Gastrointestinal tumors, colorectal
D L Arnold,H J Schmoll, J Rieraknorrenschild,F Mayer,Hendrik Kroening,Werner Scheithauer,Dieter Nitsche,Marina Tschaika,M A Schmidt,Burghardt Wittig,Timothy J Price,Kevin R Wilson,R J Simes,Desmond Yip,C S Karapetis,N C Tebbutt,Val Gebski, M Fournier,David Ferry, D Ransom,R Salazar,Enrico Mini,G Folprecht,Fabien Subtil,J Van Laethem, J J Thaler,J Bridgewater,Come Lepage,Julien Taieb,Sabine Venderbosch,T De Haan,Danielle A M Heideman, T S Maughan,Chris Smith,Philip Quirke,Susan Richman,Iris D Nagtegaal, C J A Punt,Miriam Koopman,Thomas Bachleitnerhofmann,Iris Simon,Josep Tabernero,Robert Rosenberg, J Van Der Akker,Yafei Li, B Chan,Gregory M Lanza,Annuska M Glas, Michael J Oconnell,Margarita Lopatin,Greg Yothers,Kim M Clarklangone, C Millward,Soonmyung Paik,Saima Sharif,Steven Shak,Norman Wolmark, Peihe Li, Guoqiang Chen,Pierre Laurentpuig,Gilles Manceau,J B Bachet,Benoist Chibaudel, F Liebaert,Olivier Bouche,Frederique Penaultllorca, M D Diebold,Thierry Andre,Sandrine Imbeaud,Volker Heinemann,Rudiger P Laubender,D P Modest,Andreas Jung, L Fischer Von Weikersthal, U Vehlingkaiser,Clemens Giessen,Thomas Kirchner,Ulrich Mansmann,Sebastian Stintzing, Analu Custodio, J A Moreno,Javier Blanco Aparicio,J Gallego Plazas, C Fernandez Martos,Joan Maurel, D Ramos,P Cejas, R Madero,Jaime Feliu,A Pereira, J F M Rego,Paulo M Hoff,Andre Deeke Sasse,Rachel P Riechelmann,Emmanuel Mitry, L Venatbouvet, J M Phelip,Emilie Maillard,J L Jouve,Xavier Adhoute, D Gargot, Mohamed Gasmi, L Bedenne, Teofilo Rojo Aparicio, Rachel S Midgley, Susan M Love,Van R Potter,Eva Segelov, Arthur W Weaver, C Scudder, Patrick Julier, S Grumett,D J Kerr,S Ahmed,Rabia K Shahid,Anne Leis, Karin Haider, P Pahwa,Jennifer E Hardingham, C Lee, Amanda R Townsend,Joseph W Wrin, Andrew J Weickhardt, C Munroe,Iain Beehuat Tan, T Seah,Si Lin Koo, Sooyong Choo,Chee Kian Tham,Daotong Chong, I Lopez Calderero,Andres Moya, A Gonzalez,Andres Carranza Carranza, Manuel Conde,Sonia Molinapinelo, Manuel Herrera, M L L Miron, P Garcia,Rocio Garciacarbonero,F Cappuzzo, Andrea Sacconi, L Landi,Francesca Biagioni,Vienna Ludovini, Elisa Sensi, Jessica Salvini, Gabriella Fontanini,Giovanni Blandino,Lucio Crino, A Sebio Garcia, David Paez, J Salazar Blanco,M Tobena Puyal, M Martinrichard,Agusti Barnadas,M Baiget,Santiago Zazo,Trinidad Caldes, N Perez Gonzalez, Juan Roberto Rodriguez Madoz, J Satre, Ramon Alberto Manso, D Ferrandez,T Ramos,Jesus Garciafoncillas,Eduardo Diazrubio, A Taghizadeh Kermani,Amir Hossein Jafarian, J Esmaeili, N Mohammadian Roshan,M Seilanian Toosi,A Omidi Ashrafi, M Karimi Shahri, A C Goncalves, Annecatherine Lhoumeau, Genevieve Monges,J R Delpero,J L Raoul, Jeanpaul Borg,Wilma E Mesker, Van Pelt,Hans Gelderblom, V H Krieken,R A E M Tollenaar, Saul Camposgomez,V Rosas Camargo,R A Ramirez Fallas, J H Flores Arredondo, L Morales Juarez, S I Perez Alvarez, D Valdez Bocanegra,D Huitzil Melendez,Sotaro Sadahiro, Toyoaki Suzuki, Atsushi Tanaka,Kiyotaka Okada, Atsushi Kamijo,Hisamitsu Nagase,Junji Uchida, Sandra J Shin,Kathleen Y Lee,Tae Il Kim,Nam Kyu Kim,Sun Young Rha,Jae Kyung Roh,Joong Bok Ahn, L