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