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1. Prognostic value of HER2DX in early-stage HER2-positive breast cancer: a comprehensive analysis of 757 patients in the Sweden Cancerome Analysis Network—Breast dataset (SCAN-B)

Author

Villacampa, G., Pascual, T., Brasó-Maristany, F., Paré, L., Martínez-Sáez, O., Cortés, J., Ciruelos, E., Martin, M., Conte, P., Carey, L.A., Fernandez, A., Harbeck, N., Marín-Aguilera, M., Vivancos, A., Curigliano, G., Villagrasa, P., Parker, J.S., Perou, C.M., Prat, A., and Tolaney, S.M.

Published
2024
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2. Patritumab deruxtecan in untreated hormone receptor-positive/HER2-negative early breast cancer: final results from part A of the window-of-opportunity SOLTI TOT-HER3 pre-operative study

Author

Oliveira, M., Falato, C., Cejalvo, J.M., Vila, M. Margelí, Tolosa, P., Salvador-Bofill, F.J., Cruz, J., Arumi, M., Luna, A.M., Guerra, J.A., Vidal, M., Martínez-Sáez, O., Paré, L., González-Farré, B., Sanfeliu, E., Ciruelos, E., Espinosa-Bravo, M., Pernas, S., Izarzugaza, Y., Esker, S., Fan, P.-D., Parul, P., Santhanagopal, A., Sellami, D., Villacampa, G., Ferrero-Cafiero, J.M., Pascual, T., and Prat, A.

Published
2023
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4. Low RNA disruption during neoadjuvant chemotherapy predicts pathologic complete response absence in patients with breast cancer

Author

Cazzaniga, M, Ademuyiwa, F, Petit, T, Tio, J, Generali, D, Ciruelos, E, Califaretti, N, Poirier, B, Ardizzoia, A, Dr Med, A, Dr Med, B, Mouret-Reynier, M, Dr Med, D, Isambert, N, Masetti, R, Pitre, L, Augereau, P, Milani, M, Rask, S, Dr Med, C, Pritzker, L, Noubir, S, Parissenti, A, Trudeau, M, Cazzaniga M. E., Ademuyiwa F., Petit T., Tio J., Generali D., Ciruelos E. M., Califaretti N., Poirier B., Ardizzoia A., Dr Med A. H., Dr Med B. L., Mouret-Reynier M. -A., Dr Med D. G., Isambert N., Masetti R., Pitre L., Dr Med D. W., Augereau P., Milani M., Rask S., Dr Med C. S., Pritzker L., Noubir S., Parissenti A., Trudeau M. E., Cazzaniga, M, Ademuyiwa, F, Petit, T, Tio, J, Generali, D, Ciruelos, E, Califaretti, N, Poirier, B, Ardizzoia, A, Dr Med, A, Dr Med, B, Mouret-Reynier, M, Dr Med, D, Isambert, N, Masetti, R, Pitre, L, Augereau, P, Milani, M, Rask, S, Dr Med, C, Pritzker, L, Noubir, S, Parissenti, A, Trudeau, M, Cazzaniga M. E., Ademuyiwa F., Petit T., Tio J., Generali D., Ciruelos E. M., Califaretti N., Poirier B., Ardizzoia A., Dr Med A. H., Dr Med B. L., Mouret-Reynier M. -A., Dr Med D. G., Isambert N., Masetti R., Pitre L., Dr Med D. W., Augereau P., Milani M., Rask S., Dr Med C. S., Pritzker L., Noubir S., Parissenti A., and Trudeau M. E.

Abstract

In previously reported retrospective studies, high tumor RNA disruption during neoadjuvant chemotherapy predicted for post-treatment pathologic complete response (pCR) and improved disease-free survival at definitive surgery for primary early breast cancer. The BREVITY (Breast Cancer Response Evaluation for Individualized Therapy) prospective clinical trial (NCT03524430) seeks to validate these prior findings. Here we report training set (Phase I) findings, including determination of RNA disruption index (RDI) cut points for outcome prediction in the subsequent validation set (Phase II; 454 patients). In 80 patients of the training set, maximum tumor RDI values for biopsies obtained during neoadjuvant chemotherapy were significantly higher in pCR responders than in patients without pCR post-treatment (P 1⁄4 .008). Moreover, maximum tumor RDI values ≤3.7 during treatment predicted for a lack of pCR at surgery (negative predictive value 1⁄4 93.3%). These findings support the prospect that on-treatment tumor RNA disruption assessments may effectively predict post-surgery outcome, possibly permitting treatment optimization.

