Search

Your search keyword '"X, Pivot"' showing total 30 results
Start Over Author "X, Pivot" Topic oncology
30 results on '"X, Pivot"'

3. Delayed care for patients with newly diagnosed cancer due to COVID-19 and estimated impact on cancer mortality in France

Author

Jean-Yves Blay, C. Coutant, Sylvie Chabaud, F. Penault-Llorca, Marc-André Mahé, B. Le Vu, G. Thomas, Eric Lartigau, Merrouche Y, Jean-Pierre Delord, P. Fumoleau, A. Debreuve-Theresette, Claire Cropet, Frédéric Gomez, C. Lemoine, P. Viens, J. Gentil, S. Beaupere, O. Guerin, David Pérol, Mario Campone, M. Ychou, T. Vermeulin, Anne Jaffre, T. Conroy, H. Mathieu-Daude, F.X. Mahon, J-C. Soria, E. Barranger, S. Boucher, P. Vera, X. Pivot, R. De Crevoisier, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, ANR-17-CONV-0002,PLASCAN,Institut François Rabelais pour la recherche multidisciplinaire sur le cancer(2017), and ANR-18-RHUS-0009,DEPGYN,Clinical proof of concept of dependence receptor targeting in gynecological Oncology(2018)

Subjects
Male, Cancer Research, Pediatrics, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), delay, diagnosis, [SDV]Life Sciences [q-bio], Metastasis, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Breast cancer, Prostate, Neoplasms, medicine, cancer, Humans, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, Original Research, treatment, business.industry, SARS-CoV-2, Hazard ratio, Absolute risk reduction, Cancer, COVID-19, medicine.disease, 3. Good health, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Female, France, business
Abstract

Background The impact of the first coronavirus disease 2019 (COVID-19) wave on cancer patient management was measured within the nationwide network of the Unicancer comprehensive cancer centers in France. Patients and methods The number of patients diagnosed and treated within 17 of the 18 Unicancer centers was collected in 2020 and compared with that during the same periods between 2016 and 2019. Unicancer centers treat close to 20% of cancer patients in France yearly. The reduction in the number of patients attending the Unicancer centers was analyzed per regions and cancer types. The impact of delayed care on cancer-related deaths was calculated based on different hypotheses. Results A 6.8% decrease in patients managed within Unicancer in the first 7 months of 2020 versus 2019 was observed. This reduction reached 21% during April and May, and was not compensated in June and July, nor later until November 2020. This reduction was observed only for newly diagnosed patients, while the clinical activity for previously diagnosed patients increased by 4% similar to previous years. The reduction was more pronounced in women, in breast and prostate cancers, and for patients without metastasis. Using an estimated hazard ratio of 1.06 per month of delay in diagnosis and treatment of new patients, we calculated that the delays observed in the 5-month period from March to July 2020 may result in an excess mortality due to cancer of 1000-6000 patients in coming years. Conclusions In this study, the delays in cancer patient management were observed only for newly diagnosed patients, more frequently in women, for breast cancer, prostate cancer, and nonmetastatic cancers. These delays may result is an excess risk of cancer-related deaths in the coming years., Highlights • A reduction of the number of cancer patients attending cancer centers was observed in France from January to July 2020. • This reduction was observed only for newly diagnosed patients. • The reduction of new diagnosis was more pronounced in women, for breast cancer, and prostate cancer, and nonmetastatic cancer. • No compensation was observed for the last months of 2020. The magnitude of delays may be larger in centers within the same country. • An estimation of the excess cancer death resulting from these delays is presented.

Published
2021
Full Text
View/download PDF

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

Author

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

Subjects
Adult, Male, medicine.medical_specialty, Receptor, ErbB-2, Injections, Subcutaneous, medicine.medical_treatment, RC0280.B8, Population, Breast Neoplasms, Antibodies, Monoclonal, Humanized, Disease-Free Survival, HER2/neu, Cohort Studies, RC0254, RM0147, Breast cancer, Trastuzumab, Internal medicine, Clinical endpoint, medicine, Humans, skin and connective tissue diseases, Infusions, Intravenous, Adverse effect, education, neoplasms, Aged, education.field_of_study, biology, business.industry, Hematology, Middle Aged, medicine.disease, Surgery, Treatment Outcome, Oncology, Cohort, biology.protein, Female, business, Adjuvant, medicine.drug
Abstract

Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (s.c.) trastuzumab, delivered via single-use injection device (SID), over the intravenous (i.v.) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here, we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where s.c. trastuzumab was delivered via hand-held syringe.Patients were randomized to receive four adjuvant cycles of 600 mg fixed-dose s.c. trastuzumab followed by four cycles of standard i.v. trastuzumab, or vice versa. The primary endpoint was overall preference proportions for s.c. or i.v., assessed by patient interviews in the evaluable ITT population.A total of 245 patients were randomized to receive s.c. followed by i.v. and 243 received i.v. followed by s.c. (evaluable ITT populations: 235 and 232 patients, respectively). s.c. was preferred by 415/467 [88.9%; 95% confidence interval (CI) 85.7-91.6; P0.0001; two-sided test against null hypothesis of 65% s.c. preference]; 45/467 preferred i.v. (9.6%; 95% CI 7-13); 7/467 indicated no preference (1.5%; 95% CI 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled s.c. and i.v. periods, respectively (P0.05; 2 × 2 χ(2)); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5.PrefHer revealed compelling and consistent patient preferences for s.c. over i.v. trastuzumab, regardless of SID or hand-held syringe delivery. s.c. was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared with the known i.v. profile in EBC. PrefHer and HannaH confirm that s.c. trastuzumab is a validated and preferred option over i.v. for improving patients' care in HER2-positive breast cancer.NCT01401166.

Published
2014
Full Text
View/download PDF

5. 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

6. How to strengthen the French breast cancer clinical research: the example of the PHARE trial

Author

I. Pauporté, X. Pivot, and C. Faure

Subjects
Gynecology, medicine.medical_specialty, Oncology, Anticorps monoclonal, Traitement adjuvant, Trastuzumab, business.industry, Adjuvant therapy, medicine, Anti her2, business, medicine.drug
Abstract

L’essai PHARE (NCT-00381901) a ete mis en place depuis mai 2006 et continue a recruter des patientes avec un rythme soutenu. Cet essai randomise, comparant six a 12 mois de traitement chez les patientes recevant le trastuzumab en situation adjuvante est promu par l’Institut national du cancer. Plus de 450 cliniciens et une centaine d’attaches de recherche clinique sont impliques, pres de 180 etablissements de tout type, publics ou prives, y participent. Un millier de patientes est recrute annuellement; le taux de patientes recrutees represente 20 a 25 % des patientes eligibles pour ce traitement en adjuvant. Le design tres pragmatique — toute patiente eligible pour un traitement d’un an par trastuzumab en situation adjuvante peut etre incluse — accompagne d’un recueil optimal de donnees et d’un suivi clinique identique a la pratique ont largement contribue au succes de cet essai. La transparence et l’ouverture a tous les etablissements sont une autre cle de reussite. Une collaboration etroite a ete etablie avec des equipes internationales ayant des essais similaires en cours.

Published
2009
Full Text
View/download PDF

7. ESMO activities and resources for medical training

Author

J. Y. Blay and X. Pivot

Subjects
Oncology
Abstract

L’European Society for Medical Oncology (ESMO) est la premiere organisation europeenne dediee a l’oncologie medicale. Creee en 1975 dans le but de promouvoir l’oncologie medicale, elle evolue actuellement pour promouvoir une oncologie multidisciplinaire, integrant les differents acteurs medicaux de toutes specialites, ainsi que les chercheurs, les soignants et les associations de patients. La mission de l’ESMO est de procurer des soins optimaux a tous les patients. Dans cet objectif, l’ESMO propose une large variete d’activites scientifiques et d’enseignement destinees a la communaute de l’ESMO: 1) aux jeunes oncologues — pour aider et soutenir le developpement de leur carriere; 2) pour les oncologues en activite — afin de mettre a jour leurs connaissances medicale et scientifique dans le cadre de programmes accredites; 3) pour les patients — afin de les aider a acquerir une meilleure connaissance de leur maladie, comment la combattre, comment l’assumer au quotidien. Dans ce document, nous decrivons les differentes activites de l’ESMO dans le domaine de l’education et de l’enseignement.

