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1. Skeletal adverse effects with aromatase inhibitors in early breast cancer: evidence to date and clinical guidance

Author

Sonia Servitja, Tamara Martos, Maria Rodriguez Sanz, Natalia Garcia-Giralt, Daniel Prieto-Alhambra, Laia Garrigos, Xavier Nogues, and Ignasi Tusquets

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Aromatase inhibitors (AIs) are routinely used in the adjuvant treatment of women with hormone receptor-positive early breast cancer. Patients who receive AIs have an increased risk of bone loss and arthralgia compared with those treated with tamoxifen. In addition to the effects of AIs, the population of women with early breast cancer has a high prevalence of 25-hydroxyvitamin D (25(OH)D) insufficiency. In our experience 88% of patients had concentrations lower than 30 ng/ml. Vitamin D supplementation should be adapted to the baseline concentration. Another relevant finding in our research program was the close relationship between 25(OH)D levels and intensity of AI-related arthralgia (AIrA). A target concentration of 40 ng/ml 25(OH)D may prevent development of AIrA. We also demonstrate that AIrA is genetically determined: single nucleotide polymorphisms located in genes encoding key factors for the metabolism of estrogens and vitamin D ( CYP17A 1, VDR , and CYP27B1 ) are associated with self-reported arthralgia during AI therapy. We recommend establishing an individualized protocol of bone-health surveillance based on baseline and evolutionary clinical variables.

Published
2015
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2. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Koroveshi, Dhurata, Bouzid, Kamel, Casalnuovo, Monica, Cascallar, Diana, Korbenfeld, Ernesto Pablo, Bastick, Patricia, Beith, Jane, Colosimo, Maree, Friedlander, Michael, Ganju, Vinod, Green, Michael, Patterson, Kevin, Redfern, Andrew, Richardson, Gary, Ceric, Timur, Gordana, Kecman, Beato, Carlos Augusto, Ferrari, Marcela, Hegg, Roberto, Helena, Vanessa, Ismael, Gustavo Fernando, Lessa, Alvaro Edson, Mano, Max, Morelle, Alessandra, Nogueira, Jose Alberto, Timcheva, Konstanta, Tomova, Antoaneta, Tsakova, Maya, Zlatareva-Petrova, Ani, Asselah, Jamil, Assi, Hazem, Brezden-Masley, Christine, Chia, Stephen, Freedman, Ori, Harb, Mohammed, Joy, Anil Abraham, Kulkarni, Swati, Prady, Catherine, Gaete, Alejandro Andres Acevedo, Matamala, Luis, Torres, Roberto, Yanez, Eduardo, Franco, Sandra, Urrego, Marcela, Gugić, Damir, Vrbanec, Damir, Melichar, Bohuslav, Prausová, Jana, Vyzula, Rostislav, Pilarte, Rafael Gutierrez, León, María Isabel, Muñoz, Rene, Ramos, Glenda, Azeem, Hamdy Abdel, Aziz, Amr Abdel, El Zawahry, Heba, Osegueda, Finlander Rosales, Alexandre, Jerome, Artignan, Xavier, Barletta, Hugues, Beguier, Emmanuel, Berdah, Jean-François, Marty, Chantal Bernard, Bollet, Marc, Bourgeois, Hugues, Bressac, Claude, Burki, Franck, Campone, Mario, Coeffic, David, Cojocarasu, Oana Zveltlana, Dagada, Corinne, Dalenc, Florence, Del Piano, Francesco, Desauw, Christophe, Desmoulins, Isabelle, Dohollou, Nadine, Egreteau, Joelle, Ferrero, Jean-Marc, Foa, Cyril, Garidi, Reda, Gasnault, Laurent, Gligorov, Joseph, Guardiola, Emmanuel, Hamizi, Salima, Jarcau, Rosana, Jacquin, Jean-Philippe, Jaubert, Dominique, Jolimoy, Geneviève, Mineur, Hortense Laharie, Largillier, Remy, Leduc, Bernard, Martin, Philippe, Melis, Adrien, Monge, Jeremy, Moullet, Isabelle, Mousseau, Mireille, Nguyen, Suzanne, Orfeuvre, Hubert, Petit, Thierry, Pivot, Xavier, Priou, Frank, Bach, Isabelle Sillet, Simon, Helene, Stefani, Laetitia, Uwer, Lionel, Youssef, Ali, Aktas, Bahriye, von der Assen, Albert, Augustin, Doris, Balser, Christina, Bauer, Lelia-Eveline, Bechtner, Christina, Beyer, Greta, Brucker, Cosima, Bückner, Ute, Busch, Steffi, Christensen, Bernd, Deryal, Mustafa, Farrokh, Andre, Faust, Elke, Friedrichs, Kay, Graf, Heiko, Griesshammer, Martin, Grischke, Eva-Maria, Hänle, Claudia, Heider, Andrea, Henschen, Stephan, Hesse, Tobias, Jackisch, Christian, Kisro, Jens, Köhler, Andreas, Kuemmel, Sherko, Lampe, Dieter, Lantzsch, Tilmann, Latos, Kunibert, Lex, Benno, Liedtke, Cornelia, Luedders, Doerte, Maintz, Christoph, Müller, Volkmar, Overkamp, Friedrich, Park-Simon, Tjoung-won, Paul, Marion, Prechtl, Anita, Ringsdorf, Uta, Runnebaum, Ingo, Ruth, Sylvia, Salat, Christoph, Scheffen, Iris, Schilling, Jörg, Schmatloch, Sabine, Schmidt, Marcus, Schneeweiss, Andreas, Schrader, Iris, Seipelt, Gernot, Simon, Elke, Stefek, Andrea, Stickeler, Elmar, Thill, Marc, Tio, Joke, Tuczek, Anna, Warm, Mathias, Weigel, Michael, Wischnik, Arthur, Wojcinski, Sebastian, Ziegler-Löhr, Katja, Aravantinos, Gerasimos, Ardavanis, Alexandros, Fountzilas, George, Gogas, Helen, Kakolyris, Stylianos, Mavroudis, Dimitris, Papadimitriou, Christos, Papandreou, Christos, Papazisis, Konstantinos, Castro, Hugo, Hernandez-Monroy, Cesar Estuardo, Ngan, Roger, Yeo, Winnie, Bittner, Nora, Boer, Katalin, Csejtei, Andras, Horvath, Zsolt, Kocsis, Judit, Mangel, László Csaba, Mezei, Klara, Nagy, Zsuzsanna, Szanto, Janos, Atmakusuma, Djumhana, Fadjari, Heri, Kurnianda, Djohan, Prayogo, Nugroho, Tanggo, Eddie Herman, Coate, Linda, Hennessy, Bryan, Kelly, Cathy, Martin, Michael, Nasim, Saira, O'Connor, Miriam, Aieta, Michele, Allegrini, Giacomo, Amadori, Dino, Bidoli, Paolo, Biti, Giampaolo, Bordonaro, Roberto, Bottini, Alberto, Carterni, Giacomo, Cavanna, Luigi, Cazzaniga, Marina, Cognetti, Francesco, Contu, Antonio, Cruciani, Giorgio, Donadio, Michela, Falcone, Alfredo, Farci, Daniele, Forcignanò, R. Chiara, Frassoldati, Antonio, Gaion, Fernando, Gamucci, Teresa, Giotta, Francesco, de Laurentiis, Michele, Livi, Lorenzo, Lorusso, Vito, Maiello, Evaristo, Marchetti, Paolo, Mariani, Gabriella, Mion, Marta, Moscetti, Luca, Musolino, Antonino, Pazzola, Antonio, Pedrazzoli, Paolo, Pigi, Andrea, de Placido, Sabino, Caremoli, Elena Rota, Santoro, Armando, Tienghi, Amelia, Ahn, Jin-Seok, Jung, Kyung Hae, Lee, Keun Seok, Lee, Soo Hyeon, Seo, Jae Hong, Sohn, Joo-Hyuk, Cesas, Alvydas, Juozaityte, Elona, Cheah, Nellie Lay Chin, Chong, Flora Li Tze, Devi, Beena C.R., Phua, Vincent, Teoh, Darren, Ching, Lee Wei, Yusof, Mastura, Corona, Jorge, Dominguez, Adriana, Mendoza, René Lazaro González, Hernandez, Carlos Alberto, Ramiro, Alejandro Juarez, Santos, Juan Matos, Espinosa, Paola Morales, Villarreal Garza, Cynthia Mayte, Errihani, Hassan, Bakker, Sandra, van den Berkmortel, Franchette, Blaisse, R.J.B., Huinink, Daan ten Bokkel, van den Bosch, J., Braun, J.J., Dercksen, M.W., Droogendijk, Helga, Erdkamp, Frans, Haringhuizen, Annebeth, de Jongh, F.E., Kok, T.C., Los, Maartje, Madretsma, Stanley, Terwogt, Jetske M. Meerum, van der Padt, Annemieke, van Rossum-Schornagel, Quirine Clementine, Smilde, T.J., de Valk, Bart, van der Velden, Annette, van Warmerdam, Laurence, van de Wouw, A.J., North, Richard, Kersten, Christian, Mjaaland, Ingvild, Wist, Erik, Aziz, Zeba, Masood, Nehal, Rashid, Kamran, Shah, Mazhar, Alcedo, Juan Carlos, Aleman, Diana, Neciosup, Silvia, Reategui, Rocio, Valdiviezo, Natalia, Vera, Luis, Fernando, Gracieux, Roque, Fernando, Strebel, Heinrik Martin, Krzemieniecki, Krzysztof, Litwiniuk, Maria, Mruk, Andrzej, Pienkowski, Tadeusz, Sawrycki, Piotr, Slomian, Grzegorz, Tomczak, Piotr, Afonso, Noemia, Cardoso, Fátima, Damasceno, Margarida, Nave, Monica, Badulescu, Florinel, Ciule, Larisa, Curescu, Stefan, Eniu, Alexandru, Filip, Dumitru, Grecea, Daniela, Jinga, Dan-Corneliu, Lungulescu, Dan, Oprean, Cristina Marinela, Stanculeanu, Dana Lucia, Turdean, Maria, Dvornichenko, Viktoria, Emelyanov, Sergey, Lichinitser, Mikhail, Manikhas, Alexey, Sakaeva, Dina, Shirinkin, Vadim, Stroyakovskiy, Daniil, Abulkhair, Omalkhair, Zekri, Jamal, Filipovic, Sladjana, Kovcin, Vladimir, Nedovic, Jasmina, Pesic, Jasna, Vasovic, Suzana, Ng, Raymond, Bystricky, Branislav, Leskova, Jaroslava, Mardiak, Jozef, Mišurová, Etela, Wagnerova, Maria, Takač, Iztok, Demetriou, Georgia Savva, Dreosti, Lydia, Govender, Poovandren, Jordaan, Johannes Petrus, Veersamy, Petrosian, Romero, Jose Luis Alonso, Lopez, Norberto Batista, Arias, Carmen Cañabate, Chacon, Jose, Aramburo, Antonio Fernandez, Morales, Luis Antonio Fernandez, Garcia, Mirta, Estevez, Laura Garcia, Garcia-Palomo Perez, Andres, Garcia Saenz, Jose Angel, Garcia Sanchis, Laura, Cubells, Laia Garrigos, Cortijo, Lucia Gonzalez, Santiago, Santiago Gonzalez, De Aranguiz, Blanca Hernando Fernandez, Mañas, José Juan Illarramendi, Gallego, Pedro Jimenez, Cussac, Antonio Llombart, Ferrandiz, Cristina Llorca, Garrido, Maria Lomas, Alvarez, Pilar Lopez, Vega, Jose Manuel Lopez, Del Prado, Purificacion Martinez, Jañez, Noelia Martinez, Murillo, Serafin Morales, Rosales, Adolfo Murias, Jaso, Laura Murillo, Fernandez, Ignacio Pelaez, Martorell, Antonia Perello, Carrion, Ramon Perez, Simon, Sonia Pernas, Alcibar, Arrate Plazaola, Lorenzo, Jose Ponce, Garcia, Vanesa Quiroga, Asensio, Teresa Ramon y Cajal, Maicas, Maria Dolores Torregrosa, Villanueva Silva, Maria Jose, Killander, Fredrika, Svensson, Jan Henry, Fehr, Mathias, Hauser, Nik, Müller, Andreas, Pagani, Olivia, Passmann-Kegel, Heike, Popescu, Razvan, Rabaglio, Manuela, Rauch, Daniel, Schlatter, Christina, Zaman, Khalil, Chang, Tsai-Wang, Huang, Chiun-Sheng, Wang, Hwei-Chung, Yu, Jyh-Cherng, Bandidwattanawong, Chanyoot, Maneechavakajorn, Jedzada, Seetalarom, Kasan, Dejthevaporn, Thitiya (Sirisinha), Somwangprasert, Areewan, Vongsaisuwon, Mawin, Akbulut, Hakan, Altundag, Kadri, Arican, Ali, Bozcuk, Hakan, Eralp, Yesim, Idris, Mohamed, Isikdogan, Abdurrahman, Senol, Coskun Hasan, Sevinc, Alper, Uygun, Kazim, Yucel, Eftal, Yucel, Idris, Yumuk, Fulden, Shparyk, Yaroslav, Voitko, Nataliia, Jaloudi, Mohammed, Adams, Jocelyn, Agrawal, Rajiv, Ahmed, Samreen, Alhasso, Abdulla, Allerton, Rozenn, Anwar, Suhail, Archer, Caroline, Ashford, Richard, Barraclough, Lisa, Bertelli, Gianfilippo, Bishop, Jill, Branson, Tony, Butt, Mohammed, Chakrabarti, Amit, Chakraborti, Prabir, Churn, Mark, Crowley, Clare, Davis, Ruth, Dhadda, Amandeep, Eldeeb, Hany, Fraser, Judith, Hall, Julia, Hickish, Tamas, Hogg, Martin, Howe, Theresa, Joffe, Jonathan, Kelleher, Muireann, Kelly, Stephen, Kendall, Anne, Kristeleit, Hartmut, Lumsden, Graeme, Macmillan, Craig, MacPherson, Iain, Malik, Zafar, Mithal, Natasha, Neal, Anthony, Panwar, Udaiveer, Proctor, Andrew, Proctor, Steven John, Raj, Sanjay, Rehman, Shazza, Sandri, Ines, Scatchard, Kate, Sherwin, Elizabeth, Sims, Eliot, Singer, Julian, Smith, Sarah, Tahir, Saad, Taylor, Wendy, Tsalic, Medy, Verrill, Mark, Wardley, Andrew, Waters, Simon, Wheatley, Duncan, Wright, Kathryn, Yuille, Frances, Alonso, Isabel, Artagaveytia, Nora, Rodriguez, Robinson, Arbona, Esther, Garcia, Yuraima, Lion, Lorena, Marcano, Dalila, Van Thuan, Tran, Gligorov, J., Ataseven, B., Verrill, M., De Laurentiis, M., Jung, K.H., Azim, H.A., Al-Sakaff, N., Lauer, S., Shing, M., and Pivot, X.

