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146 results on '"Baron-Hay, Sally"'

1. First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial

Author

Marth, Christian, Moore, Richard G., Bidziński, Mariusz, Pignata, Sandro, Ayhan, Ali, Rubio, M. Jesús, Beiner, Mario, Hall, Marcia, Vulsteke, Christof, Braicu, Elena Ioana, Sonoda, Kenzo, Wu, Xiaohua, Frentzas, Sophia, Mattar, André, Lheureux, Stephanie, Chen, Xiaojun, Hasegawa, Kosei, Magallanes-Maciel, Manuel, Choi, Chel Hun, Shalkova, Mariia, Kaen, Diego, Wang, Peng-Hui, Berger, Regina, Okpara, Chinyere E., McKenzie, Jodi, Yao, Lili, Orlowski, Robert, Khemka, Vivek, Gilbert, Lucy, Makker, Vicky, Kaen, Diego Lucas, Gomez Abuin, Gonzalo, Zamora, Liliana Beatriz, Alfie, Margarita Sonia, Casarini, Ignacio Alfredo, Harrison, Michelle, Ananda, Sumitra, Shannon, Catherine Margaret, Frentzas, Sophia, Friedlander, Michael, Meniawy, Tarek, Gao, Bo, Baron-Hay, Sally, Diakos, Connie, Marth, Christian, Polterauer, Stephan, Petru, Edgar, De Bock, Marlies, Vulsteke, Christof, Baurain, Jean-Francois, Van Gorp, Toon, Altintas, Sevilay, Lima, Joao Paulo da Silveira Nogueira, Mattar, Andre, de Freitas Junior, Ruffo, Santana, Rosane O., de Melo, Andreia Cristina, Franke, Fabio Andre, Zibetti Dal Molin, Graziela, Damian, Fernanda Bronzon, Guedes, João Daniel Cardoso, Ellard, Susan, Tinker, Anna, Samouëlian, Vanessa, Fortin, Suzanne, Bessette, Paul, Kolinsky, Michael, Kumar Tyagi, Nidhi, Ethier, Josee-Lyne, Gilbert, Lucy, Lheureux, Stephanie, MacKay, Helen, Lim, Charles, Wu, Xiaohua, Pan, Lingya, An, Ruifang, Chen, Xiaojun, Zheng, Hong, Wu, Yumei, Zhu, Jianqing, Yao, Shuzhong, Jia, Xuemei, Huang, Yi, Lv, Weiguo, Zhang, Yu, Zhou, Qi, Ma, Cailing, Chekerov, Radoslav, Mach, Pawel, Witteler, Ralf, Marmè, Frederik, Cadoo, Karen, Korach, Jacob, Levy, Talia, Beiner, Mario, Amnon, Amit, Scollo, Paolo, Naglieri, Emanuele, Pignata, Sandro, Zamagni, Claudio, Salutari, Vanda, Usami, Tomoka, Nakamura, Kazuto, Matsumoto, Koji, Yamagami, Wataru, Kobayashi, Yoichi, Takano, Masashi, Kato, Hidenori, Sonoda, Kenzo, Kikuchi, Akira, Katsumata, Noriyuki, Kamiura, Shoji, Horie, Koji, Hasegawa, Kosei, Tsunoda, Takuya, Suzuki, Nao, Yunokawa, Mayu, Nishio, Shin, Kudaka, Wataru, Guerrero Cabrera, Fernando Felix, Gonzalez Mendoza, Rene Lazaro, Magallanes Maciel, Manuel Ernesto, Villalobos Valencia, Ricardo, Escobar Penagos, Jose, Lopez Chuken, Yamil Alonso, Mackowiak-Matejczyk, Beata, Tarnawski, Rafal, Kalinka, Ewa, Bidzinski, Mariusz, Bednarek, Wieslawa, Danska-Bidzinska, Anna, Koralewski, Piotr, Roszak, Andrzej, Kedrova, Anna, Musaeva, Natalia, Urmancheeva, Adiliya Fettekhovna, Vasiliev, Aleksandr Gennadievich, Safina, Sufia Zievna, Lisyanskaya, Alla Sergeevna, Rykov, Ivan V., Rumyantsev, Alexey Alexandrovich, Belonogov, Aleksandr, Makarycheva, Yulia, Kim, Yong Man, Choi, Chel Hun, Kim, Yong Beom, Kim, Hee Seung, Kim, Sang Wun, Quindos Varela, Maria, Casado Herraez, Antonio, Diaz Redondo, Tamara, Rubio Perez, Maria Jesus, Romeo Marin, Margarita, Romero Noguera, Ignacio, Taus Garcia, Alvaro, Lin, Wu-Chou, Chou, Hung-Hsueh, Cheng, Wen-Fang, Lu, Chien-Hsing, Wang, Peng-Hui, Simsek, Tayup, Kose, Fatih, Ayhan, Ali, Vardar, Mehmet Ali, Ozerkan, Kemal, Hughes, Andrew, Stillie, Alison, Eminowicz, Gemma, Khalique, Saira, Shalkova, Mariia, Sukhina, Olena, Piatnytska, Tetiana, Averina, Hanna, Kulyaba, Yaroslav, Kryzhanivska, Anna, Bondarenko, Igor, Svintsitsky, Valentyn, Krasnohrud, Yuliia, Voitko, Nataliia, Buscema, Joseph, Ghamande, Sharad, Lewin, Sharyn, Graham, Deena M., Makker, Vicky, Bell, Maria, Santin, Alessandro, Lee, Christine, Blank, Stephanie, Konecny, Gottfried E., Corr, Bradley, Van Le, Linda, Moore, Richard G., Scalici, Jennifer, Anderson, Charles, Braly, Patricia, Fehniger, Julia, Westhoff, Gina, and Bollinger, Lauren

Published
2024
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2. Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Zola, Paolo, Casanova, Claudia, Arcangeli, Valentina, Antonuzzo, Lorenzo, Gadducci, Angiolo, Cosio, Stefania, Clamp, Andrew, Persic, Mojca, McNeish, Ian, Tookman, Laura, Redondo Sanchez, Andrés, Choi, Chel Hun, Baldini, Editta, Palaia, Innocenza, Benedetti Panici, Pierluigi, Takahashi, Nobutaka, Lombard, Janine, Ardizzoia, Antonio, Bologna, Alessandra, Herrero Ibáñez, Ana Maria, Musolino, Antonino, Márquez Vázquez, Raúl, Pietzner, Klaus, Braicu, Elena, Heinzelmann-Schwarz, Viola A., Powell, Melanie, Yokoyama, Yoshihito, Baron-Hay, Sally, Abeni, Chiara, Martin Lorente, Cristina, Cueva, Juan Fernando, Trillsch, Fabian, Heitz, Florian, Ataseven, Beyhan, Petru, Edgar, Heubner, MartinLeonhard, Sadozye, Azmat Hassanq, Dubey, Sidharth, Tazbirkova, Andrea, Tiley, Susan, Chrystal, Kathryn, Kim, Sang Wun, Fehr, Mathias, Scatchard, Kate, Anand, Anjana, Taylor, Alexandra, Watary, Hidemichi, Enomoto, Takayuki, Yoshihara, Kosuke, Selva-Nayagam, Sudarsha, Karki, Bhaskar, Harrison, Michelle, Wilkinson, Kate, Goh, Jeffrey, Glasgow, Amanda, Chantrill, Lorraine, Lee, Chulmin, Bertolini, Alessandro, Narducci, Filomena, Bellotti, Giovanna, Fusco, Vittorio, Aebi, Stefan, Del Grande, Maria, Colombo, Ilaria, Tokunaga, Hideki, Shigeta, Shogo, Goss, Geraldine, Siow, Zhen Rong, Steer, Christopher, Lin, Hao, Lee, Kwang-Beom, Di Meglio, Giovanni, Massa, Elena, De Marino, Elvira, Tortora, Vincenzo, Palacio Vazquez, Isabel, Tsuji, Kosuke, Tominaga, Eiichiro, Black, Allison, So, Kyeong A, Suh, Dong Hoon, Lee, Keun Ho, Kim, Yong Man, Fossati, Roldano, Carlucci, Luciano, Barberis, Massimo, Torri, Valter, Santoni, Anna, Colombo, Nicoletta, Biagioli, Elena, Harano, Kenichi, Galli, Francesca, Hudson, Emma, Antill, Yoland, Rabaglio, Manuela, Marmé, Frederic, Marth, Christian, Parma, Gabriella, Fariñas-Madrid, Lorena, Nishio, Shin, Allan, Karen, Lee, Yeh Chen, Piovano, Elisa, Pardo, Beatriz, Nakagawa, Satoshi, McQueen, John, Zamagni, Claudio, Manso, Luis, Takehara, Kazuhiro, Tasca, Giulia, Ferrero, Annamaria, Tognon, Germana, Lissoni, Andrea Alberto, Petrella, Mariacristina, Laudani, Maria Elena, Rulli, Eliana, Uggeri, Sara, and Barretina Ginesta, M Pilar