Published
2007
Full Text
View/download PDF

9. Table of Contents · Inhaltsverzeichnis

Author

B. Demirhan, C. Hasan, G. Wellis, J. Brabender, R. Metzger, P.M. Schneider, S. Seeber, P. Bollini, J. Zizka, B. Thürlimann, F. Demard, U. Höpner, P.C. Amrein, U. Kraus-Tiefenbacher, U. Warnecke-Eberz, J. Petera, R. Wessalowski, A. Huschmand-Nia, R. Dummer, G. Janßen, Z. Kocak, B. Hinney, G. Burg, H.-J. Laws, J. Schütte, N. Magné, M. Mitterer, T. Tenenbaum, B. Seifert, G. Gastl, K. Uygun, S. Meier, J.E. Zöller, A.C. Kuebler, B.G. Baumert, M. Scheer, X. Pivot, S. Karakus, R. Schwarz, S. Bauer, A. Müller, B. Melichar, S. Gutwein, M. Haberal, U. Ikinger, H.-J. Senn, Z. Akçali, S. Riedel, U. Bode, W. Queißer, O. Dassonville, Ö. Özyilkan, J. Dvorak, D. Hadzi-Nikolov, G. Poissonnet, U. Göbel, M.C. Uzal, C.M. Kramm, M. Wannenmacher, W.A. Golder, T. Krauss, R.T. Penson, C. Wawersig, M. Steurer, D. Zierhut, J. Weis, K. Sureshkumar, T. Maier, G. Emons, A.H. Hölscher, F. Gutierrez-Delgado, C. Bailet, G. Spizzo, P.-Y. Marcy, and C. Venkateswaran

Subjects
Cancer Research, Horticulture, Oncology, Chemistry, Table of contents, Hematology
Published
2004
Full Text
View/download PDF

10. Prognostic Factors in Primary Breast Sarcomas: A Series of Patients With Long-Term Follow-Up

Author

Laurent Zelek, Antonio Llombart-Cussac, X. Pivot, C. Le Pechoux, P. Terrier, F. Rochard, A. Le Cesne, Marc Spielmann, Thomas Tursz, and Jean-Marc Guinebretière

Subjects
Adult, Cancer Research, medicine.medical_specialty, Multivariate analysis, Breast Sarcoma, Adolescent, Mammary gland, Population, Breast Neoplasms, Gastroenterology, Disease-Free Survival, Medical Records, Internal medicine, medicine, Humans, education, Aged, Neoplasm Staging, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Cancer, Sarcoma, Retrospective cohort study, Middle Aged, Prognosis, medicine.disease, Surgery, medicine.anatomical_structure, Oncology, Disease Progression, Female, Histopathology, business
Abstract

Purpose: To describe the pathologic characteristics and prognostic factors of primary breast sarcomas (PBSs). Patients and Methods: We reviewed the clinical records and pathologic slides of 83 women with PBS treated in our institution between 1954 and 1991, with a median follow-up of 7.8 years. The majority of patients had undergone surgical treatment. Results: The main histologic type was malignant fibrohistiocytoma (n = 57). For the whole population, the 10-year overall survival (OS) and disease-free survival (DFS) rates were 62% and 50%, respectively. For Fédération Nationale des Centres de Lutte Contre le Cancer grade 1, 2, and 3 tumors, the 10-year OS and DFS rates were 82% and 61%, 62% and 51%, and 36% and 25%, respectively (P = .00007 and .004, respectively). For tumors measuring less than 5 cm, 5 to 10 cm, and more than 10 cm, the 10-year OS and DFS rates were 76% and 66%, 68% and 55%, and 28% and 15%, respectively (P = .002 and .009, respectively). In the multivariate analysis, the tumor size and histologic grade were correlated with the 10-year DFS rate (P = .04 and .01, respectively), but only the histologic grade was correlated with OS (P = .01). Angiosarcoma was the only histologic type significantly associated with a poorer outcome in the multivariate analysis. Conclusion: PBSs have the same clinical history and prognostic factors as sarcomas arising at other sites. Therefore, it is legitimate to use a similar treatment strategy for PBS as for other sarcomas.

Published
2003
Full Text
View/download PDF

11. Result of two randomized trials comparing nolatrexed (Thymitaq™) versus methotrexate in patients with recurrent head and neck cancer

Author

A. Johnston, C. Domenge, N. Clendeninn, S. Wadler, C. Penning, Y. Humblet, D. Belpomme, C. Kelly, J. Stern, J. Tortochaux, X. Pivot, M. Schneider, and R. Ruxer

Subjects
Adult, Diarrhea, Male, Antimetabolites, Antineoplastic, medicine.medical_specialty, Neutropenia, medicine.medical_treatment, Gastroenterology, chemistry.chemical_compound, Internal medicine, Mucositis, Humans, Medicine, Enzyme Inhibitors, Aged, Aged, 80 and over, Chemotherapy, business.industry, Thymidylate Synthase, Hematology, Middle Aged, medicine.disease, Chemotherapy regimen, Surgery, Methotrexate, Treatment Outcome, Oncology, chemistry, Epidermoid carcinoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Quinazolines, Nolatrexed, Female, Neoplasm Recurrence, Local, business, Febrile neutropenia, medicine.drug
Abstract

We report on two randomized trials performed in the USA and Europe, which compared methotrexate and nolatrexed as treatment for patients with recurrent head and neck cancer. Eligibility criteria included: histologically confirmed squamous-cell carcinoma, measurable disease, adequate hematological, renal and hepatic functions, failure of a first-line chemotherapy, and informed consent. Methotrexate 40 mg/m(2) was weekly given by short infusion, and nolatrexed 725 mg/m(2) per day was administered as a five-day continuous infusion, every three weeks. A total of 139 patients (63 in the USA, 76 in Europe) were randomized based on a ratio of 2/1: 93 and 46 received nolatrexed and methotrexate, respectively. Patient characteristics included 115 males and 24 females; median age 60 years. In the nolatrexed arm, the following grade 3-4 toxicities occurred: neutropenia (29.9%) with 3.1% of febrile neutropenia, mucositis (33.3%), and vomiting (10.3%). In the MTX arm, the grade 3-4 toxicities were neutropenia (7.1%) and mucositis (6.9%). There was no difference in activity between the nolatrexed and the methotrexate treatment: 3.3% and 10.8% of objective responses, 1.9 versus 1.5 months of disease-free progression and 3.5 versus 3.7 months of overall survival, respectively. Nolatrexed has demonstrated a similar activity to methotrexate.

Published
2001
Full Text
View/download PDF

12. XXVè Congrès de la SFPO « Cancers, cultures et pratiques de soins » Paris le 28 novembre 2008 Freins et motivations au dépistage des cancers du sein: quels profils typologiques ? Résultats issus de l’enquête ÉDIFICE

Author

A. Calazel-Benque, Jean-Yves Blay, Laurent Cals, Moïse Namer, Daniel Serin, Jérôme Viguier, Sylvie Dolbeault, Claire Roussel, Yvan Coscas, O. Rixe, X. Pivot, J-F. Morere, and François Eisinger

Subjects
Psychiatry and Mental health, Clinical Psychology, Oncology, Oncology (nursing), business.industry, Medicine, business
Published
2009
Full Text
View/download PDF

13. Clinical activity of ixabepilone, a novel epothilone b analog, across the breast cancer disease continuum

Author

I. Reeb, Ernst Kubista, P. F. Conté, X. Pivot, H. Roché, A. Llombart-Cussac, M. Piontek, P. Fumoleau, M. Martin, and Mark Verrill

Subjects
Gynecology, Oncology, medicine.medical_specialty, Continuum (topology), business.industry, Ixabepilone, Disease, medicine.disease, Epothilone B Analog, chemistry.chemical_compound, Breast cancer, chemistry, Internal medicine, medicine, business
Published
2008
Full Text
View/download PDF

14. Report of a young man with three successive curable cancers

Author

M. Pavic, X. Pivot, J.P. Droz, M. Schell, A. Fléchon, Saas, Philippe, Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Service d'oncologie pédiatrique, Centre Léon Bérard [Lyon], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])

Subjects
Oncology, medicine.medical_specialty, MESH: Combined Modality Therapy, [SDV.IMM] Life Sciences [q-bio]/Immunology, MESH: Wilms Tumor, MEDLINE, Salvage therapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Internal Medicine, Medicine, Combined Modality Therapy, MESH: Neoplasms, Multiple Primary, 030212 general & internal medicine, ComputingMilieux_MISCELLANEOUS, MESH: Humans, business.industry, MESH: Adult, MESH: Dysgerminoma, MESH: Male, MESH: Salvage Therapy, MESH: Antineoplastic Combined Chemotherapy Protocols, Extragonadal Germ Cell Tumor, 030220 oncology & carcinogenesis, MESH: Neoplasms, Germ Cell and Embryonal, [SDV.IMM]Life Sciences [q-bio]/Immunology, MESH: alpha-Fetoproteins, business
Abstract

