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3. 1712P Risk of SARS-CoV-2 infection and outcome after infection: Experience from the day-care unit at CHU Liège in Belgium

Author

Nathalie Marchal, Marie Goffin, Marie Lecocq, Amandine Catot, Concetta Elisa Onesti, Elodie Gonne, Odile Wera, Laurence Nicolaers, Aurélie Poncin, Joëlle Collignon, Andrée Rorive, Christine Gennigens, Bernard Duysinx, Guy Jerusalem, Hélène Schroeder, Pierre Frères, F Vaillant, Marc Polus, Brieuc Sautois, and Astrid Collinge

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Day care, Hematology, Systemic therapy, Article, Infection rate, Time of death, Oncology, Informed consent, Family medicine, medicine, In patient, business
Abstract

Background: No specific safety data concerning systemic oncological treatments were available at time of COVID-19 outbreak in Belgium. In our hospital we decided to maintain adjuvant and early line treatments for metastatic disease in patients under 65 and without specific comorbidities and to apply a shared decision approach in other patients while following closely the safety of these treatments. Method(s): Real time safety monitoring was proposed to all patients treated for solid tumours in our day-care unit starting March 1st, 2020. After signing informed consent patients were asked questions concerning protective measures at home, signs of SARS-CoV-2 infection and hospitalisation. Patients' charts were reviewed for outcome, including death, after suspected or proven SARS-CoV-2 infection. Minimum follow-up was 5 weeks after day care unit attendance. Result(s): 387 patients were included in our registry between March 1st and March 31st, 2020. Median age was 64 years-old (range 27-90). Most patients suffered from lung (n=96), breast (n=93), gastrointestinal (n=87), gynaecological (n=38) or urological (n=33) cancers. 131 patients received (neo)adjuvant treatments, 256 patients were treated for metastatic disease. Patients received chemotherapy (n=170), immunotherapy (n=103), targeted therapy (n=68) or other combinations (n=46). Although Belgium had one of the highest infection rates in the world, safety data concerning risk of SARS-CoV-2 infection and outcomes were rather reassuring. A total of 11 patients had either suspected (n=5, 1.3%) or proven (n=6, 1.6%) SARS-CoV-2 infection. Only one 74 years old patient died of COVID-19, another 51 years old patient died of progressive disease but presented also suspicion of SARS-CoV-2 infection at the time of death. Conclusion(s): Analysis of our data for patients treated in March 2020 in the day-care unit are reassuring and suggest higher risk related to under-treatment compared to risk related to continuation of systemic therapy at time of COVID-19 outbreak. Patients' follow-up will be updated and additional analyses and data in particular for April 2020, when the infection rate was still extremely high in Belgium, will be presented. Legal entity responsible for the study: The authors. Funding(s): Fondation Leon Fredericq. Disclosure: A. Rorive: Travel/Accommodation/Expenses: BMS;MSD. B. Sautois: Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen;Advisory/Consultancy: Clovis;Sanofi;Astellas. J. Collignon: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Amgen;Pfizer;Advisory/Consultancy: Servier;Bayer;Merck;Lilly;Sanofi;Sirtex;Celgene;Ipsen;Novartis. P. Freres: Advisory/Consultancy: Ipsen;Merck;BMS. C. Gennigens: Advisory/Consultancy, Research grant/Funding (institution): Astra-Zeneca;Advisory/Consultancy: BMS;GSK;Lilly;MSD;Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen;Pfizer;Pharmamar;Roche. G. Jerusalem: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Roche;Pfizer;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Lilly;Advisory/Consultancy, Research grant/Funding (institution): Amgen;Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;AstraZeneca;Daiichi Sankyo;Advisory/Consultancy: Abbvie;Travel/Accommodation/Expenses: Medimmune;MerckKGaA. All other authors have declared no conflicts of interest.Copyright © 2020

Published
2020
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4. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings†

