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51. Nazartinib (EGF816) in patients with treatment-naive EGFR-mutant non-small cell lung cancer (NSCLC): Updated phase II results.

Author

Tan, Daniel Shao-Weng, Leighl, Natasha B., Yang, James Chih-Hsin, Riely, Gregory J., Sequist, Lecia, V, Toyozawa, Ryo, Wolf, Juergen, Felip, Enriqueta, Kim, Sang-We, Aix, Santiago Ponce, Smit, Egbert F., Hida, Toyoaki, Grohe, Christian, Ghebremariam, Samson, O'Sullivan-Djentuh, Leslie, Belli, Riccardo, Giovannini, Monica, Kim, Dong-Wan, Tan, Daniel Shao-Weng, Leighl, Natasha B., Yang, James Chih-Hsin, Riely, Gregory J., Sequist, Lecia, V, Toyozawa, Ryo, Wolf, Juergen, Felip, Enriqueta, Kim, Sang-We, Aix, Santiago Ponce, Smit, Egbert F., Hida, Toyoaki, Grohe, Christian, Ghebremariam, Samson, O'Sullivan-Djentuh, Leslie, Belli, Riccardo, Giovannini, Monica, and Kim, Dong-Wan

Published
2020

52. Survival and course of lung function in the presence or absence of antifibrotic treatment in patients with idiopathic pulmonary fibrosis: long-term results of the INSIGHTS-IPF registry

Author

Behr, Juergen, Prasse, Antje, Wirtz, Hubert, Koschel, Dirk, Pittrow, David, Held, Matthias, Klotsche, Jens, Andreas, Stefan, Claussen, Martin, Grohe, Christian, Wilkens, Henrike, Hagmeyer, Lars, Skowasch, Dirk, Meyer, Joachim F., Kirschner, Joachim, Glaeser, Sven, Kahn, Nicolas, Welte, Tobias, Neurohr, Claus, Schwaiblmair, Martin, Bahmer, Thomas, Oqueka, Tim, Frankenberger, Marion, Kreuter, Michael, Behr, Juergen, Prasse, Antje, Wirtz, Hubert, Koschel, Dirk, Pittrow, David, Held, Matthias, Klotsche, Jens, Andreas, Stefan, Claussen, Martin, Grohe, Christian, Wilkens, Henrike, Hagmeyer, Lars, Skowasch, Dirk, Meyer, Joachim F., Kirschner, Joachim, Glaeser, Sven, Kahn, Nicolas, Welte, Tobias, Neurohr, Claus, Schwaiblmair, Martin, Bahmer, Thomas, Oqueka, Tim, Frankenberger, Marion, and Kreuter, Michael

Abstract

Objective: There is a paucity of observational data on antifibrotic therapy for idiopathic pulmonary fibrosis (IPF). We aimed to assess the course of disease of IPF patients with and without antifibrotic therapy under real-life conditions. Methods: We analysed data from a non-interventional, prospective cohort study of consecutively enrolled IPF patients from 20 interstitial lung disease expert centres in Germany. Data quality was ensured by automated plausibility checks, on-site monitoring, and source data verification. Propensity scores were applied to account for known differences in baseline characteristics between patients with and without antifibrotic therapy. Results: Among the 588 patients suitable for analysis, the mean +/- so age was 69.8 +/- 9.1 years, and 81.0% were male. The mean +/- so duration of disease since diagnosis was 1.8 +/- 3.4 years. The mean +/- SD value at baseline for forced vital capacity (FVC) and diffusion capacity (D-LCO) were 68.6 +/- 18.8% predicted and 37.8 +/- 18.5% predicted, respectively. During a mean +/- so follow-up of 1.2 +/- 0.7 years, 194 (33.0%) patients died. The 1-year and 2-year survival rates were 87% versus 46% and 62% versus 21%, respectively, for patients with versus without antifibrotic therapy. The risk of death was 37% lower in patients with antifibrotic therapy (hazard ratio 0.63, 95% CI 0.45; 0.87; p=0.005). The results were robust (and remained statistically significant) on multivariable analysis. Overall decline of FVC and D-LCO was slow and did not differ significantly between patients with or without antifibrotic therapy. Conclusions: Survival was significantly higher in IPF patients with antifibrotic therapy, but the course of lung function parameters was similar in patients with and without antifibrotic therapy. This su vests that in clinical practice, premature mortality of IPF patients eventually occurs despite stable measurements for FVC and D-LCO.