International audience

Published
2008
Full Text
View/download PDF

15. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of squamous cell carcinoma of the head and neck

Author

X. Pivot

Subjects
Oncology, medicine.medical_specialty, medicine.medical_treatment, MEDLINE, Risk Assessment, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Medicine, Combined Modality Therapy, Humans, Basal cell, Neoplasm Metastasis, Head and neck, Neoplasm Staging, business.industry, Hematology, medicine.disease, Radiation therapy, Diagnosis treatment, Head and Neck Neoplasms, Practice Guidelines as Topic, Carcinoma, Squamous Cell, Radiotherapy, Adjuvant, business, Risk assessment
Published
2003

17. Impact of Clinical Practice Guideline'S on Medical Practice and Survival for Head and Neck Cancer Management in Fisrt Line Treatment (N = 1121 Patients)

Author

Dominic Cellier, D. Girodet, X. Pivot, J. Fayette, B. Laure, E. Reyt, A. Lurkin, J. C. Pignat, M. Poupart, I.L. Ray-Coquard, Philippe Ceruse, L. Tassy, Philippe Zrounba, E. Villanueva, Jean-Michel Prades, and G. De Laroche

Subjects
medicine.medical_specialty, business.industry, General surgery, Head and neck cancer, Cancer, Medical practice, Hematology, Guideline, medicine.disease, Clinical Practice, Oncology, Physical therapy, Medicine, Progression-free survival, Quality of care, business, Head and neck
Published
2014
Full Text
View/download PDF

18. The efficacy of chemotherapy with docetaxel and paclitaxel in anthracycline-resistant breast cancer (Review)

Author

X Pivot, Gabriel N. Hortobagyi, and L Asmar

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, education.field_of_study, Anthracycline, business.industry, medicine.medical_treatment, Population, Cancer, Drug resistance, medicine.disease, chemistry.chemical_compound, Breast cancer, Docetaxel, Paclitaxel, chemistry, Internal medicine, Immunology, medicine, business, education, medicine.drug
Abstract

This review was performed to determine the efficacy of commonly used cytotoxic agents in the management of anthracycline-resistant breast cancer, using a stringent and uniform definition of drug resistance. We reviewed the reports of second- and third-line chemotherapy after anthracycline-containing regimens published over the last two decades. Only studies with sufficient information on the timing of progressive disease in relation to anthracycline therapy were considered. All assessable studies were reviewed individually, and the data obtained with taxanes in anthracycline-resistant breast cancer were also pooled to estimate the activity. The great majority of published studies on second- and third-line chemotherapy lack useful information about anthracycline resistance. Among the few studies with sufficient information about anthracycline resistance, several definitions were used. We reanalyzed those reports utilizing a uniform definition of anthracycline resistance: progression while receiving an anthracycline. Only studies using paclitaxel or docetaxel reported an activity in this anthracycline-resistant population, allowing a response rate between 6-50% and 32-57% for both agents respectively. The activity of other cytotoxic agents in anthracycline-resistant breast cancer could not be determined because a lack of accurate data using the stringent definition. Both paclitaxel and docetaxel have substantial antitumor activity in patients with clearly defined anthracycline-resistant breast cancer. The activity of other cytotoxic agents in this group of patients remains to be established.

Published
1999
Full Text
View/download PDF

19. PCN12 IMPACT OF ADJUVANT CHEMOTHERAPY WITH DOCETAXEL FOR EARLY BREAST CANCER: COST-EFFECTIVENESS ANALYSIS (CEA) OF A DOCETAXEL, DOXORUBICIN AND CYCLOPHOSPHAMIDE REGIMEN (TAC) VERSUS 5-FLUOROURACIL, DOXORUBICIN AND CYCLOPHOSPHAMIDE (FAC) IN FRANCE

Author

H Miadi-Fargier, Mc. Woronoff-Lemsi, B. Favier, Ec. Antoine, Henri Roché, M Cadilhac, Jp. Guastalla, I. Debrix, F. Pinguet, G. de Pouvourville, M. Spielmann, C Le Pen, X Pivot, and J. Gligorov

Subjects
Oncology, medicine.medical_specialty, Cyclophosphamide, business.industry, Adjuvant chemotherapy, Health Policy, Public Health, Environmental and Occupational Health, Cost-effectiveness analysis, Regimen, Docetaxel, Fluorouracil, Internal medicine, Docetaxel/doxorubicin, medicine, Doxorubicin, business, medicine.drug
Published
2005
Full Text
View/download PDF

21. Adjuvante Brustkrebstherapie in der Postmenopause: Anastrozol und Fulvestrant bringen Fortschritt

Author

J. Zizka, F. Demard, P.-Y. Marcy, G. Burg, Ö. Özyilkan, U. Göbel, M.C. Uzal, A.C. Kuebler, N. Magné, R. Dummer, B. Hinney, H.-J. Laws, S. Karakus, A. Müller, J. Schütte, G. Janßen, C. Hasan, W. Queißer, T. Tenenbaum, M. Haberal, J.E. Zöller, B. Seifert, K. Uygun, H.-J. Senn, C. Wawersig, S. Meier, Z. Kocak, Z. Akçali, J. Dvorak, U. Höpner, S. Riedel, J. Brabender, M. Steurer, R. Metzger, D. Zierhut, C.M. Kramm, S. Bauer, U. Kraus-Tiefenbacher, C. Venkateswaran, K. Sureshkumar, G. Gastl, M. Wannenmacher, T. Maier, M. Scheer, G. Poissonnet, P.M. Schneider, B. Thürlimann, A. Huschmand-Nia, O. Dassonville, C. Bailet, B. Melichar, B.G. Baumert, P.C. Amrein, B. Demirhan, G. Spizzo, S. Seeber, G. Emons, M. Mitterer, G. Wellis, U. Ikinger, T. Krauss, U. Warnecke-Eberz, R.T. Penson, U. Bode, X. Pivot, R. Schwarz, P. Bollini, J. Petera, R. Wessalowski, W.A. Golder, J. Weis, D. Hadzi-Nikolov, S. Gutwein, A.H. Hölscher, and F. Gutierrez-Delgado

Subjects
Cancer Research, Oncology, Hematology
Published
2004
Full Text
View/download PDF

22. EGFR-Blockade. Neue Therapieoption für solide Tumoren

Author

J. Zizka, G. Burg, H.-J. Laws, W. Queißer, M. Wannenmacher, B.G. Baumert, X. Pivot, G. Spizzo, C. Wawersig, U. Höpner, A. Huschmand-Nia, R. Schwarz, J.E. Zöller, U. Bode, C.M. Kramm, S. Karakus, P.C. Amrein, M. Mitterer, T. Krauss, N. Magné, M. Scheer, A. Müller, B. Demirhan, R.T. Penson, Z. Kocak, Ö. Özyilkan, C. Bailet, S. Seeber, J. Schütte, S. Gutwein, U. Ikinger, B. Seifert, U. Kraus-Tiefenbacher, G. Janßen, T. Tenenbaum, A.C. Kuebler, U. Göbel, M.C. Uzal, S. Meier, J. Petera, R. Wessalowski, P.-Y. Marcy, G. Emons, D. Hadzi-Nikolov, B. Melichar, M. Haberal, A.H. Hölscher, Z. Akçali, F. Gutierrez-Delgado, W.A. Golder, G. Gastl, H.-J. Senn, S. Riedel, C. Venkateswaran, U. Warnecke-Eberz, J. Weis, M. Steurer, D. Zierhut, K. Sureshkumar, T. Maier, G. Poissonnet, K. Uygun, P. Bollini, J. Dvorak, O. Dassonville, C. Hasan, G. Wellis, J. Brabender, R. Metzger, S. Bauer, P.M. Schneider, B. Thürlimann, R. Dummer, B. Hinney, and F. Demard

Subjects
Cancer Research, Oncology, Hematology
Published
2004
Full Text
View/download PDF

23. Potential Risk of Asbestos Exposure Among Japanese General Population: Japanese General Screening Study for Asbestos-Related Diseases (JGSARD)

