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9 results on '"M.A. Fridrik"'

1. A two arm phase II study of FOLFIRI in combination with standard or escalating dose of cetuximab as first line treatment for metastatic colorectal cancer: Everest 2 final results

Author

María Luisa Limón, G. Chiritescu, Sabine Tejpar, M.A. Fridrik, Philippe Vergauwe, T. Macarulla Mercade, Richard Greil, Jozef Janssens, Kristoffel R. Dumon, V. Moons, E. Vanderstraeten, Xavier Sagaert, Fernando Rivera, Koen Hendrickx, Marc Ferrante, E. Van Cutsem, István Láng, J.-L. Van Laethem, M. Van den Eynde, C. Santos Vivas, A. Cervantes, Julien Taieb, M. Pracht, Z. Papai, K. Geboes, and Ewald Wöll

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Cetuximab, business.industry, Colorectal cancer, Phases of clinical research, Hematology, medicine.disease, First line treatment, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, FOLFIRI, Medicine, business, medicine.drug
Published
2018
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3. Oxaliplatin, Irinotecan, Bevacizumab followed by Docetaxel, Bevacizumab in Inoperable Gastric Cancer. A Multicenter Phase II Trial (AGMT Gastric-3) of the Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT)

Author

F. Romeder, Richard Greil, M. Hejna, Wolfgang Eisterer, Ewald Wöll, M.A. Fridrik, Birgit Gruenberger, Felix Keil, and Josef Thaler

Subjects
Chemotherapy, medicine.medical_specialty, Bevacizumab, Cetuximab, business.industry, medicine.medical_treatment, Hematology, Neutropenia, medicine.disease, Gastroenterology, Hypokalemia, Oxaliplatin, Irinotecan, Oncology, Docetaxel, Internal medicine, medicine, medicine.symptom, business, medicine.drug
Abstract

Background In previous phase II trials (AGMT-Gastric-1 and AGMT Gastric-2) we could show efficacy of oxaliplatin and irinotecan as well as oxaliplatin, irinotecan and cetuximab in advanced gastric cancer. Time to progression however was short suggesting acquired chemotherapy resistance. To address this problem sequential chemotherapy combined with bevacizumab is investigated in the presented Gastric-3 trial. Methods Oxaliplatin 85 mg/m2 biweekly (q2w) and irinotecan 125 mg/m2 q2w are administered for the first three months followed by docetaxel 50mg/m2 q2w for subsequent three months. Chemotherapy is combined with bevacizumab 5 mg/kg q2w which is administered until progression. For this abstract 36 pt. with histologically proven unresectable and/or metastatic gastric adenocarcinoma treated in a first line setting have been evaluated. Median age: 62.5 years (range 26-80 years), PS 0: 25 patients, PS 1: 10 patients, missing: 1 patients, single metastatic site: 24 patients, multiple metastases: 10 patients, missing: 2. Results Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included diarrhea (25/36, 69%), polyneuropathy (17/36, 47%), nausea (17/36, 47%), fatigue (15/36, 42%), neutropenia (13/36, 36%), abdominal pain (11/36, 31%), hypokalemia (9/36, 25%). Grade 3 and 4 toxicities included neutropenia (6/36, 17%), diarrhea (3/36, 8%), hypokalemia (3/36, 8%), anemia in (2/36, 6%), leucopenia (2/36, 6%), thrombocytopenia (1/36, 3%), nausea in (1/36, 3%). Weight loss Grade 1 was initially documented in 1/36 pts., (3%). Objective response rate after 3 cycles was available in 25 patients: CR 1/25 (4%), PR 14/25 (56%), SD 8/25 (32%), PD 2/25 (8%). After 6 cycles there were 12 evaluable patients with CR 2/12 (16.7%), PR 5/12 (41.7%), SD 4/12 (33.3%) and PD 1/12 (8.3%). Median time to progression was 24 weeks, median overall survival was 48 weeks. Progression total was 12/36 (33%). Conclusions The combination of oxaliplatin and irinotecan with bevacizumab followed by docetaxel with bevacizumab is feasible and active in advanced gastric cancer. Disclosure All authors have declared no conflicts of interest.