Published
2024
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4. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice

Author

Lorusso, Domenica, Colombo, Nicoletta, Herraez, Antonio Casado, Santin, Alessandro D., Colomba, Emeline, Miller, David Scott, Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally E., Ray-Coquard, Isabelle Laure, Shapira-Frommer, Ronnie, Kim, Yong Man, McCormack, Mary, Massaad, Rachid, Nguyen, Allison Martin, Zhao, Qi, McKenzie, Jodi, Prabhu, Vimalanand S., and Makker, Vicky

Published
2023
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7. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial

Author

Ackermann, Sven, Anthuber, Christoph, Aydogdu, Mustafa, Baldauf, Angelika, Bauer, Wolfgang, Behringer, Dirk, Belau, Antje, Bender, Alexandra, Brucker, Cosima, Burges, Alexander, Canzler, Ulrich, Daabach, Trygve, Denschlag, Dominik, Deryal, Mustafa, Dörfel, Steffen, Ebert, Juliane, El-Balat, Ahmed, Fehm, Tanja, Feidicker, Susanne Maria, Feisel-Schwickardi, Gabriele, Felberbaum, Ricardo, Frank, Matthias, Gebauer, Gerhard, Gerber, Bernd, Gerhardt, Axel, Grafe, Andrea, Griesshammer, Martin, Grischke, Eva-Maria, Gröll, Isolde, Gropp-Meier, Martina, Hager, Dietrich, Hanf, Volker, Hannig, Carla Verena, Hantschmann, Peer, Harter, Philipp, Hauzenberger, Tanja, Herwig, Uwe, Heubner, Martin, Hielscher, Carsten, Hilpert, Felix, Hitschold, Thomas, Hofmann, Manfred, Jackisch, Christian, Janni, Wolfgang, Kiesel, Ludwig, Ko, Yon-Dschun, Koch, Hans-Joachim, Krabisch, Petra, Krieger, Peter, Kubin, Thomas, Kühn, Thorsten, Lampe, Björn, Ledwon, Peter, Lemster, Sabine, Lex, Benno, Liebrich, Clemens, Lorenz, Ralf, Lück, Hans-Joachim, Mahner, Sven, Mallmann, Peter, Marmé, Frederik, Meier, Werner, Meinerz, Wolfgang, Menke, Götz, Möbus, Volker, Müller, Thomas, Müller, Volker, Neunhöffer, Tanja, Ober, Angelika, Oskay-Özcelik, Gülten, Ostertag, Horst, Park-Simon, Tjoung-Won, Pölcher, Martin, Rautenberg, Beate, Rein, Daniel, Reiter, Wilhelm, Rempen, Andreas, Runnebaum, Ingo, Schmalfeldt, Barbara, Schmidt, Marcus, Schnohr, Sabine, Scholz, Heinz, Schröder, Willibald, Sehouli, Jalid, Simon, Eike, Sperfeld, Antje, Steckkönig, Annette, Strauß, Hans-Georg, Stuth, Ronaldo, Terhaag, Jürgen, Thiel, Falk, Thill, Marc, Tomé, Oliver, Uleer, Christoph, Vogel, Susanne, Voß, Hermann, Weigel, Michael, Winkler, Ulrich, Wischnik, Arthur, Zeiser, Tobias, Zorr, Andreas, Glasspool, Ros, Hudson, Emma, Jones, Rachel, Lafleur, Judith, Marth, Christian, Petru, Edgar, Reinthaller, Alexander, Antill, Yoland, Azer, Mary, Baron-Hay, Sally, Beale, Philip, Begbie, Stephen, Black, Allison, Briscoe, Karen, Dean, Andrew, Goh, Jeffrey, Harvey, Sandra, Lee, Chee, Matos, Marco, Meniawy, Tarek, Olesen, Inger, Shannon, Catherine, Vasey, Paul, Abadie-Lacourtoisie, Sophie, Arsene, Olivier, Barthier, Sophie, Becuwe-Roemer, Célia, Berton-Rigaud, Dominique, Cappiello-Bataller, Maria, Catala, Stéphanie, Costan, Cristina, Del Piano, Francesco, Deplanque, Gaël, Despax, Raymond, Dohollou, Nadine, Garnier-Tixidré, Claire, Grenier, Julien, Guardiola, Emmanuel, Hardy-Bessard, Anne-Claire, Joly, Florence, Kurtz, Jean-Emmanuel, Lefeuvre-Plesse, Claudia, Leheurteur, Marianne, Lesoin, Anne, Levache, Charles-Briac, L'Haridon, Tifenn, Longo, Raffaele, Lortholary, Alain, Meunier, Jérôme, Mouret-Reynier, Marie-Ange, Petit, Thierry, Raban, Nadia, Romano, Olivier, Vannetzel, Jean-Michel, Zannetti, Alain, Pfisterer, Jacobus, Shannon, Catherine M, Baumann, Klaus, Rau, Joern, Dean, Andrew P, Hein, Alexander, Zeimet, Alain G, Hanker, Lars C, Glasspool, Rosalind, de Gregorio, Nikolaus, Meniawy, Tarek M, Goh, Jeffrey C, Baron Hay, Sally, Kommoss, Stefan, and du Bois, Andreas

Published
2020
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8. Medicine Access Programmes: what do patients think – a patient‐reported outcome study on ribociclib in metastatic breast cancer in Australia.

Author

Yap, Natasha, Wong, Vanessa, Morton, Catherine, de Boer, Richard, Baron‐Hay, Sally, Blum, Robert, Forster, Benjamin, Chua, Susan, Clarke, Kerrie, Cuff, Katharine, Green, Michael, Lim, Elgene, Mok, Kelly, Nott, Louise, Nottage, Michelle, Tafreshi, Ali, Tsoi, Daphne, Uccellini, Anthony, Gibbs, Peter, and Lok, Sheau Wen

Subjects
HEALTH services accessibility, INTELLECT, PATIENT compliance, HUMAN services programs, ANTINEOPLASTIC agents, EVALUATION of human services programs, HEALTH outcome assessment, DRUGS, PATIENTS' attitudes, EVALUATION
Abstract

This study evaluated patient‐reported outcomes (PROs) of Medicine Access Programmes (MAPs) for Australian metastatic breast cancer patients on ribociclib. Limited patient awareness of MAP enrolment was identified, emphasising the need for improved education and consent processes. Most patients expressed gratitude for accessing non‐funded medications and perceived enhanced medication adherence as a key benefit. Integrating PRO data with real‐world registry data provides comprehensive insight for future MAP development. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Lenvatinib Plus Pembrolizumab for Advanced Endometrial Cancer

Author

Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Santin, Alessandro D., Colomba, Emeline, Miller, David S., Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally, Ray-Coquard, Isabelle, Shapira-Frommer, Ronnie, Ushijima, Kimio, Sakata, Jun, Yonemori, Kan, Kim, Yong Man, Guerra, Eva M., Sanli, Ulus A., McCormack, Mary M., Smith, Alan D., Keefe, Stephen, Bird, Steven, Dutta, Lea, Orlowski, Robert J., and Lorusso, Domenica

Published
2022
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13. PO003/#269 Ignite: a phase II signal-seeking trial of adavosertib targeting recurrent high grade serous ovarian cancer with cyclin E1 over-expression with and without gene amplification

Author

Au-Yeung, George, primary, Bressel, Mathias, additional, Prall, Owen, additional, Opar, Petra, additional, Andrews, John, additional, Mongta, Sally, additional, Lee, Yeh Chen, additional, Gao, Bo, additional, Meniawy, Tarek, additional, Baron-Hay, Sally, additional, Black, Allison, additional, Kichenadasse, Ganessan, additional, Ananda, Sumitra, additional, Fox, Peter, additional, Bowtell, David, additional, and Mileshkin, Linda, additional

Published
2023
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16. Real world evidence of systemic therapy in hormone receptor positive advanced breast cancer (HR+ ABC) in Australia: ARORA Registry.

