Cabrera Luviano, Jesus, Ramirez Godinez, Francisco, Stedman, Catherine, Wyrwicz, Lucjan, Kraj, Leszek, Surma-Wlodarczyk, Renata, Breder, Valeriy, Sekacheva, Marina, Orlova, Rashida, Vasilyev, Alexander, Zukov, Ruslan, Minguez, Beatriz, Matilla Pena, Ana, Fernandez Castroagudin, Javier, Garcia Sanchez, Araceli, Jeng, Long-Bin, Dechaphunkul, Arunee, Seker, Mesut, Bilici, Mehmet, Cil, Timucin, Ulahannan, Susanna, Zakari, Ahmed, Feun, Lynn, Al-Rajabi, Raed, Sung, Max, Kardosh, Adel, Dodlapati, Jyothi, Agrawal, Saurabh, Gopaluni, Srivalli, Loaiza-Bonilla, Arturo, Frenette, Catherine
Format:	Artikel
Sprache:	eng
Schlagworte:	Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Aspartate aminotransferase Biological products Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - pathology Clinical trials Diarrhea Double-Blind Method Drug dosages FDA approval Female Gastrointestinal Hemorrhage - drug therapy Gastrointestinal Hemorrhage - etiology Hemorrhage Hepatic encephalopathy Hepatocellular carcinoma Hepatorenal Syndrome - drug therapy Hepatorenal Syndrome - etiology Humans Immunotherapy Life expectancy Liver cancer Liver diseases Liver Neoplasms - drug therapy Liver Neoplasms - pathology Male Middle Aged Monoclonal antibodies Oncology Patients Pembrolizumab Placebos Portal vein Stroke Survival Targeted cancer therapy α-Fetoprotein
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Zusammenfassung:	Systemic therapies have improved the management of hepatocellular carcinoma, but there is still a need to further enhance overall survival in first-line advanced stages. This study aimed to evaluate the addition of pembrolizumab to lenvatinib versus lenvatinib plus placebo in the first-line setting for unresectable hepatocellular carcinoma. In this global, randomised, double-blind, phase 3 study (LEAP-002), patients aged 18 years or older with unresectable hepatocellular carcinoma, Child Pugh class A liver disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no previous systemic treatment were enrolled at 172 global sites. Patients were randomly assigned (1:1) with a central interactive voice-response system (block size of 4) to receive lenvatinib (bodyweight
ISSN:	1470-2045 1474-5488 1474-5488
DOI:	10.1016/S1470-2045(23)00469-2