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1. Patterns of initial ovarian cancer recurrence on niraparib maintenance monotherapy in patients with no baseline evidence of disease after first-line chemotherapy: An ad hoc subgroup analysis of PRIMA/ENGOT-OV26/GOG-3012

Author

Kamrava, Mitchell R., Gonzalez-Martin, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Mirza, Mansoor R., McCormick, Colleen, Lorusso, Domenica, Freyer, Gilles, O'Malley, David M., York, Whitney, Malinowska, Izabela A., and Monk, Bradley J.

Published
2024
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2. Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial

Author

Wu, Xiaohua, Zhu, Jianqing, Yin, Rutie, Yang, Jiaxin, Liu, Jihong, Wang, Jing, Wu, Lingying, Liu, Ziling, Gao, Yunong, Wang, Danbo, Lou, Ge, Yang, Hongying, Zhou, Qi, Kong, Beihua, Huang, Yi, Chen, Lipai, Li, Guiling, An, Ruifang, Wang, Ke, Zhang, Yu, Yan, Xiaojian, Lu, Xin, Lu, Weiguo, Hao, Min, Wang, Li, Cui, Heng, Chen, Qionghua, Abulizi, Guzhalinuer, Huang, Xianghua, Tian, Xiaofei, Wen, Hao, Huang, Zhao, Dong, Juan, Zhang, Charlie, Hou, Jianmei, and Mirza, Mansoor R.

Published
2024
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3. Survival and modelled cancer antigen-125 ELIMination rate constant K score in ovarian cancer patients in first-line before poly(ADP-ribose) polymerase inhibitor era: A Gynaecologic Cancer Intergroup meta-analysis

Author

Corbaux, Pauline, You, Benoit, Glasspool, Rosalind M., Yanaihara, Nozomu, Tinker, Anna V., Lindemann, Kristina, Ray-Coquard, Isabelle L., Mirza, Mansoor R., Subtil, Fabien, Colomban, Olivier, Péron, Julien, Karamouza, Eleni, McNeish, Iain, Kelly, Caroline, Kagimura, Tatsuo, Welch, Stephen, Lewsley, Liz-Anne, Paoletti, Xavier, and Cook, Adrian

Published
2023
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4. Progression-free survival and safety at 3.5 years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C., Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, O'Cearbhaill, Roisin E., Malinowska, Izabela A., Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R., and Monk, Bradley J.

Published
2023
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5. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial

Author

González-Martín, Antonio, Desauw, Christophe, Heitz, Florian, Cropet, Claire, Gargiulo, Piera, Berger, Regina, Ochi, Hiroyuki, Vergote, Ignace, Colombo, Nicoletta, Mirza, Mansoor R., Tazi, Youssef, Canzler, Ulrich, Zamagni, Claudio, Guerra-Alia, Eva M., Levaché, Charles B., Marmé, Frederik, Bazan, Fernando, de Gregorio, Nikolaus, Dohollou, Nadine, Fasching, Peter A., Scambia, Giovanni, Rubio-Pérez, María J., Milenkova, Tsveta, Costan, Cristina, Pautier, Patricia, and Ray-Coquard, Isabelle

Published
2022
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6. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer – a plain language summary.

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Graybill, Whitney, Lorusso, Domenica, McCormick, Colleen C, Freyer, Gilles, Backes, Floor, Heitz, Florian, Redondo, Andrés, Moore, Richard G, Vulsteke, Christof, O'Cearbhaill, Roisin E, Malinowska, Izabela A, Shtessel, Luda, Compton, Natalie, Mirza, Mansoor R, and Monk, Bradley J

Abstract

Plain Language Summary What is this summary about? This PLSP provides a short summary of an original scientific article that presented results from the PRIMA study after 3.5 years of follow-up time. The original article was published in the European Journal of Cancer in 2023. The PRIMA study included adult patients with newly diagnosed advanced high-risk ovarian cancer whose tumors shrunk or became undetectable after treatment with chemotherapy with or without surgery. The PRIMA study evaluated how well the drug niraparib, also known as Zejula, worked at delaying or preventing ovarian cancer from coming back (recurring) or getting worse (progressing) compared with placebo (a substance with no effects that a doctor gives to a patient instead of a drug). The first results from the PRIMA study were published in 2019, when patients had participated in the PRIMA study for about 1.2 years. The article this PLSP is based on reports longer-term data from the PRIMA study, when patients had participated in the PRIMA study for about 3.5 years. Patients were monitored (or followed) for a longer time to understand how well niraparib continued to work and to evaluate whether the safety of niraparib changed with additional time being monitored. What were the results? Patients who took niraparib had more time before their cancer came back or got worse than patients who took placebo. In terms of safety, no new types of side effects with niraparib treatment were observed with additional time being monitored as part of the PRIMA study. What do the results mean? These results support that niraparib remains an important treatment option to help delay the cancer from coming back or getting worse in patients with newly diagnosed advanced ovarian cancer that responded to initial treatment. Clinical Trial Registration:NCT02655016 (PRIMA study) (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Published
2024
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7. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial

Author

Mirza, Mansoor R., Benigno, B., Dørum, A., Mahner, S., Bessette, P., Barceló, I. Bover, Berton-Rigaud, D., Ledermann, J.A., Rimel, B.J., Herrstedt, J., Lau, S., du Bois, A., Herráez, A. Casado, Kalbacher, E., Buscema, J., Lorusso, D., Vergote, I., Levy, T., Wang, P., de Jong, F.A., Gupta, D., and Matulonis, U.A.