Published
2012
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4. Docetaxel + Trastuzumab +/- Non-Pegylated Liposomal Doxorubicin +/- Bevacizumab in the Neoadjuvant Treatment of Early, Her2-Positive Breast Cancer: First Results of Abcsg-32

Author

Marija Balic, Peter Dubsky, Richard Greil, M.A. Fridrik, A. Lang, Paul Sevelda, Georg Pfeiler, Michael Gnant, A. Petzer, Doris Mayr, S Frantal, Rupert Bartsch, Margaretha Rudas, Gabriel Rinnerthaler, Michael Hubalek, T. Czech, Daniel Egle, Günther G. Steger, Christian F. Singer, and Simon Peter Gampenrieder

Subjects
Oncology, medicine.medical_specialty, Bevacizumab, business.industry, medicine.medical_treatment, Phases of clinical research, Hematology, medicine.disease, Breast cancer, Docetaxel, Trastuzumab, Neoadjuvant treatment, Internal medicine, Medicine, business, Neoadjuvant therapy, Pegfilgrastim, medicine.drug
Abstract

Aim: ABCSG-32 was designed to evaluate the cardiac toxicity of bevacizumab (B) and non-pegylated liposomal doxorubicin (N) when added to docetaxel + trastuzumab (DH) in the neoadjuvant treatment of early, HER2-positive breast cancer (BC) within a randomized phase II trial. Secondary aims were to evaluate the non-cardiac safety and the efficacy of the 4 drug combinations as measured by the rates of pathological complete responses (pCR). Methods: 100 patients (pts) with biopsy-proven, invasive, early, HER2-pos breast cancer were stratified according to major risk factors including estrogen-receptor-status, histology, grading, and center and were randomized to receive 6 cycles (q 21 days) of either D100 mg/m2 + H8/6 mg/kg (DH, n = 25), DH + B15 mg/kg (DHB, n = 25), D75H + N 50 mg/m2 (DHN, n = 26), or D75HN + B 15 mg/m2 (DHNB, n = 24). All pts received pegfilgrastim 6 mg sc on day 2. Left ventricular (LV) ejection fraction (EF) was measured at baseline, before each treatment cycle, and before sugery. A cardiac toxicity event (CTE) was defined as the occurrence of either symptomatic LV dysfunction NYHA II-IV, or an asymptomatic drop of EF (adEF) of >15% from baseline, or an adEF Results: Cardiac toxicity was low with a CTE in only 3 pts (DH: 0, DHB: 1, DHN: 1, DHNB: 1). Non-cardiac toxicity/patient as evaluated by the incidence of serious adverse events (SAE, n = 50) and significant safety events (SSE, n = 114) was acceptable (SAE: DH: 8, DHB: 12, DHN: 14, DHNB: 16; SSE: DH: 23, DHB: 31, DHN: 29, DHNB: 31). No differences in the incidence of non-serious AE and no new safety signals for B and N were detected. In 8 pts the treatment was terminated early (DH: 0, DHB: 3,DHN: 2, DHNB: 3). The overall rate of pCR was 52% (DH: 36%, DHB: 50%, DHN: 63%, DHNB: 62%). Conclusions: Our data show that neoadjuvant DH, DHB, DHN, and DHNB can be safely administered to pts with HER2-positive early BC. Cardiac toxicity is low when 6 cycles are given and non-cardiac toxicity is acceptable but higher during the 3/4-drug combinations leading to the early termination of treatment in some patients. All regimens tested are highly effective with pCR-rates >60% after DHN and DHNB. Disclosure: G.G. Steger: Reseach grants, travel grants, advisory boards, and honoraria from Hoffmann La Roche, Roche Austria, Cephalon, TEVA/Ratiopharm, and Amgen; R. Greil: Research Support and advisory boards from Roche, Amgen, Ratiopharm/Teva, Cephalon; M. Hubalek, M.A. Fridrik, C. Singer, M. Balic, P. Dubsky, D. Mayr, P. Sevelda, A. Lang and S. Frantal: Research grants from Roche Austria, Cephalon, TEVA/Ratiopharm, Amgen; R. Bartsch: Research grants, lecture honoraria, travel support from Roche Austria, lecture honoraria Teva/Ratiopharm; D. Egle: Travel grants and honoraria from Roche Austria and TEVA/Ratiopharm; S.P. Gampenrieder: Research Support and travel Support from Roche and Amgen; G. Pfeiler: Honoraria and travel grants from Novartis, Amgen, Roche Austria; T. Czech: Travel Support from Roche Austria; G. Rinnerthaler: Research Support and travel Support from Roche and Amgen; A.L. Petzer: Research grants from Roche Austria, Cephalon, TEVA/Ratiopharm, Amgen, advisory boards and honoraria from Roche Austria, M. Gnant: Research and travel grants, advisory boards and honoraria from Roche Austria, Cephalon, TEVA/Ratiopharm, Amgen. All other authors have declared no conflicts of interest.

