Title: | Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial |
Author: | Westin, Shannon N. Moore, Kathleen Chon, Hye Sook Lee, Jung-yun Thomes Pepin, Jessica Sundborg, Michael Shai, Ayelet De La Garza, Joseph Nishio, Shin Gold, Michael A. Wang, Ke Mcintyre, Kristi Tillmanns, Todd D. Blank, Stephanie V. Liu, Ji-hong Mccollum, Michael Contreras Mejia, Fernando Nishikawa, Tadaaki Pennington, Kathryn Novak, Zoltan De Melo, Andreia Cristina Sehouli, Jalid Klasa-mazurkiewicz, Dagmara Papadimitriou, Christos Gil-martin, Marta Brasiuniene, Birute Donnelly, Conor Del Rosario, Paula Michelle Liu, Xiaochun Van Nieuwenhuysen, Els Frentzas, Sophia Ganessan, Kichendasse Gao, Bo Meniawy, Tarek Mileshkin, Linda Richardson, Gary Roncolato, Felicia Baurain, Jean-francois Bourhaba, Maryam De Cuypere, Eveline Debruyne, Philip Denys, Hannelore Forget, Frederic Honhon, Brigitte Joosens, Eric Van Nieuwenhuysen, Els Da Costa Miranda, Vanessa De Melo, Andreia Cristina Guedes, Joao Daniel Joseph De Padua, Charles Andree Lazaretti, Nicolas Vieira, Carolina Martins Mattar, Andre Palmeiro, Daniela Neves Oppermann Kussler, Christina Pimentel Rubini Liedke, Pedro Emanuel Nunes, Joao Soares Tiscoski, Katsuki Arima Covens, Allan De Guerke, Lara Ghatage, Prafull Gilbert, Lucy Lau, Susie Oza, Amit Provencher, Diane Touhami, Omar Congzhu, Li Danbo, Wang Ge, Lou Gen-hai, Zhu Guiling, Li Hong, Shi Hong, Zheng Hongwu, Wen Ji-hong, Liu Jing, Wang Ke, Wang Kui, Jiang Li, Li Li, Wang Min, Hao Qi, Zhou Qinglei, Gao Sihai, Liao Songling, Zhang Weidong, Zhao Wu, Xiaohua Wuliang, Wang Yin, Rutie Ying, Cheng Yu, Zhang Zhiqing, Liang Mejia, Fernando Contreras Hernandez, Angel Luis Lopez, Carolina Ortiz Pacheco, Carlos Javier Ramos Guette, Pedro Luis Pereira, Jaime Rendon Diaz, Julian Rivera Villegas, Tomas Sanchez Suso, Juan Pablo Torregroza Otero, Marco Antonio Grisan, Karin Vettus, Elen Aktas, Bahriye Egger, Eva Krabisch, Petra Muller, Andreas Rom, Joachim Sehouli, Jalid Sperfeld, Antje Wimberger, Pauline Zorr, Andreas Fountzilas, George Karageorgopoulou, Sofia Papadimitriou, Christos Psyrri, Amanda Zagour, Florai Loen Chan, Karen Kar Ho, Wing Ming Csoszi, Tibor Landherr, Laszlo Novak, Zoltan Papai, Zsuzsanna Poka, Robert Sipocz, Istvan Devinder, Paul Goyal, Lovenish Gupta, Sudeep Naik, Radheshyam Patil, Tushar Somashekhar, S.p. Bruchim, Ilan Kovel, Svetlana Leibovici, Anca Rosengarten, Ora Safra, Tamar Yamagami, Wataru Hamanishi, Junzo Imai, Yuichi Kado, Nobuhiro Kamiura, Shoji Kato, Hienori Kondo, Eiji Kudaka, Wataru Matsumoto, Takashi Mori, Masahiko Nishikawa, Tadaaki Nishio, Shin Okamoto, Aikou Yunokawa, Mayu Sekine, Masayuki Sumi, Toshiyuki Takano, Hirokuni Takehara, Kazuhiro Brasiuniene, Birute Inciura, Arturas Jonuskiene, Goda Cabrera Luviano, Jesus Elvis Dominguez-andrade, Adriana Gerson-cwilich, Raquel Hernandez, Carlos Hernandez Hernandez, Jesus Lopez Martinez Lira, Jose Luis Navarrete Aleman, Jaime Esteban Contreras, Jessica Reyes Camargo, Vanessa Rosas Bednarek, Wieslawa Klasa-mazurkiewicz, Dagmara Kubiatowski, Tomasz Potemski, Piotr Sikorska, Magdalena Chang, Suk-joon Hong, Sook Hee Kang, Sokbom Kim, Byoung-gie Kim, Jan-weon Kim, Yong Man Lee, Jung-yun Ryu, Sang Young Song, Yong Jung Kirtbaya, Dmitriy Kreynina, Julya Lisyanskaya, Alla Makarova, Yulia Orlova, Rashida Pirmagomedov, Albert Saevets, Valeria Safina, Sufia Skopin, Pavel Tyulyandina, Alexandra Lim, Sheow Lei Su Mien, Lynette Ngo Shao Peng, David Tan Soh, Lay Tin Company, Jesus Alarcon Barretina, Pilar Estevez-garcia, Purificacion Perez, Isaura Fernandez Galvez, Fernando Garcia, Yolanda Gil-martin, Marta Martinez, Jeronimo Redondo-sanchez, Andres