Author

Lok, Sheau Wen, primary, Tung, Iris, additional, Anton, Angelyn, additional, Baron-Hay, Sally E., additional, De Boer, Richard H., additional, Boyle, Frances M., additional, Collins, Ian M., additional, Cuff, Katharine, additional, Gately, Lucy, additional, Georgiou, Chloe L., additional, Greenberg, Sally, additional, Karki, Bhaskar, additional, Nott, Louise M., additional, Nottage, Michelle K., additional, Rainey, Natalie, additional, Torres, Javier, additional, Yeo, Belinda Jane, additional, Gibbs, Peter, additional, and Wong, Vanessa, additional

Published
2023
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17. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, Vicky, primary, Colombo, Nicoletta, additional, Herráez, Antonio Casado, additional, Monk, Bradley J., additional, Mackay, Helen, additional, Santin, Alessandro D., additional, Miller, David S., additional, Moore, Richard G., additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Ushijima, Kimio, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra Alia, Eva M., additional, Sanli, Ulus A., additional, Bird, Steven, additional, Orlowski, Robert, additional, McKenzie, Jodi, additional, Okpara, Chinyere, additional, Barresi, Gianmaria, additional, and Lorusso, Domenica, additional

Published
2023
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18. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775

Author

Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, Lorusso, Domenica, Makker, V, Colombo, N, Herráez, A, Monk, B, Mackay, H, Santin, A, Miller, D, Moore, R, Baron-Hay, S, Ray-Coquard, I, Ushijima, K, Yonemori, K, Kim, Y, Guerra Alia, E, Sanli, U, Bird, S, Orlowski, R, Mckenzie, J, Okpara, C, Barresi, G, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Herráez, Antonio Casado, Monk, Bradley J, Mackay, Helen, Santin, Alessandro D, Miller, David S, Moore, Richard G, Baron-Hay, Sally, Ray-Coquard, Isabelle, Ushijima, Kimio, Yonemori, Kan, Kim, Yong Man, Guerra Alia, Eva M, Sanli, Ulus A, Bird, Steven, Orlowski, Robert, McKenzie, Jodi, Okpara, Chinyere, Barresi, Gianmaria, and Lorusso, Domenica

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m2 intravenously once every 3 weeks or paclitaxel 80 mg/m2 intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status). Updated safety was also reported.Lenvatinib plus pembrolizumab showed benefits in OS (pMMR HR, 0.70; 95% CI, 0.58 to 0.83; all-comer HR, 0.65; 95% CI, 0.55 to 0.77), PFS (pMMR HR, 0.60; 95% CI, 0.50 to 0.72; all-comer HR, 0.56; 95% CI, 0.48 to 0.66), and ORR (pMMR patients, 32.4% v 15.1%; all-comers, 33.8% v 14.7%) versus chemotherapy. OS, PFS, and ORR favored lenvatinib plus pembrolizumab in all subgroups of interest. No new safety signals were observed. Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.

Published
2023

19. Metastatic primary breast neuroendocrine neoplasms: a case series.

Author

Batty, Kathleen, Taylor, Amelia M., Bernard, Elizabeth J., Diakos, Connie I., Clarke, Stephen J., Guminski, Alexander, Baron‐Hay, Sally, Boyle, Frances, Pavlakis, Nick, and Chan, David L.

Subjects
BREAST tumor treatment, BREAST cancer prognosis, CANCER chemotherapy, METASTASIS, RETROSPECTIVE studies, ACQUISITION of data, CANCER patients, MOLECULAR biology, NEUROENDOCRINE tumors, CASE studies, MEDICAL records, POSITRON emission tomography, HISTOLOGY, PROGRESSION-free survival, COMBINED modality therapy, BREAST tumors, OVERALL survival, CANCER patient medical care, SYMPTOMS
Abstract

Background: Breast neuroendocrine neoplasms represent a rare subtype of breast cancer which have not been well studied or characterised, particularly in the metastatic setting. Aim: To present clinicopathological characteristics, treatment and outcomes of a series of patients with metastatic neuroendocrine carcinoma of the breast and review the current literature. Methods: We performed a retrospective review to identify and describe patients with metastatic neuroendocrine carcinoma of the breast at our centre between 2011 and 2021. Medical records, pathology and imaging results were examined to evaluate the clinical and histopathological features as well as the treatment pathways and prognosis of these patients. Results: We present a series of seven female patients with metastatic neuroendocrine carcinoma of the breast, as defined by the World Health Organization classification, over a period of 10 years (2011–2021) from a single centre. Median age at diagnosis was 48 years (range 39–63). Six of seven tissue samples expressed synaptophysin and chromogranin and were also oestrogen and progesterone receptor positive; median Ki‐67 index was 50% (range 20–90%). All seven patients had demonstrated avidity on 18F‐FDG PET imaging, and the six who underwent 68Ga‐DOTATATE PET all had significant avidity. Treatment modalities and sequencing varied, but all patients received chemotherapy during their disease course. Six patients received three or more lines of treatment. Median overall survival was 31.8 months (range 3.7–108.6). Median progression‐free survival (PFS) with first‐line therapy for metastatic disease was 5.8 months (range 1.8–37.8). Conclusions: This series shows the use of multiple modalities in treating this disease, with different sequencing in different patients. Despite multiple modalities used in the first‐line setting, first‐line PFS remains short. Larger series and further molecular characterisation are required to aid clinicians in managing this condition and to guide optimal treatment sequencing to improve outcomes in this rare patient group. [ABSTRACT FROM AUTHOR]

Published
2023
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20. Abstract OT3-11-03: The PREDICT Registry Australia: A prospective registry to evaluate the clinical utility of a 7-gene predictive biosignature on treatment decisions in patients with ductal carcinoma in situ

Author

Zissiadis, Yvonne, primary, Mann, G Bruce, additional, Speakman, David, additional, Saunders, Christobel, additional, Pyke, Christopher, additional, De Viana, Daniel, additional, Bochner, Melissa, additional, French, James R., additional, Dreosti, Marcus, additional, Baron-Hay, Sally, additional, Feetham, Alexandra, additional, Kirkham, Kim, additional, Ryan, Shane, additional, Mittal, Karuna, additional, Shivers, Steven C., additional, and Bremer, Troy, additional

Published
2023
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22. Results of PD-L1 Analysis of Women Treated with Durvalumab in Advanced Endometrial Carcinoma (PHAEDRA)

Author

Smith, Deborah, primary, Robledo, Kristy P., additional, Yip, Sonia, additional, Cummins, Michelle M., additional, Kok, Peey-Sei, additional, Lee, Yeh Chen, additional, Friedlander, Michael, additional, Baron-Hay, Sally, additional, Shannon, Catherine, additional, Coward, Jermaine, additional, Beale, Philip, additional, Goss, Geraldine, additional, Meniawy, Tarek, additional, Lombard, Janine, additional, Spurdle, Amanda B., additional, Andrews, John, additional, Stockler, Martin R., additional, Mileshkin, Linda, additional, and Antill, Yoland, additional

Published
2022
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23. TP016/#1442 Keynote-C93/GOG-3064/ENGOT-EN15: phase 3, randomized, open-label study of first-line pembrolizumab versus platinum-doublet chemotherapy in mismatch repair deficient advanced or recurrent endometrial carcinoma

Author

Slomovitz, Brian, primary, Cibula, David, additional, Gultekin, Murat, additional, Mirza, Mansoor, additional, Maćkowiak-Matejczyk, Beata, additional, Taylor, Alexandra, additional, Romero, Ignacio, additional, Colombo, Nicoletta, additional, Korach, Jacob, additional, Zhu, Jianqing, additional, Gilbert, Lucy, additional, Hasegawa, Kosei, additional, Kim, Jae-Weon, additional, Baron-Hay, Sally, additional, Makker, Vicky, additional, Coleman, Robert L, additional, Orlowski, Robert J, additional, Zhou, Xuan, additional, Khemka, Vivek, additional, and Pignata, Sandro, additional