Published
2017
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3. AI-related BMD variation in actual practice conditions: A prospective cohort study

Author

Daniel Prieto-Alhambra, Maria Rodriguez-Sanz, Natalia Garcia-Giralt, Iria Gonzalez, Joan Albanell, Jaime Rodriguez-Morera, Sonia Servitja, Ignasi Tusquets, Laia Garrigos, Maria Martinez-Garcia, Xavier Nogués, and Adolfo Diez-Perez

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Bone density, Endocrinology, Diabetes and Metabolism, Osteoporosis, Breast Neoplasms, Standard score, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Breast cancer, Bone Density, Internal medicine, medicine, Humans, Prospective Studies, Aromatase, Prospective cohort study, Aged, Bone mineral, Hip, Lumbar Vertebrae, Bone Density Conservation Agents, Diphosphonates, biology, Aromatase Inhibitors, Femur Neck, business.industry, Middle Aged, medicine.disease, 030104 developmental biology, 030220 oncology & carcinogenesis, biology.protein, Female, business
Abstract

The aim of the study was to evaluate the progression of bone mineral density (BMD) during 3 years of aromatase inhibitors (AI) therapy in actual practice conditions. This prospective, clinical cohort study of Barcelona–Aromatase induced Bone Loss in Early breast cancer (B-ABLE) assessed BMD changes during 3 years of AI treatment in women with breast cancer. Patients with osteoporosis (T score < −2.5 or T score ≤ −2.0) and a major risk factor and/or prevalent fragility fractures were treated with oral bisphosphonates (BPs). Of 685 women recruited, 179 (26.1%) received BP treatment. By the third year of AI therapy, this group exhibited increased BMD in the lumbar spine (LS; 2.59%) and femoral neck (FN; 2.50%), although the increase was significant only within the first year (LS: 1.99% and FN: 2.04%). Despite BP therapy, however, approximately 15% of these patients lost more than 3% of their baseline bone mass. At 3 years, patients without BP experienced BMD decreases in the LS (−3.10%) and FN (−2.79%). In this group, BMD changes occurred during the first (LS: −1.33% and FN: −1.25%), second (LS: −1.19% and FN: −0.82%), and third (LS: −0.57% and FN: −0.65%) years of AI treatment. Increased BMD (>3%) was observed in just 7.6% and 10.8% of these patients at the LS and FN, respectively. Our data confirm a clinically relevant bone loss associated with AI therapy amongst nonusers of preventative BPs. We further report on the importance of BMD monitoring as well as calcium and 25-hydroxy vitamin D supplementation in these patients.

Published
2016
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4. Open Label Phase III Clinical Trial of Ketoconazole as CYP17 Inhibitor in Metastatic or Advanced Non-Resectable Granulosa Cell Ovarian Tumors. The GREKO (GRanulosa Et KetOconazole) Trial. GETHI 2011-03

Author

Jesus Garcia-Donas, Alicia Hurtado, Laia Garrigos, Ana Santaballa, Andres Redondo, Laura Vidal, Nuria Lainez, Eva Guerra, Victor Rodriguez, Juan Cueva, Isabel Bover, Isabel Palacio, Maria Jesus Rubio, Mario Prieto, Jose Antonio Lopez-Guerrero, Juan Francisco Rodriguez-Moreno, Zaida Garcia-Casado, Elena Garcia-Martinez, Alvaro Taus, Ignacio Pérez de Castro, Paloma Navarro, Susana Hernando, and Enrique Grande

Published
2019
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5. Vías de señalización intracelular en el carcinoma escamoso infiltrante de cérvix uterino. Identificación de nuevos marcadores pronósticos

Author

Josep Maria Sole, Montserrat Arumi-Uria, Gemma Mancebo, Laia Garrigos, Belen Lloveras, Ramon Carreras, Joan Albanell, Sergi Serrano, Federico Rojo, and Francesc Alameda

Subjects
Pathology and Forensic Medicine
Abstract

Resumen Antecedentes y objetivos Los receptores de tirosincinasa estan frecuentemente activados en los tumores humanos malignos. Esta activacion lleva a las celulas a altos niveles de proliferacion, migracion, desdiferenciacion, diseminacion y resistencia a la apoptosis. Las vias de senalizacion dependientes de la activacion de los receptores de la familia ErbB/HER en las que se han descrito alteraciones son las vias RAS-RAF-ERK, PIK3-AKT, MAPK y NFKB. El estudio de la actividad de estas vias puede ayudar a identificar aquellos tumores con alta agresividad y puede informar acerca de puntos de interes con potencial terapeutico. Material y metodos Realizamos estudio inmunohistoquimica de EGFR, p-EGFR, p38, p-ERK ½, JNK, p-AKT, p65, p50, p52, relB, c-Rel y MAPK-1 en 32 carcinomas escamosos infiltrantes de cervix uterino en una matriz de tejidos. Resultados Solamente la inmunoexpresion de p-ERK mostro correlacion con el estadio de la enfermedad (p Conclusiones Nuestras observaciones indican que los tumores mas agresivos muestran inmunoexpresion alta de p-ERK y MKP1 y bajos niveles de p-JNK y p-p38, estos ultimos favoreciendo la resistencia a la quimioterapia. La inmunoexpresion de p-ERK y MKP1 podrian usarse como factores pronosticos y dianas terapeuticas en estos tumores.