Published
2014
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5. Rituximab Plus Subcutaneous Cladribine in Patients with Extranodal Marginal Zone B-Cell Lymphoma of the Mucosa Associated Tissue (MALT-LYMPHOMA): A Phase II Study by the AGMT (Arbeitsgemeinschaft Medikamentöse Tumortherapie)

Author

M. Troch, Werner Linkesch, Richard Greil, M.A. Fridrik, Ella Willenbacher, Barbara Kiesewetter, A. Zebisch, Leonhard Müllauer, Markus Raderer, and Wolfgang Willenbacher

Subjects
medicine.medical_specialty, Leukopenia, business.industry, Gastric lymphoma, MALT lymphoma, Hematology, medicine.disease, Gastroenterology, Cutaneous lymphoma, Lymphoma, Oncology, Interquartile range, hemic and lymphatic diseases, Internal medicine, Medicine, Rituximab, medicine.symptom, business, Mucosa-associated lymphoid tissue, medicine.drug
Abstract

Background Currently, there is no standard systemic treatment for extranodal marginal zone B-cell lymphoma of the mucosa associated lymphoid tissue (MALT-lymphoma). Both rituximab (R) and 2-chlorodeoxyadenosine (2CdA) have shown activity to some extent in this disease, but the combination has not been tested so far. In view of this, we have initiated a phase II study to assess the activity and safety of R/2CdA in patients with MALT-lymphoma. Patients and methods Patients with histologically verified MALT-lymphoma were included in this study. Treatment consisted of R 375 mg/m2 i.v. day 1 and 2CdA 0.1 mg/kg s.c. days 1 – 4 every 21 days. In case of complete remission (CR) after two courses, another two cycles of therapy were administered, while patients achieving partial response (PR) or stable disease (SD) were scheduled to receive 6 cycles of treatment. Results Out of 40 evaluable patients (14 female, 26 male), 39 received treatment as scheduled while one patient died before initiation of therapy and was rated as PD in the intent to treat analysis. Twenty-one patients had gastric lymphoma, while 19 suffered from extragastric MALT-lymphoma (6 lung, 2 salivary gland, 5 ocular adnexae, 4 intestinal, one breast and one cutaneous lymphoma, respectively). Side effects were manageable and consisted mainly of hematotoxicity including leukopenia, lymphopenia, anemia and thrombocytopenia. Twenty-three patients had a CR (58 %), 9 PR (23%) for an overall reponse rate of 81%, while 5 had SD (13%) and two progressed during therapy. After a median follow-up of 16.7 months (Inter Quartile Range; 15.9 – 18.7months), 35 patients are alive (88 %) while four patients have died (one patient of post-stenotic pneumonia during the follow-up period, one of urosepsis before initiation of therapy, one due to myocardial infarction and one patient due to lymphoma progression) and one patient withdrew consent and did not allow further follow up. Conclusion Our data demonstrate that R plus 2CdA is active and safe in patients with MALT-lymphoma. Disclosure All authors have declared no conflicts of interest.