Published
2024

5. Genomic characterisation of hormone receptor-positive breast cancer arising in very young women

Author

Luen, S.J., Viale, G., Nik-Zainal, S., Savas, P., Kammler, R., Dell’Orto, P., Biasi, O., Degasperi, A., Brown, L.C., Láng, I., MacGrogan, G., Tondini, C., Bellet, M., Villa, F., Bernardo, A., Ciruelos, E., Karlsson, P., Neven, P., Climent, M., Müller, B., Joshum, W., Bonnefoi, H., Martino, S., Davidson, N.E., Geyer, C., Chia, S.K., Ingle, J.N., Coleman, R., Solbach, C., Thürlimann, B., Colleoni, M., Coates, A.S., Goldhirsch, A., Fleming, G.F., Francis, P.A., Speed, T.P., Regan, M.M., and Loi, S.

Published
2023
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6. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Miles, D., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhász, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcón Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., McCarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Müller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H.M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeño, M., Ruohola, J., Berdah, J.-F., Goncalves, A., Orfeuvre, H., Grischke, E.-M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D’Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, H.-J., Zahm, D.-M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C.H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Viñas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.

Published
2021
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8. A retrospective, multicenter study of the efficacy of lapatinib plus trastuzumab in HER2-positive metastatic breast cancer patients previously treated with trastuzumab, lapatinib, or both: the Trastyvere study

Author

Gavilá, J., De La Haba, J., Bermejo, B., Rodríguez-Lescure, Á., Antón, A., Ciruelos, E., Brunet, J., Muñoz-Couselo, E., Santisteban, M., Rodríguez Sánchez, C. A., Santaballa, A., Sánchez Rovira, P., García Sáenz, J. Á., Ruiz-Borrego, M., Guerrero-Zotano, A. L., Huerta, M., Cotes-Sanchís, A., Lao Romera, J., Aguirre, E., Cortés, J., and Llombart-Cussac, A.

Published
2020
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10. 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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13. De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017

Author

Curigliano, G, Burstein, H.J., Winer, E.P., Gnant, M., Dubsky, P., Loibl, S., Colleoni, M., Regan, M.M., Piccart-Gebhart, M., Senn, H.-J., Thürlimann, B., André, F., Baselga, J., Bergh, J., Bonnefoi, H., Brucker, S.Y., Cardoso, F., Carey, L., Ciruelos, E., Cuzick, J., Denkert, C., Di Leo, A., Ejlertsen, B., Francis, P., Galimberti, V., Garber, J., Gulluoglu, B., Goodwin, P., Harbeck, N., Hayes, D.F., Huang, C.-S., Huober, J., Khaled, H., Jassem, J., Jiang, Z., Karlsson, P., Morrow, M., Orecchia, R., Osborne, K.C., Pagani, O., Partridge, A.H., Pritchard, K., Ro, J., Rutgers, E.J.T., Sedlmayer, F., Semiglazov, V., Shao, Z., Smith, I., Toi, M., Tutt, A., Viale, G., Watanabe, T., Whelan, T.J., and Xu, B.

Published
2017
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16. Genomic characterisation of hormone receptor-positive breast cancer arising in very young women

Author

Luen, SJ, Viale, G, Nik-Zainal, S, Savas, P, Kammler, R, Dell'Orto, P, Biasi, O, Degasperi, A, Brown, LC, Lang, I, MacGrogan, G, Tondini, C, Bellet, M, Villa, F, Bernardo, A, Ciruelos, E, Karlsson, P, Neven, P, Climent, M, Mueller, B, Jochum, W, Bonnefoi, H, Martino, S, Davidson, NE, Geyer, C, Chia, SK, Ingle, JN, Coleman, R, Solbach, C, Thurlimann, B, Colleoni, M, Coates, AS, Goldhirsch, A, Fleming, GF, Francis, PA, Speed, TP, Regan, MM, Loi, S, Luen, SJ, Viale, G, Nik-Zainal, S, Savas, P, Kammler, R, Dell'Orto, P, Biasi, O, Degasperi, A, Brown, LC, Lang, I, MacGrogan, G, Tondini, C, Bellet, M, Villa, F, Bernardo, A, Ciruelos, E, Karlsson, P, Neven, P, Climent, M, Mueller, B, Jochum, W, Bonnefoi, H, Martino, S, Davidson, NE, Geyer, C, Chia, SK, Ingle, JN, Coleman, R, Solbach, C, Thurlimann, B, Colleoni, M, Coates, AS, Goldhirsch, A, Fleming, GF, Francis, PA, Speed, TP, Regan, MM, and Loi, S