Published
2014
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6. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Jose Chacon, Katja Ziegler-Löhr, Kamran Rashid, Stanley Madretsma, Hortense Laharie Mineur, Soo Hyeon Lee, Bohuslav Melichar, Jasna Pesic, Julia Hall, Jörg Schilling, Paola Morales Espinosa, Wendy Taylor, Francesco Cognetti, Doris Augustin, Ines Sandri, Laura Murillo Jaso, Alejandro Juarez Ramiro, Nora Artagaveytia, Rocio Reategui, Nataliia Voitko, Teresa Gamucci, Lisa H Barraclough, Jérôme Alexandre, Mohammed Butt, Frank Priou, A.J. van de Wouw, Cristina Marinela Oprean, Isabel Alonso, Suzana Vasovic, Fernando Roque, Marc Thill, Viktoria Dvornichenko, K. Bouzid, Idris Yucel, Andrea Stefek, Jose Manuel Lopez Vega, Daniil Stroyakovskiy, R. Chiara Forcignanò, Mohammed Harb, Andrzej Mruk, Jana Prausová, Lydia Dreosti, Prabir Chakraborti, Armando Santoro, Lee Wei Ching, Anna Tuczek, Jane Beith, Larisa Ciule, Hakan Bozcuk, Antonino Musolino, Hartmut Kristeleit, Clare Crowley, T.C. Kok, Dhurata Koroveshi, Natasha Mithal, Laura Garcia Sanchis, Stephan Henschen, Carmen Cañabate Arias, A. Contu, Antoaneta Tomova, Alper Sevinc, Helga Droogendijk, Gustavo Fernando Ismael, Konstantinos Papazisis, Laurent Gasnault, Sandra Bakker, Judit Kocsis, Bernd Christensen, Stephen Kelly, Rosana Jarcau, Christian Jackisch, George Fountzilas, Cyril Foa, Annebeth W. Haringhuizen, Silvia Neciosup, Juan Matos Santos, Finlander Rosales Osegueda, Robinson Rodriguez, Marcus Schmidt, Bart de Valk, Kathryn Wright, A.S. Dhadda, Elizabeth Sherwin, Sabino De Placido, Luigi Cavanna, Joelle Egreteau, Shazza Rehman, Giacomo Allegrini, Doerte Luedders, Poovandren Govender, Hugues Barletta, Iztok Takač, Yuraima Garcia, Michael Green, Geneviève Jolimoy, Marcela Urrego, Chanyoot Bandidwattanawong, Vito Lorusso, Annette van der Velden, Rene Muñoz, Djumhana Atmakusuma, Christos Papandreou, Craig Macmillan, Hassan Errihani, Iris Schrader, Isabelle Desmoulins, Jean-Marc Ferrero, Mohamed Idris, B. Ataseven, Andre Farrokh, Isabelle Moullet, Iain R. Macpherson, N. Al-Sakaff, Stephen Chia, Blanca Hernando Fernandez De Aranguiz, Lorena Lion, Alexandros Ardavanis, Ani Zlatareva-Petrova, Ernesto Pablo Korbenfeld, Hugo Castro, Mirta Garcia, Heike Passmann-Kegel, Lionel Uwer, Gary Richardson, Marion Paul, Georgia Demetriou, Andreas Köhler, V. Kovcin, Eliot Sims, Gerasimos Aravantinos, Adriana Dominguez, Daniel Rauch, Greta Beyer, Laurence J. C. van Warmerdam, Roberto Bordonaro, Raymond Ng, David Coeffic, Rostislav Vyzula, Bernard Leduc, Jozef Mardiak, Andrea Pigi, Ingo Runnebaum, Jose Angel Garcia Saenz, Areewan Somwangprasert, Cristina Llorca Ferrandiz, Coskun Hasan Senol, Martin Griesshammer, Friedrich Overkamp, Suzanne Nguyen, Maria Turdean, Udaiveer Panwar, Zsuzsanna Nagy, Francesco Giotta, Andreas Schneeweiss, Teresa Ramon y Cajal Asensio, Jae Hong Seo, Joohyuk Sohn, Jean-Philippe Jacquin, Daniela Grecea, Jasmina Nedovic, Arrate Plazaola Alcibar, Tadeusz Pienkowski, Jetske M. Meerum Terwogt, Elmar Stickeler, Hazem I. Assi, Vadim Shirinkin, Grzegorz Slomian, Etela Mišurová, Roberto Hegg, K. Friedrichs, Corinne Dagada, Jean-François Berdah, Fulden Yumuk, Alexandru Eniu, Amit Chakrabarti, Mathias Fehr, Christoph Salat, Dan Lungulescu, Heinrik Martin Strebel, Antonio Llombart Cussac, Rémy Largillier, Stefan Curescu, Albert von der Assen, Emmanuel Guardiola, Andras Csejtei, Tamas Hickish, Krzysztof Krzemieniecki, Yaroslav Shparyk, Ramon Perez Carrion, Michela Donadio, Purificacion Martinez del Prado, Sandra Franco, J.J. Braun, Michael Friedlander, Suhail Anwar, Thierry Petit, Sarah Smith, Rafael Gutierrez Pilarte, Laia Garrigos Cubells, Frans L. G. Erdkamp, Jedzada Maneechavakajorn, Mastura Yusof, Jocelyn Adams, Diana Cascallar, Luis Antonio Fernandez Morales, Max S. Mano, Simon Waters, Carlos Beato, Philippe Martin, Martin Hogg, Isabelle Sillet Bach, Monica Casalnuovo, Klara Mezei, Alexey Manikhas, Margarida Damasceno, Sergey Emelyanov, Gabriella Mariani, Kecman Gordana, Gianfilippo Bertelli, Ignacio Pelaez Fernandez, Damir Vrbanec, Maria Wagnerova, Johannes Petrus Jordaan, Marina Cazzaniga, Mustafa Deryal, Ruth Davis, Abdurrahman Isikdogan, Sanjay Raj, José Juan Illarramendi Mañas, Vinod Ganju, Maria Dolores Torregrosa Maicas, Glenda Ramos, Nugroho Prayogo, H. Orfeuvre, Filipovic S, Joke Tio, Andrew Redfern, M. Shing, Eduardo Yanez, Khalil Zaman, Jin-Seok Ahn, Dino Amadori, Bahriye Aktas, Miriam O'Connor, Uta Ringsdorf, Christophe Desauw, J. Gligorov, Jorge Corona, Michele De Laurentiis, Arthur Wischnik, Paolo Pedrazzoli, Katalin Boér, Caroline Archer, Anne Kendall, Ori Freedman, Maya Tsakova, Dana Lucia Stanculeanu, Kevin Patterson, Cathy Kelly, Nellie Lay Chin Cheah, X. Artignan, Anil A. Joy, Steffi Busch, Monica Nave, Bryan Hennessy, Lorenzo Livi, X. Pivot, R.J.B. Blaisse, Adolfo Murias Rosales, Juan Carlos Alcedo, Dalila Marcano, Emmanuel Beguier, Andreas Müller, László Csaba Mangel, Christina Schlatter, Fernando Gaion, Tjoung-Won Park-Simon, Sebastian Wojcinski, Ute Bückner, Florinel Badulescu, Cynthia Mayte Villarreal Garza, Rozenn Allerton, Mikhail Lichinitser, Damir Gugić, Manuela Rabaglio, Jens Kisro, Iris Scheffen, Vincent Phua, Marc A. Bollet, Giampaolo Biti, M. Verrill, Adrien Melis, Andrew M Wardley, Ali Arican, Hamdy A. Azim, Lelia-Eveline Bauer, Tsai-Wang Chang, Nik Hauser, René Lazaro González Mendoza, Dominique Jaubert, Samreen Ahmed, Mazhar Shah, János Szántó, Kunibert Latos, Xavier Pivot, Helen Gogas, Elona Juozaityte, Luca Moscetti, Helene Simon, Giacomo Carterni, Dan-Corneliu Jinga, Olivia Pagani, Elena Rota Caremoli, Esther Arbona, Cornelia Liedtke, Stylianos Kakolyris, Abdulla Alhasso, Omalkhair Abulkhair, Jose Ponce Lorenzo, Julian Singer, Tony Branson, Claudia Hänle, Ingvild Mjaaland, Chiun-Sheng Huang, Heri Fadjari, Jonathan Joffe, Laetitia Stefani, Dieter Lampe, Franck Burki, S. Lauer, Sabine Schmatloch, Gracieux Fernando, Dina Sakaeva, Christina Balser, Michael Martin, Nora Bittner, Andrea Heider, Antonio Frassoldati, Serafin Morales Murillo, Hakan Akbulut, Saad Tahir, Tilmann Lantzsch, Christine Brezden-Masley, Vanessa Helena, Tran Van Thuan, F.E. de Jongh, Roger K.C. Ngan, Elke Faust, Hugues Bourgeois, Flora Li Tze Chong, Nehal Masood, Keun Seok Lee, J. Bishop, Mathias Warm, Dimitris Mavroudis, Petrosian Veersamy, Judith Fraser, Andres Garcia-Palomo Perez, Heiko Graf, Vanesa Quiroga Garcia, Jyh-Cherng Yu, Maria Jose Villanueva Silva, Elke Simon, Diana Aleman, Kazim Uygun, Cosima Brucker, Michael Weigel, Volkmar Müller, Djohan Kurnianda, Duncan Wheatley, Amr Abdel Aziz, Benno Lex, Laura G. Estévez, Darren Teoh, María Isabel León, Noemia Afonso, Frances Yuille, Amelia Tienghi, Gernot Seipelt, Jose Alberto Nogueira, Dumitru Filip, Zafar Malik, Fatima Cardoso, Giorgio Cruciani, Winnie Yeo, Luis Vera, Santiago Gonzalez Santiago, Richard North, M.W. Dercksen, Zsolt Horváth, Noelia Martinez Jañez, Marta Mion, Marcela Ferrari, Natalia Valdiviezo, Oana Zveltlana Cojocarasu, Alessandra Morelle, Medy Tsalic, Sonia Pernas Simon, Christoph Maintz, Daniele Farci, Alvaro Edson Lessa, Jeremy Monge, Joseph Gligorov, Anthony Neal, Norberto Batista Lopez, Piotr Tomczak, Yesim Eralp, Kasan Seetalarom, Thitiya (Sirisinha) Dejthevaporn, Jamal Zekri, Steven John Proctor, Saira Nasim, Muireann Kelleher, Eftal Yucel, Quirine Clementine van Rossum-Schornagel, Linda Coate, Paolo Marchetti, Theresa Howe, Carlos