Efficacy and Safety of Autologous Dendritic Cell–Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer

作者：Nicholas J. Vogelzang, Tomasz M. Beer, Winald R. Gerritsen, Stéphane Oudard, Paweł Wiechno, Bożena Kukiełka-Budny, Vladimír Šámal, Jaroslav Hájek, Susan Feyerabend, Vincent Khoo, Arnulf Stenzl, Tibor Csőszi, Zoran Filipovic, Frederico Gonçalves, А А Прохоров, Eric Cheung, Arif Hussain, Nuno Sousa, Amit Bahl, Syed A. Hussain, Harald Fricke, Pavla Kadlecová, Tomáš Scheiner, Roman Korolkiewicz, Jiřina Bartůňková, Radek Špíšek, VIABLE Investigators, Walter M. Stadler, Arthur Berg, Karl‐Heinz Kurth, Celestia S. Higano, Matti Aapro, Michael Krainer, Stephan Hruby, Johannes Meran, S. Polyakov, Jean‐Pascal Machiels, Thierry Roumeguère, Koen Ackaert, Nicolaas Lumen, Thierry Gil, Velko Minchev, Antoaneta Tomova, Borislav D. Dimitrov, Marchela Koleva, Antonio Juretić, Ana Fröbe, Željko Vojnović, Martin Drabek, L. Jarolím, Tomáš Büchler, Eva Kindlová, Jan Schraml, Milada Zemanová, Prausova Jana, Bohuslav Melichar, Martina Chodacká, Jan Jansa, Gedske Daugaard, Nicolas Delonchamps, Brigitte Duclos, Stéphane Culine, G. Deplanque, Sylvestre Le Moulec, Peter Hammerer, Gerald Rodemer, Manuel Ritter, Axel S. Merseburger, Marc‐Oliver Grimm, Ilija Damjanoski, Manfred Wirth, Martin Burmester, Kurt Miller, Jan Herden, Bastian Keck, Christian Wuelfing, Alexander Winter, Martin Boegemann, Ingo Kausch von Schmeling, Paolo Fornara, E. Jaeger, G. Bodoky, Zsuzsanna Pápai, Géza Böszörményi-Nagy, Paola Vanella, Héctor Soto Parrà, Rodolfo Passalacqua, Francesco Ferraù, Michele Maio, Lucia Fratino, Enrico Cortesi, Gunta Purkalne, Jolita Asadauskienė, Rasa Jančiauskienė, Skaistė Tulytė, Alvydas Česas, Marco B. Polée, Brigitte C.M. Haberkorn, Fons van de Eertwegh, Pieter van den Berg, Aart Beeker, Peter Nieboer, Romuald Zdrojowy, Elżbieta Starosławska, Jacek Fijuth, Bożena Sikora-Kupis, Boguslawa Karaszewska, Isabel Fernandes, Gabriela Sousa, Tânia Rodrigues, Zoran Džamić, Nada Babović, B Cvetkovic, Roman Sokol, J Mikuláš, M Bonnet Gajdos, Marek Brezovsky, I. Minčík, J. Breza, José Ángel Arranz, Virginia Calvo, Gustavo Rubio, M. Sánchez Chapado, Pablo Gajete Boreu, A. Montesa, David Olmos, Begoña Mellado, Daniel Castellano, Javier Puente, Erika Thellenberg Karlsson, Johan Ahlgren, Hardev Pandha, Danish Mazhar, Maria Vilarino-Varela, Tony Elliott, Ian Pedley, Anjali Zarkar, Amy Law, Dennis Slater, Gary Karlin, Marijo Bilušić, Charles H. Redfern, Rakesh Gaur, Robert McCroskey, David T. Clarkson, Manish Agrawal, Mikhail Shtivelband, Luke T. Nordquist, Nagla Fawzy Abdel Karim, Ralph J. Hauke, Thomas W. Flaig, Haresh Jhangiani, Rakesh Singal, Brian S. Choi, Evangeline Reyes, John M. Corman, Clara Hwang, Leonard J. Appleman, Edward F. McClay, Mark T. Fleming, Vijay Gunuganti, Eric Cheung, Benjamin A. Gartrell, Alton Oliver Sartor, Stephen K. Williamson, Jitendra G. Gandhi, Ian D. Schnadig, John P. Burke, Stuart H. Bloom, Neal D. Shore, Tina Mayer, William Oh, Alan H. Bryce, Laurence Belkoff, Ulka N. Vaishampayan, Sanjiv S. Agarwala, Ömer Küçük, Apurv Agrawal, William D. Walsh, Bernard J. Poiesz, Lauren C. Harshman, Nancy A. Dawson, Sanjay Sharma · 发表于：JAMA Oncology · 年份：2022 · DOI：10.1001/jamaoncol.2021.7298 · 被引用次数：94 · 研究领域：Prostate Cancer Treatment and Research、Immunotherapy and Immune Responses、Cancer Immunotherapy and Biomarkers

IMPORTANCE: DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer. OBJECTIVE: To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). DESIGN, SETTING, AND PARTICIPANTS: The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020. INTERVENTIONS: Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy (docetaxel plus prednisone). The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses). MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival (OS), defined as the time from randomization until death due to any cause, in all randomized patients. Survival was compared using 2-sided log-rank test stratified by geographical region, prior therapy with abiraterone and/or enzalutamide, and Eastern Cooperative Oncology Group performance status. RESULTS: A total of 1182 men wit...