Author

Kubicka, S., Greil, R., André, T., Bennouna, J., Sastre, J., Van Cutsem, E., von Moos, R., Österlund, P., Reyes-Rivera, I., Müller, T., Makrutzki, M., Arnold, D., Andel, J, Balcke, P, Benedicic, B, Eisterer, W, Fridrik, M, Jagdt, B, Keil, F, Kretschmer, A, Krippl, P, Oexle, H, Pecherstorfer, M, Samonigg, H, Schmid, M, Thaler, J, Tinchon, C, Weiss, H., Arts, J, De Man, M, Demolin, G, Janssens, J, Polus, M., Benczikova, B, Melichar, B, Prausova, J, Vitek, P., Andersen, FZ, Jensen, BB, Keldsen, N, Østerlind, K, Vistisen, K., Elme, A, Magi, A, Ojamaa, K., Ristamäki, R, Salminen, T., Ben Abdelghani, M, Bouche, O, Borg, C, Bouhier-Leporrier, K, Breysacher, G, Chone, L, Clavero Fabri, M-C, Deplanque, G, Desseigne, F, Dourthe, L-M, Ezenfis, J, Faroux, R, François, E, Garnier, C, Gaspard, M-H, Hebbar, M, Illory, JF, Kaminsky, M-C, Lecomte, T, Legoux, J-L, Levache, B, Lobry, C, Lotz, J-P, Mabro, M, Manet-Lacombe, S, Manfredi, S, Matysiak Budnik, T, Miglianico, L, Mineur, L, Moullet, I, Naman, H, Nouyrigat, P, Oziel-Taieb, S, Perrier, H, Pezet, D, Philip, J, Pottier, V, Porneuf, M, Ramdani, M, Re, D, Rinaldi, Y, Spaeth, D, Taieb, J, Terrebonne, E, Texereau, P, Thirot Bidault, A, Tournigand, C, Tubiana-Mathieu, N, Vantelon, J-M, Viret, F, Ychou, M., Bangerter, M, Bertram, ME, Bohnsteen, B, Brinkmann, L, Caca, K, Constantin, C, Cordes, H-J, Dietrich, G, Eggert, J, Engel, E, Fahlke, J, Fensterer, H, Florschütz, A, Folprecht, G, Forstbauer, H, Freier, W, Freund, M, Frickhofen, N, Gäbele, E, Geiler, M, Gieseler, F, Göhler, T, Graeven, U, Groschek, M, Grundeis, M, Hacker, U, Hagen, V, Hebart, HF, Hegewisch-Becker, S, Heike, M, Herrmann, T, Hildebrandt, B, Höffkes, H-G, Hübner, G, Hübner, J, Kettner, E, Kneba, M, Kohnke, JW, Kojouharoff, G, König, C, Kretzschmar, A, Kröning, H, Kürner, K, Lammert, F, Lerchenmüller, C, Lück, A, Meiler, J, Mergenthaler, H-G, Müller, L, Müller-Naendrup, C, Nusch, A, Papke, J, Porschen, R, Rädle, J, Reddemann, C, Ridwelski, K, Riera-Knorrenschild, J, Rudi, J, Schmalenberger, A, Schimanski, C-C, Schlegel, F, Schlichting, C, Schmidt, P, Schmiegel, W, Schmitz, S, Schulze-Bergkamen, H, Schwaner, I, Schwarzer, A, Schwerdtfeger, M, Selbach, J, Sieber, M, Siebler, J, Staib, P, Stauch, M, Steffens, C-C, Stübs, P, Tischendorf, J, Trarbach, T, Tummes, D, Valdix, A-R, Vogel, A, Von Wichert, GPL, Walther, M, Welslau, W, Wilhelm, G, Wobster, H, Wolf, T, Zeigenhagen, N, Zomorodbaksch, B., Batman, E, Bloemendal, HJ, Kehrer, DFS., Guren, T, Indrebø, G, Kersten, C, Soerbye, H., Fragoso, M, Fragoso, R, Mellidez, JC, Sa, A., Aljobran, A, Darwish, T., Alonso-Orduna, V, Aparicio, J, Aranda, E, Bosch, C, Galan-Brotons, A, Busquier Hernandez, I, Camara, JC, Campos Cervera, JM, Carlos Garcia Giron, C, Del Prado, PM, Donnay, O, Escudero, P, Falco, E, Gallego Plazas, J, Garcia Alfonso, P, Gonzalez Flores, E, Gravalos, C, Guardeno, R, Juárez, A, Lopez Ladron, A, Losa Gaspa, F, MVicent Vergé, J, Marcuello Gaspar, E, Massuti Sureda, B, Molina, J, Montero, IC, Muñoa, AL, Naranjo, MB, Oruezabal Moreno, MJ, Pachón Olmos, V, Pericay, C, Reina Zoilo, JJ, Rivera, F, Ruiz Casado, A, Safont, MJ, Salud Salvia, A, Tobena, M, Toral, JC, Valenti, V, Valladares Ayerbes, M, Vieitez, JM, Vera, R, Vieitez, JM., Berglund, A, Fernebro, E., Hess-Umbricht, V, Pless, M, Popescu, R, and Winterhalder, R.