Author

B. Budakoglu, C. Guillen-Ponce, E.V. Kotlyarov, Şenay Ölmez, C. Gonzalez Garcia, S. McDunn, Rumeyza Kazancioglu, M. Kell, Y. Coscas, O. Uysal Sonmez, Uğur Gönüllü, X. Pivot, J. Blay, K. Eguchi, Asiye Ozkan, H. Akbulut, A.N. Sen, Shweta Gupta, M. Kusumoto, Stephen W. Duffy, E.A. Mino, O.B. Oksuzoglu, İpek Gönüllü, A. Sanjuanbenito, A.V. Filimonov, M.J. Kennedy, Deniz Çalişkan, A. Carrato, Ummugul Uyeturk, M. Muñoz Beltran, S. Koner, F. lcli, P. Hazra, K. Sunguroglu, C. Nolan, K. Barinov, François Eisinger, Ana Custodio, E. Mocci, A. Amendolara, D. Bhattacharya, Elaine M. Walsh, J. Viguier, Chinmoy K Bose, I. Gromut, J Mackay, A. Mukhopadhyay, S. Bhattacharjee, P. Gosain, I. Turker, C. Gonzalez Gordaliza, M. Farrell, Soma Mukhopadhyay, S. Dasgupta, E.V. Belan, J. Morère, Takuhiro Yamaguchi, R. Clarke, D. Avila, M. Kaneko, T. Boyle, John McCaffrey, Nobuhiko Seki, K.K. Batra, Işıl İrem Budakoğlu, Jayasri Basak, N.A. Zakharova, E. Vazquez-Sequeiros, C. Lhomel, C. Touboul, D. Gallagher, U. Yalcintas Arslan, E. Connolly, and Abhijit Chakraborty

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, Population, Hematology, Pleural plaque, Odds ratio, medicine.disease, medicine.disease_cause, Pleural thickening, Asbestos, New onset, Work period, Oncology, Internal medicine, medicine, Lung cancer, education, business
Abstract

Background Patients with pleural mesothelioma and lung cancer associated with asbestos exposure has been recently increasing in Japan. The aim of this study was to prospectively evaluate the actual situation of asbestos exposure and the prevalence of asbestos-related diseases among Japanese general population. Materials and methods From 2006 to 2008, 9810 subjects (mean age, 57 years; 54% male and 50% smokers) underwent low-dose CT (LDCT) in 26 institutions in Japan. Then, 6286 (64.1%) subjects underwent subsequent screening after 2 years of interval. Clinical information such as history of asbestos exposure for all life was reviewed. Images were interpreted independently by 15 experts. Results Self-reported history of occupational exposure was present in 2805 (28.5%) subjects, whereas self-reported history of residential exposure was present in 1193 (12.2%) subjects although asbestos factory actually existed in 2870 (29.3%) subjects. Pleural plaque, pleural thickening, and pulmonary nodule were identified in 264 (2.7%), 245 (2.5%), and 1003 (10.2%) subjects on LDCT. However, self-reported history of asbestos exposure was not confirmed in 77 (29.2%) of 264 subjects with pleural plaque although asbestos factory actually existed in 65 (84.4%) of such 77 subjects. Pleural plaque on LDCT was significantly correlated with male (odds ratio OR, 2.32), age over 60 years (OR, 1.75), smoking (OR, 1.60), self-reported history of asbestos exposure (OR, 3.92), residential period in asbestos factory area (OR every 10 years, 1.13), and asbestos-related work period (7 work identified, OR every 10 years, 1.300-3–3.21). Moreover, lung cancer was identified in 29 (0.3%) subjects, resulting in significant correlation with age over 60 years (OR, 2.67) and pleural plaque (OR, 4.17). After repeated LDCT screening, among 6286 subjects consisting of 165 and 6121 subjects with and without pleural plaque on LDCT at baseline screening, respectively, 5 (3.0%) of 165 and 7 (0.1%) of 6121 subjects showed marked progression and new onset of pleural plaque, respectively. Again, lung cancer was identified in 8 (0.1%) subjects. Conclusion Our results indicate the potential risk of asbestos exposure among Japanese general population and the importance of public relations and enlightenment for especially residential asbestos exposure. Disclosure All authors have declared no conflicts of interest.

Published
2012
Full Text
View/download PDF

24. Association Between Tumor Egfr and Kras Mutation Status and Clinical Outcomes in Nsclc Patients Randomized to Sorafenib Plus Best Supportive Care (BSC) or Bsc Alone: Subanalysis of the Phase III Mission Trial

