Details

Autor(en) / Beteiligte

• Özgüroğlu, Mustafa
• Mandalà, Mario
• Ryu, Min-Hee
• Olesiński, Tomasz
• Mansoor, Wasat
• Shacham-Shmueli, Einat
• Chen, Xinqun
• Kang, S Peter
• Fuchs, Charles S
• Lerzo, Guillermo
• Lynam, James
• Wong, Mark
• Vasey, Paul
• Van Laethem, Jean-Luc
• Van Cutsem, Eric
• Berry, Scott
• Vincent, Mark
• Muller, Bettina
• Rey, Felipe
• Zambrano, Angela
• Guerra, Joaquin
• Krogh, Merete
• Yilmaz, Mette
• Elme, Anneli
• Auvinen, Paivi
• Alanko, Tuomo
• Moehler, Markus
• Kunzmann, Volker
• Hoehler, Thomas
• Haag, Georg
• Castro, Hugo
• Aguilar Vasquez, Mynor
• Cuffe, Sinead
• Geva, Ravit
• Hubert, Ayala
• Beny, Alex
• Giuseppe, Aprile
• Passalacqua, Rodolfo
• Montesarchio, Vincenzo
• Chin, Keisho
• Nishina, Tomohiro
• Komatsu, Yoshito
• Hironaka, Shuichi
• Satoh, Taroh
• Tamura, Takao
• Sugimoto, Naotaoshi
• Cho, Haruhiko
• Omuro, Yashushi
• Kato, Ken
• Goto, Masahiro
• Hyodo, Ichinosuke
• Yoshida, Kazuhiro
• Baba, Hideo
• Esaki, Taito
• Furuse, Junji
• Wan Mohammed, Wan Zamaniah
• Dominguez Andrade, Adriana
• Glenjen, Nils
• Kubiatowski, Tomasz
• Jacek, Jassem
• Wojtukiewicz, Marek
• Lazarev, Sergey
• Lancukhay, Yuri
• Moiseyenko, Vladimir
• Kostorov, Vladimir
• Shirinkin, Vadim
• Sakaeva, Dina
• Fadeeva, Natalia
• Yong, Wei Peng
• Robertson, Barbara
• Rapaport, Bernardo
• Cohen, Graham
• Dreosti, Lydia
• Szpak, Waldemar
• Roh, Sang-Young
• Kim, Yeul Hong
• Chung, Hyun Cheol
• Longo Munoz, Federico
• Cervantes Aguilar, Andres
• Garcia Alfonso, Pilar
• Feliu Batle, Jaime
• Yeh, Kun-Huei
• Chen, Jen-Shi
• Chao, Yee
• Kara, Oguz
• Hochhauser, Daniel
• Chau, Ian
• Shaib, Walid
• Philip, Philip
• Sharma, Vivek
• Sun, Weijing
• George, Ben
• Bullock, Andrea
• Myrick, Samuel
• Faruol, Josephine
• Siegel, Richard
• Becerra, Carlos
• Richards, Donald A.
• Riche, Stephen L.

Titel

Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial

Ist Teil von

• The Lancet (British edition), 2018-07, Vol.392 (10142), p.123-133

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes. We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine. This randomised, open-label, phase 3 study was done at 148 medical centres in 30 countries. Eligible patients were randomised (1:1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or standard-dose paclitaxel. Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or higher. Safety was assessed in all patients, irrespective of CPS. The significance threshold for overall survival was p=0·0135 (one-sided). This trial is registered at ClinicalTrials.gov, number NCT02370498. Between June 4, 2015, and July 26, 2016, 592 patients were enrolled. Of the 395 patients who had a PD-L1 CPS of 1 or higher, 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel. As of Oct 26, 2017, 326 patients in the population with CPS of 1 or higher had died (151 [77%] of 196 patients in the pembrolizumab group and 175 [88%] of 199 patients in the paclitaxel group). Median overall survival was 9·1 months (95% CI 6·2–10·7) with pembrolizumab and 8·3 months (7·6–9·0) with paclitaxel (hazard ratio [HR] 0·82, 95% CI 0·66–1·03; one-sided p=0·0421). Median progression-free survival was 1·5 months (95% CI 1·4–2·0) with pembrolizumab and 4·1 months (3·1–4·2) with paclitaxel (HR 1·27, 95% CI 1·03–1·57). In the total population, grade 3–5 treatment-related adverse events occurred in 42 (14%) of the 294 patients treated with pembrolizumab and 96 (35%) of the 276 patients treated with paclitaxel. Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher. Pembrolizumab had a better safety profile than paclitaxel. Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing. Merck Sharp & Dohme, a subsidiary of Merck & Co.