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1. Influence of BRAF and PIK3CA mutations on the efficacy of FOLFIRI plus bevacizumab or cetuximab as first-line therapy in patients with RAS wild-type metastatic colorectal carcinoma and <3 baseline circulating tumour cells: the randomised phase II VISNÚ-2 study

Author

J. Sastre, P. García-Alfonso, J.M. Viéitez, M.T. Cano, F. Rivera, J.J. Reina-Zoilo, A. Salud-Salvia, G. Quintero, L. Robles-Díaz, M.J. Safont, A. La Casta, S. Gil, E. Polo, E. Asensio-Martínez, B. García-Paredes, R.L. López, M. Guillot, M. Valladares-Ayerbes, E. Aranda, E. Díaz-Rubio, P. Jiménez, E. Aranda Aguilar, A. Gómez, S. Gil Calle, A. Salud, M. Valladares, B. Graña, J.J. Reina, E. González Flores, M. Salgado, E. Grande, C. Guillén, R. Garcia Carbonero, M.J. Flor, S. Arévalo, R. López López, H. Manzano, X. Hernández Yagüe, A. Arrivi, E. Falcó, J. Gallego, P. Escudero, I. Cabezas, A. Juárez, E. Gálvez, C. Grávalos, L. Robles, R. Dueñas, J.M. Campos, A. Albert, P. Salinas, C. Montagut, M. Provencio, A. Ruiz Casado, J. Muñoz, M. Gil Raga, M.R. Chilet, F.J. González González, B. Massutí, A. López, J. Aparicio, M. Marín, J. Alfaro, M. Zanui, D. Gutiérrez Abad, A.M. García Tapiador, C. García-Girón, J. Molina Saera, E. Torres Sánchez, I. López, C. Bosch, J. Valero, P. Martínez de Prado, Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD), [Sastre,J, García-Paredes,B, Díaz-Rubio,E] Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clínico San Carlos (IdISSC). [García-Alfonso,P] Medical Oncology, Hospital Universitario Gregorio Marañón, Madrid. [Viéitez,JM] Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, [Cano,MT, Aranda,E] Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Cordoba. [Rivera,F] Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander. [Reina-Zoilo,JJ] Medical Oncology, Complejo Hospitalario Virgen de la Macarena, Seville. [Salud-Salvia,A] Hospital Universitario Arnau de Vilanova de Lleida, Lleida. [Quintero,G] Medical Oncology, Hospital Lucus Augusti, Lugo. [Robles-Díaz,L] Medical Oncology, Hospital 12 de Octubre, Madrid. [Safont,MJ] Medical Oncology, Hospital General Universitario de Valencia, Valencia. [La Casta,A] Medical Oncology, Hospital de Donostia, Guipúzcoa. [Gil,S] Medical Oncology, Hospital Universitario Regional y Virgen de la Victoria, Malaga. [Polo,E] Medical Oncology, Hospital Miguel Servet, Zaragoza. [Asensio-Martínez,E] Medical Oncology, Hospital General Universitario de Elche, Alicante. [López,RL] Medical Oncology, University Clinical Hospital and Health Research Institute (IDIS), CIBERONC, Santiago de Compostela University School of Medicine, Santiago de Compostela. [Guillot,M] Medical Oncology, Hospital Son Espases, Palma de Mallorca. [Valladares-Ayerbes,M] Medical Oncology, Complejo Hospitalario Universitario A Coruña, Instituto de Investigación Biomédica (INIBIC), A Coruña, Spain., This work was supported by Roche Farma S.A (no grant number). Medical writing support was funded by Roche Farma S.A and provided by H. Lamb and L. Miller of Miller Medical Communications Ltd., and UAM. Departamento de Medicina