Anderson, Charles Berman, Tara Blank, Stephanie Bradley, William Burke, James Cappuccini, Fabio Carney, Michael Chambers, Setsuko Chen, Lee-may Chon, Hye Sook Garza, Joseph De La Depasquale, Stephen Disilvestro, Paul Edraki, Babak Fleming, Evelyn Fox, Jenny Gold, Michael Gordinier, Mary Guy, Michael Hartenbach, Ellen Haygood, Chisten Jordan, Scott Kilgore, Larry Kim, Young Lucci, Joseph Mccollum, Michael Mchale, Michael Mcintyre, Kristi Messing, Mark Miller, Eirwen Moore, Kathleen Moroney, John Onstad, Michaela Ortiz, Taylor Ozair, Sobia Pennington, Kathryn Pfaendler, Krista Priebe, Anna Pustilnik, Terri Resnick, Kimberly Rose, Peter Salinas, Erin Sharma, Sudarshan Sobol, Urszula Soliman, Pamela Starks, David Sundborg, Michael Teplinsky, Eleonora Thomes-pepin, Jessica Tillmanns, Todd Warshal, David Westin, Shannon N. Woliver, Thomas |
Issue Date: | 20-Jan-2024 |
Publisher: | American Society of Clinical Oncology (ASCO) |
Abstract: | PURPOSE Immunotherapy and chemotherapy combinations have shown activity in endometrial cancer, with greater benefit in mismatch repair (MMR)-deficient (dMMR) than MMR-proficient (pMMR) disease. Adding a poly(ADP-ribose) polymerase inhibitor may improve outcomes, especially in pMMR disease. METHODS This phase III, global, double-blind, placebo-controlled trial randomly assigned eligible patients with newly diagnosed advanced or recurrent endometrial cancer 1:1:1 to: carboplatin/paclitaxel plus durvalumab placebo followed by placebo maintenance (control arm); carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib placebo (durvalumab arm); or carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab plus olaparib (durvalumab + olaparib arm). The primary end points were progression-free survival (PFS) in the durvalumab arm versus control and the durvalumab + olaparib arm versus control. RESULTS Seven hundred eighteen patients were randomly assigned. In the intention-to-treat population, statistically significant PFS benefit was observed in the durvalumab (hazard ratio [HR], 0.71 [95% CI, 0.57 to 0.89]; P = .003) and durvalumab + olaparib arms (HR, 0.55 [95% CI, 0.43 to 0.69]; P < .0001) versus control. Prespecified, exploratory subgroup analyses showed PFS benefit in dMMR (HR [durvalumab v control], 0.42 [95% CI, 0.22 to 0.80]; HR [durvalumab + olaparib v control], 0.41 [95% CI, 0.21 to 0.75]) and pMMR subgroups (HR [durvalumab v control], 0.77 [95% CI, 0.60 to 0.97]; HR [durvalumab + olaparib v control] 0.57; [95% CI, 0.44 to 0.73]); and in PD-L1-positive subgroups (HR [durvalumab v control], 0.63 [95% CI, 0.48 to 0.83]; HR [durvalumab + olaparib v control], 0.42 [95% CI, 0.31 to 0.57]). Interim overall survival results (maturity approximately 28%) were supportive of the primary outcomes (durvalumab v control: HR, 0.77 [95% CI, 0.56 to 1.07]; P = .120; durvalumab + olaparib v control: HR, 0.59 [95% CI, 0.42 to 0.83]; P = .003). The safety profiles of the experimental arms were generally consistent with individual agents. CONCLUSION Carboplatin/paclitaxel plus durvalumab followed by maintenance durvalumab with or without olaparib demonstrated a statistically significant and clinically meaningful PFS benefit in patients with advanced or recurrent endometrial cancer. |
Note: | Reproducció del document publicat a: https://doi.org/10.1200/JCO.23.02132 |
It is part of: | Journal of Clinical Oncology, 2024, vol. 42, issue. 3, p. 283-299 |
URI: | http://hdl.handle.net/2445/214044 |
Related resource: | https://doi.org/10.1200/JCO.23.02132 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
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