Alberto Hernandez, Roberto Torres, Konstanta Timcheva, Evaristo Maiello, Anita Prechtl, Jamil Asselah, Branislav Bystricky, Kate Scatchard, Zeba Aziz, Jaroslava Leskova, Sherko Kuemmel, Paolo Bidoli, Richard Ashford, Piotr Sawrycki, Claude Bressac, Alberto Bottini, Pilar Lopez Alvarez, Nadine Dohollou, Alejandro Andres Acevedo Gaete, M. De Laurentiis, T.J. Smilde, Andrew Proctor, Catherine Prady, Michele Aieta, Jan Henry Svensson, Reda Garidi, Erik Wist, Antonia Perello Martorell, Mohammed Jaloudi, Graeme Lumsden, Eva-Maria Grischke, Ali Youssef, Annemieke van der Padt, Kadri Altundag, Christina Bechtner, Mireille Mousseau, Heba El Zawahry, Maartje Los, Alvydas Česas, Alfredo Falcone, Salima Hamizi, Franchette W P J van den Berkmortel, Cesar Estuardo Hernandez-Monroy, K.H. Jung, Swati Kulkarni, R.K. Agrawal, Hwei Chung Wang, Hany Eldeeb, Fredrika Killander, Jose Luis Alonso Romero, Antonio Pazzola, Daan ten Bokkel Huinink, Mario Campone, Beena C.R. Devi, Florence Dalenc, Pedro Jimenez Gallego, Mawin Vongsaisuwon, Timur Ceric, Chantal Bernard Marty, R. A. Popescu, J. van den Bosch, Luis Matamala, Sylvia Ruth, Maria Litwiniuk, Maria Lomas Garrido, Mark Churn, Christian Kersten, Francesco Del Piano, Eddie Herman Tanggo, Antonio Fernandez Aramburo, Kyung Hae Jung, Christos Papadimitriou, Hamdy Abdel Azeem, Patricia Bastick, Tobias Hesse, Maree Colosimo, Lucia Gonzalez Cortijo, Mark Verrill, Gligorov, J, Ataseven, B, Verrill, M, De Laurentiis, M, Jung, K. H, Azim, H. A, Al-sakaff, N, Lauer, S, Shing, M, Pivot, X., de Laurentiis, M, Jung, K, Azim, H, Al-Sakaff, N, Pivot, X, Koroveshi, D, Bouzid, K, Casalnuovo, M, Cascallar, D, Korbenfeld, E, Bastick, P, Beith, J, Colosimo, M, Friedlander, M, Ganju, V, Green, M, Patterson, K, Redfern, A, Richardson, G, Ceric, T, Gordana, K, Beato, C, Ferrari, M, Hegg, R, Helena, V, Ismael, G, Lessa, A, Mano, M, Morelle, A, Nogueira, J, Timcheva, K, Tomova, A, Tsakova, M, Zlatareva-Petrova, A, Asselah, J, Assi, H, Brezden-Masley, C, Chia, S, Freedman, O, Harb, M, Joy, A, Kulkarni, S, Prady, C, Gaete, A, Matamala, L, Torres, R, Yanez, E, Franco, S, Urrego, M, Gugic, D, Vrbanec, D, Melichar, B, Prausova, J, Vyzula, R, Pilarte, R, Leon, M, Munoz, R, Ramos, G, Azeem, H, Aziz, A, El Zawahry, H, Osegueda, F, Alexandre, J, Artignan, X, Barletta, H, Beguier, E, Berdah, J, Marty, C, Bollet, M, Bourgeois, H, Bressac, C, Burki, F, Campone, M, Coeffic, D, Cojocarasu, O, Dagada, C, Dalenc, F, Del Piano, F, Desauw, C, Desmoulins, I, Dohollou, N, Egreteau, J, Ferrero, J, Foa, C, Garidi, R, Gasnault, L, Guardiola, E, Hamizi, S, Jarcau, R, Jacquin, J, Jaubert, D, Jolimoy, G, Mineur, H, Largillier, R, Leduc, B, Martin, P, Melis, A, Monge, J, Moullet, I, Mousseau, M, Nguyen, S, Orfeuvre, H, Petit, T, Priou, F, Bach, I, Simon, H, Stefani, L, Uwer, L, Youssef, A, Aktas, B, von der Assen, A, Augustin, D, Balser, C, Bauer, L, Bechtner, C, Beyer, G, Brucker, C, Buckner, U, Busch, S, Christensen, B, Deryal, M, Farrokh, A, Faust, E, Friedrichs, K, Graf, H, Griesshammer, M, Grischke, E, Hanle, C, Heider, A, Henschen, S, Hesse, T, Jackisch, C, Kisro, J, Kohler, A, Kuemmel, S, Lampe, D, Lantzsch, T, Latos, K, Lex, B, Liedtke, C, Luedders, D, Maintz, C, Muller, V, Overkamp, F, Park-Simon, T, Paul, M, Prechtl, A, Ringsdorf, U, Runnebaum, I, Ruth, S, Salat, C, Scheffen, I, Schilling, J, Schmatloch, S, Schmidt, M, Schneeweiss, A, Schrader, I, Seipelt, G, Simon, E, Stefek, A, Stickeler, E, Thill, M, Tio, J, Tuczek, A, Warm, M, Weigel, M, Wischnik, A, Wojcinski, S, Ziegler-Lohr, K, Aravantinos, G, Ardavanis, A, Fountzilas, G, Gogas, H, Kakolyris, S, Mavroudis, D, Papadimitriou, C, Papandreou, C, Papazisis, K, Castro, H, Hernandez-Monroy, C, Ngan, R, Yeo, W, Bittner, N, Boer, K, Csejtei, A, Horvath, Z, Kocsis, J, Mangel, L, Mezei, K, Nagy, Z, Szanto, J, Atmakusuma, D, Fadjari, H, Kurnianda, D, Prayogo, N, Tanggo, E, Coate, L, Hennessy, B, Kelly, C, Martin, M, Nasim, S, O'Connor, M, Aieta, M, Allegrini, G, Amadori, D, Bidoli, P, Biti, G, Bordonaro, R, Bottini, A, Carterni, G, Cavanna, L, Cazzaniga, M, Cognetti, F, Contu, A, Cruciani, G, Donadio, M, Falcone, A, Farci, D, Forcignano, R, Frassoldati, A, Gaion, F, Gamucci, T, Giotta, F, Livi, L, Lorusso, V, Maiello, E, Marchetti, P, Mariani, G, Mion, M, Moscetti, L, Musolino, A, Pazzola, A, Pedrazzoli, P, Pigi, A, de Placido, S, Caremoli, E, Santoro, A, Tienghi, A, Ahn, J, Lee, K, Lee, S, Seo, J, Sohn, J, Cesas, A, Juozaityte, E, Cheah, N, Chong, F, Devi, B, Phua, V, Teoh, D, Ching, L, Yusof, M, Corona, J, Dominguez, A, Mendoza, R, Hernandez, C, Ramiro, A, Santos, J, Espinosa, P, Villarreal Garza, C, Errihani, H, Bakker, S, van den Berkmortel, F, Blaisse, R, Huinink, D, van den Bosch, J, Braun, J, Dercksen, M, Droogendijk, H, Erdkamp, F, Haringhuizen, A, de Jongh, F, Kok, T, Los, M, Madretsma, S, Terwogt, J, van der Padt, A, van Rossum-Schornagel, Q, Smilde, T, de Valk, B, van der Velden, A, van Warmerdam, L, van de Wouw, A, North, R, Kersten, C, Mjaaland, I, Wist, E, Aziz, Z, Masood, N, Rashid, K, Shah, M, Alcedo, J, Aleman, D, Neciosup, S, Reategui, R, Valdiviezo, N, Vera, L, Fernando, G, Roque, F, Strebel, H, Krzemieniecki, K, Litwiniuk, M, Mruk, A, Pienkowski, T, Sawrycki, P, Slomian, G, Tomczak, P, Afonso, N, Cardoso, F, Damasceno, M, Nave, M, Badulescu, F, Ciule, L, Curescu, S, Eniu, A, Filip, D, Grecea, D, Jinga, D, Lungulescu, D, Oprean, C, Stanculeanu, D, Turdean, M, Dvornichenko, V, Emelyanov, S, Lichinitser, M, Manikhas, A, Sakaeva, D, Shirinkin, V, Stroyakovskiy, D, Abulkhair, O, Zekri, J, Filipovic, S, Kovcin, V, Nedovic, J, Pesic, J, Vasovic, S, Ng, R, Bystricky, B, Leskova, J, Mardiak, J, Misurova, E, Wagnerova, M, Takac, I, Demetriou, G, Dreosti, L, Govender, P, Jordaan, J, Veersamy, P, Romero, J, Lopez, N, Arias, C, Chacon, J, Aramburo, A, Morales, L, Garcia, M, Estevez, L, Garcia-Palomo Perez, A, Garcia Saenz, J, Garcia Sanchis, L, Cubells, L, Cortijo, L, Santiago, S, De Aranguiz, B, Manas, J, Gallego, P, Cussac, A, Ferrandiz, C, Garrido, M, Alvarez, P, Vega, J, Del Prado, P, Janez, N, Murillo, S, Rosales, A, Jaso, L, Fernandez, I, Martorell, A, Carrion, R, Simon, S, Alcibar, A, Lorenzo, J, Garcia, V, Asensio, T, Maicas, M, Villanueva Silva, M, Killander, F, Svensson, J, Fehr, M, Hauser, N, Muller, A, Pagani, O, Passmann-Kegel, H, Popescu, R, Rabaglio, M, Rauch, D, Schlatter, C, Zaman, K, Chang, T, Huang, C, Wang, H, Yu, J, Bandidwattanawong, C, Maneechavakajorn, J, Seetalarom, K, Dejthevaporn, T, Somwangprasert, A, Vongsaisuwon, M, Akbulut, H, Altundag, K, Arican, A, Bozcuk, H, Eralp, Y, Idris, M, Isikdogan, A, Senol, C, Sevinc, A, Uygun, K, Yucel, E, Yucel, I, Yumuk, F, Shparyk, Y, Voitko, N, Jaloudi, M, Adams, J, Agrawal, R, Ahmed, S, Alhasso, A, Allerton, R, Anwar, S, Archer, C, Ashford, R, Barraclough, L, Bertelli, G, Bishop, J, Branson, T, Butt, M, Chakrabarti, A, Chakraborti, P, Churn, M, Crowley, C, Davis, R, Dhadda, A, Eldeeb, H, Fraser, J, Hall, J, Hickish, T, Hogg, M, Howe, T, Joffe, J, Kelleher, M, Kelly, S, Kendall, A, Kristeleit, H, Lumsden, G, Macmillan, C, Macpherson, I, Malik, Z, Mithal, N, Neal, A, Panwar, U, Proctor, A, Proctor, S, Raj, S, Rehman, S, Sandri, I, Scatchard, K, Sherwin, E, Sims, E, Singer, J, Smith, S, Tahir, S, Taylor, W, Tsalic, M, Wardley, A, Waters, S, Wheatley, D, Wright, K, Yuille, F, Alonso, I, Artagaveytia, N, Rodriguez, R, Arbona, E, Garcia, Y, Lion, L, Marcano, D, and Van Thuan, T

