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1. The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer

Author

Abraham, Jean E., Pinilla, Karen, Dayimu, Alimu, Grybowicz, Louise, Demiris, Nikolaos, Harvey, Caron, Drewett, Lynsey M., Lucey, Rebecca, Fulton, Alexander, Roberts, Anne N., Worley, Joanna R., Chhabra, Anita, Qian, Wendi, Vallier, Anne-Laure, Hardy, Richard M., Chan, Steve, Hickish, Tamas, Tripathi, Devashish, Venkitaraman, Ramachandran, Persic, Mojca, Aslam, Shahzeena, Glassman, Daniel, Raj, Sanjay, Borley, Annabel, Braybrooke, Jeremy P., Sutherland, Stephanie, Staples, Emma, Scott, Lucy C., Davies, Mark, Palmer, Cheryl A., Moody, Margaret, Churn, Mark J., Newby, Jacqueline C., Mukesh, Mukesh B., Chakrabarti, Amitabha, Roylance, Rebecca R., Schouten, Philip C., Levitt, Nicola C., McAdam, Karen, Armstrong, Anne C., Copson, Ellen R., McMurtry, Emma, Tischkowitz, Marc, Provenzano, Elena, and Earl, Helena M.

Published
2024
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2. Aromatase inhibition plus/minus Src inhibitor saracatinib (AZD0530) in advanced breast cancer therapy (ARISTACAT): a randomised phase II study

Author

Oswald, Ailsa J., Symeonides, Stefan N., Wheatley, Duncan, Chan, Stephen, Brunt, Adrian Murray, McAdam, Karen, Schmid, Peter, Waters, Simon, Poole, Christopher, Twelves, Chris, Perren, Timothy, Bartlett, John, Piper, Tammy, Chisholm, Eve Macdonald, Welsh, Michelle, Hill, Robert, Hopcroft, Lisa E. M., Barrett-Lee, Peter, and Cameron, David A.

Published
2023
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3. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bouzid, Kamel, Campone, Mario, Coudert, Bruno, Nowecki, Zbigniew, Errihani, Hassan, Dalenc, Florence, Ferreira, Ana, Mano, Max, Ricci, Francesco, Kalofonos, Haralabos, Andreetta, Claudia, Montemurro, Filippo, Barrett, Sophie, Zhang, Qingyuan, Mavroudis, Dimitris, Matus, Juan, Beato, Carlos, Hu, Xichun, Gaafar, Rabab, Abdel Azeem, Hamdy, Perrin, Christophe, Ettl, Johannes, Lang, Istvan, Verma, Sunil, Li, Huiping, Brain, Etienne, Hoffmann, Oliver, Cariello, Anna, Tondini, Carlo, Altwegeiri, Taher, Loman, Niklas, Lux, Michael, Frassoldati, Antonio, Aziz, Zeba, Salas, Fernando, Streb, Joanna, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Laing, Robert, Tong, Zhongsheng, Boer, Katalin, Juhasz, Balazs, Gianni, Luca, Curigliano, Giuseppe, Juarez, Alejandro, Susnjar, Snezana, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Cruz, Marcelo, Bourgeois, Hugues, von Schumann, Raquel, Stemmer, Salomón, Vásquez, Flavia Morales, Dominguez, Adriana, Wojtukiewicz, Marek, Trifunovic, Jasna, Illarramendi, Jose Juan, Garcia, Laura, Peron, Yann Izarzugaza, Echarri, Maria Jose, Voitko, Natliia, Wheatley, Duncan, Waters, Simon, De Boer, Richard, Jerusalem, Guy, Cocquyt, Véronique, Barrios, Carlos, Panasci, Lawrence, Mattson, Johanna, Tanner, Minna, Gozy, Michel, Vasilopoulos, Georgios, Revesz, Janos, Latini, Luciano, Gridelli, Cesare, Lazaro, Jesus, Gonzalez, Antonio, Barnadas Molins, Agusti, Martinez, Eduardo, Alarcón, Jesús, Arance, Ana, Klint, Leif, Kovalyov, Oleksiy, Baird, Richard, Yeo, Belinda, McCarthy, Nicole, Greil, Richard, Wang, Shusen, Artignan, Xavier, Augereau, Paule, Juhasz-Boess, Ingolf, Ngan, Roger, Goldberg, Hadassah, Di Costanzo, Francesco, Ferraù, Francesco, Aleknavicius, Eduardas, Rashid, Kamran, Costa, Luís, Angel Garcia, Jose, de la Cruz, Luis Ruiz, López López, Rafael, Del Val, Olga, Ozyilkan, Ozgur, Azribi, Fathi, Verrill, Mark, Turner, Nicholas, Beith, Jane, Petzer, Andreas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Saad Eldin, Ibtessam, Achille, Mihaëla, Mueller, Volkmar, Gennari, Alessandra, Cascinu, Stefano, Ghosn, Marwan, El-Saghir, Nagi, Van den Bosch, Joan, Oosterkamp, Rianne, Kukulska, Monika, Pelaez, Ignacio, Hernandez, Carolina, del Mar Gordon, Maria, Dalmau, Elsa, Alonso, Jose Luis, Aksoy, Sercan, Coskun, Hasan Senol, Shparyk, Yaroslav, Varughese, Mohini, Panwar, Udaiveer, Barraclough, Lisa, Levitt, Nicola, Hicks, Jonathan, Rigg, Anna, Allen, Mark, Castillo, Cecila, Fein, Luis Enrique, Stuart-Harris, Robin, Singer, Christian, Stoeger, Herbert, Smiljanic, Sasha, Feng, Jifeng, Cedeño, Miguel, Berdah, Jean Francois, Orfeuvre, Hubert, Goncalves, Anthony, Grischke, Eva-Maria, Simon, Eike, Wagner, Steffen, Efremidou, Anna, Papazisis, Konstantinos, Evron, Ella, Inbar, Moshe, Baruch, Noa Ben, Geffen, David, Karminsky, Natalya, Ruggeri, Enzo Maria, Luigi, Cavanna, Grasso, Donatella, Juozaityte, Elona, Rafael Rodriguez Cid, Jeronimo, Roerdink, Henk, Siddiqi, Neelum, Passos Coelho, José Luís, Garre, Elisa Garcia, Garcia, Andres, Martínez Jañez, Noelia, Lopez Ceballos, Maria Helena, Mele, Mireia, García, María, Arcediano, Alberto, McAdam, Karen, Perren, Timothy, Taylor, Wendy, Humphreys, Alison, Vera, Raul, Kaen, Luis Alberto, Steger, Günther, Andel, Johannes, de Grève, Jacques, Huizing, Manon, Hegg, Roberto, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Ruohola, Johanna, Dohollou, Nadine, Grosjean, Jessica, Laplaige, Philippe, Largillier, Rémy, Martin, Philippe, Pottier, Virginie, Alexandre, Jerome, Christensen, Bernd, Zahm, Dirk-Michael, Khandan, Fariba, Lueck, Hans-Joachim, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Guerra, Yanin Chavarri, Van Warmerdam, Laurens, Van der Velden, Annette, Vrijaldenhoven, Suzan, de Jongh, Felix, Cavero, Milagros, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Oltra, Amparo, Redondo, Andres, Ribelles, Nuria, Bachmeier, Kilian, Joffe, Johnathan, Chakraborti, Prabir, Beresford, Mark, Butt, Mohammad, Poole, Christopher, Yordi, Gassan, Woodward, Natasha, Amorim, Gilberto, Califaretti, Nadia, Fox, Susan, Robidoux, Andre, Li, NanLi, Li, Nenxiao, Jiang, Jun, Soria, Tannia, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Barletta, Hugues, Teixeira, Luis, Facchini, Thomas, Hesse, Tobias, Kühn, Thorsten, Ober, Angelika, Repp, Roland, Schroeder, Willibald, Pectasides, Dimitrios, Bodoky, Gyorgy, Kahan, Zsuzsanna, Jiveliouk, Irina, Rosengarten, Ora, Alabiso, Oscar, Perez, Mario, Van de Wouw, Yes, Smok-Kalwat, Jolanta, Damasceno, Margarida, Sousa, Gabriela, Abulkhair, Omalkhair, Antón Torres, Antonio, Martinez, Maria Purificación, Garcia Mata, Jesús, Jesús Florián Jerico, Marta Santisteban, Llombart, Antonio, Sanchez, Rosa, Torrego, Juan Carlos, Garate, Clara Olier, Rodriguez, Cesar, Llorente, Rosa, de Prado, Diego Soto, Cortés, Javier, Llorca, Cristina, Galán, Antonio, Viñas Villaro, Gemma, Narbe, Ulrik, Bjömeklett, Helena Granstam, Westwell, Sarah, Newby, Jackie, Jafri, Mariam, Rodríguez, Robinson, Alonso, Isabel, Bachelot, T., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Bondarenko, I., Paluch-Shimon, S., Wardley, A., Merot, J.-L., du Toit, Y., Easton, V., Lindegger, N., and Miles, D.