Subjects
Oncology, Cancer Research, Colorectal cancer, Terapia dirigida, Cetuximab, Phases of clinical research, Chemicals and Drugs::Heterocyclic Compounds::Alkaloids::Camptothecin [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Confidence Intervals [Medical Subject Headings], Targeted therapy, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Neoplasias colorrectales, Antineoplastic Combined Chemotherapy Protocols, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidinones::Uracil::Fluorouracil [Medical Subject Headings], Original Research, Hazard ratio, Neoplastic Cells, Circulating, targeted therapy, Bevacizumab, Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Phosphatidylinositol 3-Kinases::Phosphatidylinositol 3-Kinase::Class I Phosphatidylinositol 3-Kinases [Medical Subject Headings], FOLFIRI, Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia [Medical Subject Headings], Colorectal Neoplasms, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Asthenia [Medical Subject Headings], medicine.drug, Diseases::Neoplasms::Neoplastic Processes::Neoplasm Metastasis::Neoplastic Cells, Circulating [Medical Subject Headings], Proto-Oncogene Proteins B-raf, medicine.medical_specialty, Medicina, Class I Phosphatidylinositol 3-Kinases, colorectal cancer, Neutropenia, Neoplastic cells circulating, BRAF, Internal medicine, medicine, Humans, neoplasms, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols [Medical Subject Headings], business.industry, Chemicals and Drugs::Enzymes and Coenzymes::Coenzymes::Tetrahydrofolates::Formyltetrahydrofolates::Leucovorin [Medical Subject Headings], Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [Medical Subject Headings], PIK3CA, medicine.disease, digestive system diseases, Irinotecan, Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Signs and Symptoms, Digestive::Diarrhea [Medical Subject Headings], Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Protein Kinases::Protein-Serine-Threonine Kinases::MAP Kinase Kinase Kinases::raf Kinases::Proto-Oncogene Proteins B-raf [Medical Subject Headings], Camptothecin, business, Células neoplásicas circulantes, RAS
Abstract

Artículo escrito por un elevado número de autores, solo se referencian el que aparece en primer lugar, el nombre del grupo de colaboración, si le hubiere, y los autores pertenecientes a la UAM, Background We explored the influence of BRAF and PIK3CA mutational status on the efficacy of bevacizumab or cetuximab plus 5-fluorouracil/leucovorin and irinotecan (FOLFIRI) as first-line therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC). Patients and methods VISNÚ-2 was a multicentre, randomised, phase II study. Patients with RAS wild-type mCRC and 1), and allocated to bevacizumab (5 mg/kg every 2 weeks) or cetuximab (400 mg/m2 then 250 mg/m2 weekly) plus FOLFIRI [irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2 (bolus) then 2400 mg/m2 (46-h continuous infusion) every 2 weeks]. The primary endpoint was progression-free survival (PFS). All analyses were exploratory. Results Two hundred and forty patients with BRAF/PIK3CA wild-type (n = 196) or BRAF- and/or PIK3CA-mutated tumours (n = 44) were enrolled. Median PFS was 12.7 and 8.8 months in patients with BRAF/PIK3CA wild-type and BRAF/PIK3CA-mutated tumours, respectively [hazard ratio (HR) = 1.22; 95% confidence interval (CI) 0.80-1.85; P = 0.3602]. In the BRAF- and/or PIK3CA-mutated cohort, median PFS was 2.8, 8.8 and 15.0 months in patients with BRAF/PI3KCA-mutated (n = 8), BRAF-mutated/PI3KCA wild-type (n = 16) and BRAF wild-type/PI3KCA-mutated (n = 20) tumours, respectively (P = 0.0002). PFS was similar with bevacizumab plus FOLFIRI versus cetuximab plus FOLFIRI in BRAF/PIK3CA wild-type (HR = 0.99; 95% CI 0.67-1.45; P = 0.9486) and BRAF/PIK3CA-mutated tumours (HR = 1.11; 95% CI 0.53-2.35; P = 0.7820). The most common grade 3/4 treatment-related adverse events were neutropenia, diarrhoea and asthenia in both treatment groups. Conclusions BRAF/PIK3CA status influences outcomes in patients with RAS wild-type mCRC but does not appear to assist with the selection of first-line targeted therapy, This work was supported by Roche Farma S.A (no grant number). Medical writing support was funded by Roche Farma S.A and provided by H. Lamb and L. Miller of Miller Medical Communications Ltd.