Subjects
0301 basic medicine, Oncology, Cancer Research, Receptor, ErbB-2, medicine.medical_treatment, Medizin, Antineoplastic Agent, 0302 clinical medicine, Breast cancer, Trastuzumab, Adjuvant, Aged, 80 and over, education.field_of_study, Middle Aged, HER2/neu, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Herceptin, Subcutaneous, subcutaneous, Female, Survival Analysi, Breast Neoplasm, medicine.drug, Human, Adult, medicine.medical_specialty, Injections, Subcutaneous, Population, Socio-culturale, Antineoplastic Agents, Breast Neoplasms, Injections, Subcutaneou, 03 medical and health sciences, Young Adult, Internal medicine, medicine, Adjuvant therapy, Humans, Subcutaneou, education, Adverse effect, Aged, Chemotherapy, Adjuvant, breast cancer, HER2/neu, herceptin, trastuzumab, business.industry, medicine.disease, Survival Analysis, Surgery, Discontinuation, 030104 developmental biology, business
Abstract

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin ® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Published
2017

7. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients

Author

Gligorov, J., primary, Ataseven, B., additional, Verrill, M., additional, De Laurentiis, M., additional, Jung, K.H., additional, Azim, H.A., additional, Al-Sakaff, N., additional, Lauer, S., additional, Shing, M., additional, Pivot, X., additional, Koroveshi, Dhurata, additional, Bouzid, Kamel, additional, Casalnuovo, Monica, additional, Cascallar, Diana, additional, Korbenfeld, Ernesto Pablo, additional, Bastick, Patricia, additional, Beith, Jane, additional, Colosimo, Maree, additional, Friedlander, Michael, additional, Ganju, Vinod, additional, Green, Michael, additional, Patterson, Kevin, additional, Redfern, Andrew, additional, Richardson, Gary, additional, Ceric, Timur, additional, Gordana, Kecman, additional, Beato, Carlos Augusto, additional, Ferrari, Marcela, additional, Hegg, Roberto, additional, Helena, Vanessa, additional, Ismael, Gustavo Fernando, additional, Lessa, Alvaro Edson, additional, Mano, Max, additional, Morelle, Alessandra, additional, Nogueira, Jose Alberto, additional, Timcheva, Konstanta, additional, Tomova, Antoaneta, additional, Tsakova, Maya, additional, Zlatareva-Petrova, Ani, additional, Asselah, Jamil, additional, Assi, Hazem, additional, Brezden-Masley, Christine, additional, Chia, Stephen, additional, Freedman, Ori, additional, Harb, Mohammed, additional, Joy, Anil Abraham, additional, Kulkarni, Swati, additional, Prady, Catherine, additional, Gaete, Alejandro Andres Acevedo, additional, Matamala, Luis, additional, Torres, Roberto, additional, Yanez, Eduardo, additional, Franco, Sandra, additional, Urrego, Marcela, additional, Gugić, Damir, additional, Vrbanec, Damir, additional, Melichar, Bohuslav, additional, Prausová, Jana, additional, Vyzula, Rostislav, additional, Pilarte, Rafael Gutierrez, additional, León, María Isabel, additional, Muñoz, Rene, additional, Ramos, Glenda, additional, Azeem, Hamdy Abdel, additional, Aziz, Amr Abdel, additional, El Zawahry, Heba, additional, Osegueda, Finlander Rosales, additional, Alexandre, Jerome, additional, Artignan, Xavier, additional, Barletta, Hugues, additional, Beguier, Emmanuel, additional, Berdah, Jean-François, additional, Marty, Chantal Bernard, additional, Bollet, Marc, additional, Bourgeois, Hugues, additional, Bressac, Claude, additional, Burki, Franck, additional, Campone, Mario, additional, Coeffic, David, additional, Cojocarasu, Oana Zveltlana, additional, Dagada, Corinne, additional, Dalenc, Florence, additional, Del Piano, Francesco, additional, Desauw, Christophe, additional, Desmoulins, Isabelle, additional, Dohollou, Nadine, additional, Egreteau, Joelle, additional, Ferrero, Jean-Marc, additional, Foa, Cyril, additional, Garidi, Reda, additional, Gasnault, Laurent, additional, Gligorov, Joseph, additional, Guardiola, Emmanuel, additional, Hamizi, Salima, additional, Jarcau, Rosana, additional, Jacquin, Jean-Philippe, additional, Jaubert, Dominique, additional, Jolimoy, Geneviève, additional, Mineur, Hortense Laharie, additional, Largillier, Remy, additional, Leduc, Bernard, additional, Martin, Philippe, additional, Melis, Adrien, additional, Monge, Jeremy, additional, Moullet, Isabelle, additional, Mousseau, Mireille, additional, Nguyen, Suzanne, additional, Orfeuvre, Hubert, additional, Petit, Thierry, additional, Pivot, Xavier, additional, Priou, Frank, additional, Bach, Isabelle Sillet, additional, Simon, Helene, additional, Stefani, Laetitia, additional, Uwer, Lionel, additional, Youssef, Ali, additional, Aktas, Bahriye, additional, von der Assen, Albert, additional, Augustin, Doris, additional, Balser, Christina, additional, Bauer, Lelia-Eveline, additional, Bechtner, Christina, additional, Beyer, Greta, additional, Brucker, Cosima, additional, Bückner, Ute, additional, Busch, Steffi, additional, Christensen, Bernd, additional, Deryal, Mustafa, additional, Farrokh, Andre, additional, Faust, Elke, additional, Friedrichs, Kay, additional, Graf, Heiko, additional, Griesshammer, Martin, additional, Grischke, Eva-Maria, additional, Hänle, Claudia, additional, Heider, Andrea, additional, Henschen, Stephan, additional, Hesse, Tobias, additional, Jackisch, Christian, additional, Kisro, Jens, additional, Köhler, Andreas, additional, Kuemmel, Sherko, additional, Lampe, Dieter, additional, Lantzsch, Tilmann, additional, Latos, Kunibert, additional, Lex, Benno, additional, Liedtke, Cornelia, additional, Luedders, Doerte, additional, Maintz, Christoph, additional, Müller, Volkmar, additional, Overkamp, Friedrich, additional, Park-Simon, Tjoung-won, additional, Paul, Marion, additional, Prechtl, Anita, additional, Ringsdorf, Uta, additional, Runnebaum, Ingo, additional, Ruth, Sylvia, additional, Salat, Christoph, additional, Scheffen, Iris, additional, Schilling, Jörg, additional, Schmatloch, Sabine, additional, Schmidt, Marcus, additional, Schneeweiss, Andreas, additional, Schrader, Iris, additional, Seipelt, Gernot, additional, Simon, Elke, additional, Stefek, Andrea, additional, Stickeler, Elmar, additional, Thill, Marc, additional, Tio, Joke, additional, Tuczek, Anna, additional, Warm, Mathias, additional, Weigel, Michael, additional, Wischnik, Arthur, additional, Wojcinski, Sebastian, additional, Ziegler-Löhr, Katja, additional, Aravantinos, Gerasimos, additional, Ardavanis, Alexandros, additional, Fountzilas, George, additional, Gogas, Helen, additional, Kakolyris, Stylianos, additional, Mavroudis, Dimitris, additional, Papadimitriou, Christos, additional, Papandreou, Christos, additional, Papazisis, Konstantinos, additional, Castro, Hugo, additional, Hernandez-Monroy, Cesar Estuardo, additional, Ngan, Roger, additional, Yeo, Winnie, additional, Bittner, Nora, additional, Boer, Katalin, additional, Csejtei, Andras, additional, Horvath, Zsolt, additional, Kocsis, Judit, additional, Mangel, László Csaba, additional, Mezei, Klara, additional, Nagy, Zsuzsanna, additional, Szanto, Janos, additional, Atmakusuma, Djumhana, additional, Fadjari, Heri, additional, Kurnianda, Djohan, additional, Prayogo, Nugroho, additional, Tanggo, Eddie Herman, additional, Coate, Linda, additional, Hennessy, Bryan, additional, Kelly, Cathy, additional, Martin, Michael, additional, Nasim, Saira, additional, O'Connor, Miriam, additional, Aieta, Michele, additional, Allegrini, Giacomo, additional, Amadori, Dino, additional, Bidoli, Paolo, additional, Biti, Giampaolo, additional, Bordonaro, Roberto, additional, Bottini, Alberto, additional, Carterni, Giacomo, additional, Cavanna, Luigi, additional, Cazzaniga, Marina, additional, Cognetti, Francesco, additional, Contu, Antonio, additional, Cruciani, Giorgio, additional, Donadio, Michela, additional, Falcone, Alfredo, additional, Farci, Daniele, additional, Forcignanò, R. Chiara, additional, Frassoldati, Antonio, additional, Gaion, Fernando, additional, Gamucci, Teresa, additional, Giotta, Francesco, additional, de