Published
2020
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8. A plain language summary of publication of the efficacy and safety of individualized niraparib dosing based on baseline body weight and platelet count in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Mirza, Mansoor R, primary, González-Martín, Antonio, additional, Graybill, Whitney S, additional, O'Malley, David M, additional, Gaba, Lydia, additional, Stephanie Yap, Oi Wah, additional, Guerra, Eva M, additional, Rose, Peter G, additional, Baurain, Jean-François, additional, Ghamande, Sharad A, additional, Denys, Hannelore, additional, Prendergast, Emily, additional, Pisano, Carmela, additional, Follana, Philippe, additional, Baumann, Klaus, additional, Calvert, Paula M, additional, Korach, Jacob, additional, Li, Yong, additional, Malinowska, Izabela A, additional, Gupta, Divya, additional, and Monk, Bradley J, additional

Published
2024
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9. Efficacy and safety of niraparib as maintenance treatment in older patients (≥ 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial

Author

Fabbro, Michel, Moore, Kathleen N., Dørum, Anne, Tinker, Anna V., Mahner, Sven, Bover, Isabel, Banerjee, Susana, Tognon, Germana, Goffin, Frederic, Shapira-Frommer, Ronnie, Wenham, Robert M., Hellman, Kristina, Provencher, Diane, Harter, Philipp, Vázquez, Isabel Palacio, Follana, Philippe, Pineda, Mario J., Mirza, Mansoor R., Hazard, Sebastien J., and Matulonis, Ursula A.

Published
2019
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11. Supplementary Appendix 1 from Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study

Author

Oaknin, Ana, primary, Pothuri, Bhavana, primary, Gilbert, Lucy, primary, Sabatier, Renaud, primary, Brown, Jubilee, primary, Ghamande, Sharad, primary, Mathews, Cara, primary, O'Malley, David M., primary, Kristeleit, Rebecca, primary, Boni, Valentina, primary, Gravina, Adriano, primary, Banerjee, Susana, primary, Miller, Rowan, primary, Pikiel, Joanna, primary, Mirza, Mansoor R., primary, Dewal, Ninad, primary, Antony, Grace, primary, Dong, Yuping, primary, Zografos, Eleftherios, primary, Veneris, Jennifer, primary, and Tinker, Anna V., primary

Published
2023
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12. Optimizing disease progression assessment using blinded central independent review and comparing it with investigator assessment in the PRIMA/ENGOT-ov26/GOG-3012 trial: challenges and solutions

Author

Herzog, Thomas J, primary, Wahab, Shaun A, additional, Mirza, Mansoor R, additional, Pothuri, Bhavana, additional, Vergote, Ignace, additional, Graybill, Whitney S, additional, Malinowska, Izabela A, additional, York, Whitney, additional, Hurteau, Jean A, additional, Gupta, Divya, additional, González-Martin, Antonio, additional, and Monk, Bradley J, additional

Published
2023
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13. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial

Author

Oza, Amit M, Matulonis, Ursula A, Malander, Susanne, Hudgens, Stacie, Sehouli, Jalid, del Campo, Josep M, Berton-Rigaud, Dominique, Banerjee, Susana, Scambia, Giovanni, Berek, Jonathan S, Lund, Bente, Tinker, Anna V, Hilpert, Felix, Vázquez, Isabel Palacio, D'Hondt, Véronique, Benigno, Benedict, Provencher, Diane, Buscema, Joseph, Agarwal, Shefali, and Mirza, Mansoor R

Published
2018
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14. #161 Final overall survival and long-term safety in the ENGOT-OV16/NOVA phase 3 trial of niraparib in patients with recurrent ovarian cancer

Author

Mirza, Mansoor R, primary, Herrstedt, Jørn, additional, Oza, Amit, additional, Mahner, Sven, additional, Redondo, Andrés, additional, Berton, Dominique, additional, Berek, Jonathan S, additional, Haslund, Charlotte A, additional, Marmé, Frederik, additional, González-Martín, Antonio, additional, Becourt, Stéphanie, additional, Tinker, Anna V, additional, Ledermann, Jonathan, additional, Benigno, Benedict, additional, Lindahl, Gabriel, additional, Colombo, Nicoletta, additional, Malinowska, Izabela A, additional, Liu, Wenlei, additional, Monk, Bradley J, additional, and Matulonis, Ursula, additional

Published
2023
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15. Data from Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study

Author

Oaknin, Ana, primary, Pothuri, Bhavana, primary, Gilbert, Lucy, primary, Sabatier, Renaud, primary, Brown, Jubilee, primary, Ghamande, Sharad, primary, Mathews, Cara, primary, O'Malley, David M., primary, Kristeleit, Rebecca, primary, Boni, Valentina, primary, Gravina, Adriano, primary, Banerjee, Susana, primary, Miller, Rowan, primary, Pikiel, Joanna, primary, Mirza, Mansoor R., primary, Dewal, Ninad, primary, Antony, Grace, primary, Dong, Yuping, primary, Zografos, Eleftherios, primary, Veneris, Jennifer, primary, and Tinker, Anna V., primary