Published
2013
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7. 1712P Risk of SARS-CoV-2 infection and outcome after infection: Experience from the day-care unit at CHU Liège in Belgium

Author

Lecocq, M., primary, Onesti, C.E., additional, Schroeder, H., additional, Rorive, A., additional, Goffin, M., additional, Gonne, E., additional, Sautois, B., additional, Catot, A., additional, Wera, O., additional, Nicolaers, L., additional, Collinge, A., additional, Collignon, J., additional, Freres, P., additional, Polus, M., additional, Duysinx, B., additional, Vaillant, F., additional, Gennigens, C., additional, Marchal, N., additional, Poncin, A., additional, and Jerusalem, G., additional

Published
2020
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8. Prognostic value of KRAS mutations in stage III colon cancer: post hoc analysis of the PETACC8 phase III trial dataset

Author

Josef Thaler, Richard Greil, Johannes Gaenzer, Wolfgang Eisterer, Joerg Tschmelitsch, Hellmut Samonigg, August Zabernigg, Franz Schmid, Günther Steger, Robert Steinacher, Johannes Andel, Alois Lang, Reinhold Függer, Friedrich Hofbauer, Ewald Woell, Dietmar Geissler, Alfred Lenauer, Manfred Prager, Jean-Luc Van Laethem, Eric Van Cutsem, Geert D'Haens, Gauthier Demolin, Joseph Kerger, Guido Deboever, Gilbert Ghillebert, Marc Polus, Hassan RezaieKalantari, Thierry Delaunoit, Jean Charles Goeminne, Marc Peeters, Philippe Vergauwe, Ghislain Houbiers, Yves Humblet, Jos Janssens, Dirk Schrijvers, Erik Vanderstraeten, Jan Vermorken, Daniel Van Daele, Michel Ferrante, Frederic Forget, Alain Hendlisz, Mette Yilmaz, Svend Erik Nielsen, Lene Vestermark, Jim Larsen, Marc Ychou, Ayman Zawadi, Mohamed-Ayman Zawadi, Olivier Bouche, Laurent Mineur, Jaafar Bennouna-Louridi, Louis Marie Dourthe, Eveline Boucher, Julien Taieb, Denis Pezet, Francoise Desseigne, Michel Ducreux, Patrick Texereau, Laurent Miglianico, Philippe Rougier, Serge Fratte, Charles-Briac Levache, Yacine Merrouche, Stephen Ellis, Christophe Locher, Jean-Francois Ramee, Claire Garnier, Frederic Viret, Bruno Chauffert, Isabelle Cojean-Zelek, Pierre Michel, Cedric Lecaille, Christian Borel, Jean-Francois Seitz, Denis Smith, Catherine Lombard-Bohas, Thierry Andre, Jean-Marc Gornet, Francine Fein, Marie-Aude Coulon-Sfairi, Marie-Christine Kaminsky, Jean-Paul Lagasse, Dominique Luet, Pierre-Luc Etienne, Mohamed Gasmi, Andre Vanoli, Suzanne Nguyen, Thomas Aparicio, Hervé Perrier, Noel Stremsdoerfer, Philippe Laplaige, Dominique Arsene, Dominique Auby, Laurent Bedenne, Romain Coriat, Bernard Denis, Patrick Geoffroy, Gilles Piot, Yves Becouarn, Gilbert Bordes, Gael Deplanque, Olivier Dupuis, Frederic Fruge, Rosine Guimbaud, Thierry Lecomte, Gérard Lledo, Iradej Sobhani, Amani Asnacios, Ahmed Azzedine, Christophe Desauw, Marie-Pierre Galais, Dany Gargot, You-Heng Lam, Abakar Abakar-Mahamat, Jean-Francois Berdah, Sylviane Catteau, Marie-Christine Clavero-Fabri, Jean-Francois Codoul, Jean-Louis Legoux, Denis Goldfain, Pierre Guichard, Denis Pere Verge, Jocelyne Provencal, Bruno Vedrenne, Catherine Brezault-Bonnet, Denis Cleau, Jean-Paul Desir, David Fallik, Bruno Garcia, Marie-Hélène Gaspard, Dominique Genet, Johannes Hartwig, Yves Krummel, Tamara MatysiakBudnik, Vanessa Palascak-Juif, Harizo Randrianarivelo, Yves Rinaldi, Albert Aleba, Ariane Darut-Jouve, Aimery de Gramont, Herve Hamon, Frederic Wendehenne, Axel Matzdorff, Michael Konrad Stahl, Wolfgang Schepp, Martin Burk, Lothar Mueller, Gunnar Folprecht, Michael Geissler, Luisa Mantovani-Loeffler, Thomas Hoehler, Walter Asperger, Hendrik Kroening, Ludwig Fischer von Weikersthal, Stefan Fuxius, Matthias Groschek, Johannes Meiler, Tanja Trarbach, Jacqueline Rauh, Nicolas Ziegenhagen, Albrecht Kretzschmar, Ullrich Graeven, Arnd Nusch, Goetz von Wichert, Ralf-Dieter Hofheinz, Gerhard Kleber, Karl-Heinz Schmidt, Ursula Vehling-Kaiser, Claudia Baum, Jochen Schuette, Georg Martin Haag, Wilhelm Holtkamp, Jochen Potenberg, Tobias Reiber, Georg Schliesser, Hans-Joachim Schmoll, Wolfgang Schneider-Kappus, Wolfgang Abenhardt, Claudio Denzlinger, Jan Henning, Bartscht Marxsen, Hans GuenterDerigs, Helmut Lambertz, Ingulf Becker-Boost, Karel Caca, Christian Constantin, Thomas Decker, Henning Eschenburg, Sigrun Gabius, Holger Hebart, Albrecht Hoffmeister, Heinz-August Horst, Stephan Kremers, Malte Leithaeuser, Sebastian Mueller, Siegfried Wagner, Severin Daum, Frank Schlegel, Martina Stauch, Volker Heinemann, Roberto Labianca, Giuseppe Colucci, Dino Amadori, Enrico Mini, Alfredo Falcone, Corrado Boni, Evaristo Maiello, Luciano Latini, Alberto Zaniboni, Giuseppe Aprile, Sandro Barni, Rodolfo Mattioli, Andrea Martoni, Rodolfo Passalacqua, Mario Nicolini, Enzo Pasquini, Carla Rabbi, Enrico Aitini, Alberto Ravaioli, Carlo Barone, Guido Biasco, Stefano Tamberi, Angelo Gambi, Claudio Verusio, Marina Marzola, Giorgio Lelli, Stefano Cascinu, Paolo Bidoli, Massimo Vaghi, Giorgio Cruciani, Francesco Di Costanzo, Alberto Sobrero, Roberto Petrioli, Massimo Aglietta, Oscar Alabiso, Federico Capuzzo, Domenico Cristi Corsi, Stefania Salvagni, Silvana Chiara, Francesco Ferraù, Francesco Giuliani, Sara Lonardi, Nicola Gebbia, Giovanni Mantovani, Evaristo Sanches, Juan Carlos Mellidez, Pedro Santos, Joao Freire, Cristina Sarmento, Luis Costa, Antonio Moreira Pinto, Sergio Barroso, Jorge Espirito Santo, Fátima Guedes, Amélia Monteiro, Anabela Sa, Irene Furtado, Josep Tabernero, Ramon Salazar, Enrique Aranda Aguilar, Fernando Rivera Herrero, Javier Sastre Valera, Manuel ValladaresAyerbes, Jaime FeliuBatlle, Silvia Gil, Carlos Garcia-Giron, Guillermo Lopez Vivanco, Antonia Salud Salvia, Vicente Alonso Orduña, Ruth Vera Garcia, Javier Gallego, Bartomeu Massuti Sureda, Jordi Remon, Maria Jose Safont Aguilera, Luis CireraNogueras, BernadoQueralt Merino, Cristina Gravalos Castro, Purificacion Martinez de Prado, Carlos PijaumePericay, Manuel ConstenlaFigueiras, InmaculadaGuasch Jordan, Maria Jose GomeReina, Amelia Lopez-Ladron Garcia, Antonio Arrivi Garcia-Ramos, Andres Cervantes, Carlos Fernandez Martos, Eugenio MarcuelloGaspar, Ines Cabezas Montero, Pilar Escudero Emperador, Ana Leon Carbonero, Manuel Gallen Castillo, Teresa Garcia Garcia, Jose Garcia Lopez, Encarnacion Gonzalez Flores, Monica GuillotMorales, Marta LlanosMuñoz, Ana López Martín, Joan Maurel, Juan Carlos Camara, Rosario Dueñas Garcia, Mercedes Salgado, Isabel HernandezBusquier, Teresa Checa Ruiz, Adelaida LacastaMuñoa, MiquelNogue Aliguer, Amalia Velasco Ortiz de Taranco, Miguel Mendez Ureña, Ferran Losa Gaspa, Jose Juan Ponce, Carlos Bosch Roig, Pedro Valero Jimenez, Antonio GalanBrotons, Santiago AlbiolRodriguez, Jose Ales Martinez, Liliana Canosa Ruiz, Margarita CentellesRuiz, John Bridgewater, Rob Glynne-Jones, Saad Tahir, Tamas Hickish, Jim Cassidy, and Leslie Samuel