Published
2012
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6. 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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7. Book Reviews · Buchbesprechnungen

Author

J. Mezger, C. Bokemeyer, B. Kneifel, A. Glasmacher, D. Kämpfe, Y. Ko, C. Haas, P. Brusa-Düwel, H.E. Schaefer, M. Azémar, J. Ritter, W. Willenbacher, W. Hohenberger, H. Bülzebruck, C. Funk, J. Drach, P. Drings, R. Obrist, M. Fiegl, M. Karthaus, T. Sauerbruch, L. Weissbach, E.L. Winnakcer, C. Clemm, N. Zojer, A. Mumm, H.H. Bartsch, H. Jürgens, P. Albers, A. Rüther, S. Rechnitzer, R. Pirker, T. Suedhoff, W.E. Berdel, M.A. Fridrik, B. Thürlimann, H.H. Wolf, J. Göhl, K. Hübel, S. Schmitz, G. Egerer, H. Serve, V. Diehl, U.R. Kleeberg, J. Weis, E. Oelmann, A. Masche, W. Ebert, B. Reufi, M.S. Topp, D. Platz, M. Arning, C. Unger, J.T. Hartmann, C. Penninger, K. Becker, T. Meyer, A. Engert, H. Heidrich, M. Bamberg, R. Souchon, and H. Wolter

Subjects
Cancer Research, Oncology, Hematology
Published
1998
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8. Kongressbericht – Congress Report

Author

H. Hausmaninger, L. Schiller, S.H. Nantel, R. Mertelsmann, N. Hoffmeister, P.M. Schlag, W. Milch, P. Liati, H.P. Werner, M. Marchner, M. Felbermayr, St. Hase, N. Schmitz, W. Kramer, K. Münstedt, H. Dralle, G.A. Nagel, M. Neubauer, L. Edler, C. Gattringer, C.J. Eaves, P. Oppitz, U. Kleeberg, H. Huber, W. Queißer, A.H. Goldstone, H. Vahrson, F.M. Rosenthal, E.D. Kreuser, S. Kerpel-Fronius, K. Küttner, Ch. Reimer, P. Lansdorp, V. Diehl, J.D. Shepherd, M. Zaiac, A. Harstrick, A. Spänle, H.J. Richter, R. Herrmann, S. Seeber, J. Büntzel, G.L. Phillips, D.E. Hogge, C. Eggl, E. Blauth-Eckmeyer, O. Gimm, P. Markmeyer, M. Schön, D.E. Reece, M.J. Barnett, M. Pfreundschuh, M. Engelhard, W. Linkesch, A.C. Eaves, A. Lindemann, K. Mross, R. Becher, M. Freund, H.J. Sutherland, W. Hiddemann, O. Bürstner, H. Wilke, F. Porzsolt, M.A. Fridrik, A. Engert, R. Mayer-Steinacker, W. Land, and H.-G. Klingemann

Subjects
Cancer Research, Oncology, Hematology
Published
1995
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9. Brief an die Herausgeber – Letter to the Editors

Author

E. Blauth-Eckmeyer, G.L. Phillips, A.C. Eaves, A. Lindemann, W. Queißer, H. Huber, A. Spänle, P. Markmeyer, O. Bürstner, W. Kramer, S. Seeber, D.E. Hogge, C. Eggl, J.D. Shepherd, W. Hiddemann, A. Harstrick, O. Gimm, J. Büntzel, C.J. Eaves, M.J. Barnett, H. Hausmaninger, L. Schiller, K. Münstedt, A.H. Goldstone, H. Dralle, M. Schön, H.J. Sutherland, Ch. Reimer, M. Freund, R. Herrmann, M. Pfreundschuh, G.A. Nagel, W. Milch, E.D. Kreuser, U. Kleeberg, P. Liati, W. Linkesch, N. Schmitz, M. Zaiac, H. Wilke, V. Diehl, S. Kerpel-Fronius, M. Felbermayr, D.E. Reece, S.H. Nantel, H.P. Werner, K. Mross, F.M. Rosenthal, P.M. Schlag, P. Oppitz, K. Küttner, St. Hase, R. Becher, P. Lansdorp, L. Edler, M. Engelhard, M.A. Fridrik, F. Porzsolt, R. Mertelsmann, N. Hoffmeister, M. Marchner, M. Neubauer, C. Gattringer, A. Engert, H. Vahrson, H.J. Richter, W. Land, H.-G. Klingemann, and R. Mayer-Steinacker

Subjects
Cancer Research, Oncology, Philosophy, Hematology, Theology, Die (integrated circuit)
Published
1995
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