Author

Chris Twelves, J. Thompson, C. Fernández, H. Bonnefoi, Robert Jones, R. de Wit, Yves Humblet, C. Boni, T. Seto, P. Rougier, I.T. Rubio, S. McMahon, V. Patel, David Gentien, A. Santoro, José Baselga, M. Barrié, E. Ciruelos, R.A. Madan, U. Jungnelius, E. Esteban, H. Abbas, C. Robert, J. Martin, F. Selle, Dong Wook Kim, H. Singh-Jasuja, Arthur L. Klatsky, Harald A. Weber, A. Bonetti, Florence Lerebours, A. Hamed, Georgina V. Long, Véronique Diéras, A. Savarese, E.M. Guerra, Richard Bell, Nick Thatcher, M.S.L. Teng, Toni K. Choueiri, M. Untch, Nicole M. Kuderer, H-J. Lenz, D. Serin, A. Fandi, Frédéric Commo, Y-L. Wu, A.S. Daud, Kazuhiko Nakagawa, Debora Barton, D. Brewer, G. Folprecht, Frank Cihon, Michael Thomas, M. Fleischer, T. Nakajima, Mary Anne Armstrong, Jonathan Cebon, M. Rios, L. Gissmann, P. Preux, A. Loundou, Lluis M. Mir, F. Lordick, Lynn M. Schuchter, B. Vasseur, Ulrika Harmenberg, B. Massuti Sureda, M. Matta, X. Durando, C. Costa, J-P. Guastalla, Brigitte Sigal-Zafrani, S. Falk, Nicolas Servant, M. Campone, Richard M. Goldberg, Petronella O. Witteveen, A. Grothey, T. Olive, Andrea Wagner, L. Crinò, R. Rosell, T. De Pas, P. Attali, Mitchell Dowsett, M. Lacroix, Y. Xu, F. Hilpert, Benjamin Solomon, Enriqueta Felip, A. Pasic, D. Genet, A. Falcone, A. Niethammer, K. Tauer, D. Berton-Rigaud, L. Bedenne, Enrico Mini, J-P. Jacquin, J.-L. Van Laethem, Egbert F. Smit, R.J. Jones, David Cella, K. Pittman, W. Hwu, D. Bollag, Yan Li, Roma Parikh, P.J. Wiechno, C. Jouannaud, Masahiro Takeuchi, P. Slaouti, Eric Pujade-Lauraine, A. Sobrero, C. Campello, H. Y. Lim, Ellie Guardino, L.S. Schwartzberg, Margarita Majem, F. Dalenc, Bruno R. Bastos, P. Senico, J.S. de Bono, Olivier Rosmorduc, Bernard Asselain, J. Atkins, C. Centeno, F. Subtil, H.J.M. Groen, F. Bonnetain, Benjamin Besse, Sarah Pearson, N. Vogelzang, J.T. Hartmann, Susan J Dutton, B. Zaric, G.A. Bjarnason, S. Olsen, L. Jia, Jun Guo, L. Venat-Bouvet, R. D. Gelber, Silvia Novello, Etienne Brain, Carlo Barone, S. Lavau-Denes, S. Zhu, C.N. Sternberg, Roman Perez-Soler, V. Tassell, D. Frappaz, C. Cremolini, J. Clancy, D. Wan, G. Masi, M. Jensen, Richard F. Kefford, Michael Baum, D. Lu, A. Gonzalez Martin, Alain Algazi, C. Valsuani, A. Maubon, C. Heery, L. Cupit, R.J. Motzer, P. Kerbrat, N. Gadea, A. P. Dei Tos, C.S. Cooper, Ricardo J. Gonzalez, A. Vuorela, A. Gonçalves, H. Tan, Thomas E. Hutson, G. Goss, M. Frenay, M. Munill, R. Kudchakar, J. Schlom, L. Mineur, Max Bulsara, J. Wei, Y. Wang, T.J. Ong, Wasaburou Koizumi, Michael Staehler, F. Ghiringhelli, F. Barlesi, C. Mermel, M. Provansal, David R. Spigel, Bernard Escudier, C. Granetto, Trever G. Bivona, Gerold Meinhardt, Jaime R. Merchan, A. Chatterjee, L. Salvatore, Suzette Delaloge, D. Laurent, J. Clark, Fabrice Andre, I. Ray-Coquard, P. Salman, Peng Sun, S. Hodge, M. Schneider, Petr Kavan, B. Biesma, Paul Ross, A. Gimenez-Capitan, T. Schmelter, J. Ritchie, Jean-Yves Pierga, W. Mansoor, R. Hubner, C. Girault, S. Di Cosimo, D.W. Fyfe, G. Allegrini, Yang Sun, S. Burgers, J. Reeves, P. Mulholland, B. Chauffert, S.M. Steinberg, David R. Ferry, H.C. Chung, N. Budnik, Sang Cheul Oh, R. Gervais, M.A. Molina, Iben Spanggaard, X. Pivot, Anna C. Pavlick, Jeffrey Crawford, M. Schirripa, K. Fife, M. Davoudianfar, Alexander Reuss, C. Sonaglio, Elena Castro, Nicholas Choong, A. Kramar, I. Chan, J. Ferrero, M. Snoj, L. Peachey, Jaap Verweij, I. El-Hariry, H.A. Azim, E. Tabouret, P. Arlen, Ian Judson, M. Praet, J.C-H. Yang, D.G. Power, R. Schott, N. Karachaliou, R. Midgely, Lei Zhang, L. Paz-Ares, W.T.A. van der Graaf, J. Labourey, Andrew X. Zhu, H. Wang, A.D. Vincent, Chris Parker, Masashi Fujii, Hirotsugu Uemura, M-J. Ahn, J. Mehta, Lauren McCann, Samar Alsafadi, A.M. Poveda, Y. Lou, S. Peoples, K. Sivarajan, S. Chiara, P. Fumoleau, O. Aren, G. McArthur, J. Zhu, Julie Gehl, P. Laurent-Puig, Martine Piccart, J. Evans, Laurence Collette, K. B. Kim, Jeffrey S Tobias, J. A. Sosman, Carol Peña, Frederik Wenz, A. Goldhirsch, F. Teofilovici, J. Thaler, Jose Leal, P. Giannikopoulos, Mark A. Socinski, Patrick Julier, L. Boni, L. Cany, C. Boucard, Ludovic Lacroix, A. Dahle-Smith, Y-K. Kang, Yi-Long Wu, Ian E. Krop, C. Heredia, O. Ishibashi, M. Santarpia, Aoife M. Ryan, B. Leyland-Jones, Paul Nathan, A-M.C. Dingemans, F.H. Blackhall, Anna Polli, C. Lepage, L. Antonuzzo, S. Cushen, D-Y. Oh, C. Dalban, A. Mori, M. Espié, V. Semiglazov, MA LeBerre, J. Adelaide, Natalia Udaltsova, Nuhad K. Ibrahim, Richard Sullivan, D.A. Fennell, J. Skrzypski, G. Romieu, H. Eidtmann, J. Bosch-Barrera, Taofeek K. Owonikoko, M. DeSilvio, C. Jackisch, Robert J. Motzer, G. Sersa, F. Boudouresque, Russell D. Petty, S. Jefferies, T. Moran Bueno, M.O. Palumbo, M. Ouafik, J. Balmana, D. Valcárcel, S. Cupini, G. Bodoky, S. Szyldergemajn, A. Fabi, M. Cardoso, R. Allerton, U. Kenny, O. Chinot, Daniel J. Sargent, U. De Giorgi, Mark D. Pegram, J. M. Del Campo, J. Surralles, H. Oltean, A. Garcia-Alonso, Kensaku Yoshida, E. Juhasz, Howard I. Scher, H. Goette, David Baer, L. Fornaro, D. Cameron, Nicholas D. James, Thomas F. Gajewski, P. Lacroix, M. Harrison, G.D. Friedman, A. Enke, C. Bouquet, I. Bradbury, S. Halford, M. Jimenez, A. Chang, J-Y Pierga, P. Pultar, T. Bachelot, Daniel C. Danila, L. Eckert, J. Douillard, L. Burns, F. De Marinis, David Miles, Q. Wang, A. Vergnenegre, D. Khayat, F.J. Carrilho, H. Codrington, K. Wang, D. Moro-Sibilot, N. Bosch, J.L. Quesada, M.D. Dibonaventura, E. de Azambuja, S. Abadie-Lacourtoisie, Christophe Massard, L. Fang, I. Pauporte, L. Feuvret, C. Manegold, Ramon Luengo-Fernandez, M. Banzi, J.S. Guillamo, B. Żurawski, Suresh S. Ramalingam, J.L. Gulley, M. Liu, M. Ychou, O. Al-Salihi, T. Hutson, S. Santillana, Alice T. Shaw, I.E. Smith, S. Culine, H. Tailla, Kiran Patel, Patrick Schöffski, Adil Daud, Luca Gianni, R. Camidge, A. Lortholary, M. Lu, L. Taillandier, A. James, M. Procter, Carmen Criscitiello, Mika Mustonen, R. Rampling, Jayant S. Vaidya, D. Agbor-Tarh, T. Gamble, Subramanian Hariharan, Andrea Cavalcanti, R. Malik, Ignace Vergote, Sandrine Marreaud, Heather A. Wakelee, Shonda M Little, Hans Gelderblom, M. Arnedos Ballester, J. Tabernero, J. Honnorat, S. Li, O. Bouché, Isabelle Gilloteau, A. Goren, J.G. Aerts, J. Blay, W. Eiermann, D. Joseph, Jie Jin, J.F. Emile, Gerhardt Attard, Markus Moehler, Yang Hyun Kim, S. Verma, Nicole Tubiana-Mathieu, J. Taieb, G. Giaccone, Shahneen Sandhu, Kenneth J. O'Byrne, E. Van Cutsem, T. Yoshino, Saskia Litière, Keith T. Flaherty, J. R. Infante, Chetan Lathia, V. Vukovic, E. Giommoni, Alison Reid, S. Siena, Keith C. Deen, Tony Mok, J. Wang, J.S. Weber, Corey J. Langer, E. Fea, P. de Souza, C. Levy, K. Kumari, A. Casado, M. Welslau, Karl D. Lewis, O. Dalesio, R. Swaby, M. Fabbro, Brian I. Rini, Janusz Jankowski, Daniel P. Petrylak, Robert E. Hawkins, M. Mohebtash, A. Adenis, A. Ribas, Igor Puzanov, I. Tennevet, H. Kim, Karim Fizazi, O. Hamid, D. Olmos Hidalgo, J.A. Bridgewater, S. Catala, H. Melezinkova, G. Kurteva, Aristotle Bamias, F. Loupakis, Vera Hirsh, Pasi A. Jänne, Kimberly L. Blackwell, M.R. Garcia-Campelo, C. Kahatt, J. Bellmunt, and J. Alexandre

Subjects
Oncology, Sorafenib, medicine.medical_specialty, Proportional hazards model, business.industry, Hematology, medicine.disease_cause, Placebo, medicine.disease, Breast cancer, Egfr mutation, Internal medicine, Medicine, Biomarker (medicine), KRAS, Stage (cooking), business, medicine.drug
Abstract

Background Tumor EGFR and KRas mutations are both predictive and prognostic biomarkers in patients with advanced NSCLC. We analyzed the correlation between these biomarkers and treatment outcomes in a phase III trial of 3rd/4th line sorafenib in patients with NSCLC. Methods The global, randomized, placebo-controlled MISSION trial enrolled 703 patients with advanced relapsed/refractory NSCLC of predominantly non-squamous histology. The primary study endpoint was overall survival (OS). EGFR and KRas mutations were analyzed in archival tumor samples and in circulating tumor DNA isolated from plasma. Results Tumor and/or plasma mutation data were available from 347 patients (49%). EGFR and KRas mutations were detected in 89 (26%) and 68 (20%) patients, respectively, and were well balanced between treatment arms. Analysis of the interaction between EGFR mutation status and treatment effect on survival suggested that patients with EGFR mutations (mEGFR) benefitted from sorafenib, while those with wild-type EGFR (wtEGFR) did not (p = 0.023). Median OS was two-fold longer in mEGFR patients receiving sorafenib versus placebo (423 vs 197 days, HR 0.48, p = 0.002). There was no significant difference in OS between patients with wtEGFR receiving sorafenib or placebo (253 vs 256 days, HR 0.92, p = 0.559). An interaction was also seen between EGFR mutation status and the sorafenib effect on PFS (p = 0.015). Patients with mEGFR treated with sorafenib had better outcomes compared to placebo based on Cox regression analysis (HR 0.27, p Conclusion Post-hoc analyses of efficacy outcomes in MISSION suggest that advanced NSCLC patients with EGFR mutations may derive a survival benefit from receiving 3rd/4th line sorafenib. These results must be interpreted with caution due to the small, non-representative nature of the genetic biomarker subpopulation analyzed in this trial. Further prospective investigation may be warranted. Disclosure T.S.K. Mok: Honoraria: AstraZeneca, Roche, Eli Lilly, Merck Serono, Eisai, BMS, BeiGene, AVEO, Pfizer, Taiho, Boehringer Ingelheim, and GSK Biologicals Speaker: Astrazeneca, Roche, Eli Lilly, Boehringer Ingelheim, and Merck Serono Research funding: Astrazeneca. L. Paz-Ares: Dr. Paz-Ares has received honoraria from Bayer HealthCare Pharmaceuticals, Lilly, Roche and Pfizer. Y. Wu: Dr. Wu has received lecture fees from Roche, AstraZeneca, Eli Lilly, and Pfizer. V. Hirsh: Member of the steering committee for the MISSION trial. C. Lathia: Dr. Lathia is an employee of Bayer HealthCare. T.J. Ong: Dr. Ong is an employee of, and owns shares in, Bayer HealthCare. C. Pena: Dr. Pena is an employee of Bayer HealthCare. All other authors have declared no conflicts of interest.

