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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
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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.
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WESTIN, Shannon n., MOORE, Kathleen, CHON, Hye sook, THOMES PEPIN, Jessica, SUNDBORG, Michael, SHAI, Ayelet, NISHIO, Shin, GOLD, Michael a., WANG, Ke, KIRTBAYA, Dmitriy, KREYNINA, Julya, LIM, Sheow lei, BOURHABA, Maryam, CARNEY, Michael, GE, Lou, GORDINIER, Mary, GUY, Michael, HARTENBACH, Ellen, HAYGOOD, Chisten, JORDAN, Scott, JOSEPH DE PADUA, Charles andree, PROVENCHER, Diane, SAFINA, Sufia, KILGORE, Larry, AKTAS, Bahriye, GUPTA, Sudeep, KIM, Young, DEVINDER, Paul, DEBRUYNE, Philip, GEN-HAI, Zhu, LUCCI, Joseph, MCCOLLUM, Michael, NOVAK, Zoltan, LOPEZ, Carolina ortiz, PAPADIMITRIOU, Christos, YU, Zhang, MCHALE, Michael, MCINTYRE, Kristi, MESSING, Mark, KRABISCH, Petra, MILLER, Eirwen, MORONEY, John, EGGER, Eva, POKA, Robert, GOYAL, Lovenish, SIPOCZ, Istvan, GUILING, Li, ONSTAD, Michaela, ZHIQING, Liang, SALINAS, Erin, DENYS, Hannelore, SHARMA, Sudarshan, SOBOL, Urszula, SOLIMAN, Pamela, EDRAKI, Babak, STARKS, David, BRASIUNIENE, Birute, JONUSKIENE, Goda, TEPLINSKY, Eleonora, TAKEHARA, Kazuhiro, BRUCHIM, Ilan, CONTRERAS MEJIA, Fernando, TILLMANNS, Todd, NAIK, Radheshyam, MULLER, Andreas, ROSENGARTEN, Ora, WARSHAL, David, WOLIVER, Thomas, FORGET, Frederic, LAZARETTI, Nicolas, DONNELLY, Conor, ROSARIO, Paula michelle del, LIU, Xiaochun, INCIURA, Arturas, HERNANDEZ, Angel luis, NIEUWENHUYSEN, Els van, SAFRA, Tamar, MARTINS VIEIRA, Carolina, PIRMAGOMEDOV, Albert, MATTAR, Andre, MAKAROVA, Yulia, NEVES PALMEIRO, Daniela, PATIL, Tushar, PIMENTEL OPPERMANN-KUSSLER, Christina, RUBINI LIEDKE, Pedro emanuel, RYU, Sang young, LÓPEZ HERNÁNDEZ, Jesús, YAMAGAMI, Wataru, NUNES, Joao soares, CABRERA LUVIANO, Jesús elvis, TISCOSKI, Katsuki arima, COVENS, Allan, GUERKE, Lara de, HONG, Zheng, GHATAGE, Prafull, GILBERT, Lucy, LAU, Susie, SONG, Yong jung, HAMANISHI, Junzo, ORLOVA, Rashida, LISYANSKAYA, Alla, SOMASHEKHAR, S.p., OZA, Amit m., DOMÍNGUEZ ANDRADE, Adriana, HONGWU, Wen, JI-HONG, Liu, WIMBERGER, Pauline, JING, Wang, KE, Wang, IMAI, Yuichi, RONCOLATO, Felicia, KUI, Jiang, LI, Li, DEPASQUALE, Stephen, LI, Wang, CHEN, Lee-may, SUSO, Juan pablo, GERSON-CWILICH, Raquel, MIN, Hao, SAEVETS, Valeria, FERNÁNDEZ PÉREZ, Isaura, QI, Zhou, SOH, Lay tin, QINGLEI, Gao, SIHAI, Liao, SONGLING, Zhang, FOUNTZILAS, George, ZORR, Andreas, WEIDONG, Zhao, WU, Xiaohua, GARZA, Joseph de la, CHAMBERS, Setsuko, HERNÁNDEZ HERNÁNDEZ, Carlos, WULIANG, Wang, ALARCÓN COMPANY, Jesús, PACHECO, Carlos javier, KOVEL, Svetlana, RAMOS GUETTE, Pedro luis, RENDON PEREIRA, Jaime, RIVERA DIAZ, Julian, SKOPIN, Pavel, SÁNCHEZ VILLEGAS, Tomas, PENNINGTON, Kathryn, KARAGEORGOPOULOU, Sofia, ORTIZ, Taylor, FOX, Jenny, BARRETINA, Pilar, PSYRRI, Amanda, DISILVESTRO, Paul, ZAGOUR, Florai, LOEN CHAN, Karen kar, HO, Wing ming, LEIBOVICI, Anca, LIU, Ji-hong, TILLMANNS, Todd d., CSOSZI, Tibor, LANDHERR, Laszlo, OZAIR, Sobia, ESTÉVEZ GARCÍA, Purificación, PAPAI, Zsuzsanna, KADO, Nobuhiro, MILESHKIN, Linda, KAMIURA, Shoji, ROM, Joachim, TYULYANDINA, Alexandra, VETTUS, Elen, KATO, Hienori, KONDO, Eiji, FRENTZAS, Sophia, ROSE, Peter, KUDAKA, Wataru, PFAENDLER, Krista, MATSUMOTO, Takashi, MORI, Masahiko, OKAMOTO, Aikou, MARTINEZ LIRA, José luís, YUNOKAWA, Mayu, SEKINE, Masayuki, SUMI, Toshiyuki, GANESSAN, Kichendasse, MENIAWY, Tarek, GAO, Bo, FLEMING, Evelyn, TAKANO, Hirokuni, PRIEBE, Anna, NAVARRETE ALEMAN, Jaime esteban, SU MIEN, Lynette ngo, REYES CONTRERAS, Jessica, ROSAS CAMARGO, Vanessa, BEDNAREK, Wieslawa, BLANK, Stephanie v., KUBIATOWSKI, Tomasz, NISHIKAWA, Tadaaki, CONGZHU, Li, POTEMSKI, Piotr, SPERFELD, Antje, CUYPERE, Eveline de, PUSTILNIK, Terri, SIKORSKA, Magdalena, RICHARDSON, Gary, CHANG, Suk-joon, HONHON, Brigitte, HONG, Sook hee, KANG, Sokbom, SHAO PENG, David tan, GÁLVEZ, Fernando, KIM, Byoung-gie, KIM, Jan-weon, KIM, Yong man, TOUHAMI, Omar, RESNICK, Kimberly, LEE, Jung-yun, JOOSENS, Eric, TORREGROZA OTERO, Marco antonio, KLASA-MAZURKIEWICZ, Dagmara, MELO, Andreia cristina de, GARCÍA, Yolanda, GIL MARTÍN, Marta, BAURAIN, Jean francois, MARTÍNEZ, Jerónimo, REDONDO SÁNCHEZ, Andrés, YIN, Rutie, HONG, Shi, COSTA MIRANDA, Vanessa da, ANDERSON, Charles, DANBO, Wang, BERMAN, Tara, BLANK, Stephanie, BRADLEY, William, GOLD, Michael, BURKE, James, GRISAN, Karin, CAPPUCCINI, Fabio, YING, Cheng, GUEDES, Joao daniel, SEHOULI, Jalid. 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. _Journal of Clinical Oncology_. 2024. Vol. 42, núm. 3, pàgs. 283-299. [consulta: 20 de gener de 2026]. ISSN: 1527-7755. [Disponible a: https://hdl.handle.net/2445/214044]