Subjects
Oncology, Hematology
Published
2015

9. Effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (MAGNET trial)

Author

Piessevaux, H., primary, Demey, W., additional, Bols, A., additional, Janssens, J., additional, Polus, M., additional, Rezaei Kalantari, H., additional, Laurent, S., additional, Demols, A., additional, Humblet, Y., additional, Deboever, G., additional, Kargar Samani, K., additional, Ferrante, M., additional, Monsaert, E., additional, Rondou, T., additional, van Laethem, J.-L., additional, and Tejpar, S., additional

Published
2018
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10. Effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (MAGNET trial)

Author

Yves Humblet, Wim Demey, K. Kargar Samani, Marc Ferrante, H. Rezaei Kalantari, J.-L. Van Laethem, Hubert Piessevaux, Sabine Tejpar, Guido Deboever, Anne Demols, Stéphanie Laurent, Alain Bols, T. Rondou, Jozef Janssens, Marc Polus, and E Monsaert

Subjects
medicine.medical_specialty, Magnesium supplementation, Magnesium, Colorectal cancer, business.industry, Kinetics, chemistry.chemical_element, Hematology, medicine.disease, Gastroenterology, Oncology, chemistry, Internal medicine, medicine, medicine.symptom, business, Antibody therapy, Wasting
Published
2018

12. Prognostic value of KRAS mutations in stage III colon cancer: post hoc analysis of the PETACC8 phase III trial dataset