Published
2012
Full Text
View/download PDF

25. TH-302 + Gemcitabine (G + T) vs Gemcitabine (G) in Patients with Previously Untreated advanced Pancreatic Cancer (PAC)

Author

Alain Duhamel, A. Tsuburaya, Mali Okada, S. Kuwabara, H. Hasegawa, A.L. Cohn, Anne Thirot-Bidault, J.R. Delgado, O.U. Unal, J. Isaacson, S. Khudayorov, Sue Ward, N. Mueller, Riccardo Lencioni, Giovanni Abbadessa, D. Takahari, T. Watanabe, Luca Faloppi, Y. Hamamoto, Julia Hocke, Elwyn Loh, M. Aizawa, E. Trejo, A. Novarino, A. Ohtsu, K. Okita, M.J. Flor, Riccardo Giampieri, C. Rose, D. Gonzalez-De-Castro, H. Isayama, M. Esaki, Jean-Pierre Bronowicki, S. Cereda, S. Hironaka, A. Sawaki, I. Iwanicki-Caron, L. Ferrari, J. Stephenson, F. Gerevini, E. Francois, T. Okusaka, S. De Minicis, Cristian Loretelli, S.Y. Roh, A. González-Vicente, F. Richard, H. Tuyev, A. Laforest, K. Lin, M. Milic´evic´, Chunming Li, Wolfgang Eisterer, P. Basile, Mohamed Gasmi, S. Hazama, M. Botta, Seiji Kawazoe, Jean-Luc Raoul, Y. Jiang, I. Trouilloud, B. Nagy, E. del Valle, Satoshi Yuki, K.W. Park, Hanno Riess, M. Bartosiewicz, L. Rolfe, H. Fang, E. Gardner, A. Benedetti, A. Carrato, E. Vasile, Takayuki Kii, N. Suzuki, Y. Shimada, S.F. Ang, S. Fushida, V. Vaccaro, Y. Liu, E. Castanon Alvarez, Y. Ozaki, D. Mirabelli, Ozgur Ozyilkan, J.E. Battley, C.H.S. Kim, N. Weijl, B. Bui, J.C. Sabourin, M. Hejna, Raymond Miller, N. Besova, Jinhui Xu, Ian Chau, J.-L. Van Laethem, Eric Vibert, Philippe Mathurin, H. Yabusaki, Melissa Frizziero, J. Soberino García, S. Salvagni, M. Zhu, Christoph Schuhmacher, Y. Yamada, A. Hubert, R. Libener, S.T. Dimoudis, Jonathan Wadsley, J. Martinez-Galan, Coskun U, V. Karavasilis, Cem Parlak, N. Jain, T. Gamucci, Elisa Giovannetti, R. Gupta, Suleyman Buyukberber, Jose Javier Sanchez, Taro Tokui, Kenneth K. Tanabe, V. Nerich, G. Dyson, Y. Kawachi, J. Reis-Filho, Junichi Sakamoto, A. Mohar-Betancourt, Masahide Mori, Aytug Uner, S. Martin Algarra, C.-J. Yen, J.J. Critchfield, Y. Naomoto, Julien Taieb, Young Seon Hong, Hironori Yamaguchi, S. Jiao, Alan P. Venook, C. Pericay, R.H. Wilson, D. Ferrari, Peter R. Galle, S. Falcon, Emilio Bria, L. Paz-Ares, Anna Tomezzoli, S. Al-Batran, G. Luppi, Jean-Marie Boher, I. Park, F. De Vita, Roland Leung, M. Abdelwahab, A. Ravaioli, Takuya Suzuki, C. Szczylik, C. González-Rivas, Sarita Dubey, Y. Miyashita, J.Y. Lim, Y. Chen, F. El Hajbi, Ichinosuke Hyodo, Tsutomu Chiba, C. Kondo, S. Ye, Thomas Aparicio, M. Nesrine, T. Ganten, T. Nishina, G. Grazi, A.C. Dupont-Gossard, I. Oze, F. Nosrati, J.H. Yook, C. Yoo, N.A. Adu-Aryee, M. Choi, Narikazu Boku, P. Chan, John Bridgewater, A. Gimenez-Capitan, Hamim Zahir, R. Hela, T. Villegas, Stefano Barbi, György Bodoky, D. Degiovanni, Y. Honma, A. Croitoru, K. Koufuji, Lorenza Rimassa, A. Tsuji, Yueyang Shen, Nathan Bahary, S. Abdelwahab, N. Matsuura, Parsee Tomar, L. Yu, Mohammed Elbassiouny, B. Ryoo, S. Adachi, Jean-Robert Delpero, V.D.N.K. Vanderpuye, S.T. Oh, E. Samantas, Amit Bahl, N. Karachaliou, Thierry Lecomte, S. Yoshino, H. Hahn, A. Matsuki, K. Nakamura, D.S. Johnston, M. Del Prete, Per Stål, R. Greil, Dirk Arnold, K. Ridwelski, J. Zhao, K. Shirouzu, Meltem Baykara, G. De Manzoni, I. Lang, K. Aoyagi, A. Fukutomi, Joji Kitayama, Antonieta Salud, K. Beecham, Y. Inoue, Armando Santoro, R. Rosell, P. Malfertheiner, Tsutomu Fujii, Jeong-Yeol Park, S. Taylor, K. Nakajima, Matus Studeny, H. Jiang, M. Shimada, O. Abdelrhman, Camillo Porta, P. Ballesteros, S. Lecleire, K. Han, G. Svegliati Baroni, Michitaka Nagase, François Paye, W. Rodriguez Pantigoso, M.M. Eatock, H.C. Toh, M. Ikeda, Hironori Ishigami, N. Stankovic, H. Kumada, K. Shitara, X. Zhang, E. Arevalo, R. Poon, M. Allard, Y.-Y. Lin, D. Egamberdiev, Shin'ichi Miyamoto, P. Afchain, Harpreet Wasan, Mitesh J. Borad, J. Blay, Dong Sup Yoon, H. Kawai, L. Jin, Margaret Sheehan, T. Otsuji, M. Lichinitser, Ahmet Ozet, R. Savage, Heind Smith, L. Zubiri, Tim Meyer, Erkan Topkan, Ross C. Donehower, Joanne Chiu, T. Tsuda, P. Jimenez Fonseca, U. Selek, N. Musha, B. Liu, A. Magnusson, S.C. Sharma, C. Purcell, H. Wong, E. Lucchini, Jean-Marc Phelip, E. Jeon, J. Fujita, Kelly S. Oliner, W. Schelman, W. Mao, S. Hato, A-L Cheng, D.-L. Ou, Tarek Sahmoud, J. Waters, Jorge A. Marrero, David Malka, P. Xavier, M. Haibo, S. Takiguchi, Q. Pan, S. Ohkawa, J. Kizaki, I.P. Le, A. Roveta, D.H. Koo, H.J. Kim, H. Choi, T. Göhler, A. Gelibter, C. Borg, X. Qiang, Masaya Suenaga, Ozan Cem Guler, Niall C. Tebbutt, M. Emi, S. Ota, N. Nagata, S. Iwasa, Mira Ayadi, K. Matsuo, Henk M.W. Verheul, Christoph C. Zielinski, S. Choo, M.W. Büchler, René Adam, M. Pistelli, J.A. Gonzalez, Charles S. Fuchs, G. Vallati, G. Pentheroudakis, S. Tokunaga, U. Demirci, Lin Shen, B. Heyd, X. Zhou, T. Ioka, Toshiyoshi Fujiwara, O. Testori, Y.S. Park, A. Allen, Rakesh Kapoor, Bruno Daniele, T. Hirai, Z. Lakkis, I.B. Tan, Y-K Kang, S.A. Aledavood, N. Reynoso, F. Serejo, Sergio Ricci, Jennifer Gansert, M. Miyagi, S. Santi, A. Parthan, A C Wotherspoon, L. Chaigneau, Sumera Rizvi, M.G. Fabrini, Véronique Vendrely, W. Su, V. Shalenkov, L. Tu, G. Numico, Joon Seong Park, J.H. Kim, Hope E. Uronis, Mustafa