Published
2023
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16. Safety, Efficacy, and Biomarker Analyses of Dostarlimab in Patients with Endometrial Cancer: Interim Results of the Phase I GARNET Study

Author

Oaknin, Ana, primary, Pothuri, Bhavana, additional, Gilbert, Lucy, additional, Sabatier, Renaud, additional, Brown, Jubilee, additional, Ghamande, Sharad, additional, Mathews, Cara, additional, O'Malley, David M., additional, Kristeleit, Rebecca, additional, Boni, Valentina, additional, Gravina, Adriano, additional, Banerjee, Susana, additional, Miller, Rowan, additional, Pikiel, Joanna, additional, Mirza, Mansoor R., additional, Dewal, Ninad, additional, Antony, Grace, additional, Dong, Yuping, additional, Zografos, Eleftherios, additional, Veneris, Jennifer, additional, and Tinker, Anna V., additional

Published
2023
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17. Niraparib in Patients With Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, Pothuri, Bhavana, Vergote, Ignace, Christensen, René DePont, Graybill, Whitney, Mirza, Mansoor R., McCormick, Colleen, Lorusso, Domenica, Hoskins, Paul, Freyer, Gilles, Baumann, Klaus, Jardon, Kris, Redondo, Andrés, Moore, Richard G., Vulsteke, Christof, OʼCearbhaill, Roisin E., Lund, Bente, Backes, Floor, Barretina-Ginesta, Pilar, Haggerty, Ashley F., Rubio-Pérez, Maria J., Shahin, Mark S., Mangili, Giorgia, Bradley, William H., Bruchim, Ilan, Sun, Kaiming, Malinowska, Izabela A., Li, Yong, Gupta, Divya, and Monk, Bradley J.

Published
2020
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18. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer

Author

Mirza, Mansoor R., primary, Chase, Dana M., additional, Slomovitz, Brian M., additional, dePont Christensen, René, additional, Novák, Zoltán, additional, Black, Destin, additional, Gilbert, Lucy, additional, Sharma, Sudarshan, additional, Valabrega, Giorgio, additional, Landrum, Lisa M., additional, Hanker, Lars C., additional, Stuckey, Ashley, additional, Boere, Ingrid, additional, Gold, Michael A., additional, Auranen, Annika, additional, Pothuri, Bhavana, additional, Cibula, David, additional, McCourt, Carolyn, additional, Raspagliesi, Francesco, additional, Shahin, Mark S., additional, Gill, Sarah E., additional, Monk, Bradley J., additional, Buscema, Joseph, additional, Herzog, Thomas J., additional, Copeland, Larry J., additional, Tian, Min, additional, He, Zangdong, additional, Stevens, Shadi, additional, Zografos, Eleftherios, additional, Coleman, Robert L., additional, and Powell, Matthew A., additional

Published
2023
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19. Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: Results from the PRIMA/ENGOT‐OV26/GOG‐3012 trial

Author

Mirza, Mansoor R., primary, González‐Martín, Antonio, additional, Graybill, Whitney S., additional, O’Malley, David M., additional, Gaba, Lydia, additional, Stephanie Yap, Oi Wah, additional, Guerra, Eva M., additional, Rose, Peter G., additional, Baurain, Jean‐François, additional, Ghamande, Sharad A., additional, Denys, Hannelore, additional, Prendergast, Emily, additional, Pisano, Carmela, additional, Follana, Philippe, additional, Baumann, Klaus, additional, Calvert, Paula M., additional, Korach, Jacob, additional, Li, Yong, additional, Malinowska, Izabela A., additional, Gupta, Divya, additional, and Monk, Bradley J., additional

Published
2023
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20. BRCA1/2 mutations associated with progression-free survival in ovarian cancer patients in the AGO-OVAR 16 study

Author

Harter, Philipp, Johnson, Toby, Berton-Rigaud, Dominique, Park, Sang-Yoon, Friedlander, Michael, del Campo, Josep M., Shimada, Muneaki, Forget, Frédéric, Mirza, Mansoor R., Colombo, Nicoletta, Zamagni, Claudio, Chan, John K., Imhof, Martin, Herzog, Thomas J., O'Donnell, Dearbhaile, Heitz, Florian, King, Karen, Stinnett, Sandy, Barrett, Catherine, Jobanputra, Minesh, Xu, Chun-Fang, and du Bois, Andreas

Published
2016
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21. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial

Author

du Bois, Andreas, Kristensen, Gunnar, Ray-Coquard, Isabelle, Reuss, Alexander, Pignata, Sandro, Colombo, Nicoletta, Denison, Ursula, Vergote, Ignace, del Campo, Jose M, Ottevanger, Petronella, Heubner, Martin, Minarik, Thomas, Sevin, Emmanuel, de Gregorio, Nikolaus, Bidziński, Mariusz, Pfisterer, Jacobus, Malander, Susanne, Hilpert, Felix, Mirza, Mansoor R, Scambia, Giovanni, Meier, Werner, Nicoletto, Maria O, Bjørge, Line, Lortholary, Alain, Sailer, Martin Oliver, Merger, Michael, and Harter, Philipp

Published
2016
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22. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer

Author

Lorusso, Domenica, Hilpert, Felix, González Martin, Antonio, Rau, Joern, Ottevanger, Petronella, Greimel, Elfriede, Lück, Hans-Joachim, Selle, Frédéric, Colombo, Nicoletta, Kroep, Judith R, Mirza, Mansoor R, Berger, Regina, Pardo, Beatriz, Grischke, Eva-Maria, Berton-Rigaud, Dominique, Martinez-Garcia, Jeronimo, Vergote, Ignace, Redondo, Andrés, Cardona, Andrés, Bastière-Truchot, Lydie, du Bois, Andreas, and Kurzeder, Christian

Published
2019
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26. Data from Inhibition of the Nuclear Export Receptor XPO1 as a Therapeutic Target for Platinum-Resistant Ovarian Cancer

Author

Chen, Ying, primary, Camacho, Sandra Catalina, primary, Silvers, Thomas R., primary, Razak, Albiruni R.A., primary, Gabrail, Nashat Y., primary, Gerecitano, John F., primary, Kalir, Eva, primary, Pereira, Elena, primary, Evans, Brad R., primary, Ramus, Susan J., primary, Huang, Fei, primary, Priedigkeit, Nolan, primary, Rodriguez, Estefania, primary, Donovan, Michael, primary, Khan, Faisal, primary, Kalir, Tamara, primary, Sebra, Robert, primary, Uzilov, Andrew, primary, Chen, Rong, primary, Sinha, Rileen, primary, Halpert, Richard, primary, Billaud, Jean-Noel, primary, Shacham, Sharon, primary, McCauley, Dilara, primary, Landesman, Yosef, primary, Rashal, Tami, primary, Kauffman, Michael, primary, Mirza, Mansoor R., primary, Mau-Sørensen, Morten, primary, Dottino, Peter, primary, and Martignetti, John A., primary

Published
2023
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29. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial

Author

Oza, Amit M, Cook, Adrian D, Pfisterer, Jacobus, Embleton, Andrew, Ledermann, Jonathan A, Pujade-Lauraine, Eric, Kristensen, Gunnar, Carey, Mark S, Beale, Philip, Cervantes, Andrés, Park-Simon, Tjoung-Won, Rustin, Gordon, Joly, Florence, Mirza, Mansoor R, Plante, Marie, Quinn, Michael, Poveda, Andrés, Jayson, Gordon C, Stark, Dan, Swart, Ann Marie, Farrelly, Laura, Kaplan, Richard, Parmar, Mahesh K B, and Perren, Timothy J

Published
2015
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30. 2022-RA-1194-ESGO Efficacy of dostarlimab in endometrial cancer by molecular subtype: a post hoc analysis of the GARNET study

Author

Tinker, Anna V, primary, Pothuri, Bhavana, additional, Gilbert, Lucy, additional, Sabatier, Renaud, additional, Brown, Jubilee, additional, Ghamande, Sharad, additional, Mathews, Cara, additional, O’Malley, David M, additional, Boni, Valentina, additional, Gravina, Adriano, additional, Banerjee, Susana, additional, Miller, Rowan E, additional, Pikiel, Joanna, additional, Mirza, Mansoor R, additional, Duan, Tao, additional, Han, Xinwei, additional, Zildjian, Sybil, additional, Zografos, Eleftherios, additional, Veneris, Jennifer, additional, and Oaknin, Ana, additional

Published
2022
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31. 2022-RA-1267-ESGO A randomised clinical Trial Investigating olaparib, durvalumab and an anticancer vaccine, UV1 as maintenance therapy in patients with recurrent ovarian cancer. ENGOT-OV56-NSGO-CTU-DOVACC

Author

Mirza, Mansoor R, primary, Niewenhuvsen, Eve, additional, Marth, Christian, additional, Zagouri, Flora, additional, Sonke, Gabe, additional, Hietanen, Sakari, additional, Fernebro, Josefin, additional, Brasiuniene, Birute, additional, Jogi, Tonu, additional, Kryhlmand, Birthe, additional, Madsen, Kristine, additional, and Pietzner, Klaus, additional

Published
2022
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34. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Author

Mirza, Mansoor R., Monk, Bradley J., Herrstedt, Jørn, Oza, Amit M., Mahner, Sven, Redondo, Andrés, Fabbro, Michel, Ledermann, Jonathan A., Lorusso, Domenica, Vergote, Ignace, Ben-Baruch, Noa E., Marth, Christian, Mądry, Radoslaw, Christensen, René D., Berek, Jonathan S., Dørum, Anne, Tinker, Anna V., du Bois, Andreas, González-Martín, Antonio, Follana, Philippe, Benigno, Benedict, Rosenberg, Per, Gilbert, Lucy, Rimel, Bobbie J., Buscema, Joseph, Balser, John P., Agarwal, Shefali, and Matulonis, Ursula A.