Abstract

BACKGROUND: Very young premenopausal women diagnosed with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+HER2-) early breast cancer (EBC) have higher rates of recurrence and death for reasons that remain largely unexplained. PATIENTS AND METHODS: Genomic sequencing was applied to HR+HER2- tumours from patients enrolled in the Suppression of Ovarian Function Trial (SOFT) to determine genomic drivers that are enriched in young premenopausal women. Genomic alterations were characterised using next-generation sequencing from a subset of 1276 patients (deep targeted sequencing, n = 1258; whole-exome sequencing in a young-age, case-control subsample, n = 82). We defined copy number (CN) subgroups and assessed for features suggestive of homologous recombination deficiency (HRD). Genomic alteration frequencies were compared between young premenopausal women (<40 years) and older premenopausal women (≥40 years), and assessed for associations with distant recurrence-free interval (DRFI) and overall survival (OS). RESULTS: Younger women (<40 years, n = 359) compared with older women (≥40 years, n = 917) had significantly higher frequencies of mutations in GATA3 (19% versus 16%) and CN amplifications (CNAs) (47% versus 26%), but significantly lower frequencies of mutations in PIK3CA (32% versus 47%), CDH1 (3% versus 9%), and MAP3K1 (7% versus 12%). Additionally, they had significantly higher frequencies of features suggestive of HRD (27% versus 21%) and a higher proportion of PIK3CA mutations with concurrent CNAs (23% versus 11%). Genomic features suggestive of HRD, PIK3CA mutations with CNAs, and CNAs were associated with significantly worse DRFI and OS compared with those without these features. These poor prognostic features were enriched in younger patients: present in 72% of patients aged <35 years, 54% aged 35-39 years, and 40% aged ≥40 years. Poor prognostic features [n = 584 (46%)] versus none [n = 692 (54%)] had an 8-year DRFI of 84% v

Published
2023

18. A definition for aggressive disease in patients with HER-2 negative metastatic breast cancer: an expert consensus of the Spanish Society of Medical Oncology (SEOM)

Author

González, A., Lluch, A., Aba, E., Albanell, J., Antón, A., Álvarez, I., Ayala, F., Barnadas, A., Calvo, L., Ciruelos, E., Cortés, J., de la Haba, J., López-Vega, J. M., Martínez, E., Muñoz, M., Peláez, I., Redondo, A., Rodríguez, Á., Rodríguez, C. A., Ruíz, A., and Llombart, A.

Published
2017
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20. Reply to ‘The St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017: the point of view of an International Panel of Experts in Radiation Oncology’ by Kirova et al.

Author

Dubsky, P, Curigliano, G, Burstein, H J, Winer, E P, Gnant, M, Loibl, S, Colleoni, M, Regan, M M, Piccart-Gebhart, M, Senn, H -J, Thürlimann, B, André, F, Baselga, J, Bergh, J, Bonnefoi, H, Brucker, S Y, Cardoso, F, Carey, L, Ciruelos, E, Cuzick, J, Denkert, C, Di Leo, A, Ejlertsen, B, Francis, P, Galimberti, V, Garber, J, Gulluoglu, B, Goodwin, P, Harbeck, N, Hayes, D F, Huang, C -S, Huober, J, Khaled, H, Jassem, J, Jiang, Z, Karlsson, P, Morrow, M, Orecchia, R, Osborne, K C, Pagani, O, Partridge, A H, Pritchard, K, Ro, J, Rutgers, E J T, Sedlmayer, F, Semiglazov, V, Shao, Z, Smith, I, Toi, M, Tutt, A, Viale, G, Watanabe, T, Whelan, T J, and Xu, B

Published
2018
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22. Immune milieu associated with PD-L1 status in TNBC is dependent on time of biomarker assessment and treatment received: A secondary analysis of the NeoTRIPaPDL1 trial

Author

Callari, M, Huang, C, Egle, D, Bermejo, B, Zamagni, C, Dugo, M, Thill, M, Anton, A, Barreca, M, Russo, S, Ciruelos, E, Greil, R, Zambelli, S, Gyorffy, B, Smart, C, Biasi, O, Valagussa, P, Viale, G, Gianni, L, Bianchini, G, Huang, CS, Ciruelos, EM, Callari, M, Huang, C, Egle, D, Bermejo, B, Zamagni, C, Dugo, M, Thill, M, Anton, A, Barreca, M, Russo, S, Ciruelos, E, Greil, R, Zambelli, S, Gyorffy, B, Smart, C, Biasi, O, Valagussa, P, Viale, G, Gianni, L, Bianchini, G, Huang, CS, and Ciruelos, EM

Published
2022

24. Functional Mapping of AKT Signaling and Biomarkers of Response from the FAIRLANE Trial of Neoadjuvant Ipatasertib plus Paclitaxel for Triple-Negative Breast Cancer

Author

Shi Z, Wulfkuhle J, Nowicka M, Gallagher R, Saura C, Nuciforo P, Calvo I, Andersen J, Passos-Coelho J, Gil-Gil M, Bermejo B, Pratt D, Ciruelos E, Villagrasa P, Wongchenko M, Petricoin E, Oliveira M, and Isakoff S