Published
2020

53. Safety run-in results from phase 3 study of canakinumab (CAN) or placebo in combination with pembrolizumab (PEM) plus platinum based doublet chemotherapy (Ctx) as 1st line therapy in patients (pts) with advanced or metastatic NSCLC (CANOPY-1)

Author

Johnson, Bruce E., Kim, Tae Min, Hiltermann, T. Jeroen N., Barlesi, Fabrice, Grohe, Christian, Goto, Yasushi, Gunnarsson, Orvar, Overbeck, Tobias, Reguart, Noemi, Wermke, Martin, Castro, Gilberto, Felip, Enriqueta, Greystoke, Alastair, Solomon, Benjamin J., Nebot, Noelia, Deudon, Stephanie, Louveau, Anne-Laure, Passos, Vanessa Q., Tan, Daniel S. W., and Translational Immunology Groningen (TRIGR)

Published
2019

54. Durvalumab, with or without tremelimumab, plus platinum–etoposide versus platinum–etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial

Author

Goldman, Jonathan W, primary, Dvorkin, Mikhail, additional, Chen, Yuanbin, additional, Reinmuth, Niels, additional, Hotta, Katsuyuki, additional, Trukhin, Dmytro, additional, Statsenko, Galina, additional, Hochmair, Maximilian J, additional, Özgüroğlu, Mustafa, additional, Ji, Jun Ho, additional, Garassino, Marina Chiara, additional, Voitko, Oleksandr, additional, Poltoratskiy, Artem, additional, Ponce, Santiago, additional, Verderame, Francesco, additional, Havel, Libor, additional, Bondarenko, Igor, additional, Każarnowicz, Andrzej, additional, Losonczy, György, additional, Conev, Nikolay V, additional, Armstrong, Jon, additional, Byrne, Natalie, additional, Thiyagarajah, Piruntha, additional, Jiang, Haiyi, additional, Paz-Ares, Luis, additional, Voitko, Nataliia, additional, Kazarnowicz, Andrzej, additional, Özgüroglu, Mustafa, additional, Conev, Nikolay, additional, Hochmair, Maximilian, additional, Burghuber, Otto, additional, Çiçin, Irfan, additional, Moiseenko, Vladimir, additional, Erman, Mustafa, additional, Kowalski, Dariusz, additional, Wojtukiewicz, Marek, additional, Adamchuk, Hryhoriy, additional, Vasilyev, Alexander, additional, Shevnia, Serhii, additional, Valev, Spartak, additional, Insa Molla, Maria Amelia, additional, Ursol, Grygorii, additional, Chiang, Anne, additional, Hartl, Sylvia, additional, Horváth, Zsolt, additional, Pajkos, Gábor, additional, Kim, Sang-We, additional, Smolin, Alexey, additional, Göksel, Tuncay, additional, Dakhil, Shaker, additional, Roubec, Jaromir, additional, Bogos, Krisztina, additional, Cornelissen, Robin, additional, Lee, Jong-Seok, additional, Garcia Campelo, Maria Rosario, additional, Lopez Brea, Marta, additional, Alacacioglu, Ahmet, additional, Casarini, Ignacio, additional, Ilieva, Rumyana, additional, Tonev, Ivan, additional, Somfay, Attila, additional, Bar, Jair, additional, Zer Kuch, Alona, additional, Minelli, Mauro, additional, Bartolucci, Roberta, additional, Roila, Fausto, additional, Saito, Haruhiro, additional, Azuma, Koichi, additional, Lee, Gyeong-Won, additional, Luft, Alexander, additional, Urda, Michal, additional, Delgado Mingorance, Juan Ignacio, additional, Majem Tarruella, Margarita, additional, Spigel, David, additional, Koynov, Krassimir, additional, Zemanova, Milada, additional, Panse, Jens, additional, Schulz, Christian, additional, Pápai Székely, Zsolt, additional, Sárosi, Veronika, additional, Delmonte, Angelo, additional, Bettini, Anna Cecilia, additional, Nishio, Makoto, additional, Okamoto, Isamu, additional, Hendriks, Lizza, additional, Mandziuk, Slawomir, additional, Lee, Yun Gyoo, additional, Vladimirova, Lyubov, additional, Isla Casado, Dolores, additional, Domine Gomez, Manuel, additional, Navarro Mendivil, Alejandro, additional, Morán