Published
2022
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24. Metastatic primary breast neuroendocrine neoplasms: a case series

Author

Batty, Kathleen, primary, Taylor, Amelia M., additional, Bernard, Elizabeth J., additional, Diakos, Connie I., additional, Clarke, Stephen J., additional, Guminski, Alexander, additional, Baron‐Hay, Sally, additional, Boyle, Frances, additional, Pavlakis, Nick, additional, and Chan, David L., additional

Published
2022
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25. 2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775

Author

Lorusso, Domenica, primary, Makker, Vicky, additional, Herraez, Antonio Casado, additional, Monk, Bradley J, additional, Mackay, Helen, additional, Santin, Alessandro D, additional, Miller, David S, additional, Moore, Richard, additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Shapira-Frommer, Ronnie, additional, Ushijima, Kimio, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra Alia, Eva M, additional, Sanli, Ulus A, additional, Huang, Jie, additional, McKenzie, Jodi, additional, Barresi, Gianmaria, additional, and Colombo, Nicoletta, additional

Published
2022
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26. Pertuzumab study in the neoadjuvant setting for HER2‐positive nonmetastatic breast cancer in Australia (PeRSIA)

Author

Lok, Sheau Wen, primary, De Boer, Richard, additional, Baron‐Hay, Sally, additional, Button, Peter, additional, Devitt, Bianca, additional, Forster, Benjamin C., additional, Fox, Peter, additional, Harold, Michael, additional, Ketheeswaran, Sahisha, additional, Kichenadasse, Ganessan, additional, Kiely, Belinda E., additional, Marx, Gavin, additional, Nott, Louise, additional, Pellegrini, Laura, additional, Tafreshi, Ali, additional, and Gibbs, Peter, additional

Published
2022
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27. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer

Author

Makker, V, Colombo, N, Casado Herráez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Ushijima, K, Sakata, J, Yonemori, K, Kim, Y, Guerra, E, Sanli, U, Mccormack, M, Smith, A, Keefe, S, Bird, S, Dutta, L, Orlowski, R, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Casado Herráez, Antonio, Santin, Alessandro D, Colomba, Emeline, Miller, David S, Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally, Ray-Coquard, Isabelle, Shapira-Frommer, Ronnie, Ushijima, Kimio, Sakata, Jun, Yonemori, Kan, Kim, Yong Man, Guerra, Eva M, Sanli, Ulus A, McCormack, Mary M, Smith, Alan D, Keefe, Stephen, Bird, Steven, Dutta, Lea, Orlowski, Robert J, Lorusso, Domenica, Makker, V, Colombo, N, Casado Herráez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Ushijima, K, Sakata, J, Yonemori, K, Kim, Y, Guerra, E, Sanli, U, Mccormack, M, Smith, A, Keefe, S, Bird, S, Dutta, L, Orlowski, R, Lorusso, D, Makker, Vicky, Colombo, Nicoletta, Casado Herráez, Antonio, Santin, Alessandro D, Colomba, Emeline, Miller, David S, Fujiwara, Keiichi, Pignata, Sandro, Baron-Hay, Sally, Ray-Coquard, Isabelle, Shapira-Frommer, Ronnie, Ushijima, Kimio, Sakata, Jun, Yonemori, Kan, Kim, Yong Man, Guerra, Eva M, Sanli, Ulus A, McCormack, Mary M, Smith, Alan D, Keefe, Stephen, Bird, Steven, Dutta, Lea, Orlowski, Robert J, and Lorusso, Domenica

Abstract

BACKGROUND Standard therapy for advanced endometrial cancer after failure of platinum-based chemotherapy remains unclear. METHODS In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced endometrial cancer who had previously received at least one platinum-based chemotherapy regimen to receive either lenvatinib (20 mg, administered orally once daily) plus pembrolizumab (200 mg, administered intravenously every 3 weeks) or chemotherapy of the treating physician’s choice (doxorubicin at 60 mg per square meter of body-surface area, administered intravenously every 3 weeks, or paclitaxel at 80 mg per square meter, administered intravenously weekly [with a cycle of 3 weeks on and 1 week off]). The two primary end points were progression-free survival as assessed on blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.1, and overall survival. The end points were evaluated in patients with mismatch repair–proficient (pMMR) disease and in all patients. Safety was also assessed. RESULTS A total of 827 patients (697 with pMMR disease and 130 with mismatch repair–deficient disease) were randomly assigned to receive lenvatinib plus pembrolizumab (411 patients) or chemotherapy (416 patients). The median progression-free survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 6.6 vs. 3.8 months; hazard ratio for progression or death, 0.60; 95% confidence interval [CI], 0.50 to 0.72; P<0.001; overall: 7.2 vs. 3.8 months; hazard ratio, 0.56; 95% CI, 0.47 to 0.66; P<0.001). The median overall survival was longer with lenvatinib plus pembrolizumab than with chemotherapy (pMMR population: 17.4 vs. 12.0 months; hazard ratio for death, 0.68; 95% CI, 0.56 to 0.84; P<0.001; overall: 18.3 vs. 11.4 months; hazard ratio, 0.62; 95% CI, 0.51 to 0.75; P<0.001). Adverse events of grade 3 or higher occurred in 88.9% of the patients who received lenvatinib plus pembr

Published
2022

28. IGNITE: A phase II signal-seeking trial of adavosertib targeting recurrent high-grade, serous ovarian cancer with cyclin E1 overexpression with and without gene amplification.

Author

Au-Yeung, George, primary, Bressel, Mathias, additional, Prall, Owen, additional, Surace, Daniela, additional, Andrews, John, additional, Mongta, Sally, additional, Lee, Yeh Chen, additional, Gao, Bo, additional, Meniawy, Tarek, additional, Baron-Hay, Sally E., additional, Black, Allison Jane, additional, Kichenadasse, Ganessan, additional, Ananda, Sumitra, additional, Fox, Peter, additional, Bowtell, David, additional, and Mileshkin, Linda R., additional

Published
2022
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29. KEYNOTE-C93/GOG-3064/ENGOT-en15: A phase 3, randomized, open-label study of first-line pembrolizumab versus platinum-doublet chemotherapy in mismatch repair deficient advanced or recurrent endometrial carcinoma.

Author

Slomovitz, Brian M., primary, Cibula, David, additional, Simsek, Tayup, additional, Mirza, Mansoor Raza, additional, Maćkowiak-Matejczk, Beata, additional, Hudson, Emma, additional, Romero, Ignacio, additional, Colombo, Nicoletta, additional, Korach, Jacob, additional, Yin, Rutie, additional, Gilbert, Lucy, additional, Hasegawa, Kosei, additional, Tyulyandina, Alexandra, additional, Baron-Hay, Sally E., additional, Willmott, Lyndsay, additional, Backes, Floor Jenniskens, additional, Orlowski, Robert J., additional, Zhou, Xuan, additional, Khemka, Vivek, additional, and Pignata, Sandro, additional

Published
2022
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31. Abstract GS1-01: KEYNOTE-522 study of neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Event-free survival sensitivity and subgroup analyses

Author

Schmid, Peter, primary, Cortes, Javier, additional, Dent, Rebecca, additional, Pusztai, Lajos, additional, McArthur, Heather, additional, Kümmel, Sherko, additional, Bergh, Jonas, additional, Denkert, Carsten, additional, Park, Yeon Hee, additional, Hui, Rina, additional, Harbeck, Nadia, additional, Takahashi, Masato, additional, Untch, Michael, additional, Fasching, Peter A., additional, Cardoso, Fatima, additional, Andersen, Jay, additional, Patt, Debra, additional, Danso, Michael, additional, Ferreira, Marta, additional, Mouret-Reynier, Marie-Ange, additional, Im, Seock-Ah, additional, Ahn, Jin-Hee, additional, Gion, Maria, additional, Baron-Hay, Sally, additional, Boileau, Jean-Francois, additional, Zhu, Yalin, additional, Pan, Wilbur, additional, Tryfonidis, Konstantinos, additional, Karantza, Vassiliki, additional, and O’Shaughnessy, Joyce, additional

Published
2022
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32. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer

Author

Schmid, Peter, primary, Cortes, Javier, additional, Dent, Rebecca, additional, Pusztai, Lajos, additional, McArthur, Heather, additional, Kümmel, Sherko, additional, Bergh, Jonas, additional, Denkert, Carsten, additional, Park, Yeon Hee, additional, Hui, Rina, additional, Harbeck, Nadia, additional, Takahashi, Masato, additional, Untch, Michael, additional, Fasching, Peter A., additional, Cardoso, Fatima, additional, Andersen, Jay, additional, Patt, Debra, additional, Danso, Michael, additional, Ferreira, Marta, additional, Mouret-Reynier, Marie-Ange, additional, Im, Seock-Ah, additional, Ahn, Jin-Hee, additional, Gion, Maria, additional, Baron-Hay, Sally, additional, Boileau, Jean-François, additional, Ding, Yu, additional, Tryfonidis, Konstantinos, additional, Aktan, Gursel, additional, Karantza, Vassiliki, additional, and O’Shaughnessy, Joyce, additional

Published
2022
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33. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer

Author

Makker, Vicky, primary, Colombo, Nicoletta, additional, Casado Herráez, Antonio, additional, Santin, Alessandro D., additional, Colomba, Emeline, additional, Miller, David S., additional, Fujiwara, Keiichi, additional, Pignata, Sandro, additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Shapira-Frommer, Ronnie, additional, Ushijima, Kimio, additional, Sakata, Jun, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra, Eva M., additional, Sanli, Ulus A., additional, McCormack, Mary M., additional, Smith, Alan D., additional, Keefe, Stephen, additional, Bird, Steven, additional, Dutta, Lea, additional, Orlowski, Robert J., additional, and Lorusso, Domenica, additional

Published
2022
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34. Pertuzumab study in the neoadjuvant setting for HER2‐positive nonmetastatic breast cancer in Australia (PeRSIA).

Author

Lok, Sheau Wen, De Boer, Richard, Baron‐Hay, Sally, Button, Peter, Devitt, Bianca, Forster, Benjamin C., Fox, Peter, Harold, Michael, Ketheeswaran, Sahisha, Kichenadasse, Ganessan, Kiely, Belinda E., Marx, Gavin, Nott, Louise, Pellegrini, Laura, Tafreshi, Ali, and Gibbs, Peter

Subjects
HER2 positive breast cancer, TUMOR classification, NEOADJUVANT chemotherapy, MEDICAL registries
Abstract

The pertuzumab study in the neoadjuvant setting for HER2+ nonmetastatic breast cancer in Australia (PeRSIA—ML39622) is an analysis of safety and effectiveness data from the pertuzumab patient registry. Although the prognosis of patients with early stage HER2+ breast cancer has been greatly improved by advances in chemotherapy approximately 25% to 30% of patients develop recurrent disease. Our study aimed to examine the effectiveness of neoadjuvant pertuzumab on surgical outcomes, describe the medium‐term effectiveness outcomes of patients treated with pertuzumab, and describe the planned and actual anticancer treatment regimens that patients received. Deidentified data were collected from the patients' medical records and entered into REDCap, between March 2018 and July 2019 (n = 95). The adverse events (AEs) reported most frequently were diarrhea (20; 21.1%), rash (4; 4.2%), and LVSD (4; 4.2%; two patients during neoadjuvant treatment and two patients during adjuvant treatment). AEs, ≥Grade 3 were diarrhea (2; 2.1%) and LVSD (1; 1.1%). Following surgery, a breast pathological complete response (bpCR) was achieved in 65 patients (70.7%; 95% CI: 60.2%‐79.7%) and total pathological complete response (tpCR) in 59 patients (64.1%; 95% CI: 53.4%‐73.9%). All patients who did not achieve a tpCR obtained a partial response (33/92, 35.9%). Our study is the first to capture real‐world data on the use of pertuzumab in the neoadjuvant setting in Australia. The effectiveness and safety data are consistent with those reported in clinical trials of pertuzumab in patients with HER2+ breast cancer, with no new safety concerns. [ABSTRACT FROM AUTHOR]

Published
2023
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35. Results of PD-L1 Analysis of Women Treated with Durvalumab in Advanced Endometrial Carcinoma (PHAEDRA).

Author

Smith, Deborah, Robledo, Kristy P., Yip, Sonia, Cummins, Michelle M., Kok, Peey-Sei, Lee, Yeh Chen, Friedlander, Michael, Baron-Hay, Sally, Shannon, Catherine, Coward, Jermaine, Beale, Philip, Goss, Geraldine, Meniawy, Tarek, Lombard, Janine, Spurdle, Amanda B., Andrews, John, Stockler, Martin R., Mileshkin, Linda, and Antill, Yoland

Subjects
PROGRAMMED death-ligand 1, IMMUNE checkpoint inhibitors, STAINS & staining (Microscopy), IMMUNOHISTOCHEMISTRY, WOMEN, ENDOMETRIAL tumors, RESEARCH funding, RECEIVER operating characteristic curves, PROGRESSION-free survival, SENSITIVITY & specificity (Statistics), IMMUNOTHERAPY, OVERALL survival
Abstract

Simple Summary: Until recently the outcome for women with advanced endometrial carcinoma has been poor. New immune therapies have resulted in much better outcomes for some, but not all, women with advanced disease. Determining which women are likely to respond is important, both to identify potential responders and prevent overtreatment of women who are not likely to respond. In this study we looked to see if there were any other markers that could be used to better predict those tumors that would be more likely to respond to the immune therapy known as durvalumab versus those tumors more likely to be resistant. Using statistical methods to evaluate each of the components examined we determined the cut-off point with the best performance. We found that the presence of tumor associated inflammatory cells had the strongest association with response. We also found that an algorithm derived from our best performing cut-off points identified women not likely to respond to treatment. While the presence of inflammatory cells was not significant when mismatch repair status was considered, our novel algorithm was. This is a small study and the findings do require validation in a larger group of women. Women with advanced endometrial carcinoma (EC) with mismatch repair (MMR) deficiency have improved outcomes when treated with immune checkpoint inhibitors; however, additional biomarkers are needed to identify women most likely to respond. Scores for programmed death ligand 1 (PD-L1), immunohistochemical staining of tumor (TC+), immune cells (IC+) and presence of tumor-associated immune cells (ICP) on MMR deficient (n = 34) and proficient (n = 33) EC from women treated with durvalumab in the PHAEDRA trial (ANZGOG1601/CTC0144) (trial registration number ACTRN12617000106336, prospectively registered 19 January 2017) are reported and correlated with outcome. Receiver operating characteristic (ROC) analyses and area under the ROC curve were used to determine optimal cutpoints. Performance was compared with median cutpoints and two algorithms; a novel algorithm derived from optimal cutpoints (TC+ ≥ 1 or ICP ≥ 10 or IC+ ≥ 35) and the Ventana urothelial carcinoma (UC) algorithm (either TC+ ≥ 25, ICP > 1 and IC+ ≥ 25 or ICP = 1 and IC+ = 100). The cutpoint ICP ≥ 10 had highest sensitivity (53%) and specificity (82%), being prognostic for progression-free survival (PFS) (p = 0.01), while the optimal cutpoints algorithm was associated with overall survival (p = 0.02); these results were not significant after adjusting for MMR status. The optimal cutpoints algorithm identified non-responders (p = 0.02) with high sensitivity (88%) and negative predictive value (92%), remaining significant after adjustment for MMR. Although MMR status had the strongest association with response, further work to determine the significance of ICP ≥ 10 and the novel optimal cutpoint algorithm is needed. [ABSTRACT FROM AUTHOR]

Published
2023
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38. A multicenter, open-label, randomized, phase III study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab versus treatment of physician's choice in patients with advanced endometrial cancer

Author

Makker, Vicky, primary, Colombo, Nicoletta, additional, Herráez, Antonio Casado, additional, Santin, Alessandro, additional, Colomba, Emeline, additional, Miller, David, additional, Fujiwara, Keiichi, additional, Pignata, Sandro, additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Shapira-Frommer, Ronnie, additional, Ushijima, Kimio, additional, Sakata, Jun, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra, Eva, additional, Sanli, Ulus, additional, McCormack, Mary, additional, Huang, Jie, additional, Smith, Alan, additional, Keefe, Stephen, additional, Dutta, Lea, additional, Orlowski, Robert, additional, and Lorusso, Domenica, additional