Laurentiis, Michele, additional, Livi, Lorenzo, additional, Lorusso, Vito, additional, Maiello, Evaristo, additional, Marchetti, Paolo, additional, Mariani, Gabriella, additional, Mion, Marta, additional, Moscetti, Luca, additional, Musolino, Antonino, additional, Pazzola, Antonio, additional, Pedrazzoli, Paolo, additional, Pigi, Andrea, additional, de Placido, Sabino, additional, Caremoli, Elena Rota, additional, Santoro, Armando, additional, Tienghi, Amelia, additional, Ahn, Jin-Seok, additional, Jung, Kyung Hae, additional, Lee, Keun Seok, additional, Lee, Soo Hyeon, additional, Seo, Jae Hong, additional, Sohn, Joo-Hyuk, additional, Cesas, Alvydas, additional, Juozaityte, Elona, additional, Cheah, Nellie Lay Chin, additional, Chong, Flora Li Tze, additional, Devi, Beena C.R., additional, Phua, Vincent, additional, Teoh, Darren, additional, Ching, Lee Wei, additional, Yusof, Mastura, additional, Corona, Jorge, additional, Dominguez, Adriana, additional, Mendoza, René Lazaro González, additional, Hernandez, Carlos Alberto, additional, Ramiro, Alejandro Juarez, additional, Santos, Juan Matos, additional, Espinosa, Paola Morales, additional, Villarreal Garza, Cynthia Mayte, additional, Errihani, Hassan, additional, Bakker, Sandra, additional, van den Berkmortel, Franchette, additional, Blaisse, R.J.B., additional, Huinink, Daan ten Bokkel, additional, van den Bosch, J., additional, Braun, J.J., additional, Dercksen, M.W., additional, Droogendijk, Helga, additional, Erdkamp, Frans, additional, Haringhuizen, Annebeth, additional, de Jongh, F.E., additional, Kok, T.C., additional, Los, Maartje, additional, Madretsma, Stanley, additional, Terwogt, Jetske M. Meerum, additional, van der Padt, Annemieke, additional, van Rossum-Schornagel, Quirine Clementine, additional, Smilde, T.J., additional, de Valk, Bart, additional, van der Velden, Annette, additional, van Warmerdam, Laurence, additional, van de Wouw, A.J., additional, North, Richard, additional, Kersten, Christian, additional, Mjaaland, Ingvild, additional, Wist, Erik, additional, Aziz, Zeba, additional, Masood, Nehal, additional, Rashid, Kamran, additional, Shah, Mazhar, additional, Alcedo, Juan Carlos, additional, Aleman, Diana, additional, Neciosup, Silvia, additional, Reategui, Rocio, additional, Valdiviezo, Natalia, additional, Vera, Luis, additional, Fernando, Gracieux, additional, Roque, Fernando, additional, Strebel, Heinrik Martin, additional, Krzemieniecki, Krzysztof, additional, Litwiniuk, Maria, additional, Mruk, Andrzej, additional, Pienkowski, Tadeusz, additional, Sawrycki, Piotr, additional, Slomian, Grzegorz, additional, Tomczak, Piotr, additional, Afonso, Noemia, additional, Cardoso, Fátima, additional, Damasceno, Margarida, additional, Nave, Monica, additional, Badulescu, Florinel, additional, Ciule, Larisa, additional, Curescu, Stefan, additional, Eniu, Alexandru, additional, Filip, Dumitru, additional, Grecea, Daniela, additional, Jinga, Dan-Corneliu, additional, Lungulescu, Dan, additional, Oprean, Cristina Marinela, additional, Stanculeanu, Dana Lucia, additional, Turdean, Maria, additional, Dvornichenko, Viktoria, additional, Emelyanov, Sergey, additional, Lichinitser, Mikhail, additional, Manikhas, Alexey, additional, Sakaeva, Dina, additional, Shirinkin, Vadim, additional, Stroyakovskiy, Daniil, additional, Abulkhair, Omalkhair, additional, Zekri, Jamal, additional, Filipovic, Sladjana, additional, Kovcin, Vladimir, additional, Nedovic, Jasmina, additional, Pesic, Jasna, additional, Vasovic, Suzana, additional, Ng, Raymond, additional, Bystricky, Branislav, additional, Leskova, Jaroslava, additional, Mardiak, Jozef, additional, Mišurová, Etela, additional, Wagnerova, Maria, additional, Takač, Iztok, additional, Demetriou, Georgia Savva, additional, Dreosti, Lydia, additional, Govender, Poovandren, additional, Jordaan, Johannes Petrus, additional, Veersamy, Petrosian, additional, Romero, Jose Luis Alonso, additional, Lopez, Norberto Batista, additional, Arias, Carmen Cañabate, additional, Chacon, Jose, additional, Aramburo, Antonio Fernandez, additional, Morales, Luis Antonio Fernandez, additional, Garcia, Mirta, additional, Estevez, Laura Garcia, additional, Garcia-Palomo Perez, Andres, additional, Garcia Saenz, Jose Angel, additional, Garcia Sanchis, Laura, additional, Cubells, Laia Garrigos, additional, Cortijo, Lucia Gonzalez, additional, Santiago, Santiago Gonzalez, additional, De Aranguiz, Blanca Hernando Fernandez, additional, Mañas, José Juan Illarramendi, additional, Gallego, Pedro Jimenez, additional, Cussac, Antonio Llombart, additional, Ferrandiz, Cristina Llorca, additional, Garrido, Maria Lomas, additional, Alvarez, Pilar Lopez, additional, Vega, Jose Manuel Lopez, additional, Del Prado, Purificacion Martinez, additional, Jañez, Noelia Martinez, additional, Murillo, Serafin Morales, additional, Rosales, Adolfo Murias, additional, Jaso, Laura Murillo, additional, Fernandez, Ignacio Pelaez, additional, Martorell, Antonia Perello, additional, Carrion, Ramon Perez, additional, Simon, Sonia Pernas, additional, Alcibar, Arrate Plazaola, additional, Lorenzo, Jose Ponce, additional, Garcia, Vanesa Quiroga, additional, Asensio, Teresa Ramon y Cajal, additional, Maicas, Maria Dolores Torregrosa, additional, Villanueva Silva, Maria Jose, additional, Killander, Fredrika, additional, Svensson, Jan Henry, additional, Fehr, Mathias, additional, Hauser, Nik, additional, Müller, Andreas, additional, Pagani, Olivia, additional, Passmann-Kegel, Heike, additional, Popescu, Razvan, additional, Rabaglio, Manuela, additional, Rauch, Daniel, additional, Schlatter, Christina, additional, Zaman, Khalil, additional, Chang, Tsai-Wang, additional, Huang, Chiun-Sheng, additional, Wang, Hwei-Chung, additional, Yu, Jyh-Cherng, additional, Bandidwattanawong, Chanyoot, additional, Maneechavakajorn, Jedzada, additional, Seetalarom, Kasan, additional, Dejthevaporn, Thitiya (Sirisinha), additional, Somwangprasert, Areewan, additional, Vongsaisuwon, Mawin, additional, Akbulut, Hakan, additional, Altundag, Kadri, additional, Arican, Ali, additional, Bozcuk, Hakan, additional, Eralp, Yesim, additional, Idris, Mohamed, additional, Isikdogan, Abdurrahman, additional, Senol, Coskun Hasan, additional, Sevinc, Alper, additional, Uygun, Kazim, additional, Yucel, Eftal, additional, Yucel, Idris, additional, Yumuk, Fulden, additional, Shparyk, Yaroslav, additional, Voitko, Nataliia, additional, Jaloudi, Mohammed, additional, Adams, Jocelyn, additional, Agrawal, Rajiv, additional, Ahmed, Samreen, additional, Alhasso, Abdulla, additional, Allerton, Rozenn, additional, Anwar, Suhail, additional, Archer, Caroline, additional, Ashford, Richard, additional, Barraclough, Lisa, additional, Bertelli, Gianfilippo, additional, Bishop, Jill, additional, Branson, Tony, additional, Butt, Mohammed, additional, Chakrabarti, Amit, additional, Chakraborti, Prabir, additional, Churn, Mark, additional, Crowley, Clare, additional, Davis, Ruth, additional, Dhadda, Amandeep, additional, Eldeeb, Hany, additional, Fraser, Judith, additional, Hall, Julia, additional, Hickish, Tamas, additional, Hogg, Martin, additional, Howe, Theresa, additional, Joffe, Jonathan, additional, Kelleher, Muireann, additional, Kelly, Stephen, additional, Kendall, Anne, additional, Kristeleit, Hartmut, additional, Lumsden, Graeme, additional, Macmillan, Craig, additional, MacPherson, Iain, additional, Malik, Zafar, additional, Mithal, Natasha, additional, Neal, Anthony, additional, Panwar, Udaiveer, additional, Proctor, Andrew, additional, Proctor, Steven John, additional, Raj, Sanjay, additional, Rehman, Shazza, additional, Sandri, Ines, additional, Scatchard, Kate, additional, Sherwin, Elizabeth, additional, Sims, Eliot, additional, Singer, Julian, additional, Smith, Sarah, additional, Tahir, Saad, additional, Taylor, Wendy, additional, Tsalic, Medy, additional, Verrill, Mark, additional, Wardley, Andrew, additional, Waters, Simon, additional, Wheatley, Duncan, additional, Wright, Kathryn, additional, Yuille, Frances, additional, Alonso, Isabel, additional, Artagaveytia, Nora, additional, Rodriguez, Robinson, additional, Arbona, Esther, additional, Garcia, Yuraima, additional, Lion, Lorena, additional, Marcano, Dalila, additional, and Van Thuan, Tran, additional