Author

Thaler, Josef, primary, Greil, Richard, additional, Gaenzer, Johannes, additional, Eisterer, Wolfgang, additional, Tschmelitsch, Joerg, additional, Samonigg, Hellmut, additional, Zabernigg, August, additional, Schmid, Franz, additional, Steger, Günther, additional, Steinacher, Robert, additional, Andel, Johannes, additional, Lang, Alois, additional, Függer, Reinhold, additional, Hofbauer, Friedrich, additional, Woell, Ewald, additional, Geissler, Dietmar, additional, Lenauer, Alfred, additional, Prager, Manfred, additional, Van Laethem, Jean-Luc, additional, Van Cutsem, Eric, additional, D'Haens, Geert, additional, Demolin, Gauthier, additional, Kerger, Joseph, additional, Deboever, Guido, additional, Ghillebert, Gilbert, additional, Polus, Marc, additional, RezaieKalantari, Hassan, additional, Delaunoit, Thierry, additional, Goeminne, Jean Charles, additional, Peeters, Marc, additional, Vergauwe, Philippe, additional, Houbiers, Ghislain, additional, Humblet, Yves, additional, Janssens, Jos, additional, Schrijvers, Dirk, additional, Vanderstraeten, Erik, additional, Vermorken, Jan, additional, Van Daele, Daniel, additional, Ferrante, Michel, additional, Forget, Frederic, additional, Hendlisz, Alain, additional, Yilmaz, Mette, additional, Nielsen, Svend Erik, additional, Vestermark, Lene, additional, Larsen, Jim, additional, Ychou, Marc, additional, Zawadi, Ayman, additional, Zawadi, Mohamed-Ayman, additional, Bouche, Olivier, additional, Mineur, Laurent, additional, Bennouna-Louridi, Jaafar, additional, Dourthe, Louis Marie, additional, Boucher, Eveline, additional, Taieb, Julien, additional, Pezet, Denis, additional, Desseigne, Francoise, additional, Ducreux, Michel, additional, Texereau, Patrick, additional, Miglianico, Laurent, additional, Rougier, Philippe, additional, Fratte, Serge, additional, Levache, Charles-Briac, additional, Merrouche,, Yacine, additional, Ellis, Stephen, additional, Locher, Christophe, additional, Ramee, Jean-Francois, additional, Garnier, Claire, additional, Viret, Frederic, additional, Chauffert, Bruno, additional, Cojean-Zelek, Isabelle, additional, Michel, Pierre, additional, Lecaille, Cedric, additional, Borel, Christian, additional, Seitz, Jean-Francois, additional, Smith, Denis, additional, Lombard-Bohas, Catherine, additional, Andre, Thierry, additional, Gornet, Jean-Marc, additional, Fein, Francine, additional, Coulon-Sfairi, Marie-Aude, additional, Kaminsky, Marie-Christine, additional, Lagasse, Jean-Paul, additional, Luet, Dominique, additional, Etienne, Pierre-Luc, additional, Gasmi, Mohamed, additional, Vanoli, Andre, additional, Nguyen, Suzanne, additional, Aparicio, Thomas, additional, Perrier, Hervé, additional, Stremsdoerfer, Noel, additional, Laplaige, Philippe, additional, Arsene, Dominique, additional, Auby, Dominique, additional, Bedenne, Laurent, additional, Coriat, Romain, additional, Denis, Bernard, additional, Geoffroy, Patrick, additional, Piot, Gilles, additional, Becouarn, Yves, additional, Bordes, Gilbert, additional, Deplanque, Gael, additional, Dupuis, Olivier, additional, Fruge, Frederic, additional, Guimbaud, Rosine, additional, Lecomte, Thierry, additional, Lledo, Gérard, additional, Sobhani, Iradej, additional, Asnacios, Amani, additional, Azzedine, Ahmed, additional, Desauw, Christophe, additional, Galais, Marie-Pierre, additional, Gargot, Dany, additional, Lam, You-Heng, additional, Abakar-Mahamat, Abakar, additional, Berdah, Jean-Francois, additional, Catteau, Sylviane, additional, Clavero-Fabri, Marie-Christine, additional, Codoul, Jean-Francois, additional, Legoux, Jean-Louis, additional, Goldfain, Denis, additional, Guichard, Pierre, additional, Verge, Denis Pere, additional, Provencal, Jocelyne, additional, Vedrenne, Bruno, additional, Brezault-Bonnet, Catherine, additional, Cleau, Denis, additional, Desir, Jean-Paul, additional, Fallik, David, additional, Garcia, Bruno, additional, Gaspard, Marie-Hélène, additional, Genet, Dominique, additional, Hartwig, Johannes, additional, Krummel, Yves, additional, MatysiakBudnik, Tamara, additional, Palascak-Juif, Vanessa, additional, Randrianarivelo, Harizo, additional, Rinaldi, Yves, additional, Aleba, Albert, additional, Darut-Jouve, Ariane, additional, de Gramont, Aimery, additional, Hamon, Herve, additional, Wendehenne, Frederic, additional, Matzdorff, Axel, additional, Stahl, Michael Konrad, additional, Schepp, Wolfgang, additional, Burk, Martin, additional, Mueller, Lothar, additional, Folprecht, Gunnar, additional, Geissler, Michael, additional, Mantovani-Loeffler, Luisa, additional, Hoehler, Thomas, additional, Asperger, Walter, additional, Kroening, Hendrik, additional, von Weikersthal, Ludwig Fischer, additional, Fuxius, Stefan, additional, Groschek, Matthias, additional, Meiler, Johannes, additional, Trarbach, Tanja, additional, Rauh, Jacqueline, additional, Ziegenhagen, Nicolas, additional, Kretzschmar, Albrecht, additional, Graeven, Ullrich, additional, Nusch, Arnd, additional, von