Published
2019
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4. Central pathology review with two-stage quality assurance for pathological response after neoadjuvant chemotherapy in the ARTemis Trial

Author

Thomas, Jeremy St John, Provenzano, Elena, Hiller, Louise, Dunn, Janet, Blenkinsop, Clare, Grybowicz, Louise, Vallier, Anne-Laure, Gounaris, Ioannis, Abraham, Jean, Hughes-Davies, Luke, McAdam, Karen, Chan, Stephen, Ahmad, Rizvana, Hickish, Tamas, Houston, Stephen, Rea, Daniel, Caldas, Carlos, Bartlett, John MS, Cameron, David Allan, Hayward, Richard Laurence, and Earl, Helena Margaret

Published
2017
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5. Addition of gemcitabine to paclitaxel, epirubicin, and cyclophosphamide adjuvant chemotherapy for women with early-stage breast cancer (tAnGo): final 10-year follow-up of an open-label, randomised, phase 3 trial

Author

Earl, Helena M, Hiller, Louise, Howard, Helen C, Dunn, Janet A, Young, Jennie, Bowden, Sarah J, McDermaid, Michelle, Waterhouse, Anna K, Wilson, Gregory, Agrawal, Rajiv, O'Reilly, Susan, Bowman, Angela, Ritchie, Diana M, Goodman, Andrew, Hickish, Tamas, McAdam, Karen, Cameron, David, Dodwell, David, Rea, Daniel W, Caldas, Carlos, Provenzano, Elena, Abraham, Jean E, Canney, Peter, Crown, John P, Kennedy, M John, Coleman, Robert, Leonard, Robert C, Carmichael, James A, Wardley, Andrew M, and Poole, Christopher J

Published
2017
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6. Modelling drug responses and evolutionary dynamics using triple negative breast cancer patient-derived xenografts

Author

Shea, Abigail, primary, Eyal-Lubling, Yaniv, additional, Guerrero-Romero, Daniel, additional, Garcia, Raquel Manzano, additional, Greenwood, Wendy, additional, O’Reilly, Martin, additional, Georgopoulou, Dimitra, additional, Callari, Maurizio, additional, Lerda, Giulia, additional, Wix, Sophia, additional, Giovannetti, Agnese, additional, Masina, Riccardo, additional, Esmaeilishirazifard, Elham, additional, Martin, Alistair G., additional, Nagano, Ai, additional, Young, Lisa, additional, Kupczak, Steven, additional, Cheng, Yi, additional, Bardwell, Helen, additional, Provenzano, Elena, additional, Kane, Justine, additional, Lay, Jonny, additional, Grybowicz, Louise, additional, McAdam, Karen, additional, Caldas, Carlos, additional, Abraham, Jean, additional, Rueda, Oscar M, additional, and Bruna, Alejandra, additional

Published
2023
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7. Efficacy of neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide, for women with HER2-negative early breast cancer (ARTemis): an open-label, randomised, phase 3 trial

Author

Earl, Helena M, Hiller, Louise, Dunn, Janet A, Blenkinsop, Clare, Grybowicz, Louise, Vallier, Anne-Laure, Abraham, Jean, Thomas, Jeremy, Provenzano, Elena, Hughes-Davies, Luke, Gounaris, Ioannis, McAdam, Karen, Chan, Stephen, Ahmad, Rizvana, Hickish, Tamas, Houston, Stephen, Rea, Daniel, Bartlett, John, Caldas, Carlos, Cameron, David A, and Hayward, Larry

Published
2015
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8. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

Author

Fallowfield, Lesley, Jenkins, Valerie, Kilkerr, Justine, Langridge, Carolyn, Monson, Kathryn, Jakobsen, Erik Hugger, Nielsen, Mette Holck, Linnet, Soeren, Knoop, Ann, Pivot, Xavier, Bonnefoi, Herve, Mousseau, Mireille, Zelek, Laurent, Bourgeois, Hugues, Lefeuvre, Claudia Plesse, Bachelot, Thomas, Petit, Thierry, Brain, Etienne, Levy, Christelle, Gligorov, Joseph, Augustin, Doris, Graf, Heiko, Heinrich, Georg, Kroening, Hendrik, Kuemmel, Sherko, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-Won, Schmidt, Marcus, Perlova-Griff, Lidia, Wolf, Christopher, Colleoni, Marco, Ballestrero, Alberto, Bernardo, Antonio, Ribecco, Angela Stefania, Gianni, Luca, Curigliano, Giuseppe, Brewczynska, Elżbieta, Jassem, Jacek, Shirinkin, Vadim, Manikhas, Alexey, Dvornichenko, Victoria, Lichinitser, Mikhail, Semiglazov, Vladimir, Mukhametshina, Guzel, Bulavina, Irina, Arranz, Enrique Espinosa, Ocon, Francisco Carabantes, Vivanco, Guillermo López, Bofill, Javier Salvador, Quintela, Ignacio Porras, Muñoz, Alfonso Sanchez, Pérez, Yolanda Fernández, Espinosa, Javier Cassinello, Alvarez, José Valero, del Prado, Rodrigo Lastra, De Merino, LuisLa Cruz, García, José Manuel Pérez, Frances, Santos Enrech, Edlund, Per, Norberg, Bengt, Wennstig, Anna-Karin, Lind, Pehr, Hauser, Nik, Tausch, Christoph, Camci, Celalettin, Arpaci, Fikret, Abali, Huseyin, Uslu, Ruchan, Tahir, Saad, Wheatley, Duncan, Chan, Stephen, Barrett-Lee, Peter, McAdam, Karen, Simcock, Richard, Burcombe, Russell, El-Maraghi, Robert, Califaretti, Nadia, Spadafora, Silvana, Sehdev, Sandeep, Sami, Amer, Verma, Sunil, Pivot, X., Gligorov, J., Müller, V., Curigliano, G., Knoop, A., Verma, S., Jenkins, V., Scotto, N., Osborne, S., and Fallowfield, L.

Published
2014
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9. Gemcitabine and capecitabine with or without telomerase peptide vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer (TeloVac): an open-label, randomised, phase 3 trial

Author

Middleton, Gary, Silcocks, Paul, Cox, Trevor, Valle, Juan, Wadsley, Jonathan, Propper, David, Coxon, Fareeda, Ross, Paul, Madhusudan, Srinivasan, Roques, Tom, Cunningham, David, Falk, Stephen, Wadd, Nick, Harrison, Mark, Corrie, Pippa, Iveson, Tim, Robinson, Angus, McAdam, Karen, Eatock, Martin, Evans, Jeff, Archer, Caroline, Hickish, Tamas, Garcia-Alonso, Angel, Nicolson, Marianne, Steward, William, Anthoney, Alan, Greenhalf, William, Shaw, Victoria, Costello, Eithne, Naisbitt, Dean, Rawcliffe, Charlotte, Nanson, Gemma, and Neoptolemos, John

Published
2014
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10. Effects of the addition of gemcitabine, and paclitaxel-first sequencing, in neoadjuvant sequential epirubicin, cyclophosphamide, and paclitaxel for women with high-risk early breast cancer (Neo-tAnGo): an open-label, 2×2 factorial randomised phase 3 trial