Benekli, I. Aoyama, M. Gauthier, S. Lazzarelli, W. Liguigli, N. Atsushi, H. Kastrissios, J. Thaler, Z. Zou, T. Tsujinaka, S. Barbero, F. Fiteni, Irene Kührer, Aldo Scarpa, C. Desauw, J.F. Seitz, Takahiro Horimatsu, R. von Roemeling, T. Yamamoto, H.R. Alexander, Timothy Iveson, F.M. Negri, Ermek Tangsakar, Pascal Artru, Jia Zhang, S. Lee, Satoshi Morita, E. Garralda, M. Moore, J. Lee, M. Seilanian Tousi, J. Gornet, Yasuhiro Kodera, Werner Scheithauer, L. Marthey, D. Atanackovic, P. Zhao, D. Wang, I. Davidenko, T.S. Waddell, S. Takeda, N. Fan, R. Kawabata, M. Raponi, Giampaolo Tortora, M. Ogasawara, B. Gruenberger, Guido Gerken, Ivan Borbath, N. Fuse, Denis Smith, Emmanuel Mitry, Vikki Tang, I. Stilidi, Min-Hee Ryu, Tulay Akman, C. Saffery, Roopinder Gillmore, K. Ligier, R. Coriat, T. Namikawa, L. Sun, R. Xu, Gary Middleton, W. Tröger, F. Keil, Bruno Chauffert, K. Achilles, David Cunningham, H. Raies, M.Y. Teo, Y. Hamai, S. Tjulandin, I. Boukovinas, J. Kazakin, J. Beebe-Dimmer, Pippa Corrie, J.A. Ortega, A. Cueff, C. Costa, V. Da Prat, Y. Tanaka, F. Rivera, K. Hashimoto, Tianshu Liu, K. Kato, J.C. Plaza, G. Fountzilas, N. Chaiet, Byung Sik Kim, K. Ueda, Pierre Laurent-Puig, Y.-C. Cheng, Mendel Jansen, T. Salman, C. Papandreou, T. Carothers, H. Van Vlierberghe, M. Rios, S. Barni, Y. Arai, G. Afc, Julia Klech, Bryan C. Fuchs, S.T. Fan, A. Falcone, J-B. Bachet, Y. Fujiwara, S. Navruzov, Fumihiko Kanai, H. Shiah, J. Xia, N. Xu, X. Garcia del Muro, M. Lucchesi, Jae Yong Cho, A. Leon, W. Jin, C. Eng, A.U. Yilmaz, L.-T. Chen, Laurent Bedenne, I. Vynnychenko, Brian Schwartz, J. Ruíz Vozmediano, Toshihiro Tanaka, Jinwan Wang, F. Musante, C. Belli, K. Imanaka, W. Fang, J.P. Fusco, S. Gupta, Daniel H. Palmer, M. Ninomiya, N. Ryuge, M. Djuraev, B. Benzidane, H. Yasui, P.G. Betta, M. Sanon, J. Mizusawa, M. Hou, H. Pan, Y. Osaki, Darren Sigal, E. Schott, J. Rodriguez, E. Wöll, S. Nakamori, Anthony F. Shields, Yasuo Ohashi, M. Raikou, M.W. Bennett, Zhilong Zhao, G. Colucci, R. Stauber, M. Nakamura, T. Nguyen, Xin Li, C. Greco, K. Hanazaki, C. Mao, Y. Matsumura, S. Emoto, Maristella Bianconi, Yoon Ho Ko, E. Trusilova, J. Coombs, H. Iwase, V.A. Gorbunova, M. Lencioni, M. Svrcek, S. Leo, Mahmoud Ellithy, N. Silvestris, Y.H. Min, N. Urata, A. Sainato, K. Yoshimura, U. Boggi, D.C. Huang, T. Tsuzuki, S.H. Hong, K. Ikeda, Mohammed Shaker, Olivier Turrini, Arsene-Bienvenu Loembe, Jaffer A. Ajani, G. Pelletier, Stefano Cascinu, F. Bergamo, I.T. Unek, T. Di Palma, H. Li, Maria Lamar, H. Inagaki, M. Ratti, M. Iida, F. Pons Valladares, S. Caponi, A. Sa-Cunha, A. Passardi, J. Wei, S. Azevedo, W. Wang, S. Luelmo, M. Brighenti, A. Mezlini, Y. Zheng, S. Reddy, M. Milella, S. Nered, D. Li, Carsten Bokemeyer, Manabu Muto, C. Krüger, X.J. Sun, T. Ueno, M. Harrison, F. Cognetti, Y. Kida, M. Kobayashi, S. Akamaru, G. Leonard, Y. Inaba, A. Jayaram, Özgür Ekinci, Y. Bai, F. Subtil, Wasaburo Koizumi, M.A. Fridrik, Pierre Michel, R.C. Turkington, D. Galun, N. De Lio, A. Le Cesne, L. Toppo, Thorsten Füreder, R. Poli, V. Moiseyenko, Jean-Louis Jouve, Y. Lu, A. Babaev, N. Okumura, Isamu Okamoto, G.C. Ruiz, I. Oztop, T. Isobe, W. Fischbach, A. Takashima, Alessandro Bittoni, Y-C Chang, K. Yamaguchi, Vincent J. Picozzi, K. Muro, M. Sebagh, Y. Shindo, S. Beghelli, M. Skoblar Vidmar, Alessandra Mandolesi, M. Reni, K. Nishikawa, Marine Gilabert, Y. Maeda, Francesco Massari, E.B. Ruiz, K. Pan, H. Lou, H.S. Won, C. Diaz, J.P. O'Brien, Shuichi Kaneko, C. Gomez-Martin, J. Sgouros, A. Funakoshi, W. Figg, F. Chai, M.S. Pino, X. Pivot, K. Anvari, J. Turnes, M. Reif, F. Lopez-Rios, W. Cheung, David P. Ryan, M. Oka, I. Varthalitis, A. Deptala, Masatoshi Kudo, F. Romeder, J. Qian, J. Hihara, T. Shibata, T. Yamatsuji, B. Gonzalez-Astorga, B. Allani, Y. Tsuji, J. Liu, Thomas Yau, S. Lim, F. Grosso, Y.D. Zheng, R. Passalacqua, J. Chen, I. Sperduti, H. C. Kwon, C. Cappelli, C. Guettier, O. Nematov, Lanjun Zhou, C. Caparello, F. Bonnetain, R. Ferrara, A. Nashimoto, A. Schumann, Richard Martin Bambury, C. Mazzara, T. Aramaki, B. Saracino, M. Takagi, G. Di Lucca, Philip A. Philip, A. Aloui, Philippe Bachellier, N. Hirabayashi, S. Osanto, S. So, N. Fukushima, K.-H. Yeh, Y. Aoki, M. Baretti, Y-L. Gong, Koichiro Yamakado, C.-H. Hsu, R. Buder, D.G. Power, H. Matsumoto, Chiara Costantini, Y. Xu, G. Tomasello, A. Lopez Pousa, D.K. Lee, F. Di Fiore, O. Polat, K. Suzuki, L. Arbea, R. McDermott, S.-H. Kim, E. Toure, O. Bouche, A. Zaanan, T. Hamaguchi, Mary Geitona, M.H. Tan, M. Antonietti, Italo Bearzi, Juan W. Valle, D. Castaing, H. Shoji, Eylem Pınar Eser, Mario Scartozzi, R. Abdul Rahman, Yukinori Kurokawa, F. Pardo, T. Sasatomi, Y. Kimura, Suguru Yamada, K. El Ouagari, F. Mosca, Yuichiro Doki, A.O. Singh, Goro Nakayama, Lara Lipton, H.J. An, B. Kato, Y. Ezoe, M. Salem, Samantha Bersani, B. Paule, O.E. Carranza Rua, Gabriela Kornek, L. Gray, S. Tamura, J.-F. Blanc, and L. Ginocchi

Subjects
medicine.medical_specialty, Gastrointestinal tumors, Performance status, business.industry, Hematology, Severe hypoxia, Neutropenia, medicine.disease, Rash, Gastroenterology, Discontinuation, Non colorectal, Oncology, Internal medicine, Toxicity, medicine, medicine.symptom, business
Abstract