Wichert, Goetz, additional, Hofheinz, Ralf-Dieter, additional, Kleber, Gerhard, additional, Schmidt, Karl-Heinz, additional, Vehling-Kaiser, Ursula, additional, Baum, Claudia, additional, Schuette, Jochen, additional, Haag, Georg Martin, additional, Holtkamp, Wilhelm, additional, Potenberg, Jochen, additional, Reiber, Tobias, additional, Schliesser, Georg, additional, Schmoll, Hans-Joachim, additional, Schneider-Kappus, Wolfgang, additional, Abenhardt, Wolfgang, additional, Denzlinger, Claudio, additional, Henning, Jan, additional, Marxsen, Bartscht, additional, GuenterDerigs, Hans, additional, Lambertz, Helmut, additional, Becker-Boost, Ingulf, additional, Caca, Karel, additional, Constantin, Christian, additional, Decker, Thomas, additional, Eschenburg, Henning, additional, Gabius, Sigrun, additional, Hebart, Holger, additional, Hoffmeister, Albrecht, additional, Horst, Heinz-August, additional, Kremers, Stephan, additional, Leithaeuser, Malte, additional, Mueller, Sebastian, additional, Wagner, Siegfried, additional, Daum, Severin, additional, Schlegel, Frank, additional, Stauch, Martina, additional, Heinemann, Volker, additional, Labianca, Roberto, additional, Colucci, Giuseppe, additional, Amadori, Dino, additional, Mini, Enrico, additional, Falcone, Alfredo, additional, Boni, Corrado, additional, Maiello, Evaristo, additional, Latini, Luciano, additional, Zaniboni, Alberto, additional, Aprile, Giuseppe, additional, Barni, Sandro, additional, Mattioli, Rodolfo, additional, Martoni, Andrea, additional, Passalacqua, Rodolfo, additional, Nicolini, Mario, additional, Pasquini, Enzo, additional, Rabbi, Carla, additional, Aitini, Enrico, additional, Ravaioli, Alberto, additional, Barone, Carlo, additional, Biasco, Guido, additional, Tamberi, Stefano, additional, Gambi, Angelo, additional, Verusio, Claudio, additional, Marzola, Marina, additional, Lelli, Giorgio, additional, Cascinu, Stefano, additional, Bidoli, Paolo, additional, Vaghi, Massimo, additional, Cruciani, Giorgio, additional, Di Costanzo, Francesco, additional, Sobrero, Alberto, additional, Petrioli, Roberto, additional, Aglietta, Massimo, additional, Alabiso, Oscar, additional, Capuzzo, Federico, additional, Corsi, Domenico Cristi, additional, Salvagni, Stefania, additional, Chiara, Silvana, additional, Ferraù, Francesco, additional, Giuliani, Francesco, additional, Lonardi, Sara, additional, Gebbia, Nicola, additional, Mantovani, Giovanni, additional, Sanches, Evaristo, additional, Mellidez, Juan Carlos, additional, Santos, Pedro, additional, Freire, Joao, additional, Sarmento, Cristina, additional, Costa, Luis, additional, Pinto, Antonio Moreira, additional, Barroso, Sergio, additional, Santo, Jorge Espirito, additional, Guedes, Fátima, additional, Monteiro, Amélia, additional, Sa, Anabela, additional, Furtado, Irene, additional, Tabernero, Josep, additional, Salazar, Ramon, additional, Aguilar, Enrique Aranda, additional, Herrero, Fernando Rivera, additional, Valera, Javier Sastre, additional, ValladaresAyerbes, Manuel, additional, FeliuBatlle, Jaime, additional, Gil, Silvia, additional, Garcia-Giron, Carlos, additional, Vivanco, Guillermo Lopez, additional, Salvia, Antonia Salud, additional, Orduña, Vicente Alonso, additional, Garcia, Ruth Vera, additional, Gallego, Javier, additional, Sureda, Bartomeu Massuti, additional, Remon, Jordi, additional, Safont Aguilera, Maria Jose, additional, CireraNogueras, Luis, additional, Merino, BernadoQueralt, additional, Castro, Cristina Gravalos, additional, de Prado, Purificacion Martinez, additional, PijaumePericay, Carlos, additional, ConstenlaFigueiras, Manuel, additional, Jordan, InmaculadaGuasch, additional, GomeReina, Maria Jose, additional, Garcia, Amelia Lopez-Ladron, additional, Garcia-Ramos, Antonio Arrivi, additional, Cervantes, Andres, additional, Martos, Carlos Fernandez, additional, MarcuelloGaspar, Eugenio, additional, Montero, Ines Cabezas, additional, Emperador, Pilar Escudero, additional, Carbonero, Ana Leon, additional, Castillo, Manuel Gallen, additional, Garcia, Teresa Garcia, additional, Lopez, Jose Garcia, additional, Flores, Encarnacion Gonzalez, additional, GuillotMorales, Monica, additional, LlanosMuñoz, Marta, additional, Martín, Ana López, additional, Maurel, Joan, additional, Camara, Juan Carlos, additional, Garcia, Rosario Dueñas, additional, Salgado, Mercedes, additional, HernandezBusquier, Isabel, additional, Ruiz, Teresa Checa, additional, LacastaMuñoa, Adelaida, additional, Aliguer, MiquelNogue, additional, Ortiz de Taranco, Amalia Velasco, additional, Ureña, Miguel Mendez, additional, Gaspa, Ferran Losa, additional, Ponce, Jose Juan, additional, Roig, Carlos Bosch, additional, Jimenez, Pedro Valero, additional, GalanBrotons, Antonio, additional, AlbiolRodriguez, Santiago, additional, Martinez, Jose Ales, additional, Ruiz, Liliana Canosa, additional, CentellesRuiz, Margarita, additional, Bridgewater, John, additional, Glynne-Jones, Rob, additional, Tahir, Saad, additional, Hickish, Tamas, additional, Cassidy, Jim, additional, and Samuel, Leslie, additional