Published
2017
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8. Analysis of tumor infiltrating CD4+ and CD8+ CDR3 sequences reveals shared features putatively associated to the anti-tumor immune response

Author

Andrea Aran, Gonzalo Lázaro, Vicente Marco, Elisa Molina, Ferran Abancó, Vicente Peg, María Gión, Laia Garrigós, José Pérez-García, Javier Cortés, and Mercè Martí

Subjects
tumor-infiltrating lymphocytes, CD4+ T cells, CD8+ T cells, T cell receptor, breast cancer, Immunologic diseases. Allergy, RC581-607
Abstract

IntroductionTumor-infiltrating lymphocytes (TILs) have predictive and prognostic value in breast cancer (BC) and exert a protective function against tumor growth, indicating that it is susceptible to treatment using adoptive cell transfer of TILs or T cell receptor (TCR)-based therapies. TCR can be used to identify naturally tumor-reactive T cells, but little is known about the differences in the TCR repertoires of CD4+ and CD8+ TILs.MethodsTCR high-throughput sequencing was performed using TILs derived from the initial cultures of 11 BC biopsies and expanded and sorted CD4+ and CD8+ TILs as well as using PBMCs from healthy donors expanded and sorted using the same methodology.ResultsPhysicochemical TCR differences between T cell subsets were observed, as CD4+ TILs presented larger N(D)Nnt TRB sequences and with a higher usage of positively charged residues, although only the latest was also observed in peripheral T cells from healthy individuals. Moreover, in CD4+ TILs, a more restricted TCR repertoire with a higher abundance of similar sequences containing certain amino acid motifs was observed.DiscussionSome differences between CD4+ and CD8+ TCRs were intrinsic to T cell subsets as can also be observed in peripheral T cells from healthy individuals, while other were only found in TILs samples and therefore may be tumor-driven. Notably, the higher similarity among CD4+ TCRs suggests a higher TCR promiscuity in this subset.

Published
2023
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9. Evolución de la DMO durante el tratamiento con inhibidores de aromatasa y su relación con el gen CYP11A1: estudio prospectivo de la cohorte B-ABLE

Author

Joan Albanell, Natalia Garcia-Giralt, M. Rodríguez-Sanz, Ignasi Tusquets, Sonia Servitja, Laia Garrigos, Xavier Nogués, I. González, A Diez-Perez, Maria Martinez-Garcia, Daniel Prieto-Alhambra, and T. Martos

Subjects
inhibidores de aromatasa, polimorfismos genéticos, Polimorfisme genètic, Endocrinology, Diabetes and Metabolism, lcsh:R, Aromatasa -- Inhibidors, lcsh:Medicine, tamoxifeno, lcsh:Osteopathy, densidad mineral ósea, CYP11A1, lcsh:RZ301-397.5, Densitat mineral òssia, Tamoxifèn
Abstract

Objetivos: El objetivo del estudio fue analizar los cambios en la densidad mineral ósea (DMO) a lo largo del tratamiento con inhibidores de aromatasa (IA) en la práctica clínica y evaluar la asociación entre el gen CYP11A1 y la variación de DMO al final del tratamiento. Material y métodos: La cohorte B-ABLE es un estudio prospectivo de mujeres postmenopáusicas con cáncer de mama, en tratamiento con IA. Se analizó la variación de DMO durante todo el tratamiento con IA, así como las diferencias entre las pacientes tratadas y no-tratadas previamente con tamoxifeno (TMX). Tres polimorfismos (rs4077581, rs11632698 y rs900798) del gen CYP11A1, fueron genotipados para su asociación con la variación de DMO. Resultados: Las pacientes tratadas con TMX mostraron pérdidas más aceleradas de DMO que las no tratadas previamente con TMX (60% menos en columna y 46% en fémur a los 2 años y 70% menos en columna y 63% en fémur a los 3 años). No obstante, al final del tratamiento no se detectaron diferencias significativas en la pérdida de DMO entre ambos grupos de pacientes. Los 3 polimorfismos del gen CYP11A1 resultaron significativamente asociados a la variación de DMO en fémur al final del tratamiento. Conclusiones: La DMO disminuyó de forma más acelerada en las pacientes con tratamiento previo con TMX que en las que solo recibieron AI, a pesar de que no se detectaron diferencias significativas al final de tratamiento. Polimorfismos en el gen CYP11A1 están relacionados con la variación de la DMO en respuesta al tratamiento con IA. Objectives: The aim of this study was to analyze bone mineral density (BMD) changes throughout aromatase inhibitor (AI) treatment in clinical cases and also consider its association with the CYP11A1 gene and the BMD variation after treatment. Material and methods: The B-ABLE cohort is a prospective study of postmenopausal women with breast cancer, in AI treatment. BMD variation was analyzed during AI treatment, as well as the differences those patients who were treated and not treated previously with tamoxifen (TMX). Three polymorphisms (rs4077581, rs11632698 and rs900798) of the CYP11A1 gene were genotyped for their association with BMD variation. Results: TMX-treated patients presented more rapid BMD loss than those who did not undergo prior TMX treatment (60% less in spine and 46% in femur at 2 years and 70% less in the spine and 63% in the femur at 3 years). However, no significant BMD loss was detected after treatment in either group. The 3 CYP11A1 gene polymorphisms were significantly associated with BMD variation in the femur at the end of the treatment. Conclusions: BMD was reduced more rapidly in patients with prior TMX treatment than in those who only received AI, although no significant differences were detected after treatment. The 3 CYP11A1 gene polymorphisms were associated with BMD variation in response to AI treatment. Este trabajo ha sido financiado por la Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF; RD12/0043/0022), y las ayudas FIS PI10/01464 y PI13/00444 (Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación). La Generalitat de Cataluña (DIUE 2014 SGR 775) y los fondos FEDER también han contribuido a su financiación

Published
2015

10. [Two cases of pituitary metastases as initial presentation form of small cell lung cancer]

Author

David, Benaiges, Montserrat, Zanui, Juan José, Chillaron, Edurne, Arriola, Laia, Garrigos, and Juan, Pedro-Botet

Subjects
Male, Lung Neoplasms, Humans, Pituitary Neoplasms, Small Cell Lung Carcinoma, Aged
Abstract

Metastases in the sellar region are rare and are frequently found incidentally or in necropsies. Only 7% are reported to be symptomatic. Diabetes insipidus, anterior pituitary dysfunction, visual field defects, headache/pain and ophthalmoplegia are the most commonly reported symptoms. We present the cases of two male patients with a small-cell lung carcinoma whose first clinical symptoms were due to pituitary metastasis. One case presented with symptoms of cavernous sinus invasion and panhypopituitarism and the other case with diabetes insipidus. Both patients had a rapid progression of their disease despite chemotherapy and died after a few months. Pituitary metastases occur most commonly with breast cancer in women and lung cancer in men. The presence of polyuria and polydipsia in an oncologic patient should alert the physician for diabetes insipidus and, if confirmed, an imaging procedure of the pituitary gland is mandatory. Treatment for these tumors is often multimodal and includes surgery, radiation therapy, chemotherapy and hormone replacement. Although surgical series have not shown any significant survival benefits given by tumor resection, the patient's quality of life may be improved.

Published
2013

11. Bone health in a prospective cohort of postmenopausal women receiving aromatase inhibitors for early breast cancer

Author

Marta de Ramón, Adolfo Diez-Perez, Sonia Servitja, Laia Garrigos, Maria Martinez-Garcia, Maria Jesus Peña, Xavier Nogués, Joan Albanell, Ignasi Tusquets, and Daniel Prieto-Alhambra

Subjects
medicine.medical_specialty, Bone density, medicine.drug_class, Osteoporosis, Breast Neoplasms, Bone and Bones, Bone remodeling, Bone Density, Internal medicine, medicine, Humans, Prospective Studies, Bone Resorption, Prospective cohort study, Aged, Gynecology, Bone mineral, Aromatase inhibitor, Aromatase Inhibitors, business.industry, Letrozole, General Medicine, Middle Aged, medicine.disease, Osteopenia, Fractures, Spontaneous, Quality of Life, Female, Surgery, Bone Remodeling, business, medicine.drug
Abstract

Objective: Baseline bone health in postmenopausal women is poorly characterized in prospective series of early breast cancer (EBC) patients candidates to aromatase inhibitor (AI) therapy. Our objective is to comprehensively evaluate bone health in a prospective clinical cohort of patients recruited prior to adjuvant AI therapy, with the aim of establishing potential AI impact on bone loss and fractures. Methods: From January 2006 to April 2010, we consecutively included 343 women with EBC who were about to start adjuvant AI therapy. Participants were assessed at baseline (before AI initiation) and at 3 months, with annual assessments thereafter. Bone mineral density (BMD), spine X-ray, bone metabolism (vitamin D [25(OH)D], bone turnover markers [BTM]), arthralgia and quality of life are measured. Results: Mean age was 61.9 years; 197 (57.4%) had been previously treated with tamoxifen; 145 (42.3%) were taking exemestane, 187 (54.5%) letrozole, and 11 (3.2%) anastrozole. Analysis of baseline data shows only 59 women (17.7%) had normal BMD; 200 (60.1%) had osteopenia and 74 (22.2%) had osteoporosis; 39 women (11.4%) had a prevalent fracture, 293 (89.1%) had 25(OH)D insufficiency (

Published
2012

12. Open label phase II clinical trial of orteronel (TAK-700) in metastatic or advanced non-resectable granulosa cell ovarian tumors: The Greko II study—GETHI 2013-01

Author

Jf. Rodriguez-Moreno, Jesús García-Donas, Laia Garrigos, Nuria Laínez, Ana Santaballa, Andrés Redondo, Juan Fernando Cueva, Maria Jesus Rubio, Susana Hernando Polo, Isabel Bover, Isabel Palacio, Zaida Garcia-Casado, Enrique Grande, and Alicia Hurtado

Subjects
Cancer Research, Oncology
Published
2015
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13. Bone turnover markers at 3 months of aromatase inhibitor therapy for prediction of 1-year bone mineral density loss: The B-ABLE cohort

Author

Xavi Nogues, Ignacio Tusquets, Elisabet Torres, D Prieto-Alhambra, Laia Garrigos, Tamara Martos, Maria Rodriguez-Sanz, Joan Albanell, Sonia Servitja, and Adolf Diez-Perez

Subjects
Bone mineral, Oncology, Cancer Research, medicine.medical_specialty, Aromatase inhibitor, medicine.drug_class, business.industry, Bone remodeling, Endocrinology, Internal medicine, Cohort, medicine, Bisphosphonate therapy, business
Abstract

581 Background: Most guidelines recommend bone mineral density (BMD) monitoring at 1-2 years of aromatase inhibitor (AI) therapy for women who do not need bisphosphonate therapy according to baseli...