Background TH-302 is a hypoxia targeted prodrug with a hypoxia-triggered 2-nitroimidazole component designed to release the DNA alkylator, bromo-isophosphoramide mustard (Br-IPM), when reduced in severe hypoxia. A randomized Phase 2B study (NCT01144455) was conducted to assess the benefit of G + T to standard dose G as first-line therapy of PAC. Materials and methods An open-label multi-center study of two dose levels of TH-302 (240 mg/m2 or 340 mg/m2) in combination with G versus G alone (randomized 1:1:1). G (1000 mg/m2) and T were administered IV over 30-60 minutes on Days 1, 8 and 15 of a 28-day cycle. Patients on the G could crossover after progression and be randomized to a G + T arm. The primary efficacy endpoint was a comparison of progression-free survival (PFS) between the combination arms and G alone (80% power to detect 50% improvement in PFS with one-sided alpha of 10%). Summary PFS outcome has previously been reported; more detailed PFS as well as the initial overall survival (OS) data are presented. Results 214 pts were treated; 164 (77%) Stage IV and 50 (23%) Stage IIIB. Median age 65 (range 29-86); 126 M/88 F; 40% ECOG 0/60% ECOG 1. Receiving 6 or more cycles: 32% G; 45% G + T240; 55% G + T340. Median PFS was 3.6 mo in G vs 5.5 mo in G + T240 (p = 0.031) and 6.0 mo in G + T340 (p = 0.008). Poorer prognostic factors (older age, poorer performance status, reduced albumin) were associated with larger treatment effect. Median OS was 7.0 mo in G vs 9.0 in G + T240 and 9.5 mo in G + T340. RECIST best response was 12% in G vs 17% in G + T240 and 27% in G + T340. CA19-9 decreases were significantly greater G + T340. A >50% CA19-9 decrease was 52% with G vs 50% with G + T240 and 70% with G + T340. AEs leading to discontinuation were: 16% G, 15% G + T240 and 11% G + T340. Rash (45% in G + T340) and stomatitis (36% in G + T340) were greater in combination, 4 pts Grade 3 rash. Grd 3/4 thrombocytopenia were 11% G, 39% G + T240 and 59% G + T340 and Grd 3/4 neutropenia were 28% G, 56% G + T240 and 59% G + T340. Conclusions The combination of G plus TH-302 improved the efficacy of G. A TH-302 dose of 340 mg2 was identified for future studies. Skin and mucosal toxicity and myelosuppression were the most common TH-302 related AEs with no increase in treatment discontinuation. Disclosure All authors have declared no conflicts of interest.

Published
2012
Full Text
View/download PDF

27. First-line lapatinib combined with letrozole versus letrozole alone for hormone receptor positive (HR+) metastatic breast cancer (MBC): Subgroup analyses of borderline FISH+, IHC 2+, HER2 unknown (UNK), and treatment-naive (TN) populations from EGF30008

Author

L. O'Rourke, M. Pegram, M. Press, J. Pippen, X. Pivot, H. Gomez, A. Florance, J. Maltzman, and S. Johnston

Subjects
Oncology, Cancer Research, medicine.medical_specialty, education.field_of_study, business.industry, Letrozole, Population, Hazard ratio, Lapatinib, medicine.disease, Placebo, Metastatic breast cancer, Internal medicine, medicine, Clinical endpoint, skin and connective tissue diseases, education, business, Tamoxifen, medicine.drug
Abstract

1062 Background: This double-blind, placebo-controlled, phase III trial assessed the benefit of adding lapatinib, an oral EGFR/HER2 tyrosine-kinase inhibitor, to letrozole alone in patients (pts) with HR+ MBC. The previously reported primary endpoint, investigator (INV) assessed PFS in HER2+ tumors, showed a significant benefit from dual therapy. Median PFS in the HR+ HER2+ population increased from 3 months (mo) in the letrozole/placebo group to 8.2 mo in the letrozole/lapatinib group [Hazard Ratio (95% CI)=0.71 (0.53,0.96), stratified log rank p = 0.019]. The HER-2-ve population did not derive benefit from the combination. Benefit from combined treatment was evaluated in a number of pre-planned exploratory subsets, including a noted trend in the HER2-ve population who progressed within 6 mo of receiving prior tamoxifen. Methods: 1286 pts were randomized to letrozole/lapatinib or letrozole/placebo. HER2 positivity was defined by a positive FISH ratio or by immunohistochemistry (IHC) 3+ in a central laboratory. INV assessed PFS in the sub-populations were analyzed using Kaplan-Meier with stratified log rank to compare treatment arms. These included tumor samples that were FISH borderline1.8–2.2 (n = 52), IHC 2+ (n = 215), HER2 status UNK (n = 115), and neo/adjuvant TN (n = 656). Results: INV assessed PFS demonstrated no significant prolongation for dual therapy for any of the exploratory populations [Hazard Ratio: (95%CI), p-value]; FISH 1.8–2.2 [1.03 (0.55, 1.95), p = 0.918]; IHC 2+ [1.13 (0.82, 1.57), p = 0.441]; HER2 UNK [0.71 (0.45,1.11), p = 0.126]; TN [0.88 (0.73, 1.07), [p = 0.199]. Conclusions: The combination of letrozole and lapatinib did not significantly improve PFS in any of the pts with lower levels of HER2 expression (borderline FISH, IHC 2+, or HER2 UNK) or in TN pts. These data confirm the HER2-ve result previously reported and substantiate that only tumors with the target benefit from the addition of a targeted therapy. [Table: see text]

Published
2009
Full Text
View/download PDF

28. Cardiac safety of the lapatinib/letrozole combination as first-line therapy in patients (pts) with metastatic breast cancer (MBC)

Author

D. Zembryki, H. Gomez, M. Koehler, S. Johnston, J. Pippen, A. Florance, L. O'Rourke, J. Maltzman, and X. Pivot

Subjects
Oncology, Cancer Research, Cardiotoxicity, medicine.medical_specialty, Ejection fraction, business.industry, medicine.medical_treatment, medicine.disease, Metastatic breast cancer, Surgery, Lapatinib/letrozole, Radiation therapy, Left breast, First line therapy, Internal medicine, medicine, In patient, business
Abstract

1095 Background: Cardiotoxicity of traztuzumab therapy increases in pts pretreated with anthracyclines (A), radiotherapy to left breast, hypertension, or low baseline ejection fraction (EF). We report the cardiac safety profile of lapatinib, an oral, dual EGFR/HER-2 tyrosine kinase inhibitor, in a chemotherapy naïve or A-exposed pts with MBC. Methods: Women (n = 1286) with endocrine sensitive, previously untreated MBC received lapatinib and letrozole (L+L) or letrozole and placebo (L+P): 33% received previous A; 48% previous tamoxifen; [Table: see text]

Published
2009
Full Text
View/download PDF

29. Krebs im Alter – eine wachsende Herausforderung. Studienkonzepte und Therapieoptionen für ältere Tumorpatienten

Author

J. Zizka, Ö. Özyilkan, G. Janßen, J. Schütte, C. Hasan, T. Krauss, A. Müller, R.T. Penson, G. Gastl, U. Göbel, M.C. Uzal, G. Wellis, M. Mitterer, J. Brabender, R. Metzger, W. Queißer, A.C. Kuebler, C. Venkateswaran, U. Höpner, F. Demard, G. Burg, C. Wawersig, H.-J. Laws, U. Bode, U. Warnecke-Eberz, T. Tenenbaum, M. Haberal, C. Bailet, S. Karakus, A.H. Hölscher, W.A. Golder, J.E. Zöller, P. Bollini, F. Gutierrez-Delgado, G. Spizzo, Z. Kocak, B. Melichar, B. Seifert, S. Meier, K. Uygun, U. Kraus-Tiefenbacher, M. Wannenmacher, O. Dassonville, Z. Akçali, N. Magné, D. Hadzi-Nikolov, M. Steurer, P.-Y. Marcy, U. Ikinger, D. Zierhut, K. Sureshkumar, M. Scheer, T. Maier, B.G. Baumert, G. Emons, G. Poissonnet, B. Demirhan, J. Weis, S. Seeber, A. Huschmand-Nia, P.C. Amrein, J. Dvorak, S. Gutwein, X. Pivot, R. Schwarz, J. Petera, R. Wessalowski, H.-J. Senn, S. Riedel, C.M. Kramm, S. Bauer, R. Dummer, B. Hinney, P.M. Schneider, and B. Thürlimann

Subjects
Cancer Research, Oncology, Hematology
Published
2004
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results