Author

Earl, Helena M, Vallier, Anne-Laure, Hiller, Louise, Fenwick, Nicola, Young, Jennie, Iddawela, Mahesh, Abraham, Jean, Hughes-Davies, Luke, Gounaris, Ioannis, McAdam, Karen, Houston, Stephen, Hickish, Tamas, Skene, Anthony, Chan, Stephen, Dean, Susan, Ritchie, Diana, Laing, Robert, Harries, Mark, Gallagher, Christopher, Wishart, Gordon, Dunn, Janet, Provenzano, Elena, and Caldas, Carlos

Published
2014
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12. Abstract OT2-24-01: PARTNER: Randomised, phase II/III trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in triple negative and/or germline BRCA mutated breast cancer patients

Author

Drewett, Lynsey M, primary, Pinilla, Karen A, additional, Grybowicz, Louise, additional, Wulff, Jerome, additional, Dayimu, Alimu, additional, Demiris, Nikolaos, additional, Martin, Jessica, additional, de Pontes, Camila Maida, additional, Johnson, Nicola, additional, Harvey, Caron, additional, Demir, Erdem, additional, Green, Kimberley St John, additional, Jones, James, additional, Young, Gemma, additional, Vallier, Anne-Laure, additional, Qian, Wendi, additional, Machin, Andrea, additional, McAdam, Karen, additional, Roylance, Rebecca, additional, Copson, Ellen R, additional, Armstrong, Anne, additional, Levitt, Nicola, additional, Provenzano, Elena, additional, Tischkowitz, Marc, additional, McMurtry, Emma, additional, Earl, Helena, additional, and Abraham, Jean E, additional

Published
2022
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13. Patientsʼ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

Author

Pivot, X., Gligorov, J., Müller, V., Curigliano, G., Knoop, A., Verma, S., Jenkins, V., Scotto, N., Osborne, S., Fallowfield, L., Fallowfield, Lesley, Jenkins, Valerie, Kilkerr, Justine, Langridge, Carolyn, Monson, Kathryn, Jakobsen, Erik Hugger, Nielsen, Mette Holck, Linnet, Soeren, Knoop, Ann, Pivot, Xavier, Bonnefoi, Herve, Mousseau, Mireille, Zelek, Laurent, Bourgeois, Hugues, Lefeuvre, Claudia Plesse, Bachelot, Thomas, Petit, Thierry, Brain, Etienne, Levy, Christelle, Gligorov, Joseph, Augustin, Doris, Graf, Heiko, Heinrich, Georg, Kroening, Hendrik, Kuemmel, Sherko, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-Won, Schmidt, Marcus, Perlova-Griff, Lidia, Wolf, Christopher, Colleoni, Marco, Ballestrero, Alberto, Bernardo, Antonio, Ribecco, Angela Stefania, Gianni, Luca, Curigliano, Giuseppe, Brewczynska, Elżbieta, Jassem, Jacek, Shirinkin, Vadim, Manikhas, Alexey, Dvornichenko, Victoria, Lichinitser, Mikhail, Semiglazov, Vladimir, Mukhametshina, Guzel, Bulavina, Irina, Arranz, Enrique Espinosa, Ocon, Francisco Carabantes, Vivanco, Guillermo López, Bofill, Javier Salvador, Quintela, Ignacio Porras, Muñoz, Alfonso Sanchez, Pérez, Yolanda Fernández, Espinosa, Javier Cassinello, Alvarez, José Valero, del Prado, Rodrigo Lastra, Merino, Luis De La Cruz, García, José Manuel Pérez, Frances, Santos Enrech, Edlund, Per, Norberg, Bengt, Wennstig, Anna-Karin, Lind, Pehr, Hauser, Nik, Tausch, Christoph, Camci, Celalettin, Arpaci, Fikret, Abali, Huseyin, Uslu, Ruchan, Tahir, Saad, Wheatley, Duncan, Chan, Stephen, Barrett-Lee, Peter, McAdam, Karen, Simcock, Richard, Burcombe, Russell, El-Maraghi, Robert, Califaretti, Nadia, Spadafora, Silvana, Sehdev, Sandeep, Sami, Amer, and Verma, Sunil

Published
2014
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14. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer

Author

Poole, Christopher J., Earl, Helena M.; Hiller, Louise, Dunn, Janet A.; Bathers, Sarah; Grieve, Robert J.; Spooner, David A., Agrawal, Rajiv K.; Fernando, Indrajit N., Brunt, Murray A.; O'Reilly, Susan M., Crawford, Michael S.; Rea, Daniel W., Simmonds, Peter; Mansi, Janine L.; Stanley, Andrew; Harvey, Peter, McAdam, Karen; Foster, Liz, and Leonard, Robert C.F.; Twelves, Christopher J.

Subjects
Breast cancer -- Drug therapy, Epirubicin -- Dosage and administration, Cyclophosphamide -- Dosage and administration, Methotrexate -- Dosage and administration, Fluorouracil -- Dosage and administration, Cancer -- Adjuvant treatment, Cancer -- Health aspects
Abstract

The National Epirubicin Adjuvant Trial (NEAT) and the BR9601 trial were designed jointly by English and Scottish investigators in 1994 and 1995 to determine the value of anthracyclines in the adjuvant treatment of early breast cancer. Adjuvant treatment of early breast cancer with epirubicin plus CMF was significantly superior over CMF alone in terms of relapse free survival and overall survival, and hence epirubicin plus CMF as an option for anthracycline-based adjuvant chemotherapy in women with early breast cancer was recommended.

Published
2006

16. Six versus 12 months’ adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT

Author

Earl, Helena, primary, Hiller, Louise, additional, Vallier, Anne-Laure, additional, Loi, Shrushma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Rea, Daniel, additional, Howe, Donna, additional, Raynes, Kerry, additional, Higgins, Helen B, additional, Wilcox, Maggie, additional, Plummer, Chris, additional, Mahler-Araujo, Betania, additional, Provenzano, Elena, additional, Chhabra, Anita, additional, Gasson, Sophie, additional, Balmer, Claire, additional, Abraham, Jean E, additional, Caldas, Carlos, additional, Hall, Peter, additional, Shinkins, Bethany, additional, McCabe, Christopher, additional, Hulme, Claire, additional, Miles, David, additional, Wardley, Andrew M, additional, Cameron, David A, additional, and Dunn, Janet A, additional

Published
2020
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17. Abstract P3-10-05: Preliminary safety data from stage 1 and 2 of the phase II/III PARTNER trial: Addition of olaparib to platinum-based neoadjuvant chemotherapy in triple negative and/or germline BRCA mutated breast cancer patients

Author

Alba, Karen Pinilla, primary, McMurtry, Emma, additional, Vallier, Anne-Laure, additional, Grybowicz, Louise, additional, Copson, Ellen, additional, Armstrong, Anne, additional, Roylance, Rebecca, additional, Qian, Wendi, additional, Demiris, Nikolaos, additional, Thomas, Stanly, additional, Harvey, Caron, additional, Hughes-Davies, Luke, additional, McAdam, Karen, additional, del Rosario, Paula, additional, Harrop, Bryony, additional, Provenzano, Elena, additional, Tischkowitz, Marc, additional, Earl, Helena M, additional, and Abraham, Jean E, additional

Published
2020
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18. Abstract P3-11-09:ARISTACAT - Aromataseinhibition plus minussaracatinib asadvanced breastcancertherapy: A randomised phase II study of aromatase inhibition plus/minus the Src-inhibitor AZD0530 in post-menopausal women with advanced breast cancer

Author

Cameron, David, primary, Symeonides, Stefan, additional, Brunt, Murray, additional, Schmid, Peter, additional, Waters, Simon, additional, Twelves, Christopher, additional, Barrett-Lee, Peter, additional, Bartlett, John, additional, Piper, Tammy, additional, McAdam, Karen, additional, Chisholm, Eve Macdonald, additional, Welsh, Michelle, additional, and Hill, Robert, additional

Published
2020
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20. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P, Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M, Palmer, Daniel H, Campbell, Fiona, Valle, Juan W, Faluyi, Olusola, O'Reilly, Derek A, Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R, Middleton, Gary William, Cummins, Sebastian, Ross, Paul J, Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M, Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W, Neoptolemos, John P, Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, and Canc, European Study Grp Pancreatic

Subjects
medicine.medical_specialty, Chemotherapy, Randomization, business.industry, medicine.medical_treatment, 030230 surgery, medicine.disease, Gastroenterology, Gemcitabine, law.invention, Capecitabine, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030220 oncology & carcinogenesis, Internal medicine, Pancreatic cancer, medicine, Carcinoma, Surgery, Prospective cohort study, business, medicine.drug
Abstract

Importance The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures Overall survival, recurrence, and sites of recurrence. Results Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98;P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45;P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09;P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 andP = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98;P = .03). Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection. Trial Registration ClinicalTrials.gov identifier:NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.