Published
2014
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14. Concordance between radiologic and pathologic complete response in patients with breast cancer treated with neoadjuvant chemotherapy

Author

Ana Rodríguez-Arana, Maria Martinez-Garcia, Josep M. Corominas, Joan Albanell, Ignacio Tusquets, Maria Dolors Sabadell, Sonia Servitja, Laia Garrigos, Tamara Martos, and Iria Gonzalez

Subjects
Cancer Research, Chemotherapy, medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Concordance, Pathological response, Magnetic resonance imaging, medicine.disease, Breast cancer, Oncology, Medicine, In patient, Radiology, business, Complete response
Abstract

e12028 Background: Magnetic Resonance Imaging (MRI) is accepted as the best exploration to predict pathological response to neoadjuvant chemotherapy(NAC) in breast cancer. Our goal is to analyze th...

Published
2014
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15. COVID-19 in breast cancer patients: a subanalysis of the OnCovid registry

Author

Laia Garrigós, Cristina Saura, Clara Martinez-Vila, Alberto Zambelli, Mark Bower, Barbara Pistilli, Matteo Lambertini, Diego Ottaviani, Nikolaos Diamantis, Ailsa Lumsden, Sonia Pernas, Daniele Generali, Elia Seguí, Gemma Viñas, Eudald Felip, Ana Sanchez, Gianpiero Rizzo, Armando Santoro, Alessio Cortellini, Ylenia Perone, John Chester, Maria Iglesias, Marta Betti, Bruno Vincenzi, Michela Libertini, Francesca Mazzoni, Federica Zoratto, Rossana Berardi, Annalisa Guida, Rachel Wuerstlein, Angela Loizidou, Rachel Sharkey, Juan Aguilar Company, Marta Matas, Chiara Saggia, Lorenzo Chiudinelli, Emeline Colomba-Blameble, Myria Galazi, Uma Mukherjee, Mieke Van Hemelrijck, Mar Marin, Carla Strina, Aleix Prat, Helena Pla, Eva Maria Ciruelos, Alexia Bertuzzi, Lucia del Mastro, Giampiero Porzio, Thomas Newsom-Davis, Isabel Ruiz, Maria Belen Delany, Marco Krengli, Vittoria Fotia, Alessandro Viansone, Neha Chopra, Margarita Romeo, Ramon Salazar, Ignacio Perez, Francesca d’Avanzo, Michela Franchi, Manuela Milani, Fanny Pommeret, Marco Tucci, Paolo Pedrazzoli, Nadia Harbeck, Daniela Ferrante, David J. Pinato, and Alessandra Gennari

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Cancer patients are at higher risk of COVID-19 complications and mortality than the rest of the population. Breast cancer patients seem to have better prognosis when infected by SARS-CoV-2 than other cancer patients. Methods: We report a subanalysis of the OnCovid study providing more detailed information in the breast cancer population. Results: We included 495 breast cancer patients with a SARS-CoV-2 infection. Mean age was 62.6 years; 31.5% presented more than one comorbidity. The most frequent breast cancer subtype was luminal-like ( n = 245, 49.5%) and 177 (35.8%) had metastatic disease. A total of 332 (67.1%) patients were receiving active treatment, with radical intent in 232 (47.6%) of them. Hospitalization rate was 58.2% and all-cause mortality rate was 20.3%. One hundred twenty-nine (26.1%) patients developed one COVID-19 complication, being acute respiratory failure the most common ( n = 74, 15.0%). In the multivariable analysis, age older than 70 years, presence of COVID-19 complications, and metastatic disease were factors correlated with worse outcomes, while ongoing anticancer therapy at time of COVID-19 diagnosis appeared to be a protective factor. No particular oncological treatment was related to higher risk of complications. In the context of SARS-CoV-2 infection, 73 (18.3%) patients had some kind of modification on their oncologic treatment. At the first oncological reassessment (median time: 46.9 days ± 36.7), 255 (51.6%) patients reported to be fully recovered from the infection. There were 39 patients (7.9%) with long-term SARS-CoV-2-related complications. Conclusion: In the context of COVID-19, our data confirm that breast cancer patients appear to have lower complications and mortality rate than expected in other cancer populations. Most breast cancer patients can be safely treated for their neoplasm during SARS-CoV-2 pandemic. Oncological treatment has no impact on the risk of SARS-CoV-2 complications, and, especially in the curative setting, the treatment should be modified as little as possible.

Published
2021
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16. Vitamin D repletion and prevention of bone loss in nonosteoporotic women with breast cancer

Author

Joan Albanell, Laia Garrigos, Adolf Diez-Perez, Xavi Nogues, D Prieto-Alhambra, Sonia Servitja, Maria Jesus Peña, Ignasi Tusquets, and Maria Martinez-Garcia

Subjects
Oncology, Fracture risk, Cancer Research, medicine.medical_specialty, Aromatase inhibitor, medicine.drug_class, business.industry, medicine.disease, Breast cancer, Internal medicine, medicine, Vitamin D and neurology, business
Abstract

9026 Background: Aromatase inhibitor (AI)-associated bone loss increases fracture rates. Vitamin D might play a role in minimizing this fracture risk. We sought to assess the association between 25...

Published
2011
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17. Bone Health in Postmenopausal Women Treated with Adjuvant Aromatase Inhibitors for Early Breast Cancer: 12 Months Follow-Up

Author

Sonia Servitja, Xavier Nogués, Joan Albanell, M. I. Martínez, Rosa Nadal, A. Díez Pérez, Laia Garrigos, Maria Jesus Peña, and Ignasi Tusquets

Subjects
musculoskeletal diseases, Bone mineral, Gynecology, Cancer Research, medicine.medical_specialty, business.industry, Osteoporosis, Urology, medicine.disease, Bone remodeling, chemistry.chemical_compound, Breast cancer, medicine.anatomical_structure, Oncology, Exemestane, chemistry, medicine, medicine.symptom, business, Bone pain, Tamoxifen, Femoral neck, medicine.drug
Abstract

Background:The use of aromatase inhibitors (AI) in the adjuvant setting for postmenopausal women with receptor-positive breast cancer is well established. The AI treatment has been associated with decline in bone mineral density (BMD), and increased bone turnover markers. We designed a prospective study to evaluate the effect of oral bisphosphonates (BP) on vertebral and non vertebral fractures (VF), bone turnover markers (bTM), BMD, and quality of life (QoL) in postmenopausal women receiving adjuvant AI for hormone receptor positive early breast cancer.Material and methods:Postmenopausal, receptor-positive breast cancer women treated with AI as initial therapy [Letrozol (LET)] or after 2 or 5 years of tamoxifen [switched to exemestane (EXE)] were included. Patients were stratified by lumbar spine, femoral neck and total hip BMD to receive open-label treatment with BP, alendronate or risedronate, (if osteoporosis [T-score-2.0 and no major risk factor). Levels of 25-OH vitamin D, N-telopeptide (NTx), bone alkaline phosphatase (bALP) and osteocalcin (OC) were measured at baseline, 3, 12 and 24 moths, and BMD and thoracic and lumbar spine X-rays were assesed at baseline, 1 and 2 years. QoL was evaluated by ECOS-16 questionnaire and a visual analogue scale used to evaluate arthralgia. Results:from 03/2006 to 03/2009, 261 patients have been included and 117 have completed >12 month follow up. All the bTM increased after 12 months of AI treatment and a significant decrease on BMD was also observed (Table 1). This effect is reverted with oral BP treatment, maintaining the BMD level and reducing the bTM. With the AI introduction QoL of patients became worse, and the BP treatment did not improve neither arthralgia nor bone pain. Osteoporotic fractures were recorded at baseline in 12.3% of women (4.2% VF and 7.7% non VF).Conclusions:AI treatment increased bone turnover, decreased BMD and QoL. Of note, BP use decreased bone turnover, has neutral effect in BMD and does not improve QoL. This study suggests that the current recommendation of the use of BP should be revisited to consider including all postmenopausal women treated with adjuvant AI to avoid increased bone turnover and bone mass decrease.Table 1. BMD at baseline, 12 months and changes Without BP (n=76) With BP (n=41) BMD value (g/cm2)AIBasal12 month% change / pBasal12 month% change / pFemoral NeckLET0.7650.751- 1.96 / 0.020.6480.657+ 1.61 / NS EXE0.7560.749- 0.6 / NS0.6260.644+ 2.63 / 0.013Lumbar spineLET0.9900.969- 2.36 / 0.00010.8150.813- 0.17 / NS EXE0.9570.940- 1.57 / 0.0430.8110.814+ 0.86 / NS Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3175.

Published
2009
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