Pare, M A Lee,Shin Taek Oh,Won Kyung Kang,Sang Woo Kim, M J Ortizmorales, C Morales,Ana Maria Gomez, Guillermo Diaz Pulido, M T Cano Osuna,Juan Carlos Jimenez, Pablo Del Amo Sanchez, M C Medina, J De La Haba Rodriguez,E Aranda Aguilar, F Dane,Mehmet Ozturk, M Kocar, B M Atasoy, B Aktas, F Telli, M Kanitez, M Bes Irog Lu,P F Yumuk,Serdar Turhal, Boyd E Metzger,Mario Dicato,Gwendolyn M Mahon, S Obertin, J Kayser, J Garcia Foncillas, Cristina Carames, Guillermo Eliezer Avila Serrano,America De Leon, Alejandro D Campos, Jose Ignacio Martinvalades, Carmen Canadas, T Hernandezguerrero,Federico Rojo, J Maroun, Michael D Hill, S Hoersch, K Rittweger,Daniel G Haller, Ashish Kumar, Hagen F Kennecke, H Lim, Robert M Woods, Daniel Renouf, C Speers, Kazuhiro Kondo,Toshie Tsuchiya, Katsunori Sasaki, Kenichi Katsumata, Genshiro Nishimura,Yoshihiro Kakeji, H Baba, Susumu Kodaira,Shigehira Saji, C Qvortrup,Milada Cvancarova,Bengt Glimelius, Paul Pfeiffer,Halfdan Sorbye, Ute Sartorius,M Schlichting,Anno Graser,Fairooz F Kabbinavar,H Hurwitz, B J Giantonio, Zhicheng Guan, Laura E Mitchell,Daniel Waterkamp, Ruiquan Zhang,Zhenghong Lu, Xin Wu, Dafang Wan, Zongming Pan, Jianfeng Xu, Ling Ye, Lidi Ren, Y Wei,J Y Douillard,Salvatore Siena,Marc Peeters, Carolyn Davison, S Braun,Rajinder S Sidhu, Clauschristoph Steffens,J Bennouna, Javier Sastre,Pia Osterlund,R Von Moos,I Reyesrivera, M A Sersch,S Y Zafar,Axel Grothey,Tanios Bekaiisaab,Johanna C Bendell, B M Sherrill, L F Bennett,Yeungchul Mun, Deepan S Dalal, Istvan Lang, C H Kohne,Philippe Rougier,Dennis P Curran,Erika Hitre, I Griebsch, L Heijmen, E E G W Ter Voert,L De Geusoei,Arend Heerschap,Johan Bussink, Valerio Zerbi,W J G Oyen,Otto C Boerman,H W M Van Laarhoven,Fausto Petrelli, Karen Borgonovo, Mary Cabiddu, M Ghilardi, M Cremonesi, F Maspero,Sandro Barni, Z Zhao, Brian R Barber,Jun Zhang, Mark M Gallagher, J M Vieitez De Prado,Christophe Borg,Richard Greil,E J D Van Cutsem, Belguendouz Bendahmane, S Kubicka,Dae Young Zang, I J Chung,Heungkwun Oh,Kyoung Un Park,Bokghee Han,Dong Rack Choi,Hyung Sik Kim,Antonio Avallone,E Di Gennaro,Luigi Aloj,Paolo Delrio,Biagio Pecori,Fabiana Tatangelo,Antonella Petrillo,Vincenzo Rosario Iaffaioli,Secondo Lastoria,A Budillon, Francis Levi,Valerie Boige, Mohamed Hebbar,D A Smith,C Focan,Rosine Guimbaud, C F Carvalho, M Bouchahda,M Ducreux, A Deleporte,Alain Hendlisz,Thierry Delaunoit, Raphael Marechal, Stephane Holbrechts,M Van Den Eynde, G Houbiers, Marie Moreau,Patrick Flamen,A Rong, V Alonsoorduna, C Schlichting,Bevode C Mccall, J P Metges, J F Ramee, O Dupuis, P Deguiral, E Boucher, O Cojocarasu, M Ferec, Marc Porneuf, F Grude,Masahiko Yoshida, Tomohisa Kato, Shotaro Iwamoto, Yutaka Miyake, Miwa Nakamura,Tomohiro Sato, Daisuke Sakai, Masaru Matsuoka, Tsuyoshi Otsuji,Hiroyuki Furukawa, Eiji Shinozaki, Hideaki Bando, Takeshi Nishina, Kaoruko Yamazaki,Seijiro Kadowaki, Satoshi Yuki, S Kajiura,Katsuya Tsuchihara, S Fujii, T Yoshino, Shinichiro Kawada, Masato Ishiguro, Hiroyuki Uetake, Tomoko Ishikawa, Yoshiki Kusunoki,Fujihisa Kinoshita, Nobuo Kashiwagi, Y Nagata, Y Matsubara,Kenichi Sugihara, S Khays, K G Mamontov, A