Published
2017
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35. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Harter, Philipp, primary, Sehouli, Jalid, additional, Vergote, Ignace, additional, Ferron, Gwenael, additional, Reuss, Alexander, additional, Meier, Werner, additional, Greggi, Stefano, additional, Mosgard, Berit J., additional, Selle, Frederic, additional, Guyon, Frederic, additional, Pomel, Christophe, additional, Lécuru, Fabrice, additional, Zang, Rongyu, additional, Avall-Lundqvist, Elisabeth, additional, Kim, Jae‐Weon, additional, Ponce, Jordi, additional, Raspagliesi, Francesco, additional, Kristensen, Gunnar, additional, Classe, Jean-Marc, additional, Hillemanns, Peter, additional, Jensen, Pernille, additional, Hasenburg, Annette, additional, Ghaem-Maghami, Sadaf, additional, Mirza, Mansoor R., additional, Lund, Bente, additional, Reinthaller, Alexander, additional, Santaballa, Ana, additional, Olaitan, Adeola, additional, Hilpert, Felix, additional, and du Bois, Andreas, additional

Published
2022
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36. Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

Author

Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klaus, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Tomas, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, Bois, Du, Andreas, Ferrandina, Ferrandina, Maria Gabriella, AGO Study Group-led GCIG/ENGOT Intergroup Consortium, Ray-Coquard, I, Cibula, D, Mirza, M, Reuss, A, Ricci, C, Colombo, N, Koch, H, Goffin, F, González-Martin, A, Ottevanger, P, Baumann, K, Bjørge, L, Lesoin, A, Burges, A, Rosenberg, P, Gropp-Meier, M, Harrela, M, Harter, P, Frenel, J, Minarik, T, Pisano, C, Hasenburg, A, Merger, M, and du Bois, A

Subjects
Cancer Research, Indoles, medicine.medical_treatment, Gastroenterology, Carboplatin, Placebos, chemistry.chemical_compound, tyrosine kinase inhibitor, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, nintedanib, Clinical endpoint, anti-angiogenic, Aged, 80 and over, Ovarian Neoplasms, Hazard ratio, Area under the curve, Cytoreduction Surgical Procedures, Middle Aged, Progression-Free Survival, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], ovarian cancer, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Nintedanib, Adult, medicine.medical_specialty, Paclitaxel, overall survival, Placebo, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Chemotherapy, business.industry, Ovary, antiangiogenic, medicine.disease, Settore MED/40 - GINECOLOGIA E OSTETRICIA, chemistry, Ovarian cancer, business, Follow-Up Studies
Abstract

Contains fulltext : 218867.pdf (Publisher’s version ) (Closed access) AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB-IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m(2) ) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2-21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83-1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

Published
2020

37. Supplementary Material – Niraparib treatment for patients with BRCA-mutated ovarian cancer: review of clinical data and therapeutic context

Author

Future Science Group, Figshare, Gonzalez-Martın, Antonio, Matulonis, Ursula A, Korach, Jacob, Mirza, Mansoor R, Moore, Kathleen N, Wu, Xiaohua, York, Whitney, Gupta, Divya, Lechpammer, Stanislav, and Monk, Bradley J

Subjects
Cancer therapy (excl. chemotherapy and radiation therapy)
Abstract

Plain Language Summary of Publication

Published
2022
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38. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, S Ristinge, Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, and Ristinge, S

Subjects
EPITHELIAL OVARIAN, Oncology, medicine.medical_specialty, BEVACIZUMAB, MULTICENTER, Antineoplastic Agents, PACLITAXEL, Systemic therapy, law.invention, Antineoplastic Agent, Randomized controlled trial, law, Internal medicine, Humans, Medicine, RECURRENT, Proportional Hazards Models, Aged, Ovarian Neoplasms, SECONDARY CYTOREDUCTION, business.industry, Ovarian Neoplasm, Antineoplastic Agents/therapeutic use, Obstetrics and Gynecology, Ovarian Neoplasms/drug therapy, Cytoreduction Surgical Procedures, General Medicine, CHEMOTHERAPY, Middle Aged, OPEN-LABEL, medicine.disease, Survival Analysis, Combined Modality Therapy, Neoplasm Recurrence, Local/drug therapy, Recurrent Ovarian Cancer, Proportional Hazards Model, Quality of Life, Female, Survival Analysi, Neoplasm Recurrence, Local, business, Cytoreductive surgery, Ovarian cancer, Human
Abstract

BACKGROUND: Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS: We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS: A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS: In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overall survival than chemotherapy alone. (Funded by the AGO Study Group and others; DESKTOP III ClinicalTrials.gov number, NCT01166737.).

Published
2021
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40. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer

Author

Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, S Ristinge, Philipp, H, Jalid, S, Ignace, V, Gwenael, F, Alexander, R, Werner, M, Stefano, G, Berit J, M, Frederic, S, Frédéric, G, Christophe, P, Fabrice, L, Rongyu, Z, Elisabeth, A, Jae-Weon, K, Jordi, P, Francesco, R, Gunnar, K, Jean-Marc, C, Peter, H, Pernille, J, Annette, H, Sadaf, G, Mansoor R, M, Bente, L, Ana, S, Adeola, O, Felix, H, Andreas, D, Buchholz, S, Burges, A, Canzler, U, Denschlag, D, El-Balat, A, Emons, G, Felberbaum, R, de Gregorio, N, Gropp-Meier, M, Hanf, V, Hanker, L, Hils, R, Kurzeder, C, Lampe, B, Mustea, A, Schmidt, M, Schutz, R, Weigel, M, Weiser, S, Zorr, A, Marth, C, Petru, E, Scholl, T, Beltran, M, Bover, I, Gomez di Laino, A, Lainez, N, Martinez, S, Poveda Velasco, A, Romeo, M, Crouet, H, de Gournay, E, Deplanque, G, Follana, P, Floquet, A, Lanvin, D, Leveque, J, Pujade-Lauraine, E, Raban, N, Resch, B, M Savoye, A, Aletti, G, Giorda, G, Landoni, F, Scaffa, C, Abu, J, Alexander-Sefre, F, Barton, D, Butler-Manuel, S, Clayton, R, Crawford, R, Duncan, T, El-Ghobashy, A, Fotopoulou, C, Hall, M, Intrivici, C, Lawrence, A, Luesley, D, Naik, R, Nordin, A, Tidy, J, Fokdahl, L, Hofsjö, A, Kjolhede, P, Eyjolfsdottir, B, Y Dai, Z, Zhang, P, Aminossadati, B, Hahmann, M, Nasemann, C, Yahiaoui, S, Wittenberg, M, Schade-Brittinger, C, Elser, G, Reddig, D, Kuncke, M, Polleis, S, Mattukat, Y, Riha, A, Berger, R, de Roover, J, Kaur, B, Crook, J, Nepote, F, Votan, B, Andriamamonjy, M, Bryce, J, Ristinge, S, Harter, Philipp, Sehouli, Jalid, Vergote, Ignace, Ferron, Gwenael, Reuss, Alexander, Meier, Werner, Greggi, Stefano, Mosgard, Berit J, Selle, Frederic, Guyon, Frédéric, Pomel, Christophe, Lécuru, Fabrice, Zang, Rongyu, Avall-Lundqvist, Elisabeth, Kim, Jae-Weon, Ponce, Jordi, Raspagliesi, Francesco, Kristensen, Gunnar, Classe, Jean-Marc, Hillemanns, Peter, Jensen, Pernille, Hasenburg, Annette, Ghaem-Maghami, Sadaf, Mirza, Mansoor R, Lund, Bente, Reinthaller, Alexander, Santaballa, Ana, Olaitan, Adeola, Hilpert, Felix, du Bois, Andreas, S Buchholz, A Burges, U Canzler, D Denschlag, A El-Balat, G Emons, R Felberbaum, N de Gregorio, M Gropp-Meier, V Hanf, L Hanker, R Hils, C Kurzeder, B Lampe, A Mustea, M Schmidt, R Schutz, M Weigel, S Weiser, A Zorr, C Marth, E Petru, T Scholl, M Beltran, I Bover, A Gomez di Laino, N Lainez, S Martinez, A Poveda Velasco, M Romeo, H Crouet, E de Gournay, G Deplanque, P Follana, A Floquet, D Lanvin, J Leveque, E Pujade-Lauraine, N Raban, B Resch, A M Savoye, G Aletti, G Giorda, F Landoni, C Scaffa, J Abu, F Alexander-Sefre, D Barton, S Butler-Manuel, R Clayton, R Crawford, T Duncan, A El-Ghobashy, C Fotopoulou, M Hall, C Intrivici, A Lawrence, D Luesley, R Naik, A Nordin, J Tidy, L Fokdahl, A Hofsjö, P Kjolhede, B Eyjolfsdottir, Z Y Dai, P Zhang, B Aminossadati, M Hahmann, C Nasemann, S Yahiaoui, M Wittenberg, C Schade-Brittinger, G Elser, D Reddig, M Kuncke, S Polleis, Y Mattukat, A Riha, R Berger, J de Roover, B Kaur, J Crook, F Nepote, B Votan, M Andriamamonjy, J Bryce, and S Ristinge

Abstract

BACKGROUND Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS We randomly assigned patients with recurrent ovarian cancer who had a first relapse after a platinum-free interval (an interval during which no platinum-based chemotherapy was used) of 6 months or more to undergo secondary cytoreductive surgery and then receive platinum-based chemotherapy or to receive platinumbased chemotherapy alone. Patients were eligible if they presented with a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, defined as an Eastern Cooperative Oncology Group performance-status score of 0 (on a 5-point scale, with higher scores indicating greater disability), ascites of less than 500 ml, and complete resection at initial surgery. A positive AGO score is used to identify patients in whom a complete resection might be achieved. The primary end point was overall survival. We also assessed quality of life and prognostic factors for survival. RESULTS A total of 407 patients underwent randomization: 206 were assigned to cytoreductive surgery and chemotherapy, and 201 to chemotherapy alone. A complete resection was achieved in 75.5% of the patients in the surgery group who underwent the procedure. The median overall survival was 53.7 months in the surgery group and 46.0 months in the no-surgery group (hazard ratio for death, 0.75; 95% confidence interval, 0.59 to 0.96; P = 0.02). Patients with a complete resection had the most favorable outcome, with a median overall survival of 61.9 months. A benefit from surgery was seen in all analyses in subgroups according to prognostic factors. Quality-of-life measures through 1 year of follow-up did not differ between the two groups, and we observed no perioperative mortality within 30 days after surgery. CONCLUSIONS In women with recurrent ovarian cancer, cytoreductive surgery followed by chemotherapy resulted in longer overa

Published
2021

41. Niraparib treatment for patients with -mutated ovarian cancer: review of clinical data and therapeutic context.

Author

González-Martín, Antonio, Matulonis, Ursula A, Korach, Jacob, Mirza, Mansoor R, Moore, Kathleen N, Wu, Xiaohua, York, Whitney, Gupta, Divya, Lechpammer, Stanislav, and Monk, Bradley J