Published
2019

21. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Author

Earl, Helena M, Hiller, Louise, Vallier, Anne-Laure, Loi, Shrushma, McAdam, Karen, Hughes-Davies, Luke, Harnett, Adrian N, Ah-See, Mei-Lin, Simcock, Richard, Rea, Daniel, Raj, Sanjay, Woodings, Pamela, Harries, Mark, Howe, Donna, Raynes, Kerry, Higgins, Helen B, Wilcox, Maggie, Plummer, Chris, Mansi, Janine, Gounaris, Ioannis, Mahler-Araujo, Betania, Provenzano, Elena, Chhabra, Anita, Abraham, Jean E, Caldas, Carlos, Hall, Peter S, McCabe, Christopher, Hulme, Claire, Miles, David, Wardley, Andrew M, Cameron, David A, Dunn, Janet A, PERSEPHONE Steering Committee And Trial Investigators, Earl, Helena [0000-0003-1549-8094], Abraham, Jean [0000-0003-0688-4807], Caldas, Carlos [0000-0003-3547-1489], and Apollo - University of Cambridge Repository

Subjects
Adult, Aged, 80 and over, Receptor, ErbB-2, Injections, Subcutaneous, Breast Neoplasms, Middle Aged, Trastuzumab, Disease-Free Survival, Drug Administration Schedule, United Kingdom, Young Adult, Antineoplastic Agents, Immunological, Treatment Outcome, Chemotherapy, Adjuvant, Humans, Female, Prospective Studies, Infusions, Intravenous, Aged
Abstract

BACKGROUND: Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is non-inferior to the standard 12-month treatment regarding disease-free survival. METHODS: This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006-007018-39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140). FINDINGS: Between Oct 4, 2007, and July 31, 2015, 2045 patients were assigned to 12-month trastuzumab treatment and 2044 to 6-month treatment (one patient was excluded because they were double randomised). Median follow-up was 5·4 years (IQR 3·6-6·7) for both treatment groups, during which a disease-free survival event occurred in 265 (13%) of 2043 patients in the 6-month group and 247 (12%) of 2045 patients in the 12-month group. 4-year disease-free survival was 89·4% (95% CI 87·9-90·7) in the 6-month group and 89·8% (88·3-91·1) in the 12-month group (hazard ratio 1·07 [90% CI 0·93-1·24], non-inferiority p=0·011), showing non-inferiority of the 6-month treatment. 6-month trastuzumab treatment resulted in fewer patients reporting severe adverse events (373 [19%] of 1939 patients vs 459 [24%] of 1894 patients, p=0·0002) or stopping early because of cardiotoxicity (61 [3%] of 1939 patients vs 146 [8%] of 1894 patients, p

Published
2019
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23. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma : A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial

Author

Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, Millat, Bertrand, Jones, Robert P., Psarelli, Eftychia-Eirini, Jackson, Richard, Ghaneh, Paula, Halloran, Christopher M., Palmer, Daniel H., Campbell, Fiona, Valle, Juan W., Faluyi, Olusola, O'Reilly, Derek A., Cunningham, David, Wadsley, Jonathan, Darby, Suzanne, Meyer, Tim, Gillmore, Roopinder, Anthoney, Alan, Lind, Pehr, Glimelius, Bengt, Falk, Stephen, Izbicki, Jakob R., Middleton, Gary William, Cummins, Sebastian, Ross, Paul J., Wasan, Harpreet, McDonald, Alec, Crosby, Tom, Ting, Yuk, Patel, Kinnari, Sherriff, David, Soomal, Rubin, Borg, David, Sothi, Sharmila, Hammel, Pascal, Lerch, Markus M., Mayerle, Julia, Tjaden, Christine, Strobel, Oliver, Hackert, Thilo, Buchler, Markus W., Neoptolemos, John P., Hill, Mark, Corrie, Pippa, Hickish, Tamas, Napier, Mark, Slater, Sarah, Valle, Juan, Shablak, Alaaeldin, Cunnell, Michelle, Guimbaud, Rosine, Roques, Tom, Iveson, Tim, Jamil, Arshad, Robinson, Angus, Garcia-Alonso, Angel, Chang, David, Tsang, David, Wadd, Nick, Wall, Lucy, Nielsen, Niels Hilmer, Lerch, Markus, Mehta, Ajay, Sivaramalingam, Muthiah, Fyfe, David, Osborne, Richard, Blesing, Claire, Bulusu, Venkata Ramesh, Rathbone, Emma, Seitz, Jean-Francois, Beaumont, Erica, Dernedde, Ulrike, McAdam, Karen, Dimopoulos, Prokopios, Cominos, Mathilda, Askill, Colin, Piwowar, Andrzej, Bachet, Jean-Baptiste, Sumpter, Kate, Raouf, Sherif, Nicoll, Jonathan, Rees, Charlotte, Dhinakaran, Kathirvelu, Haux, Johan, Bengrine-Lefevre, Leila, Terrebonne, Eric, Shankland, Catherine, Palmer, Cheryl, Medley, Louise, Toy, Elizabeth, Kaur, Jasvinder, Gupta, Kamalnayan, Cheeseman, Sue, Patterson, Daniel, Candish, Charles, Thompson, Joyce, Coxon, Fareeda, Connolly, Caroline, McPhail, Neil, Williams, Rachel, Flygare, Petra, Elmlund, Mattias, Artru, Pascal, and Millat, Bertrand

Abstract

Importance: The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective: To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants: Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions: Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures: Overall survival, recurrence, and sites of recurrence. Results: Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P=.03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P=.04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P=.27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32

Published
2019
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25. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Author

Earl, Helena M, primary, Hiller, Louise, additional, Vallier, Anne-Laure, additional, Loi, Shrushma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Harnett, Adrian N, additional, Ah-See, Mei-Lin, additional, Simcock, Richard, additional, Rea, Daniel, additional, Raj, Sanjay, additional, Woodings, Pamela, additional, Harries, Mark, additional, Howe, Donna, additional, Raynes, Kerry, additional, Higgins, Helen B, additional, Wilcox, Maggie, additional, Plummer, Chris, additional, Mansi, Janine, additional, Gounaris, Ioannis, additional, Mahler–Araujo, Betania, additional, Provenzano, Elena, additional, Chhabra, Anita, additional, Abraham, Jean E, additional, Caldas, Carlos, additional, Hall, Peter S, additional, McCabe, Christopher, additional, Hulme, Claire, additional, Miles, David, additional, Wardley, Andrew M, additional, Cameron, David A, additional, Dunn, Janet A, additional, Agarwal, Roshan, additional, Algurafi, Hafiz, additional, Allerton, Rozenn, additional, Archer, Caroline, additional, Armstrong, Anne, additional, Bale, Catherine, additional, Barraclough, Lisa, additional, Barthakur, Urmila, additional, Bedi, Carolyn, additional, Benstead, Kim, additional, Bloomfield, David, additional, Bowen, Rebecca, additional, Bradley, Chris, additional, Brown, Jane, additional, Butt, Mohammad, additional, Churn, Mark, additional, Cleator, Susan, additional, Cliff, Joanne, additional, Crellin, Perric, additional, Daly, Margaret, additional, De Silva-Minor, Shiroma, additional, Dhadda, Amandeep, additional, Din, Omar, additional, Down, Sue, additional, Earl, Helena, additional, Eaton, David, additional, Eichholz, Andrew, additional, Epurescu, Daniel, additional, Goh, Chee, additional, Goodman, Andrew, additional, Grieve, Robert, additional, Hadaki, Maher, additional, Harper-Wynne, Catherine, additional, Hayward, Larry, additional, Humphreys, Alison, additional, Innes, Helen, additional, Jafri, Mariam, additional, Jegannathen, Apurna, additional, Kelleher, Muireann, additional, Kristeleit, Hartmut, additional, Lee, Daniela, additional, Lupton, Susan, additional, MacGregor, Carol, additional, Malik, Zafar, additional, Marshall, Jennifer, additional, McGolick, Trevor, additional, Mehra, Rakesh, additional, Mithal, Natasha, additional, Moss, Charlotte, additional, Moss, Aian, additional, Mukesh, Mukesh, additional, Neal, Anthony, additional, Nelmes, Daniel, additional, Neville-Webbe, Helen, additional, Newby, Jacqueline, additional, O'Reilly, Susan, additional, Ostler, Peter, additional, Persic, Mojca, additional, Pettit, Laura, additional, Raja, Fharat, additional, Reed, Catherine, additional, Rigg, Anne, additional, Roe, Helen, additional, Shah, Nihal, additional, Simmonds, Peter, additional, Sims, Eliot, additional, Smith, Sarah, additional, Storey, Nicola, additional, Taylor, Wendy, additional, Thanvi, Narottam, additional, Tipples, Karen, additional, Vaidya, Jayant, additional, Varughese, Mohini, additional, Vinayan, Anup, additional, Walji, Nawaz, additional, Waters, Simon, additional, Wright, Kathryn, additional, and Yahya, Sundus, additional