Published
2015
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13. Final Results of a Randomized Phase Ii Study with Neo-Adjuvant Triplet or Doublet Therapy, Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer: Axe Beam

Author

Chiritescu, G., primary, Dumon, K., additional, Vergauwe, P., additional, Arts, J., additional, Verbeke, L., additional, Polus, M., additional, Humblet, Y., additional, van Laethem, J., additional, Daisne, J., additional, Decaestecker, J., additional, D'Hoore, A., additional, Mardjuadi, F., additional, Debucquoy, A., additional, Verstraete, M., additional, Sagaert, X., additional, Haustermans, K., additional, and Van Cutsem, E., additional

Published
2014
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14. AXE Beam: Neo-Adjuvant Triplet Versus Doublet Therapy with Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer – A Randomized Phase II Study at the End of Recruitment

Author

Chiritescu, G., primary, Dumon, K., additional, Vergauwe, P., additional, Arts, J., additional, Verbeke, L., additional, Polus, M., additional, Humblet, Y., additional, Van Laethem, J.L., additional, Daisne, J.F., additional, Decaestecker, J., additional, D'Hoore, A., additional, Mardjuadi, F., additional, Debucquoy, A., additional, Verstraete, M., additional, Sagaert, X., additional, Haustermans, K., additional, and Van Cutsem, E., additional

Published
2014
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15. Final Results of a Randomized Phase Ii Study with Neo-Adjuvant Triplet or Doublet Therapy, Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer: Axe Beam