Abstract

We reviewed clinical data for niraparib monotherapy in BRCA-mutated (BRCAm) epithelial ovarian cancer (OC), contextualizing results with data from other poly(ADP-ribose) polymerase inhibitors (PARPis). Niraparib reduced the likelihood of progression or death by 60% as first-line maintenance therapy and by 73-78% in recurrent disease. In heavily pretreated OC, efficacy was greater in the BRCAm versus non-BRCAm cohort. Quality-of-life (QoL) was maintained throughout treatment. Adverse events were consistent with the known niraparib safety profile. Cumulative efficacy, safety and QoL evidence demonstrate niraparib maintenance monotherapy has a positive benefit:risk ratio in BRCAm OC. Niraparib significantly improved progression-free survival as first-line maintenance therapy in all patients with OC (i.e., of any biomarker status). [ABSTRACT FROM AUTHOR]

Published
2022
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43. Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

Author

Ray-Coquard, I, Cibula, D, Mirza, M, Reuss, A, Ricci, C, Colombo, N, Koch, H, Goffin, F, González-Martin, A, Ottevanger, P, Baumann, K, Bjørge, L, Lesoin, A, Burges, A, Rosenberg, P, Gropp-Meier, M, Harrela, M, Harter, P, Frenel, J, Minarik, T, Pisano, C, Hasenburg, A, Merger, M, du Bois, A, Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klaus, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Tomas, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, du Bois, Andreas, Ray-Coquard, I, Cibula, D, Mirza, M, Reuss, A, Ricci, C, Colombo, N, Koch, H, Goffin, F, González-Martin, A, Ottevanger, P, Baumann, K, Bjørge, L, Lesoin, A, Burges, A, Rosenberg, P, Gropp-Meier, M, Harrela, M, Harter, P, Frenel, J, Minarik, T, Pisano, C, Hasenburg, A, Merger, M, du Bois, A, Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klaus, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Tomas, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, and du Bois, Andreas

Abstract

AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB–IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m2) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2–21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83–1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75–0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

Published
2020

45. A Phase 3 Trial of Bevacizumab in Ovarian Cancer

Author

Perren, Timothy J., Swart, Ann Marie, Pfisterer, Jacobus, Ledermann, Jonathan A., Pujade-Lauraine, Eric, Kristensen, Gunnar, Carey, Mark S., Beale, Philip, Cervantes, Andrés, Kurzeder, Christian, du Bois, Andreas, Sehouli, Jalid, Kimmig, Rainer, Stähle, Anne, Collinson, Fiona, Essapen, Sharadah, Gourley, Charlie, Lortholary, Alain, Selle, Frédéric, Mirza, Mansoor R., Leminen, Arto, Plante, Marie, Stark, Dan, Qian, Wendi, Parmar, Mahesh K.B., and Oza, Amit M.

Published
2011

46. 387 ENGOT-EN6/GOG-3031/NSGO-RUBY: a phase 3, randomised, double-blind, multicenter study of dostarlimab + carboplatin-paclitaxel versus placebo + carboplatin-paclitaxel in recurrent or primary advanced endometrial cancer (EC)

Author

Mirza, Mansoor R, primary, Coleman, Robert L, additional, Hanker, Lars, additional, Slomovitz, Brian, additional, Valabrega, Giorgio, additional, Im, Ellie, additional, Walker, Monica, additional, and Powell, Matthew, additional

Published
2020
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47. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial

Author

Matulonis, Ursula A., Walder, Lydia, Nøttrup, Trine J, Bessette, Paul, Mahner, Sven, Gil-Martin, Marta, Kalbacher, Elsa, Ledermann, Jonathan A, Wenham, Robert M, Woie, Kathrine, Lau, Susie, Marmé, Frederik, Casado Herraez, Antonio, Hardy-Bessard, Anne-Claire, Banerjee, Susana, Lindahl, Gabriel, Benigno, Benedict, Buscema, Joseph, Travers, Karin, Guy, Holly, Mirza, Mansoor R., Matulonis, Ursula A., Walder, Lydia, Nøttrup, Trine J, Bessette, Paul, Mahner, Sven, Gil-Martin, Marta, Kalbacher, Elsa, Ledermann, Jonathan A, Wenham, Robert M, Woie, Kathrine, Lau, Susie, Marmé, Frederik, Casado Herraez, Antonio, Hardy-Bessard, Anne-Claire, Banerjee, Susana, Lindahl, Gabriel, Benigno, Benedict, Buscema, Joseph, Travers, Karin, Guy, Holly, and Mirza, Mansoor R.

Abstract

This study estimated time without symptoms or toxicity (TWiST) with niraparib compared with routine surveillance (RS) in the maintenance treatment of patients with recurrent ovarian cancer.