G Kotelnikov, S Lazarev, A B Lazarev, M Gizzi, G Pairet, Pierre Lefesvre, V Lannoy, Jeanfrancois Gigot, Benoit Navez,J L Canon,Christine Sempoux,J Carrasco,M Blanco Codesido, J F Wilkerson, L Rodriguez Gayo, M Rodriguez Alonso, P Nava Garcia, A Matas Ochoa, A J Munoz Martin, S Alvarez Suarez, P Garcia Alfonso,Tito Fojo,David Malka, M Faron, Caroline Caramella, Pascual Ramos Rivera,T De Baere,D Goere, J P Pignon,Radek Lakomy,Jana Prausova,Paul Ruff,Vladimir M Moiseyenko, Emmanuelle Boelle,Joseph Mckendrick,Carmen J Allegra, Michael Krebs, S Gollins, Ian Chau, J Hasan, M J Braun, Kevin V Morris, J Beech, G Adaway,Caroline Dive, M P Saunders, C Phuan, C Tan, L Lee,Tin Aung,Chinseng Chua,David W M Tai, H El Mansy, Christopher K Garcia, Laurent Ameye, Seiji Ohigashi, Katsuko Sudo, Hidetoshi Onodera, Dai Kobayashi, Osamu Takahashi,T Takahashi, Takashi Asahara, Koji Nomoto, K Chan, Tam Vuong, P Kavan, T Niazi,Christina A Holcroft, E Ferland, Jeremy Sturgeon, D Melnychuk,T Alcindor,Gerald Batist,Narikazu Boku, Akihiko Gemma, Noboru Yamazaki,Kei Muro, Tomoya Hamaguchi, Hiroshi Ueno, Atsushi Ohtsu, Yusuke Kinugasa,Takeru Shiroiwa,Riichiro Nezu, Shoichi Hazama, Toshio Fukuda,Junichi Sakamoto, Noriko Tomita, Yuansheng Zhong, Dalong Zhu,Nozomu Machida, Y Komatsu, R Oyama, Yoko Yachi, H Onuma, A F Carneiro, J Godinho Bexiga, D Marques, C Faustino, N O Sousa, Maria Iracema Lacerda Machado,Pedro G Ferreira, Ana H Raimundo, R Fragoso,Kazuteru Hatanaka, Takaaki Miyagishima, Masayuki Kudo, Maki Tateyama,Masahiro Asaka, Yoshiharu Sakata, Y Sasaki,Yoshiya Yamada, Yayoi Shimada, Kota Kato, Susumu Iwasa, Yoko Honma, Daniel A Lawrence,Maurizia Del Maschio, S Yunger,Jacob C Easaw, N Aucoin,Milton C Weinstein, Ke Feng Ding, Da Xu, J Li,Young Min Song, J W Wang, F F Sun, J J Zhou, Yingchun Liu, S Z Zhang, Veena Shankaran, David G Mummy, Lisel Koepl, David K Blough,Yeun Mi Yim,Eunsil Yu, Scott D Ramsey, Antonio Martin, Yijun Xu,Kevin Knopf, S Iqbal, J Jassomosqueda, Kazunari Akiyoshi, Y Nagai, Hideaki Yasui, Gota Sakai, Shinya Akatsuka, Ayumu Hosokawa, S Hirai, Kenichi Yoshimura, D Quietzsch, Daniel Oruzio, H T Lambertz, A Schalhorn, C H S Kim, E Curti, T Nguyen,Tristan Maurina, Zaher Lakkis, Bruno Heyd, Erion Dobi, Serge Fratte, B Winkfield, Thomas Boucher, K Alloul, C D Mullins, K Bikov,Eberechukwu Onukwugha, Nader Hanna, B Seal, Maria Salgado, J Montero, M J Devesa,Javier Die Trill, Victor Abraira, Agustin Riquelme, Alfredo Carrato,Francesco Leone, Donato Marino, Salvatore Artale,C Cagnazzo,Stefano Cascinu, A Martoni, A Sobrero, Marco Tampellini, M Aglietta, F Guida, Francesco Pantano,Enrico Vasile, M Rodriguez Garrote, Enrique Grande,Nicola Silvestris,Bruno Vincenzi,Daniele Santini,A Falcone,Gian Paolo Tonini, J F Bosset, G Mantion, F Boudghene,Francoise Piard, F Mornex, P Maingon,A Adenis, Magali Piutti,Arthur Sun Myint, S Susnerwala, D Sebagmontefiori, Stephanie K Beare, E Williams, Nancy A West, M Jitlal, F E Marti Marti, Alison Backen,Andrew G Renehan,Andrew Jackson,P K Manoharan, Ozlem U Ataman,Vinod K Misra,G C Jayson, D J Lucey, Andrew J Murphy, V Curran, Mary P Mccourt, E J Andrews, M Oriordain, D