Published
2019
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26. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bachelot, T., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Bondarenko, I., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, du Toit, Y., additional, Easton, V., additional, Lindegger, N., additional, Miles, D., additional, Bouzid, Kamel, additional, Campone, Mario, additional, Coudert, Bruno, additional, Nowecki, Zbigniew, additional, Errihani, Hassan, additional, Dalenc, Florence, additional, Ferreira, Ana, additional, Mano, Max, additional, Ricci, Francesco, additional, Kalofonos, Haralabos, additional, Andreetta, Claudia, additional, Montemurro, Filippo, additional, Barrett, Sophie, additional, Zhang, Qingyuan, additional, Mavroudis, Dimitris, additional, Matus, Juan, additional, Beato, Carlos, additional, Hu, Xichun, additional, Gaafar, Rabab, additional, Abdel Azeem, Hamdy, additional, Perrin, Christophe, additional, Ettl, Johannes, additional, Lang, Istvan, additional, Verma, Sunil, additional, Li, Huiping, additional, Brain, Etienne, additional, Hoffmann, Oliver, additional, Cariello, Anna, additional, Tondini, Carlo, additional, Altwegeiri, Taher, additional, Loman, Niklas, additional, Lux, Michael, additional, Frassoldati, Antonio, additional, Aziz, Zeba, additional, Salas, Fernando, additional, Streb, Joanna, additional, Wronski, Andrzej, additional, Menjón Beltrán, Salomón, additional, Cicin, Irfan, additional, Schmid, Peter, additional, Laing, Robert, additional, Tong, Zhongsheng, additional, Boer, Katalin, additional, Juhasz, Balazs, additional, Gianni, Luca, additional, Curigliano, Giuseppe, additional, Juarez, Alejandro, additional, Susnjar, Snezana, additional, Matos, Erika, additional, Uslu, Ruchan, additional, Wildiers, Hans, additional, Cruz, Marcelo, additional, Bourgeois, Hugues, additional, von Schumann, Raquel, additional, Stemmer, Salomón, additional, Vásquez, Flavia Morales, additional, Dominguez, Adriana, additional, Wojtukiewicz, Marek, additional, Trifunovic, Jasna, additional, Illarramendi, Jose Juan, additional, Garcia, Laura, additional, Peron, Yann Izarzugaza, additional, Echarri, Maria Jose, additional, Voitko, Natliia, additional, Wheatley, Duncan, additional, Waters, Simon, additional, De Boer, Richard, additional, Jerusalem, Guy, additional, Cocquyt, Véronique, additional, Barrios, Carlos, additional, Panasci, Lawrence, additional, Mattson, Johanna, additional, Tanner, Minna, additional, Gozy, Michel, additional, Vasilopoulos, Georgios, additional, Revesz, Janos, additional, Latini, Luciano, additional, Gridelli, Cesare, additional, Lazaro, Jesus, additional, Gonzalez, Antonio, additional, Barnadas Molins, Agusti, additional, Martinez, Eduardo, additional, Alarcón, Jesús, additional, Arance, Ana, additional, Klint, Leif, additional, Kovalyov, Oleksiy, additional, Baird, Richard, additional, Yeo, Belinda, additional, McCarthy, Nicole, additional, Greil, Richard, additional, Wang, Shusen, additional, Artignan, Xavier, additional, Augereau, Paule, additional, Juhasz-Boess, Ingolf, additional, Ngan, Roger, additional, Goldberg, Hadassah, additional, Di Costanzo, Francesco, additional, Ferraù, Francesco, additional, Aleknavicius, Eduardas, additional, Rashid, Kamran, additional, Costa, Luís, additional, Angel Garcia, Jose, additional, de la Cruz, Luis Ruiz, additional, López López, Rafael, additional, Del Val, Olga, additional, Ozyilkan, Ozgur, additional, Azribi, Fathi, additional, Verrill, Mark, additional, Turner, Nicholas, additional, Beith, Jane, additional, Petzer, Andreas, additional, Andrade, Jurandyr, additional, Bernstein, Vanessa, additional, Rayson, Daniel, additional, Saad Eldin, Ibtessam, additional, Achille, Mihaëla, additional, Mueller, Volkmar, additional, Gennari, Alessandra, additional, Cascinu, Stefano, additional, Ghosn, Marwan, additional, El-Saghir, Nagi, additional, Van den Bosch, Joan, additional, Oosterkamp, Rianne, additional, Kukulska, Monika, additional, Pelaez, Ignacio, additional, Hernandez, Carolina, additional, del Mar Gordon, Maria, additional, Dalmau, Elsa, additional, Alonso, Jose Luis, additional, Aksoy, Sercan, additional, Coskun, Hasan Senol, additional, Shparyk, Yaroslav, additional, Varughese, Mohini, additional, Panwar, Udaiveer, additional, Barraclough, Lisa, additional, Levitt, Nicola, additional, Hicks, Jonathan, additional, Rigg, Anna, additional, Allen, Mark, additional, Castillo, Cecila, additional, Fein, Luis Enrique, additional, Stuart-Harris, Robin, additional, Singer, Christian, additional, Stoeger, Herbert, additional, Smiljanic, Sasha, additional, Feng, Jifeng, additional, Cedeño, Miguel, additional, Berdah, Jean Francois, additional, Orfeuvre, Hubert, additional, Goncalves, Anthony, additional, Grischke, Eva-Maria, additional, Simon, Eike, additional, Wagner, Steffen, additional, Efremidou, Anna, additional, Papazisis, Konstantinos, additional, Evron, Ella, additional, Inbar, Moshe, additional, Baruch, Noa Ben, additional, Geffen, David, additional, Karminsky, Natalya, additional, Ruggeri, Enzo Maria, additional, Luigi, Cavanna, additional, Grasso, Donatella, additional, Juozaityte, Elona, additional, Rafael Rodriguez Cid, Jeronimo, additional, Roerdink, Henk, additional, Siddiqi, Neelum, additional, Passos Coelho, José Luís, additional, Garre, Elisa Garcia, additional, Garcia, Andres, additional, Martínez Jañez, Noelia, additional, Lopez Ceballos, Maria Helena, additional, Mele, Mireia, additional, García, María, additional, Arcediano, Alberto, additional, McAdam, Karen, additional, Perren, Timothy, additional, Taylor, Wendy, additional, Humphreys, Alison, additional, Vera, Raul, additional, Kaen, Luis Alberto, additional, Steger, Günther, additional, Andel, Johannes, additional, de Grève, Jacques, additional, Huizing, Manon, additional, Hegg, Roberto, additional, Joy, Anil, additional, Sehdev, Sandeep, additional, Kütner, Riina, additional, Ruohola, Johanna, additional, Dohollou, Nadine, additional, Grosjean, Jessica, additional, Laplaige, Philippe, additional, Largillier, Rémy, additional, Martin, Philippe, additional, Pottier, Virginie, additional, Alexandre, Jerome, additional, Christensen, Bernd, additional, Zahm, Dirk-Michael, additional, Khandan, Fariba, additional, Lueck, Hans-Joachim, additional, Fountzilas, Georgios, additional, Fried, Georgeta, additional, Giacobino, Alice, additional, Bonetti, Andrea, additional, Guerra, Yanin Chavarri, additional, Van Warmerdam, Laurens, additional, Van der Velden, Annette, additional, Vrijaldenhoven, Suzan, additional, de Jongh, Felix, additional, Cavero, Milagros, additional, Andres Conejero, Raquel, additional, Murias, Adolfo, additional, Saura, Salvador, additional, Oltra, Amparo, additional, Redondo, Andres, additional, Ribelles, Nuria, additional, Bachmeier, Kilian, additional, Joffe, Johnathan, additional, Chakraborti, Prabir, additional, Beresford, Mark, additional, Butt, Mohammad, additional, Poole, Christopher, additional, Yordi, Gassan, additional, Woodward, Natasha, additional, Amorim, Gilberto, additional, Califaretti, Nadia, additional, Fox, Susan, additional, Robidoux, Andre, additional, Li, NanLi, additional, Li, Nenxiao, additional, Jiang, Jun, additional, Soria, Tannia, additional, Padrik, Peeter, additional, Saarni, Outi, additional, Genet, Dominique, additional, Catala, Stéphanie, additional, Barletta, Hugues, additional, Teixeira, Luis, additional, Facchini, Thomas, additional, Hesse, Tobias, additional, Kühn, Thorsten, additional, Ober, Angelika, additional, Repp, Roland, additional, Schroeder, Willibald, additional, Pectasides, Dimitrios, additional, Bodoky, Gyorgy, additional, Kahan, Zsuzsanna, additional, Jiveliouk, Irina, additional, Rosengarten, Ora, additional, Alabiso, Oscar, additional, Perez, Mario, additional, Van de Wouw, Yes, additional, Smok-Kalwat, Jolanta, additional, Damasceno, Margarida, additional, Sousa, Gabriela, additional, Abulkhair, Omalkhair, additional, Antón Torres, Antonio, additional, Martinez, Maria Purificación, additional, Garcia Mata, Jesús, additional, Jesús Florián Jerico, Marta Santisteban, additional, Llombart, Antonio, additional, Sanchez, Rosa, additional, Torrego, Juan Carlos, additional, Garate, Clara Olier, additional, Rodriguez, Cesar, additional, Llorente, Rosa, additional, de Prado, Diego Soto, additional, Cortés, Javier, additional, Llorca, Cristina, additional, Galán, Antonio, additional, Viñas Villaro, Gemma, additional, Narbe, Ulrik, additional, Bjömeklett, Helena Granstam, additional, Westwell, Sarah, additional, Newby, Jackie, additional, Jafri, Mariam, additional, Rodríguez, Robinson, additional, and Alonso, Isabel, additional