Abstract

Purpose: Despite extensive genomic and transcriptomic profiling, it remains unknown how signaling pathways are differentially activated and how tumors are differentially sensitized to certain perturbations. Here, we aim to characterize AKT signaling activity and its association with other genomic or IHC-based PI3K/AKT pathway biomarkers as well as the clinical activity of ipatasertib (AKT inhibitor) in the FAIRLANE trial. Experimental Design: In FA1 KANE, 151 patients with early triple-negative breast cancer (TNBC) were randomized 1:1 to receive paclitaxel with ipatasertib or placebo for 12 weeks prior to surgery. Adding ipatasertib did not increase pathologic complete response rate and numerically unproved overall response rate by MRI. We used reverse-phase protein microarrays (RPPA) to examine the total level and/or phosphorylation states of over 100 proteins in various signaling or cell processes including PI3K/AKT and mTOR signaling. One hundred and twenty-five baseline and 127 on-treatment samples were evaluable by RPPA, with 110 paired samples at both time points. Results: Tumors with genomic/protein alterations in PIK3CA/AKT1/PTEN were associated with higher levels of AKT phosphorylation. In addition, phosphorylated AKT (pAKT) levels exhibited a significant association with enriched clinical benefit of ipatasertib, and identified patients who received benefit in the absence of PIK3CA/AKT1/PTEN alterations. Ipatasertib treatment led to a downregulation of AKT/mTORC1 signaling, which was more pronounced among the tumors with PIK3CA/AKT1/PTEN alterations or among the responders to the treatment. Conclusions: We showed that the high baseline pAKT levels are associated with the alterations of PI3K/AKT pathway components and enriched benefit of ipatasertib in TNBC.

Published
2022

27. Metastatic or locally advanced breast cancer patients: towards an expert consensus on nab-paclitaxel treatment in HER2-negative tumours—the MACBETH project

Author

Cazzaniga, M, Ciruelos, E, Fabi, A, Garcia-Saenz, J, Lindman, H, Mavroudis, D, Schem, C, Steger, G, Timotheadou, E, Zaman, K, Torri, V, Cazzaniga M. E., Ciruelos E., Fabi A., Garcia-Saenz J., Lindman H., Mavroudis D., Schem C., Steger G., Timotheadou E., Zaman K., Torri V., Cazzaniga, M, Ciruelos, E, Fabi, A, Garcia-Saenz, J, Lindman, H, Mavroudis, D, Schem, C, Steger, G, Timotheadou, E, Zaman, K, Torri, V, Cazzaniga M. E., Ciruelos E., Fabi A., Garcia-Saenz J., Lindman H., Mavroudis D., Schem C., Steger G., Timotheadou E., Zaman K., and Torri V.

Abstract

Introduction: Despite the large use of nab-paclitaxel as a treatment option in metastatic breast cancer (MBC) across different countries, no definitive data are available in particular clinical situations. Areas covered: Efficacy, safety and schedule issues concerning available literature on nab-paclitaxel in advanced breast cancer and in specific subgroups of patients have been discussed and voted during an International Expert Meeting. Ten expert specialists in oncology, with extensive clinical experience on Nab-P and publications in the field of MBC have been identified. Six scientific areas of interest have been covered, generating 13 specific Statements for Nab-P, after literature review. For efficacy issues, a summary of research quality was performed adopting the GRADE algorithm for evidence scoring. The panel members were invited to express their opinion on the statements, in case of disagreement all the controversial opinions and the relative motivations have been made public. Expert opinion: Consensus was reached in 30.8% of the Nab-P statements, mainly those regarding safety issues, whereas ones regarding efficacy and schedule still remain controversial areas, requiring further data originated by the literature.

Published
2019

28. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, Vasilopoulos, G., additional, Papandreou, C., additional, Revesz, J., additional, Battelli, N., additional, Benedetti, G., additional, Latini, L., additional, Gridelli, C., additional, Lazaro Leon, J., additional, Alarcón Company, J., additional, Arance Fernandez, A., additional, Barnadas Molins, A., additional, Calvo Plaza, I., additional, Bratos, R., additional, Gonzalez Martin, A., additional, Izarzugaza Peron, Y., additional, Klint, L., additional, Kovalev, A., additional, McCarthy, N., additional, Yeo, B., additional, Kee, D., additional, Thomson, J., additional, White, S., additional, Greil, R., additional, Wang, S., additional, Artignan, X., additional, Juhasz-Böess, I., additional, Rody, A., additional, Ngan, R., additional, Dourleshter, F., additional, Goldberg, H., additional, Doni, L., additional, Di Costanzo, F., additional, Ferraù, F., additional, Drobniene, M., additional, Aleknavicius, E., additional, Rashid, K., additional, Costa, L., additional, de la Cruz Merino, L., additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, B., additional, Khandan, F., additional, Lück, H.-J., additional, Zahm, D.-M., additional, Fountzilas, G., additional, Karavasilis, V., additional, Safra, T., additional, Inbar, M., additional, Ryvo, L., additional, Bonetti, A., additional, Seles, E., additional, Giacobino, A., additional, Chavarri Guerra, Y., additional, de Jongh, F., additional, van der Velden, A., additional, van Warmerdam, L., additional, Vrijaldenhoven, S., additional, Smorenburg, C.H., additional, Cavero, M., additional, Andres Conejero, R., additional, Oltra Ferrando, A., additional, Redondo Sanchez, A., additional, Ribelles Entrena, N., additional, Saura Grau, S., additional, Viñas Vilaro, G., additional, Bachmeier, K., additional, Beresford, M., additional, Butt, M., additional, Joffe, J., additional, Poole, C., additional, Woodings, P., additional, Chakraborti, P., additional, Yordi, G., additional, Woodward, N., additional, Nobre, A., additional, Luiz Amorim, G., additional, Califaretti, N., additional, Fox, S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional

Published
2021
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29. 335TiP Open-label, multinational, multicenter, phase IIIb/IV study of trastuzumab deruxtecan (T-DXd) in patients with or without baseline brain metastasis with previously treated advanced/metastatic human epidermal growth factor receptor 2–positive breast cancer (HER2+ BC): DESTINY-Breast12

Author

Lin, N.U., primary, Ciruelos, E., additional, Jerusalem, G., additional, Müller, V., additional, Niikura, N., additional, Viale, G., additional, Oscroft, E., additional, Anand, S., additional, Walker, G., additional, and Harbeck, N., additional

Published
2021
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31. Final results from PERUSE, a global study of pertuzumab (P), trastuzumab (H) and investigator’s chosen taxane as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC)

Author

Schneeweiss, A, additional, Miles, D, additional, Ciruelos, E, additional, Puglisi, F, additional, Peretz-Yablonski, T, additional, Campone, M, additional, Bondarenko, I, additional, Nowecki, Z, additional, Errihani, H, additional, Paluch-Shimon, S, additional, Wardley, A, additional, Merot, J-L, additional, du Toit, Y, additional, Klingbiel, D, additional, Revelant, V, additional, and Bachelot, T, additional

Published
2021
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32. Solti-1903 hope: Real-world clinical practice study to assess the impact of using comprehensive genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain

Author

Casas, A, Ciruelos, E, Oliveira, M, Saura, C, Bellet, M, Pernas, S, Gavila, J, Munoz, M, Vidal, M, Farre, BG, Cejalvo, JM, Lopez, R, Vivancos, A, Scaltriti, M, Bofill, JS, Blancas, I, Alba, E, Boni, V, De la Cruz, S, Galve, E, Perello, A, Margeli, M, Canes, J, Celiz, P, Masanas, H, Olmos, R, Fonts, M, Fernandez-Pascual, P, Villagrasa, P, and Prat, A

Published
2021

33. Original Research Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study

Author

Kahan, Z, Gil-Gil, M, Ruiz-Borrego, M, Carrasco, E, Ciruelos, E, Munoz, M, Bermejo, B, Margeli, M, Anton, A, Casas, M, Csoszi, T, Murillo, L, Morales, S, Calvo, L, Lang, I, Alba, E, de la Haba-Rodriguez, J, Ramos, M, Lopez, IA, Gal-Yam, E, Garcia-Palomo, A, Alvarez, E, Gonzalez-Santiago, S, Rodriguez, CA, Servitja, S, Corsaro, M, Rodrigalvarez, G, Zielinski, C, and Martin, M

Subjects
Endocrine therapy, CDK4, Hormone receptor-positive metastatic breast cancer, Health-related quality of life, 6 inhibitor, Palbociclib
Abstract

Background: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. Patients and methods: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQC30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. Results: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs.-2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. Conclusion: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. Trial registration number: NCT02028507 (ClinTrials.gov). EudraCT study number: 2013-003170-27. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Published
2021

34. Oestrogen receptor activity in hormone-dependent breast cancer during chemotherapy: ER activity in pre-menopausal HR+ breast cancer during CT

Author

Schettini, F., Chic, N., Bellet, M., Vidal, M., Oliveira, M., Perou, C.M., Saura, C., Sanfeliu, E., Gonz��lez-Farr��, B., Carey, L.A., Bras��-Maristany, F., Ciruelos, E., Mart��nez-S��ez, O., Pernas, S., Mu��oz, M., Soberino, J., Galv��n, P., Adamo, B., Mart��nez, D., Gavil��, J., Prat, A., Cort��s, J., and Pascual, T.