G Power, S Oreilly, Peter J Kelly,Vy Broadbridge, Karen J Pittman, Margaret Colbeck, B Hooper, Jung Gu Kim,Byoung Won Kang, S J Lee, Young Jae Lee,Yee Soo Chae, Joao Casaltalopes, I Nobregois, Tânia Teixeira,Manuel Ruiz Borrego, Priscila Graca Soares, Anabela Sa,Mitsushi Inomata, M Pauly, Alexander Menzel, Melanie Rammer, Holger Rumpold, Hanschristian Bosmuller,Renate Marschon, Theodora Malli, Wolfgang Kranewitter, Martin Erdel, Sabine Deutschbauer,Andreas L Petzer,Gerald Webersinke, S Y You, F Bergamo, G Griguolo, Elisabetta Zulato, Giovanni Esposito, M Nardin, C Mescoli,Massimo Rugge,Vittorina Zagonel, S Lonardi,Stefano Indraccolo, A Zwenger, G Grosman, S Demichellis,Amada Segaleiras,Maria Virginia Croce, F Carneiro, Maria F Fragoso,Mitsuhiro Yokota,Masayasu Kojima, Shinsuke Nomura,Akio Koyama, Masanori Sugito, Masahiro Ito, Atsushi Kobayashi, Yoshiki Nishizawa,Atsushi Ochiai,Nagahito Saito, T J M Ruers,Daniela E Aust, Martin Fuchs, J M Smit, A Victor, Sonia Quaratino,Atsunobu Tsunoda, Yuri Tsunoda, Y Katayose, Junichi Yamauchi, Minako Oikawa, Nozomu Sakurai,Hiroaki Musya, Hideki Shimamura, Katsuya Miura, Keigo Nakagawa, Satoshi Egawa,Michiaki Unno, J Yamamoto, Kazuo Hatsuse,Norihiro Kokudo, Mari S Oba,Teruou Takayama,Shinichi Miyagawa,Yasutsugu Bandai, Katumi Hasegawa,Akio Saiura,Masatoshi Makuuchi, R Schlijper,D De Ruysscher, J P Grutters,Ruud Houben,Annemarie C Dingemans,Joachim E Wildberger,Dirk Van Raemdonck,Guido Lammering,Philippe Lambin,E I Gutierrez Damian, A Sancho Gutierrez, M Arruti, S Carrera,I Rubio, Ines Marrodan, Antonio Serrano Munoz, E Azkona, Aitziber Buque, G Lopezvivanco,Filippo Pietrantonio, Pamela Biondani, Massimo Milione,Francesco Perrone, F G M De Braud, G Bertarelli, Luigi Mariani, Flavia Melotti, G Montemurro,M Di Bartolomeo,Gemma Bruera,Katia Cannita, D Di Giacomo, Aude Lamy, A Dal Mas, Thierry Frebourg,J C Sabourin, Mia Tosi,Corrado Ficorella,Enrico Ricevuto,Evangelia Razis,Mattheos Bobos,W De Roock, M Bai, Anna Gousia,Ioannis Xanthakis,Eleftheria Tsolaki,Pavlos Papakostas,Sabine Tejpar,George Fountzilas,Zacharenia Saridaki, Maria Tzardi,Marita Sfakianaki,Chara Papadaki, K Mpananis, E Tsakalaki,Maria Trypaki,Ippokratis Messaritakis,Vasilis Georgoulias,John Souglakos, O Moulard,Jodhbir S Mehta, S Naoshy, R Olivares, F Joulain, Usman Iqbal, F Diamand, W Y Cheung, M Messina, Emanuele Sinagra, S Dolcimascolo,C A Rizzolo, F Puccia,Filippo Mocciaro, S Marasa, Giovanna Perricone,Davide Bedognetti, D Sinagra, L C M Aquino, M Rossi, P C Val, Miguel Alfonso Oliveira, T Mattacastro, D Herchenhorn, C Duque, Rosario Gil, Benedict Pereira, F G Minear, J Mcgrane,I R Daniels, A S Gee, M S Osborne, M Marshall, E Atif, H Sakr, S Teama, D Zayed, Jiying Zhao,Weihua Zhang, Wei Li,Wei Guo, Shiwei Cai, Mei Sun, Zhiwen Zhang, Q Yu, E Murata, A Stradella, E M Targarona, Weihua Gu, Jianping Cai, C Song, Peiling Chi,Heping Wu,E S Seber,Taner Korkmaz, Kerem Okutur, Gokhan Demir, M D P Solis Hernandez, P Jimenez Fonseca, Q Perez, C Alvarez Fernandez, Laura Ruiz, D Rodriguez Rubi, M L Sanchez, L Faez,Jose Maria Vieitez, B Asselain, H Senellart, B Commenges, M Rouyer, E Francois, Alain