Published
2019
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27. PARTNER: Randomised, phase II/III trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in triple negative and/or germline BRCA mutated breast cancer patients.

Author

Abraham, Jean, primary, Vallier, Anne-Laure, additional, Qian, Wendi, additional, Machin, Andrea, additional, Grybowicz, Louise, additional, Thomas, Stanly, additional, Harvey, Caron, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Roylance, Rebecca, additional, Copson, Ellen, additional, Provenzano, Elena, additional, Pinilla, Karen, additional, McMurtry, Emma, additional, Tischkowitz, Marc, additional, and Earl, Helena Margaret, additional

Published
2018
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28. Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

Ali, H. Raza, Dariush, Aliakbar, Provenzano, Elena, Bardwell, Helen, Abraham, Jean E., Iddawela, Mahesh, Vallier, Anne-Laure, Hiller, Louise, Dunn, Janet. A., Bowden, Sarah J., Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike J., Pharoah, Paul D. P., Brenton, James D., Walton, Nicholas A., Earl, Helena M., Caldas, Carlos, Ali, Raza [0000-0001-7587-0906], Abraham, Jean [0000-0003-0688-4807], Irwin, Mike [0000-0002-2191-9038], Pharoah, Paul [0000-0001-8494-732X], Brenton, James [0000-0002-5738-6683], Walton, Nicholas [0000-0003-3983-8778], Earl, Helena [0000-0003-1549-8094], Caldas, Carlos [0000-0003-3547-1489], and Apollo - University of Cambridge Repository

Subjects
Adult, PROGNOSIS, PROTEIN EXPRESSION, AUTOMATED-ANALYSIS, Receptor, ErbB-2, Biopsy, Immunology, Breast Neoplasms, Treatment resistance, SYSTEMS PATHOLOGY, RC0254, Breast cancer, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Humans, TUMOR-INFILTRATING LYMPHOCYTES, Oncology & Carcinogenesis, Lymphocytes, ANTHRACYCLINE CHEMOTHERAPY, Aged, Epirubicin, Medicine(all), Science & Technology, ASSOCIATION, Middle Aged, Computational pathology, Neoadjuvant Therapy, QR, Oncology, MPDL3280A, Chemotherapy, Adjuvant, NEO-TANGO, TRIAL, Female, Taxoids, Neoadjuvant, Life Sciences & Biomedicine, 1112 Oncology And Carcinogenesis, Research Article
Abstract

Background There is a need to improve prediction of response to chemotherapy in breast cancer in order to improve clinical management and this may be achieved by harnessing computational metrics of tissue pathology. We investigated the association between quantitative image metrics derived from computational analysis of digital pathology slides and response to chemotherapy in women with breast cancer who received neoadjuvant chemotherapy. Methods We digitised tissue sections of both diagnostic and surgical samples of breast tumours from 768 patients enrolled in the Neo-tAnGo randomized controlled trial. We subjected digital images to systematic analysis optimised for detection of single cells. Machine-learning methods were used to classify cells as cancer, stromal or lymphocyte and we computed estimates of absolute numbers, relative fractions and cell densities using these data. Pathological complete response (pCR), a histological indicator of chemotherapy response, was the primary endpoint. Fifteen image metrics were tested for their association with pCR using univariate and multivariate logistic regression. Results Median lymphocyte density proved most strongly associated with pCR on univariate analysis (OR 4.46, 95 % CI 2.34-8.50, p < 0.0001; observations = 614) and on multivariate analysis (OR 2.42, 95 % CI 1.08-5.40, p = 0.03; observations = 406) after adjustment for clinical factors. Further exploratory analyses revealed that in approximately one quarter of cases there was an increase in lymphocyte density in the tumour removed at surgery compared to diagnostic biopsies. A reduction in lymphocyte density at surgery was strongly associated with pCR (OR 0.28, 95 % CI 0.17-0.47, p < 0.0001; observations = 553). Conclusions A data-driven analysis of computational pathology reveals lymphocyte density as an independent predictor of pCR. Paradoxically an increase in lymphocyte density, following exposure to chemotherapy, is associated with a lack of pCR. Computational pathology can provide objective, quantitative and reproducible tissue metrics and represents a viable means of outcome prediction in breast cancer. Trial registration ClinicalTrials.gov NCT00070278; 03/10/2003 Electronic supplementary material The online version of this article (doi:10.1186/s13058-016-0682-8) contains supplementary material, which is available to authorized users.