Published
2019
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48. Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

Author

Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klau, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Toma, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, Du, Boi, Andreas, Ferrandina, Ferrandina, Maria Gabriella, AGO Study Group-led GCIG/ENGOT Intergroup, Consortium, Maria Gabriella (ORCID:0000-0003-4672-4197), Ray-Coquard, Isabelle, Cibula, David, Mirza, Mansoor R, Reuss, Alexander, Ricci, Caterina, Colombo, Nicoletta, Koch, Horst, Goffin, Frédéric, González-Martin, Antonio, Ottevanger, Petronella B, Baumann, Klau, Bjørge, Line, Lesoin, Anne, Burges, Alexander, Rosenberg, Per, Gropp-Meier, Martina, Harrela, Maija, Harter, Philipp, Frenel, Jean-Sébastien, Minarik, Toma, Pisano, Carmela, Hasenburg, Annette, Merger, Michael, Du, Boi, Andreas, Ferrandina, Ferrandina, Maria Gabriella, AGO Study Group-led GCIG/ENGOT Intergroup, Consortium, and Maria Gabriella (ORCID:0000-0003-4672-4197)

Abstract

AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary end point) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m2 ) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2-21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83-1.17, p = 0.86; median 62.0 months with nintedanib versus 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the non-high-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

Published
2019

49. Molecular and clinical predictors of improvement in progression‐free survival with maintenance PARP inhibitor therapy in women with platinum‐sensitive, recurrent ovarian cancer: A meta‐analysis.

Author

Lee, Chee Khoon, Friedlander, Michael L., Tjokrowidjaja, Angelina, Ledermann, Jonathan A., Coleman, Robert L., Mirza, Mansoor R., Matulonis, Ursula A., Pujade‐Lauraine, Eric, Bloomfield, Ralph, Goble, Sandra, Wang, Ping, Glasspool, Rosalind M., and Scott, Clare L.

Subjects
OVARIAN cancer, PROGRESSION-free survival, GENETIC mutation, FORECASTING, POLY(ADP-ribose) polymerase, BRCA genes, POLYMERASES
Abstract

BACKGROUND: The authors performed a meta‐analysis to better quantify the benefit of maintenance poly(ADP‐ribose) polymerase inhibitor (PARPi) therapy to inform practice in platinum‐sensitive, recurrent, high‐grade ovarian cancer for patient subsets with the following characteristics: germline BRCA mutation (gBRCAm), somatic BRCA mutation (sBRCAm), wild‐type BRCA but homologous recombinant‐deficient (HRD), homologous recombinant‐proficient (HRP), and baseline clinical prognostic characteristics. METHODS: Randomized trials comparing a PARPi versus placebo as maintenance treatment were identified from electronic databases. Treatment estimates of progression‐free survival were pooled across trials using the inverse variance weighted method. RESULTS: Four trials included 972 patients who received a PARPi (olaparib, 31%; niraparib, 35%; or rucaparib, 34%) and 530 patients who received placebo. For patients who had germline BRCA1 mutation (gBRCAm1) (N = 471), the hazard ratio (HR) was 0.29 (95% CI, 0.23‐0.37); for those who had germline BRCA2 mutation (gBRCAm2) (N = 236), the HR was 0.26 (95% CI, 0.17‐0.39); and, for those who had sBRCAm (N = 123), the HR was 0.22 (95% CI, 0.12‐0.41). The treatment effect was similar between the gBRCAm and sBRCAm subsets (P =.48). In patients who had wild‐type BRCA HRD tumors (excluding sBRCAm; N = 309), the HR was 0.41 (95% CI, 0.31‐0.56); and, in those who had wild‐type BRCA HRP tumors (N = 346), the HR was 0.64 (95% CI, 0.49‐0.83). The relative treatment effect was greater for the BRCAm versus HRD (P =.03), BRCAm versus HRP (P <.00001), and HRD versus HRP (P <.00001) subsets. There was no difference in benefit based on age, response after recent chemotherapy, and prior bevacizumab. CONCLUSIONS: In platinum‐sensitive, recurrent, high‐grade ovarian cancer, maintenance PARPi improves progression‐free survival for all patient subsets. PARPi therapy has a similar magnitude of benefit for sBRCAm and gBRCAm. Although patients with BRCAm derive the greatest benefit, the absence of a BRCAm or HRD could not be used to exclude patients from maintenance PARPi therapy. BRCA mutation status is able to predict for the magnitude of PARP inhibitor benefit in platinum‐sensitive recurrent high‐grade ovarian tumor. However, the absence of a BRCA mutation or homologous recombinant deficiency in high‐grade ovarian tumor cannot be used to exclude patients from such therapy. [ABSTRACT FROM AUTHOR]

Published
2021
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50. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, primary, Pothuri, Bhavana, additional, Vergote, Ignace, additional, DePont Christensen, René, additional, Graybill, Whitney, additional, Mirza, Mansoor R., additional, McCormick, Colleen, additional, Lorusso, Domenica, additional, Hoskins, Paul, additional, Freyer, Gilles, additional, Baumann, Klaus, additional, Jardon, Kris, additional, Redondo, Andrés, additional, Moore, Richard G., additional, Vulsteke, Christof, additional, O’Cearbhaill, Roisin E., additional, Lund, Bente, additional, Backes, Floor, additional, Barretina-Ginesta, Pilar, additional, Haggerty, Ashley F., additional, Rubio-Pérez, Maria J., additional, Shahin, Mark S., additional, Mangili, Giorgia, additional, Bradley, William H., additional, Bruchim, Ilan, additional, Sun, Kaiming, additional, Malinowska, Izabela A., additional, Li, Yong, additional, Gupta, Divya, additional, and Monk, Bradley J., additional

Published
2019
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