Subjects
skin and connective tissue diseases
Abstract

Background: Chemotherapy efficacy in early-stage hormone receptor-positive (HR+) breast cancer (BC) according to menopausal status needs a biological explanation. Methods: We compared early-stage HR+ BC biological features before and after (neo)adjuvant chemotherapy or endocrine therapy (ET), and assessed oestrogen receptor (ER) pathway activity in both pre- and post-menopausal patients. The nCounter platform was used to detect gene expression levels. Findings: In 106 post-menopausal patients with HR+/HER2-negative BC randomized to neoadjuvant chemotherapy or ET (letrozole+ribociclib), a total of 19 oestrogen-regulated genes, including progesterone receptor (PGR), were found downregulated in the ET-based arm-only. We confirmed this finding in an independent dataset of 20 letrozole-treated post-menopausal patients and found, conversely, an up-regulation of the same signature in HR+/HER2-negative MCF7 cell line treated with estradiol. PGR was found down-regulated by 2 weeks of ET+anti-HER2 therapy in pre-/post-menopausal patients with HR+/HER2-positive (HER2+) BC, while anti-HER2 therapy alone increased PGR expression in HR-negative/HER2+ BC. In 88 pre- and post-menopausal patients with newly diagnosed HR+/HER2-negative BC treated with chemotherapy, the 19 oestrogen-regulated genes were found significantly downregulated only in pre-menopausal patients. In progesterone receptor (PR)+/HER2-negative BC treated with neoadjuvant chemotherapy (n=40), tumours became PR-negative in 69.2% of pre-menopausal patients and 14.8% of post-menopausal patients (p=0.001). Finally, a mean decrease in PGR levels was only observed in pre-menopausal patients undergoing anti-HER2-based multi-agent chemotherapy. Interpretation: Chemotherapy reduces the expression of ER-regulated genes in pre-menopausal women suffering from hormone-dependent BC by supressing ovarian function. Further studies should test the value of chemotherapy in this patient population when ovarian function is suppressed by other methods. Funding: Instituto de Salud Carlos III, Breast Cancer Now, the Breast Cancer Research Foundation, the American Association for Cancer Research, Fundaci�� La Marat�� TV3, the European Union's Horizon 2020 Research and Innovation Programme, Pas a Pas, Save the Mama, Fundaci��n Cient��fica Asociaci��n Espa��ola Contra el C��ncer, PhD4MDgrant of ���Departament de Salut���, exp SLT008/18/00122, Fundaci��n SEOM and ESMO. Any views, opinions, findings, conclusions, or recommendations expressed in this material are those solely of the author(s)

Published
2021
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36. 73TiP SOLTI1710 PROMETEO II: Palbociclib in combination with letrozole in hormone receptor-positive (HR+)/HER2-negative residual disease after standard neoadjuvant chemotherapy (NAC)

Author

Ciruelos, E., primary, Salvador Bofill, F.J., additional, Perello Martorell, A., additional, Conejo, E. Alba, additional, González-Farré, X., additional, Palacios-Ozores, P., additional, Merino, M., additional, Villagrasa, P., additional, Navarro, E. Vila, additional, Pascual, T., additional, Prat, A., additional, and Pernas Simon, S., additional

Published
2021
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38. Contextualizing pertuzumab approval in the treatment of HER2-positive breast cancer patients

Author

Cortes J, Ciruelos E, Perez-Garcia J, Albanell J, Garcia-Estevez L, Ruiz-Borrego M, Espinosa R, Gallegos I, Gonzalez S, Alvarez I, and Llombart A

Subjects
Dual blockade, Breast cancer, Pertuzumab, HER2, Trastuzumab, Adjuvant therapy
Abstract

The use of adjuvant pertuzumab in HER2-positive early-stage breast cancer has recently been approved by the EMA on the basis of data from the APHINITY trial. Accordingly, we have produced this opinion article with the aim of putting the study data in perspective against other add-on therapeutic strategies, to clarify methodological or statistical doubts about the study, and to define the population of high-risk patients with hormone receptor-negative breast cancer that we agree, in general, should be treated. With this approval, physicians must be well prepared to place the APHINITY study data in context. It is now up to each country to ratify the EMA-approved indications and to agree on reimbursement, and doctors must optimize their use based on knowledge and discussion with patients.

Published
2020

40. Abemaciclib, a CDK4 and CDK6 inhibitor for the treatment of metastatic breast cancer

Author

Martin M, Garcia-Saenz JA, Manso L, Llombart A, Cassinello A, Atienza M, Ringeisen F, and Ciruelos E

Subjects
breast cancer, CDK4, 6 inhibitors, hormone receptor-positive, abemaciclib, human epidermal growth factor receptor 2-negative, metastatic
Abstract

The addition of CDK4 and 6 inhibitors (abemaciclib, palbociclib or ribociclib) to endocrine therapy, as first-line treatment or following progression after initial endocrine therapy, significantly increased progression-free survival, objective response rates and in some trials overall survival, compared with endocrine therapy alone in HR+ and HER2- breast metastatic breast cancer. These CDK4 and 6 inhibitors are now approved in this context and have become a new standard of care. A hypothesis-generating exploratory analysis suggested that the addition of abemaciclib to endocrine therapy showed the largest effects in subgroups of women with indicators of poor prognosis, although these data require confirmation. This review provides updated clinical trial data for all three drugs in metastatic breast cancer, focusing on abemaciclib, the most recently approved agent.