Published
2021

2. Physical separation and reduction of contact duration with sexually hyperactive bucks decrease testosterone concentrations and sexual behaviour in bucks in sexual rest

Author

N. López-Magaña, L.M. Tejada, D. López-Magaña, H. Hernández, M.J. Flores, J. Vielma, J.A. Abecia, M. Keller, P. Chemineau, and J.A. Delgadillo

Subjects
Libido, Male goats, Photoperiodic treatments, Reproductive seasonality, Sociosexual interactions, Animal culture, SF1-1100
Abstract

Sexually hyperactive bucks are more efficient than sexually hypoactive bucks in stimulating testosterone secretion and sexual behaviour in other bucks in seasonal sexual rest by the phenomenon that we called the “buck-to-buck effect”. Here, we determined whether physical separation and reduction of the duration of contact with the sexually hyperactive bucks would modify those parameters in sexually hypoactive bucks exposed to the “buck-to-buck effect”. Bucks were subjected to natural day length throughout the study; this was the sexually hypoactive group. Other bucks were subjected to artificial long days (16 h of light per day) from 15 November to 15 January followed by exposure to natural day length to stimulate their sexual activity during the rest season; this was the sexually hyperactive group. In Experiment 1, we determined testosterone concentrations and sexual behaviour of six sexually hypoactive bucks separated 1.5 m from six sexually hyperactive bucks for 60 days by a metal open work fence, while a control group of six sexually hypoactive bucks was in permanent contact with six sexually hyperactive bucks. In Experiment 2, the duration of contact with sexually hyperactive males was reduced from 31 days (contact group, six bucks) to 10 days (withdraw group, seven bucks). In experiments 1 and 2, there was an effect of time (P

Published
2024
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3. Translational endpoints in patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC) treated with durvalumab plus monalizumab (anti-NKG2A)

Author

T. Alonso Gordoa, Xia Li, Ding Wang, Chris Morehouse, Hormas Ghadially, M. Jure-Kunkel, Sandip Pravin Patel, J. Rodriguez Canales, M.J. Flor Oncala, Nathan Standifer, Jennifer R. Diamond, Marlon Rebelatto, D.C. Jones, Maria Libera Ascierto, Shaad Essa Abdullah, Jarushka Naidoo, Matthew D. Hellmann, L. Mazzarella, Xuyang Song, and Simon J. Marshall

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Durvalumab, business.industry, Colorectal cancer, Hematology, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Microsatellite Stable, 030220 oncology & carcinogenesis, Internal medicine, medicine, Monalizumab, In patient, business
Published
2018
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4. 180P: Immunotherapy as an effective therapy approach for advanced non-small cell lung cancer (NSCLC): A single institution experience in the context of clinical trials and expanded access use

Author

Pérez, J. Martínez, primary, González, A. Falcón, additional, Simón, I. Sánchez, additional, Cervera, A., additional, García, M. Alonso, additional, Oncala, M.J. Flor, additional, Jiménez, I. Gallego, additional, Maíquez, P., additional, González-Serna, L. Jiménez, additional, and Corral, J., additional

Published
2016
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5. 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
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6. Nutritional supplementation improves the sexual response of bucks exposed to long days in semi-extensive management and their ability to stimulate reproduction in goats

Author

J.A. Delgadillo, P.I. Sifuentes, M.J. Flores, L.A. Espinoza-Flores, J.D. Andrade-Esparza, H. Hernández, M. Keller, and P. Chemineau

Subjects
Caprine, Male effect, Nutrition, Photoperiod, Subtropics, Animal culture, SF1-1100
Abstract

In confined management systems, well-nourished bucks rendered sexually active by exposure to long days are efficient in fertilizing out-of-season goats. However, underfeeding is common in semi-extensive management systems and may reduce the reproductive efficiency of bucks. The objective of the present study was to determine whether nutritional supplementation improved the sexual activity of bucks submitted to long days in semi-extensive management systems and their ability to stimulate the reproduction of goats in semi-extensive or confined conditions. In experiment 1, three groups of bucks were placed in different flocks and grazed daily with females for 7 h. Each day after grazing, males were separated from females and moved into open pens. One group did not receive any treatment (control group; n = 6). Two other groups were submitted to artificially long days from 15 November to 15 January. From 16 January, one group did not receive nutritional supplementation (long-day group; n = 5), whereas bucks from the other group each received 600 g of a commercial concentrate (long-day+supplementation group; n = 5). The fourth group was kept in confined conditions, exposed to long days and fed alfalfa hay (long-day confined group; n = 6). On 26 March, anovulatory goats from other flocks were assigned to four groups (n = 27 each) and confined separately in open pens. Three bucks of each group were housed with the females. Pregnancy rates were greater in the goats housed with the long-day group than those housed with the control group (P

Published
2021
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