Published
2021
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39. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial

Author

Pfisterer, Jacobus, primary, Shannon, Catherine M, additional, Baumann, Klaus, additional, Rau, Joern, additional, Harter, Philipp, additional, Joly, Florence, additional, Sehouli, Jalid, additional, Canzler, Ulrich, additional, Schmalfeldt, Barbara, additional, Dean, Andrew P, additional, Hein, Alexander, additional, Zeimet, Alain G, additional, Hanker, Lars C, additional, Petit, Thierry, additional, Marmé, Frederik, additional, El-Balat, Ahmed, additional, Glasspool, Rosalind, additional, de Gregorio, Nikolaus, additional, Mahner, Sven, additional, Meniawy, Tarek M, additional, Park-Simon, Tjoung-Won, additional, Mouret-Reynier, Marie-Ange, additional, Costan, Cristina, additional, Meier, Werner, additional, Reinthaller, Alexander, additional, Goh, Jeffrey C, additional, L'Haridon, Tifenn, additional, Baron Hay, Sally, additional, Kommoss, Stefan, additional, du Bois, Andreas, additional, Kurtz, Jean-Emmanuel, additional, Ackermann, Sven, additional, Anthuber, Christoph, additional, Aydogdu, Mustafa, additional, Baldauf, Angelika, additional, Bauer, Wolfgang, additional, Behringer, Dirk, additional, Belau, Antje, additional, Bender, Alexandra, additional, Brucker, Cosima, additional, Burges, Alexander, additional, Daabach, Trygve, additional, Denschlag, Dominik, additional, Deryal, Mustafa, additional, Dörfel, Steffen, additional, Ebert, Juliane, additional, Fehm, Tanja, additional, Feidicker, Susanne Maria, additional, Feisel-Schwickardi, Gabriele, additional, Felberbaum, Ricardo, additional, Frank, Matthias, additional, Gebauer, Gerhard, additional, Gerber, Bernd, additional, Gerhardt, Axel, additional, Grafe, Andrea, additional, Griesshammer, Martin, additional, Grischke, Eva-Maria, additional, Gröll, Isolde, additional, Gropp-Meier, Martina, additional, Hager, Dietrich, additional, Hanf, Volker, additional, Hannig, Carla Verena, additional, Hantschmann, Peer, additional, Hauzenberger, Tanja, additional, Herwig, Uwe, additional, Heubner, Martin, additional, Hielscher, Carsten, additional, Hilpert, Felix, additional, Hitschold, Thomas, additional, Hofmann, Manfred, additional, Jackisch, Christian, additional, Janni, Wolfgang, additional, Kiesel, Ludwig, additional, Ko, Yon-Dschun, additional, Koch, Hans-Joachim, additional, Krabisch, Petra, additional, Krieger, Peter, additional, Kubin, Thomas, additional, Kühn, Thorsten, additional, Lampe, Björn, additional, Ledwon, Peter, additional, Lemster, Sabine, additional, Lex, Benno, additional, Liebrich, Clemens, additional, Lorenz, Ralf, additional, Lück, Hans-Joachim, additional, Mallmann, Peter, additional, Meinerz, Wolfgang, additional, Menke, Götz, additional, Möbus, Volker, additional, Müller, Thomas, additional, Müller, Volker, additional, Neunhöffer, Tanja, additional, Ober, Angelika, additional, Oskay-Özcelik, Gülten, additional, Ostertag, Horst, additional, Pölcher, Martin, additional, Rautenberg, Beate, additional, Rein, Daniel, additional, Reiter, Wilhelm, additional, Rempen, Andreas, additional, Runnebaum, Ingo, additional, Schmidt, Marcus, additional, Schnohr, Sabine, additional, Scholz, Heinz, additional, Schröder, Willibald, additional, Simon, Eike, additional, Sperfeld, Antje, additional, Steckkönig, Annette, additional, Strauß, Hans-Georg, additional, Stuth, Ronaldo, additional, Terhaag, Jürgen, additional, Thiel, Falk, additional, Thill, Marc, additional, Tomé, Oliver, additional, Uleer, Christoph, additional, Vogel, Susanne, additional, Voß, Hermann, additional, Weigel, Michael, additional, Winkler, Ulrich, additional, Wischnik, Arthur, additional, Zeiser, Tobias, additional, Zorr, Andreas, additional, Glasspool, Ros, additional, Hudson, Emma, additional, Jones, Rachel, additional, Lafleur, Judith, additional, Marth, Christian, additional, Petru, Edgar, additional, Antill, Yoland, additional, Azer, Mary, additional, Baron-Hay, Sally, additional, Beale, Philip, additional, Begbie, Stephen, additional, Black, Allison, additional, Briscoe, Karen, additional, Dean, Andrew, additional, Goh, Jeffrey, additional, Harvey, Sandra, additional, Lee, Chee, additional, Matos, Marco, additional, Meniawy, Tarek, additional, Olesen, Inger, additional, Shannon, Catherine, additional, Vasey, Paul, additional, Abadie-Lacourtoisie, Sophie, additional, Arsene, Olivier, additional, Barthier, Sophie, additional, Becuwe-Roemer, Célia, additional, Berton-Rigaud, Dominique, additional, Cappiello-Bataller, Maria, additional, Catala, Stéphanie, additional, Del Piano, Francesco, additional, Deplanque, Gaël, additional, Despax, Raymond, additional, Dohollou, Nadine, additional, Garnier-Tixidré, Claire, additional, Grenier, Julien, additional, Guardiola, Emmanuel, additional, Hardy-Bessard, Anne-Claire, additional, Lefeuvre-Plesse, Claudia, additional, Leheurteur, Marianne, additional, Lesoin, Anne, additional, Levache, Charles-Briac, additional, Longo, Raffaele, additional, Lortholary, Alain, additional, Meunier, Jérôme, additional, Raban, Nadia, additional, Romano, Olivier, additional, Vannetzel, Jean-Michel, additional, and Zannetti, Alain, additional

Published
2020
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41. Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial

Author

Antill, Yoland, primary, Kok, Peey-Sei, additional, Robledo, Kristy, additional, Yip, Sonia, additional, Cummins, Michelle, additional, Smith, Deborah, additional, Spurdle, Amanda, additional, Barnes, Elizabeth, additional, Lee, Yeh Chen, additional, Friedlander, Michael, additional, Baron-Hay, Sally, additional, Shannon, Catherine, additional, Coward, Jermaine, additional, Beale, Philip, additional, Goss, Geraldine, additional, Meniawy, Tarek, additional, Lombard, Janine, additional, Andrews, John, additional, Stockler, Martin R, additional, and Mileshkin, Linda, additional

Published
2021
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42. Tumor-associated immune cells and progression-free survival in advanced endometrial cancer (EC), results from the PHAEDRA trial (ANZGOG 1601).

Author

Smith, Deborah, primary, Robledo, Kristy, additional, Yip, Sonia, additional, Cummins, Michelle, additional, Kok, Peey-Sei, additional, Lee, Yeh Chen, additional, Friedlander, Michael, additional, Baron-Hay, Sally E., additional, Shannon, Catherine M., additional, Coward, Jermaine, additional, Beale, Philip James, additional, Goss, Geraldine, additional, Meniawy, Tarek, additional, Lombard, Janine Margaret, additional, Spurdle, Amanda B., additional, Andrews, John, additional, Stockler, Martin R., additional, Mileshkin, Linda R., additional, and Antill, Yoland Catherine, additional

Published
2021
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43. Australian real-world outcomes of ribociclib and aromatase inhibitor in hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): Results from Kisqali Access Registry for Metastatic breast cancer in Australia (KARMA) collected alongside a medicine access program.

Author

Wong, Vanessa, primary, de Boer, Richard, additional, Baron-Hay, Sally E., additional, Blum, Robert helmut, additional, Forster, Benjamin Carl, additional, Chua, Susan Li Ling, additional, Cuff, Katharine, additional, Green, Michael, additional, Lim, Elgene, additional, Mok, Kelly, additional, Nott, Louise M., additional, Nottage, Michelle K., additional, Tafreshi, Ali, additional, Tsoi, Daphne T. F., additional, Yeo, Belinda, additional, Gibbs, Peter, additional, and Lok, Sheau Wen, additional

Published
2021
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44. Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC).