Monnereau, Antonio Sacunha, J Jove, P Noize,Nicholas Moore,Annie Fourrierreglat, Zhikui Wang, Liang Zhao, Frank Wang,Yenhung Lin,Yiping Huang, Feng Xu, C Xue, H Zhao,Zhenhui Li,Elena Maccaroni,Riccardo Giampieri,Mario Scartozzi, M Del Prete,Alessandro Bittoni,Luca Faloppi,Maristella Bianconi,Keisei Taku, Kazuko Ohata,Genya Nishikawa, Masataka Watanabe, S Sato, Tetsuya Oshima, Hisashi Hirano, Takayuki Amano,Yasuo Ohashi,Saadettin Kilickap, Ahmet Altun, Nalan Akgul Babacan,Hilmi Ataseven, Tijen Kaya, Goro Nakayama, Kiyoshi Ishigure,Asahiko Ishiyama, Keiichi Uehara,Tatsuzo Fujii,Norio Hayashi,Yukio Ando, Y Kodera, Michael J Overman,Scott Kopetz, Sweeseong Wong, J Tie, Suzanne Kosmider,Ajey P Jacob, Eduardo Vilar,Peter E M Gibbs,Jayesh Desai, B Tran, H Djedi, Kamel Bouzid, Dilek Erdem, Idris Yucel, Burcak Yilmaz, G Demirag, E Kut, Fatih Mehmet Cilingir, Y Kemal, F Teker, T Malheiro Sarmento,Miguel Henriques Abreu, G Kim,Mitesh J Borad,Henry C Pitot, J P Rubin, Jeffrey D Greenberg, P Mccroskery, Robert A Beckman, G Chiritescu, K Dumon,Philippe L Vergauwe, Janine Arts, A Dhoore,Annelies Debucquoy, M Verstraete, Xavier Sagaert,Karin Haustermans,Joaquina Baranda, G B Reed, Samuel J Williamson, E Dickman, M Stoltz, Ritesh Madan, Lisa P Wright,K B Bhalla,Andrew K Godwin,Wolf H Rogowski, B Piko, C Andras, E Molnar
Annals of Oncology（2012）
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摘要
ABSTRACT Introduction Standard chemotherapy is increasingly discontinued after successful “induction” in patients (pts) undergoing 1st line treatment for mCRC. MGN1703 is a synthetic DNA-based immunomodulator acting as an agonist of TLR-9 that has shown preclinical activity in mCRC. This study has been conducted to assess clinical efficacy, immunogenicity, and safety of MGN1703 as maintenance vs. placebo. Methods The IMPACT study is an international, multicenter, randomized double-blind placebo-controlled phase II/III study. Pts with mCRC showing disease control (CR, PR or SD) after 4.5 to 6 months of 1st-line standard therapy with FOLFOX/XELOX or FOLFIRI +/- bevacizumab (investigatoŕs choice) were included. Results Interim analysis of the unblinded data revealed a strong therapeutic effect compared to anticipated PFS. Therefore, patients were withheld from further randomization, according to a decision of the steering committee. In the ITT population (N = 55 pts), hazard ratio (HR) was 0.53 in favor of MGN1703 (p = 0.062). In the per-protocol population (excluding screening failures; N = 50), HR was 0.43 (p = 0.015). In the pre-defined target population (2 out of 3 factors: CEA Conclusions Maintenance therapy with MGN1703 after standard chemotherapy with or without bevacizumab, is associated with significantly improved progression-free survival compared to placebo and is accompanied by low toxicity. A confirmatory clinical study in patients with metastatic CRC is currently being planned. Disclosure M. Tschaika: Employment, stock ownership. M. Schmidt: Employment. B. Wittig: Stock ownership. All other authors have declared no conflicts of interest.
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