Published
2016

29. Additional file 8: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Univariate and multivariate logistic regression models for all 15 image metrics. (DOCX 16Â kb)

Published
2016
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30. Additional file 12: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Distribution of median lymphocyte density from pre-treatment biopsies by clinical variables. Horizontal gray lines represent median values. Results of Kruskal-Wallis tests are depicted within graphs; red text denotes p values

Published
2016
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31. Additional file 7: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Distribution of post-treatment sample image metrics by tumor molecular subtype. Horizontal gray lines represent median values. Results of Kruskal-Wallis tests are depicted within graphs; red text denotes p values

Published
2016
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32. Additional file 9: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Multivariate logistic regression model including clinical prognostic factors and image metrics derived from model depicted in Additional File 8. (DOCX 14Â kb)

Published
2016
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33. Additional file 3: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Histograms depicting the distribution of all image metrics from pre-treatment samples. (PDF 25Â kb)

Published
2016
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34. Additional file 5: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Correlation matrix of all image metrics from pre-treatment samples. Correlation matrix of 15 image metrics derived from pre-treatment biopsies. Correlations are Pearsonâ s coefficients. Text size is proportional to the strength of the correlation. Pink boxes denote positive correlations and blue boxes denote negative correlations. (PDF 82Â kb)

Published
2016
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35. Additional file 6: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

Correlation matrix of all image metrics from post-treatment surgical samples. Correlation matrix of 15 image metrics derived from post-treatment surgical samples. Correlations are Pearsonâ s coefficients. Text size is proportional to the strength of the correlation. Pink boxes denote positive correlations and those blue boxes denote negative correlations. (PDF 82Â kb)

Published
2016
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36. Additional file 2: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Abstract

CONSORT diagram illustrating the flow of patients at each analytical stage. (PDF 7Â kb)

Published
2016
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37. Additional file 4: of Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer

Author

H. Ali, Aliakbar Dariush, Provenzano, Elena, Bardwell, Helen, Abraham, Jean, Iddawela, Mahesh, Anne-Laure Vallier, Hiller, Louise, Janet. Dunn, Bowden, Sarah, Hickish, Tamas, McAdam, Karen, Houston, Stephen, Irwin, Mike, Pharoah, Paul, Brenton, James, Walton, Nicholas, Earl, Helena, and Caldas, Carlos

Subjects
body regions, nervous system, fungi, sense organs, equipment and supplies
Abstract

Histograms depicting the distribution of all image metrics from post-treatment surgical samples. (PDF 26Â kb)

Published
2016
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38. PARTNER: Randomised, phase II/III trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in triple negative and/or germline BRCA mutated breast cancer patients.

Author

Earl, Helena Margaret, primary, Vallier, Anne-Laure, additional, Qian, Wendi, additional, Grybowicz, Louise, additional, Thomas, Stanly, additional, Mahmud, Saba, additional, Harvey, Caron, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Roylance, Rebecca, additional, Copson, Ellen, additional, Brown, Jessica, additional, Provenzano, Elena, additional, McMurtry, Emma, additional, Tischkowitz, Marc, additional, and Abraham, Jean, additional

Published
2017
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39. Trastuzumab-associated cardiac events in the Persephone trial

Author

Earl, Helena M, primary, Vallier, Anne-Laure, additional, Dunn, Janet, additional, Loi, Shrushma, additional, Ogburn, Emma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Harnett, Adrian, additional, Abraham, Jean, additional, Wardley, Andrew, additional, Cameron, David A, additional, Miles, David, additional, Gounaris, Ioannis, additional, Plummer, Chris, additional, and Hiller, Louise, additional

Published
2016
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40. Erratum: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

Author

Dalgleish, Angus G, primary, Stebbing, Justin, additional, Adamson, Douglas J A, additional, Arif, Seema Safia, additional, Bidoli, Paolo, additional, Chang, David, additional, Cheeseman, Sue, additional, Diaz-Beveridge, Robert, additional, Fernandez-Martos, Carlos, additional, Glynne-Jones, Rob, additional, Granetto, Cristina, additional, Massuti, Bartomeu, additional, McAdam, Karen, additional, McDermott, Raymond, additional, Martín, Andrés J Muñoz, additional, Papamichael, Demetris, additional, Pazo-Cid, Roberto, additional, Vieitez, Jose M, additional, Zaniboni, Alberto, additional, Carroll, Kevin J, additional, Wagle, Shama, additional, Gaya, Andrew, additional, and Mudan, Satvinder S, additional

Published
2016
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41. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

Author

Dalgleish, Angus G, primary, Stebbing, Justin, additional, Adamson, Douglas JA, additional, Arif, Seema Safia, additional, Bidoli, Paolo, additional, Chang, David, additional, Cheeseman, Sue, additional, Diaz-Beveridge, Robert, additional, Fernandez-Martos, Carlos, additional, Glynne-Jones, Rob, additional, Granetto, Cristina, additional, Massuti, Bartomeu, additional, McAdam, Karen, additional, McDermott, Raymond, additional, Martín, Andrés J Muñoz, additional, Papamichael, Demetris, additional, Pazo-Cid, Roberto, additional, Vieitez, Jose M, additional, Zaniboni, Alberto, additional, Carroll, Kevin J, additional, Wagle, Shama, additional, Gaya, Andrew, additional, and Mudan, Satvinder S, additional

Published
2016
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42. Abstract PD2-3: ARTemis: A randomised trial of bevacizumab with neo-adjuvant chemotherapy for patients with HER2-negative early breast cancer

Author

Earl, Helena M, primary, Hiller, Louise, additional, Dunn, Janet A, additional, Blenkinsop, Clare, additional, Grybowicz, Louise, additional, Vallier, Anne-Laure, additional, Abraham, Jean, additional, Thomas, Jeremy, additional, Provenzano, Elena, additional, Hughes-Davies, Luke, additional, McAdam, Karen, additional, Chan, Stephen, additional, Ahmad, Rizvana, additional, Hickish, Tamas, additional, Houston, Stephen, additional, Rea, Daniel, additional, Bartlett, John, additional, Caldas, Carlos, additional, Cameron, David, additional, and Hayward, Larry, additional

Published
2015
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46. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

