Domenica Lorusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leiva, Pier Ramos-Elias, Alejandro Acevedo, Jakub Cvek, Leslie Randall, Andrea Juliana Pereira de Santana Gomes, Fernando Contreras Mejía, Limor Helpman, Hüseyin Akıllı, Jung-Yun Lee, Valeriya Saevets, Flora Zagouri, Lucy Gilbert, Jalid Sehouli, Ekkasit Tharavichitkul, Kristina Lindemann, Nicoletta Colombo, Chih-Long Chang, Marketa Bednarikova, Hong Zhu, Ana Oaknin, Melissa Christiaens, Edgar Petru, Tomoka Usami, Peng Liu, Karin Yamada, Sarper Toker, Stephen M Keefe, Sandro Pignata, Linda R Duska
BACKGROUND: At the first interim analysis of the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study, the addition of pembrolizumab to chemoradiotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival in patients with locally advanced cervical cancer. We report the overall survival results from the second interim analysis of this study. METHODS: Eligible patients with newly diagnosed, high-risk (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA regardless of nodal status), locally advanced, histologically confirmed, squamous cell carcinoma, adenocarcinoma, or adenosquamous cervical cancer were randomly assigned 1:1 to receive five cycles of pembrolizumab (200 mg) or placebo every 3 weeks with concurrent chemoradiotherapy, followed by 15 cycles of pembrolizumab (400 mg) or placebo every 6 weeks...
September 13, 2024: Lancet