Author

Lorusso, Domenica, primary, Colombo, Nicoletta, additional, Casado Herraez, Antonio, additional, Santin, Alessandro, additional, Colomba, Emeline, additional, Miller, David Scott, additional, Fujiwara, Keiichi, additional, Pignata, Sandro, additional, Baron-Hay, Sally E., additional, Ray-Coquard, Isabelle Laure, additional, Shapira-Frommer, Ronnie, additional, Kim, Yong Man, additional, McCormack, Mary, additional, Bird, Steven, additional, Prabhu, Vimalanand S., additional, Martin Nguyen, Allison, additional, Zhao, Qi, additional, Dutta, Lea, additional, and Makker, Vicky, additional

Published
2021
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45. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial

Author

Vassiliki Karantza, Shparyk Yaroslav, Sumrall Bradley, Javier Cortes, Iwata Hiroji, Kolesnik Oleksii, Ahn Jin Hee, Harbeck Nadia, Prausova Jana, Song Xinni, Berzoy Oleksandr, Mena Raul, Osaki Akihiko, Kahan Zsuzsanna, Simon Michael, Ozguroglu Mustafa, Chmielowska Ewa, Tsugawa Koichiro, Tsao Chao-Jung, Ozyilkan Ozgur, Nowecki Zbigniew, Fadeeva Natalia, Kaen Diego, Garcia Saenz Jose, Porter David, Ngan Kai Cheong Roger, Sherene Loi, Bermejo de las Heras Begona, Turner Nicholas, David W. Cescon, Hope S. Rugo, Oliff Ira, Kelly Catherine, Barrios Carlos, Cole Scott, Shevnya Sergii, Seock-Ah Im, Hoskins Kent, Komisarenko Hanna, Yavuz Sinan, Chaudhry Madhu, Sagara Yasuaki, Brust Leandro, Chan Steve, Gomez Villanueva Angel, Gallardo Carlos, Watanabe Junichiro, Ishikawa Takashi, Schleider Michael, Salas Claudio, Hardy-Bessard Anne-Claire, Erhan Gokmen, Adamchuk Hryhoriy, Beelen Karin, Holeckova Petra, Szczylik Cezary, Fujii Takaaki, Nakamura Seigo, Aruga Tomoyuki, Gokmen Erhan, Jing Zhao, Hiroji Iwata, Molinas Mandel Nil, Gogineni Keerthi, Im Seock-Ah, Zifang Guo, Loi Sherene, Costa Fabiano, Forstmeyer Dirk, Kosaka Yoshimasa, Gomez Diaz Alvaro, Ponomarova Olga, Wimberger Pauline, DAlessio Antonietta, Suzuki Eiji, Blohmer Jens-Uwe, Kowalwszyn Ruben, Molina Matias, Clingan Philip, Yamamoto Yutaka, Sabanathan Dhanusha, Gursel Aktan, Vynnychenko Ihor, Ferrario Cristiano, Schumann Raquel Von, Trukhin Dmytro, Arkosy Peter, Tseng Ling-Ming, Moore Susan, Gunduz Seyda, Stampleman Laura, de Freitas Junior Ruffo, Acevedo Alejandro, Lipatov Oleg, Niikura Naoki, Norikazu Masuda, Rusyn Andrii, Kral Zdenek, Crown John, Yamamoto Naohito, Jakobsen Erik, Blau Sibel, Bustam Anita, Zamora Adelantado Esther, Nanda Rita, Omene Coral, Arslan Cagatay, Kwong Ava, Teixeira Luis, Jensen Jeanette, Ito Yoshinori, Siegel Robert, Mastura Md Yusof, Nowakowska-Zajdel Ewa, Miyoshi Yasuo, Yu Joanne, Tuthill Mark, Mukhametshina Guzel, Matsumoto Koji, Gion Maria, Melichar Bohuslav, Desmoulins Isabelle, Moiseyenko Vladimir, Zurawski Bogdan, Carlos Gallardo, Lorincz Tamas, Cruz Jurado Josefina, Bondarenko Igor, Kaczerowsky Flores de Sousa Anna, Yamauchi Teruo, Loutfi Randa, Esther Holgado, Holgado Esther, Twelves Christopher, Streb Joanna, Tanabe Yuko, Tarnawski Rafal, Morales-Vasquez Flavia, Park Kwong Hwa, Csoszi Tibor, Meshcheryakov Andrey, Scalabrini Neto Antonio Orlando, Oleg Lipatov, Iwasa Tsutomu, Ricevuto Enrico, Tamura Kenji, Patson Brian, Liu Mei-Ching, Cinieri Saverio, Loibl Sibylle, Tjan-Heijnen Vivianne, Glavicic Vesna, Panwalkar Amit, Hargis Jeffrey, Kryzhanivska Anna, Yusof Mastura, O'Reilly Seamus, Rubovszky Gabor, Irvin William, Takahashi Masato, Ohtani Shoichiro, Peter Schmid, Carlos H. Barrios, Sanchez Cesar, Zbigniew Nowecki, Arkhipov Alexander, Chung Michael, Liu Chien-Ting, Mukai Hirofumi, Marco Torregroza Otero, Charpentier Danielle, Park-Simon Tjoung-Won, Lee Keun Seok, Leshchenko Iurii, Huang Chiun-Sheng, Tsai Michaela, Panella Timothy, Petrakova Katarina, MacPherson Iain, Schmid Peter, Baron-Hay Sally, Ursol Grygorii, Lacerda Domicio Carvalho, Cobb Patrick, Sanchez Jesus, Park Yeon Hee, Reyes Contreras Jessica, Fein Luis, Hegg Roberto, Diamond Jennifer, Huober Jens, Rugo Hope, Rybalova Irina, de la Cruz Merino Luis, Linnet Soren, Inoue Kenichi, Wheatley Duncan, Cescon David, Cicin Irfan, Gombos Andrea, Bonnefoi Herve, Nasonova Alla, Taylor Donatienne, Martinez Rodriguez Jorge, Valdes-Albini Frances, Juarez Ramiro Alejandro, Cortes Javier, Lu Janice, Silva Felipe, Lueftner Diana, Landherr Laszlo, Gomez Abuin Gonzalo, Yanez Eduardo, Rocha Roberto Odebrecht, Chow Louis, Otchenash Natalya, Radecka Barbara, Kolesnik Olena, Basaran Gul, Kurbacher Christian, Mahr Karoly, Goncalves Anthony, Begbie Stephen, Graham Janine, Fasching Peter, Varela Mirta, and Lissa Fernando Cezar Toniazzi

Subjects
Oncology, double blind procedure, pharmacist, CD274 protein, human, hazard ratio, 0302 clinical medicine, middle aged, Antineoplastic Combined Chemotherapy Protocols, cancer survival, comparative study, education.field_of_study, progression free survival, adult, drug effect, gemcitabine, clinical trial, General Medicine, nausea, anemia, Progression-Free Survival, priority journal, immunological antineoplastic agent, thyroiditis, pembrolizumab, metastatic breast cancer, neoadjuvant chemotherapy, medicine.medical_specialty, Antineoplastic Agents, intention to treat analysis, Article, skin manifestation, 03 medical and health sciences, Breast cancer, cancer combination chemotherapy, neutropenia, Humans, Progression-free survival, human, education, protein expression, cancer immunotherapy, treatment response, Interim analysis, medicine.disease, major clinical study, tumor recurrence, Carboplatin, programmed death 1 ligand 1, drug efficacy, multicenter study, chemistry, monoclonal antibody, randomized controlled trial, fatigue, drug tolerability, cancer patient, age distribution, drug safety, colitis, clinical outcome, Triple Negative Breast Neoplasms, Pembrolizumab, 030204 cardiovascular system & hematology, B7-H1 Antigen, Placebos, chemistry.chemical_compound, paclitaxel, Antineoplastic Agents, Immunological, Outcome Assessment, Health Care, 030212 general & internal medicine, antineoplastic agent, cancer adjuvant therapy, Eastern Cooperative Oncology Group performance status, female, carboplatin, sodium chloride, immunohistochemistry, medicine.drug, interactive voice response system, alanine aminotransferase, overall survival, Population, Antibodies, Monoclonal, Humanized, Double-Blind Method, Internal medicine, medicine, follow up, hyperthyroidism, pneumonia, controlled study, Taxane, phase 3 clinical trial, business.industry, hypertransaminasemia, alopecia, Gemcitabine, human tissue, cancer recurrence, functional status assessment, triple negative breast cancer, placebo, inoperable cancer, pathology, hypothyroidism, Neoplasm Recurrence, Local, business, metabolism, Follow-Up Studies
Abstract