Author

Pivot, X., Gligorov, J., Müller, V., Curigliano, G., Knoop, A., Verma, S., Jenkins, V., Scotto, N., Osborne, S., Fallowfield, L., Fallowfield, Lesley, Jenkins, Valerie, Kilkerr, Justine, Langridge, Carolyn, Monson, Kathryn, Jakobsen, Erik Hugger, Nielsen, Mette Holck, Linnet, Soeren, Knoop, Ann, Pivot, Xavier, Bonnefoi, Herve, Mousseau, Mireille, Zelek, Laurent, Bourgeois, Hugues, Lefeuvre, Claudia Plesse, Bachelot, Thomas, Petit, Thierry, Brain, Etienne, Levy, Christelle, Gligorov, Joseph, Augustin, Doris, Graf, Heiko, Heinrich, Georg, Kroening, Hendrik, Kuemmel, Sherko, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-Won, Schmidt, Marcus, Perlova-Griff, Lidia, Wolf, Christopher, Colleoni, Marco, Ballestrero, Alberto, Bernardo, Antonio, Ribecco, Angela Stefania, Gianni, Luca, Curigliano, Giuseppe, Brewczynska, Elżbieta, Jassem, Jacek, Shirinkin, Vadim, Manikhas, Alexey, Dvornichenko, Victoria, Lichinitser, Mikhail, Semiglazov, Vladimir, Mukhametshina, Guzel, Bulavina, Irina, Arranz, Enrique Espinosa, Ocon, Francisco Carabantes, Vivanco, Guillermo López, Bofill, Javier Salvador, Quintela, Ignacio Porras, Muñoz, Alfonso Sanchez, Pérez, Yolanda Fernández, Espinosa, Javier Cassinello, Alvarez, José Valero, del Prado, Rodrigo Lastra, Merino, Luis De La Cruz, García, José Manuel Pérez, Frances, Santos Enrech, Edlund, Per, Norberg, Bengt, Wennstig, Anna-Karin, Lind, Pehr, Hauser, Nik, Tausch, Christoph, Camci, Celalettin, Arpaci, Fikret, Abali, Huseyin, Uslu, Ruchan, Tahir, Saad, Wheatley, Duncan, Chan, Stephen, Barrett-Lee, Peter, McAdam, Karen, Simcock, Richard, Burcombe, Russell, El-Maraghi, Robert, Califaretti, Nadia, Spadafora, Silvana, Sehdev, Sandeep, Sami, Amer, Verma, Sunil, Pivot, X., Gligorov, J., Müller, V., Curigliano, G., Knoop, A., Verma, S., Jenkins, V., Scotto, N., Osborne, S., Fallowfield, L., Fallowfield, Lesley, Jenkins, Valerie, Kilkerr, Justine, Langridge, Carolyn, Monson, Kathryn, Jakobsen, Erik Hugger, Nielsen, Mette Holck, Linnet, Soeren, Knoop, Ann, Pivot, Xavier, Bonnefoi, Herve, Mousseau, Mireille, Zelek, Laurent, Bourgeois, Hugues, Lefeuvre, Claudia Plesse, Bachelot, Thomas, Petit, Thierry, Brain, Etienne, Levy, Christelle, Gligorov, Joseph, Augustin, Doris, Graf, Heiko, Heinrich, Georg, Kroening, Hendrik, Kuemmel, Sherko, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-Won, Schmidt, Marcus, Perlova-Griff, Lidia, Wolf, Christopher, Colleoni, Marco, Ballestrero, Alberto, Bernardo, Antonio, Ribecco, Angela Stefania, Gianni, Luca, Curigliano, Giuseppe, Brewczynska, Elżbieta, Jassem, Jacek, Shirinkin, Vadim, Manikhas, Alexey, Dvornichenko, Victoria, Lichinitser, Mikhail, Semiglazov, Vladimir, Mukhametshina, Guzel, Bulavina, Irina, Arranz, Enrique Espinosa, Ocon, Francisco Carabantes, Vivanco, Guillermo López, Bofill, Javier Salvador, Quintela, Ignacio Porras, Muñoz, Alfonso Sanchez, Pérez, Yolanda Fernández, Espinosa, Javier Cassinello, Alvarez, José Valero, del Prado, Rodrigo Lastra, Merino, Luis De La Cruz, García, José Manuel Pérez, Frances, Santos Enrech, Edlund, Per, Norberg, Bengt, Wennstig, Anna-Karin, Lind, Pehr, Hauser, Nik, Tausch, Christoph, Camci, Celalettin, Arpaci, Fikret, Abali, Huseyin, Uslu, Ruchan, Tahir, Saad, Wheatley, Duncan, Chan, Stephen, Barrett-Lee, Peter, McAdam, Karen, Simcock, Richard, Burcombe, Russell, El-Maraghi, Robert, Califaretti, Nadia, Spadafora, Silvana, Sehdev, Sandeep, Sami, Amer, and Verma, Sunil

Abstract

PrefHer revealed compelling and consistent patient preference for subcutaneous (s.c.) trastuzumab, regardless of delivery by single-use injection device or hand-held syringe. s.c. trastuzumab was well-tolerated and safety data, including immunogenicity, were consistent with previous reports. No new safety signals were identified compared with the known intravenous trastuzumab profile in early breast cancer

47. Trastuzumab beyond Progression in Advanced Breast Cancer: National Guidance versus Oncologist's Decision.

Author

Wong, Han Hsi, Collins, Jennifer, McAdam, Karen, and Wilson, Charles

Subjects
TRASTUZUMAB, ACADEMIC medical centers, BREAST tumors, DECISION making, MEDICAL protocols, MEDICAL records, METASTASIS, ONCOGENES, SURVIVAL, RETROSPECTIVE studies, LOG-rank test, THERAPEUTICS
Abstract

No abstract available Copyright © 2012 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Published
2014
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48. Modeling Drug Responses and Evolutionary Dynamics using Patient-Derived Xenografts Reveals Precision Medicine Strategies for Triple Negative Breast Cancer.

Author

Shea A, Eyal-Lubling Y, Guerrero-Romero D, Manzano Garcia R, Greenwood W, O'Reilly M, Georgopoulou D, Callari M, Lerda G, Wix S, Giovannetti A, Masina R, Esmaeilishirazifard E, Cope W, Martin AG, Nagano A, Young L, Kupczak S, Cheng Y, Bardwell H, Provenzano E, Kane J, Lay J, Grybowicz L, McAdam K, Caldas C, Abraham J, Rueda OM, and Bruna A

Abstract

The inter- and intra-tumor heterogeneity of triple negative breast cancers (TNBC), which is reflected in diverse drug responses, interplays with tumor evolution. Here, we developed a preclinical experimental and analytical framework using treatment-naive TNBC patient-derived tumor xenografts (PDTX) to test their predictive value in personalized cancer treatment approaches. Patients and their matched PDTX exhibited concordant drug responses to neoadjuvant therapy using two trial designs and dosing schedules. This platform enabled analysis of non-genetic mechanisms involved in relapse dynamics. Treatment resulted in permanent phenotypic changes with functional and therapeutic consequences. High throughput drug screening methods in ex vivo patient derived tumor xenograft cells (PDTCs) revealed patient-specific drug response changes dependent on first-line therapy. This was validated in vivo, as exemplified by a change in olaparib sensitivity in tumors previously treated with clinically relevant cycles of standard-of-care chemotherapy. In summary, PDTXs provide a robust tool to test patient drug responses and therapeutic regimens and to model evolutionary trajectories. However, high inter-model variability and permanent non-genomic transcriptional changes constrain their use for personalized cancer therapy. This work highlights important considerations associated with preclinical drug response modeling and potential uses of the platform to identify efficacious and preferential sequential therapeutic regimens.

Published
2024
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49. Computational pathology of pre-treatment biopsies identifies lymphocyte density as a predictor of response to neoadjuvant chemotherapy in breast cancer.

Author

Ali HR, Dariush A, Provenzano E, Bardwell H, Abraham JE, Iddawela M, Vallier AL, Hiller L, Dunn JA, Bowden SJ, Hickish T, McAdam K, Houston S, Irwin MJ, Pharoah PD, Brenton JD, Walton NA, Earl HM, and Caldas C

Subjects
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Biomarkers, Tumor blood, Biopsy, Breast Neoplasms blood, Breast Neoplasms pathology, Epirubicin administration & dosage, Female, Humans, Middle Aged, Receptor, ErbB-2 genetics, Taxoids administration & dosage, Breast Neoplasms drug therapy, Chemotherapy, Adjuvant methods, Lymphocytes pathology, Neoadjuvant Therapy methods
Abstract

Background: There is a need to improve prediction of response to chemotherapy in breast cancer in order to improve clinical management and this may be achieved by harnessing computational metrics of tissue pathology. We investigated the association between quantitative image metrics derived from computational analysis of digital pathology slides and response to chemotherapy in women with breast cancer who received neoadjuvant chemotherapy., Methods: We digitised tissue sections of both diagnostic and surgical samples of breast tumours from 768 patients enrolled in the Neo-tAnGo randomized controlled trial. We subjected digital images to systematic analysis optimised for detection of single cells. Machine-learning methods were used to classify cells as cancer, stromal or lymphocyte and we computed estimates of absolute numbers, relative fractions and cell densities using these data. Pathological complete response (pCR), a histological indicator of chemotherapy response, was the primary endpoint. Fifteen image metrics were tested for their association with pCR using univariate and multivariate logistic regression., Results: Median lymphocyte density proved most strongly associated with pCR on univariate analysis (OR 4.46, 95 % CI 2.34-8.50, p < 0.0001; observations = 614) and on multivariate analysis (OR 2.42, 95 % CI 1.08-5.40, p = 0.03; observations = 406) after adjustment for clinical factors. Further exploratory analyses revealed that in approximately one quarter of cases there was an increase in lymphocyte density in the tumour removed at surgery compared to diagnostic biopsies. A reduction in lymphocyte density at surgery was strongly associated with pCR (OR 0.28, 95 % CI 0.17-0.47, p < 0.0001; observations = 553)., Conclusions: A data-driven analysis of computational pathology reveals lymphocyte density as an independent predictor of pCR. Paradoxically an increase in lymphocyte density, following exposure to chemotherapy, is associated with a lack of pCR. Computational pathology can provide objective, quantitative and reproducible tissue metrics and represents a viable means of outcome prediction in breast cancer., Trial Registration: ClinicalTrials.gov NCT00070278 ; 03/10/2003.

Published
2016
Full Text
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