Author

F. Mardjuadi, Marc Polus, Yves Humblet, Xavier Sagaert, Annelies Debucquoy, J.-L. Van Laethem, G. Chiritescu, Philippe Vergauwe, J. Decaestecker, J.F. Daisne, J. Arts, Len Verbeke, Karin Haustermans, E. Van Cutsem, André D'Hoore, Kristoffel R. Dumon, and M. Verstraete

Subjects
medicine.medical_specialty, Bevacizumab, business.industry, Surrogate endpoint, Urology, Phases of clinical research, Hematology, Total mesorectal excision, Surgery, Oxaliplatin, Capecitabine, Oncology, Clinical endpoint, medicine, business, Chemoradiotherapy, medicine.drug
Abstract

Aim: To assess the activity and safety of bevacizumab (A) with capecitabine (X) and radiotherapy (RT) with or without oxaliplatin (E) in the preoperative treatment (thx) of locally advanced rectal cancer (LARC). To identify biomarkers for early response prediction. Methods: Patients (pts) with LARC were randomized to RT (1.8Gy/day) with the triplet A (5mg/kg), X (1650mg/m2/day) and E (50mg/m2) in Arm A or the doublet A + X without E in Arm B. Chemoradiotherapy (CRT) started at 2 weeks after 1st infusion of A and continued for 5 weeks. Total mesorectal excision (TME) was planned at 6-8 weeks post CRT. Pathological complete response (pCR) rate in Arm A was the primary endpoint. Safety profile and identification of biomarkers for early response prediction were secondary endpoints. Immunohistochemical staining for the functionality of blood vessels, proliferation and hypoxia as well as Luminex analyses to assess changes in circulating VEGF ligands are performed on tissues and blood samples from consenting pts. Results: Eighty-four pts with median age 61 completed thx, 81 including surgery, with a relative dose intensity of 98% for A and X and 93% for E. During CRT, serious adverse events (SAEs) were more frequent in Arm A vs Arm B: fever (4 vs 0), diarrhea (3 vs 0), infection (4 vs 1). Postoperative SAEs (wound infections, leaks) occurred in 17 pts, 10 in Arm A and 7 in Arm B. Five pts deceased post-study, 3 due to distant disease progression, 2 to postoperative complications. Post-surgery data are available for 81 pts. pCR was seen in 18 pts, 33% (14/43) in Arm A and 10% (4/41) in Arm B in an intent-to-treat analysis (ITT). The rate of good responders (Dworak TRG 3, 4) was higher in Arm A 29/43 vs Arm B 16/41 in ITT. Changes of the pericyte coverage of the blood vessels were observed. The decrease of plasma concentration of PDGF-AA and PDGF-BB correlated with pCR (p = 0.04 and 0.03 respectively). Conclusions: Both triplet and doublet combination showed acceptable safety profiles. The addition of E to X and A with RT seemed beneficial in terms of pCR rates in this patient population, with a slight increase of toxicity. The main endpoint has been reached with 14/43 pCRs in Arm A. PDGF may be a predictor of response in this setting. Final data after a blind central review of the main endpoint and translational research data will be available at the conference. Support from Roche and Sanofi Aventis. Disclosure: K. Haustermans: The author declares an educational grant from Roche for this study. No further conflict of interest; E. Van Cutsem: The author received research funding from Roche and Sanofi, paid to the university. All other authors have declared no conflicts of interest.

Published
2014

16. AXE Beam: Neo-Adjuvant Triplet Versus Doublet Therapy with Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer – A Randomized Phase II Study at the End of Recruitment

Author

Philippe Vergauwe, J. Decaestecker, G. Chiritescu, Xavier Sagaert, J.F. Daisne, J. Arts, Len Verbeke, Kristoffel R. Dumon, M. Verstraete, Karin Haustermans, J.-L. Van Laethem, André D'Hoore, Marc Polus, E. Van Cutsem, Annelies Debucquoy, Yves Humblet, and F. Mardjuadi

Subjects
medicine.medical_specialty, business.industry, Colorectal cancer, Locally advanced, Phases of clinical research, Hematology, Neo adjuvant, medicine.disease, Total mesorectal excision, Surgery, Pharmaceutical Adjuvants, Oncology, Rectal carcinoma, medicine, business
Published
2014

18. O-0010 - AXE Beam: Neo-Adjuvant Triplet Versus Doublet Therapy with Radiation and Total Mesorectal Excision for Locally Advanced Rectal Cancer – A Randomized Phase II Study at the End of Recruitment

Author

Chiritescu, G., Dumon, K., Vergauwe, P., Arts, J., Verbeke, L., Polus, M., Humblet, Y., Van Laethem, J.L., Daisne, J.F., Decaestecker, J., D'Hoore, A., Mardjuadi, F., Debucquoy, A., Verstraete, M., Sagaert, X., Haustermans, K., and Van Cutsem, E.

Published
2014
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