Published
2020

41. Results from PEARL study (GEICAM/2013-02_CECOG/BC.1.3.006): A phase 3 trial of Palbociclib (PAL) in combination with endocrine therapy (ET) versus Capecitabine (CAPE) in hormonal receptor (HR)-positive/human epidermal growth factor receptor (HER) 2-negative metastatic breast cancer (MBC) patients (pts) whose disease progressed on aromatase inhibitors (AIs)

Author

Martin, M, Zielinski, C, Ruiz-Borrego, M, Carrasco, E, Ciruelos, E, Munoz, M, Bermejo, B, Margeli, M, Turner, N, Casas, M, Anton, A, Csoszi, T, Corsaro, M, Murillo, L, Morales, S, Alba, E, Bartlett, CH, Koehler, M, Guerrero, A, Kahan, Z, and Gil-Gil, M

Published
2020

42. Phase III study to evaluate patient's preference of subcutaneous versus intravenous trastuzumab in HER2-positive metastatic breast cancer patients: Results from the ChangHER study (GEICAM/2012-07)

Author

Ciruelos E, Montano A, Rodriguez C, Gonzalez-Flores E, Lluch A, Garrigos L, Quiroga V, Anton A, Malon D, Chacon J, Velasco M, Gonzalez-Cortijo L, Jolis L, Echarri M, Munoz M, Pascual T, Amigo Y, Casas M, Carrasco E, and Casas A

Abstract

OBJECTIVE: We compared patients' preferences for intravenous (IV-t) versus subcutaneous (SC-t) trastuzumab administration.; METHODS: Phase III, open-label, multicentre study in HER2-positive metastatic breast cancer. Patients were receiving IV-t for at least 4months without progression. Randomisation was 1:1 to administer 2 cycles of SC-t with vial followed by 2 cycles with single injection device (SID) or the reverse sequence (600mg SC-t every 3weeks for 4 cycles).; PRIMARY OBJECTIVE: patients' preference for IV-t versus SC-t; secondary objectives: patients' preference for vial versus SID, healthcare professional (HCP) preference and safety.; RESULTS: We randomised 166 patients in 26 sites. Median number of previous lines of chemotherapy and/or endocrine therapy was 1 (1-7). Median duration of prior IV-t was 1.8years (0.3-14). Of the159 patients completing the questionnaires, 86.2% preferred SC-t, 6.9% preferred IV-t, and 6.9% had no preference. Patients preferred SID (59.2%) over vial (26.3%). Most (87.2%) HCP preferred SC-t of whom 51.3% and 28.2% preferred SID and vial respectively. Related adverse events included G1-2 injection site reactions in 18 patients (10.8%), G1 pain in 8 (4.8%), G1-2 allergic reaction in 2 (1.2%), one G3 heart failure and 1 G2 ejection fraction decrease.; CONCLUSIONS: SC-t is preferred with no safety impact. © 2020 John Wiley & Sons Ltd.

Published
2020

43. Immune system and angiogenesis-related potential surrogate biomarkers of response to everolimus-based treatment in hormone receptor-positive breast cancer: an exploratory study

Author

Schettini, F, Sobhani, N, Ianza, A, Triulzi, T, Molteni, A, Lazzari, MC, Strina, C, Milani, M, Corona, SP, Sirico, M, Bernocchi, O, Giudici, F, Cappelletti, MR, Ciruelos, E, Jerusalem, G, Loi, S, Fox, SB, Generali, D, Schettini, F, Sobhani, N, Ianza, A, Triulzi, T, Molteni, A, Lazzari, MC, Strina, C, Milani, M, Corona, SP, Sirico, M, Bernocchi, O, Giudici, F, Cappelletti, MR, Ciruelos, E, Jerusalem, G, Loi, S, Fox, SB, and Generali, D

Abstract

PURPOSE: mTOR inhibitor everolimus is used for hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (mBC). No reliable predictive biomarker of response is available. Following evidences from other solid tumors, we aimed to assess the association between treatment-associated immune system features and everolimus activity. METHODS: We retrospectively explored a correlation with the therapeutic activity of everolimus and tumor-associated immune pathways with ingenuity pathway analysis (IPA), neutrophil-to-lymphocyte ratio (NLR), circulating lymphocytes, and endothelial cells (CECs) in 3 different HR+ mBC studies, including the BALLET phase IIIb study. RESULTS: The circulating levels of CD3+/CD8+, CD3+/CD4+, and overall T lymphocytes were higher in responders versus non-responders at baseline (p = 0.017, p < 0.001, p = 0.034) and after treatment (p = 0.01, p = 0.003, p = 0.023). Reduced CECs, a tumor neoangiogenesis marker, were observed in responders after treatment (p < 0.001). Patients with low NLR (≤ 4.4) showed a better progression-free survival compared to patients with high NLR (> 4.4) (p = 0.01). IPA showed that the majority of immunity-related genes were found upregulated in responders compared to non-responders before treatment, but not after. CONCLUSIONS: Lymphocytes subpopulations, CECs and NLR could be interesting biomarkers predictive of response to everolimus-based regimens, potentially useful in daily clinical practice to select/monitor everolimus-based treatment in mBC. Further studies to confirm such hypotheses are warranted.