Background: Pembrolizumab monotherapy showed durable antitumour activity and manageable safety in patients with metastatic triple-negative breast cancer. We aimed to examine whether the addition of pembrolizumab would enhance the antitumour activity of chemotherapy in patients with metastatic triple-negative breast cancer. Methods: In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we randomly assigned patients 2:1 with untreated locally recurrent inoperable or metastatic triple-negative breast cancer using a block method (block size of six) and an interactive voice-response system with integrated web-response to pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin) or placebo plus chemotherapy. Randomisation was stratified by type of on-study chemotherapy (taxane or gemcitabine–carboplatin), PD-L1 expression at baseline (combined positive score [CPS] ?1 or, Breast Cancer Research Foundation, BCRF; Pfizer; AstraZeneca; Merck; Roche; Samsung; Merck Sharp and Dohme, MSD; Eisai, JC reports personal fees and research funding paid to his institution from Roche, AstraZeneca, Merck Sharp & Dohme, and Eisai; personal fees from Celgene, Cellestia, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, GlaxoSmithKline, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Kyowa Kirin, Novartis, Pfizer, Samsung Bioepis; research funding paid to his institution from Ariad Pharmaceuticals, Bayer Healthcare, F Hoffman-La Roche, Guardanth Health, Piqur Therapeutics, Puma C, and Queen Mary University of London, outside the submitted work. In addition, JC has a MedSIR patent pending. DWC reports research support from Merck during the conduct of the study; research support paid to his institution from Merck, Pfizer, and GlaxoSmithKline; personal fees from Merck, Roche–Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Pfizer, Puma, Agenda, Exact Sciences, and Dynamo Therapeutics, outside the submitted work. In addition, DWC has a Biomarkers of TTK inhibitors patent pending. HSR reports funding for sponsored studies paid to the University of California San Francisco from Pfizer, Novartis, Lilly, Roche–Genentech, Macrogenics, OBI, Merck, Eisai, Immunomedics, Daiichi Sankyo, Seattle Genetics, and Odonate; travel support for educational meetings from Daiichi Sankyo, Mylan, Pfizer, Merck, AstraZeneca, Novartis, and Macrogenics; and consulting fees from Samsung and Puma, outside the submitted work. S-AI reports grants from AstraZeneca, Eisai, Pfizer, Roche, and Daewoong; an advisory role for AstraZeneca, Amgen, Eisai, Hanmi, Novartis, Lily, MedPacto, Pfizer, and Roche; and travel expenses for presentation from Novartis, outside the submitted work. CG reports Advisory Board fees from Merck Sharp & Dohme and Roche; and speaker's bureau fees from Bristol Myers Squibb and AstraZeneca, outside the submitted work. CHB reports grants and fees from Merck Sharp & Dohme for clinical research consulting during the conduct of the study; consulting–advisory role fees from Boehringer Ingelheim, GlaxoSmithKline, and Bayer; consulting–advisory role fees and grants for clinical research from Novartis, Pfizer, Roche–Genentech, Eisai, Merck Sharp & Dohme, and AstraZeneca; grants for clinical research from Abbvie, Amgen, Astellas Pharma, Bristol Myers Squibb, Celgene, Covance, Lilly, Medication, Merck Serono, and PharmaMar; grants for academic research projects from CPO, Pontificia Universidade Católica do Rio Grande do Sul, Latin American Cooperative Oncology Group, Grupo Brasileiro Estudos Câncer Mama, and Instituto Nacional de Câncer-Brazil, outside the submitted work. HI reports a grant from Merck Sharp & Dohme during the conduct of the study; honoraria and consulting fees from Novartis, AstraZeneca, Pfizer, Lilly, Daiichi Sankyo, Eisai, and Chugai; and a grant from Chugai, outside the submitted work. NM reports honoraria and research funding paid to his institution from Chugai, AstraZeneca, Pfizer, Eli-Lilly, Eisai, Takeda, Kyowa-Kirin, Merck Sharp & Dohme, Novartis, and Daiichi Sankyo, outside the submitted work. EG reports non-financial support from Merck Sharp & Dohme during the conduct of the study; honoraria, consulting–advisory fees and meeting support from Novartis, Roche, Bristol Myers Squibb, and Pfizer; and honoraria from AstraZeneca and Astellas, outside the submitted work. SL reports research funding or consulting fees paid to her institution from Bristol Myers Squibb, Roche–Genentech, Puma Biotechnology, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, Eli Lilly, Aduro Biotech, GI Therapeutics, AstraZeneca, and GlaxoSmithKline; and non-remunerated consultancy for Bristol Myers Squibb, Roche–Genentech, Pfizer, Seattle Genetics, Novartis, Merck Sharp & Dohme, and AstraZeneca, outside the submitted work. In addition, SL is supported by the National Breast Cancer Foundation of Australia Endowed Chair and the Breast Cancer Research Foundation, New York. ZG, JZ, GA, and VK are employees of Merck Sharp & Dohme and own stock or stock options in Merck. PS reports consultancy fees from Pfizer, AstraZeneca, Novartis, Roche, Merck Sharp & Dohme, Boehringer Ingelheim, Bayer, Eisai, Celgene, and Puma; consultancy fees to his spouse from Genentech and Roche; and grants or funding to his institution from Roche, Genentech, Oncogenex, Novartis, Astellas, and AstraZeneca, outside the submitted work. All other authors declare no competing interests., The authors thank the patients, their families and caregivers for participating in this trial, all of the investigators and site personnel, and the following employees of Merck Sharp & Dohme: Wilbur Pan, Deborah Card, Eleanor Readinger, Shana Hamm, Roger Maxwell, and Krystal Bourdon, for collection of data, supervision of research, provision of study materials or patients or administrative or logistical support; Aline Galvao, for collection of data, supervision of research, administrative or logistical support, and review of imaging data related to the primary end point; Donna Letizia, for collection of data and imaging expertise; Jennifer Kimmel, for study management; Mercedes Bustamante, for data collection and management; Xuan Zhou and Madhusudhan Reddy Papasani, for statistical expertise; Christine McCrary Sisk, for medical writing and editorial assistance; and Joseph C Naggar and Michele McColgan, for administrative or logistical support.

Published
2020

46. Low meprin (alpha) expression differentiates primary ovarian mucinous carcinoma from gastrointestinal cancers that commonly metastasise to the ovaries

Author

Heinzelmann-Schwarz, Viola A., Scolyer, Richard A., Scurry, James P., Smith, Alison N., Gardiner-Garden, Margaret, Biankin, Andrew V., Baron-Hay, Sally, Scott, Carolyn, Ward, Robyn L., Fink, Daniel, Hacker, Neville F., Sutherland, Robert L., and O'Brien, Philippa M.

Subjects
Metalloproteins -- Genetic aspects, Metalloproteins -- Research, Gene expression -- Research, Gastrointestinal cancer -- Complications and side effects, Metastasis -- Diagnosis, Ovarian cancer -- Diagnosis, Health
Published
2007

49. Abstract OT2-02-01: A 'real world' experience of CDK4/6 inhibition with ribociclib and endocrine therapy in hormone receptor positive metastatic breast cancer in Australia

Author

Lok, Sheau Wen, primary, Baron-Hay, Sally, additional, Lim, Elgene, additional, Blum, Robert, additional, Boyle, Fran, additional, Clarke, Kerrie, additional, Cuff, Katharine, additional, Green, Michael, additional, Malik, Laeeq, additional, Mok, Kelly, additional, Murray, Nick, additional, Nott, Louise, additional, Nottage, Michelle, additional, Tafreshi, Ali, additional, Tsoi, Daphne, additional, Yeo, Belinda, additional, Gibbs, Peter, additional, and De Boer, Richard, additional

Published
2020
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