Published
2020

44. Impact of BMI on the outcome of metastatic breast cancer patients treated with everolimus: A retrospective exploratory analysis of the BALLET study

Author

Corona, S., primary, Giudici, F., additional, Jerusalem, G., additional, Ciruelos, E., additional, Strina, C., additional, Sirico, M., additional, Bernocchi, O., additional, Milani, M., additional, Dester, M., additional, Ziglioli, N., additional, Barbieri, G., additional, Cervoni, V., additional, Montemurro, F., additional, and Generali, D., additional

Published
2020
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47. Broad consensus on the optimal sequence for the systemic treatment of metastatic breast cancer: results from a survey of Spanish medical oncologists

Author

Sanchez-Rovira P, Zamora P, Salvador-Bofill J, Morales S, Martinez-Janez N, Martinez-de-Duenas E, Lluch A, Illarramendi J, Gomez-Pardo P, Gregori J, Garcia-Palomo A, Garcia-Mata J, Fernandez Y, del Barco S, de Juan A, Ciruelos E, Chacon J, Calvo L, Barnadas A, and Albanell J

Subjects
hormone therapy, HER2 receptor, triple negative tumor, survey, Metastatic breast cancer, chemotherapy, clinical practice
Abstract

Objective: The aim of this survey conducted by 20 leading Spanish oncologists was to analyze the concurrence between Spanish clinical practice and the recently published definition of the optimal sequence for the systemic treatment of metastatic breast cancer (MBC) according to patient profiles. Methods: A self-administered questionnaire was developed, divided into five sections comprising 34 specific questions related to sequential treatments, plus three additional general questions. Respondents were asked to justify negative answers. Participants were recruited randomly by invitation out of a total of 619 oncologists. The questionnaire was sent and collected via e-mail between October 2015 and May 2016. A total of 191 completed questionnaires were received. Results: Overall, 70% of oncologists would keep the three patient profiles exactly as proposed (hormone receptor-positive and HER2-negative, HER2-positive, and triple negative breast cancer). Affirmative answers to questions regarding treatment sequences for these patient profiles (1-34) ranged from 77.8-99.5%, with an average of 90.9% of oncologists being in agreement with the recommended sequential treatments. The lowest degree of consensus was observed for endocrine treatments in pre-menopausal women and for chemotherapy options in hormone-resistant patients, whilst the highest degree of consensus was reached for targeted therapies in HER2-positive patients and for endocrine therapy in post-menopausal women. In their comments, participants revealed a number of economic constraints that prevented them from implementing some of the best treatment options. Conclusions: In conclusion, despite the complexity of MBC treatment, there is general agreement on the optimal treatment sequences.

Published
2019

49. Patient preference for oral chemotherapy in the treatment of metastatic breast and lung cancer

Author

Ciruelos E, Diaz M, Isla M, Lopez R, Bernabe R, Gonzalez E, Cirauqui B, Coves J, Morales S, Arcediano A, Barneto I, Cerezuela P, Illarramendi J, Morales C, and Ponce S

Subjects
quality of life, oral administration, intravenous administration, tablets, metastasis, patient preference
Abstract

Objectives Although new therapies against metastatic cancer have been developed in recent decades, chemotherapy is still an important treatment option. Prolonged treatment and side-effects are often discouraging for patients, and in many cases, therapy is only palliative, not curative. This study explores patient preference for oral or intravenous (IV) chemotherapy in the treatment of metastatic breast or lung cancer. Methods It is a descriptive, open label, multicentre, nation-wide study, in which a 16-item questionnaire consisting of single-choice questions scored on a 5-point Likert scale was administered to patients in a single visit, and another 11-item questionnaire was self-administered by the patient's oncologist. Results A total of 131 breast and lung cancer specialists at 64 hospitals enrolled 412 patients (lung cancer = 161; breast cancer = 251). To be eligible, patients must have already received IV therapy and at least 2 cycles of oral chemotherapy. Most (77%) patients expressed preference for oral therapy. Most considered their daily life was less disrupted with tablets (70.4%), had no trouble swallowing them (86.9%), and were not concerned about forgetting to take them (56.8%). Half (56.3%) were worried about problems related to drug infusion with IV therapy, 61.7% were concerned about nurses failing to find a suitable vein, and 63.1% were dissatisfied with hospital waiting times. A uniform response was obtained from both samples of patients. Conclusion Convenience, ease of administration, fewer side effects and better quality of life tilt the balance towards oral drug administration.

Published
2019

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