Bueno, Teresa, additional, Wu, Shang-Yin, additional, Knoble, Jeanna, additional, Skrickova, Jana, additional, Venkova, Violetka, additional, Hilgers, Werner, additional, Laack, Eckart, additional, Bischoff, Helge, additional, Fülöp, Andrea, additional, Laczó, Ibolya, additional, Kósa, Judit, additional, Telekes, András, additional, Yoshida, Tatsuya, additional, Kanda, Shintaro, additional, Hida, Toyoaki, additional, Hayashi, Hidetoshi, additional, Maeda, Tadashi, additional, Kawamura, Tetsuji, additional, Nakahara, Yasuharu, additional, Claessens, Niels, additional, Lee, Ki Hyeong, additional, Chiu, Chao-Hua, additional, Lin, Sheng-Hao, additional, Li, Chien-Te, additional, Demirkazik, Ahmet, additional, Schaefer, Eric, additional, Nikolinakos, Petros, additional, Schneider, Jeffrey, additional, Babu, Sunil, additional, Lamprecht, Bernd, additional, Studnicka, Michael, additional, Fausto Nino Gorini, Carlos, additional, Kultan, Juraj, additional, Kolek, Vitezslav, additional, Souquet, Pierre-Jean, additional, Moro-Sibilot, Denis, additional, Gottfried, Maya, additional, Smit, Egbert, additional, Lee, Kyung Hee, additional, Kasan, Peter, additional, Chovanec, Jozef, additional, Goloborodko, Olexandr, additional, Kolesnik, Oleksii, additional, Ostapenko, Yuriy, additional, Lakhanpal, Shailendra, additional, Haque, Basir, additional, Chua, Winston, additional, Stilwill, Joseph, additional, Sena, Susana Noemi, additional, Girotto, Gustavo Colagiovanni, additional, De Marchi, Pedro Rafael Martins, additional, Martinelli de Oliveira, Fabricio Augusto, additional, Dos Reis, Pedro, additional, Krasteva, Rositsa, additional, Zhao, Yanqiu, additional, Chen, Chengshui, additional, Koubkova, Leona, additional, Robinet, Gilles, additional, Chouaid, Christos, additional, Grohe, Christian, additional, Alt, Jürgen, additional, Csánky, Eszter, additional, Somogyiné Ezer, Éva, additional, Heching, Norman Isaac, additional, Kim, Young Hak, additional, Aatagi, Shinji, additional, Kuyama, Shoichi, additional, Harada, Daijiro, additional, Nogami, Naoyuki, additional, Nokihara, Hiroshi, additional, Goto, Hisatsugu, additional, Staal van den Brekel, Agnes, additional, Cho, Eun Kyung, additional, Kim, Joo-Hang, additional, Ganea, Doina, additional, Ciuleanu, Tudor, additional, Popova, Ekaterina, additional, Sakaeva, Dina, additional, Stresko, Marian, additional, Demo, Pavol, additional, Godal, Robert, additional, Wei, Yu-Feng, additional, Chen, Yen-Hsun, additional, Hsia, Te-Chun, additional, Lee, Kang-Yun, additional, Chang, Huang-Chih, additional, Wang, Chin-Chou, additional, Dowlati, Afshin, additional, Sumey, Christopher, additional, Powell, Steven, additional, Goldman, Jonathan, additional, Zarba, Juan Jose, additional, Batagelj, Emilio, additional, Pastor, Andrea Viviana, additional, Zukin, Mauro, additional, Baldotto, Clarissa Serodio da Rocha, additional, Schlittler, Luis Alberto, additional, Calabrich, Aknar, additional, Sette, Claudia, additional, Dudov, Asen, additional, Zhou, Caicun, additional, Lena, Hervé, additional, Lang, Susanne, additional, Pápai, Zsuzsanna, additional, Goto, Koichi, additional, Umemura, Shigeki, additional, Kanazawa, Kenya, additional, Hara, Yu, additional, Shinoda, Masahiro, additional, Morise, Masahiro, additional, Hiltermann, Jeroen, additional, Mróz, Robert, additional, Ungureanu, Andrei, additional, Andrasina, Igor, additional, Chang, Gee-Chen, additional, Vynnychenko, Ihor, additional, Shparyk, Yaroslav, additional, Kryzhanivska, Anna, additional, Ross, Helen, additional, Mi, Kailhong, additional, Jamil, Rodney, additional, Williamson, Michael, additional, Spahr, Joseph, additional, Han, Zhigang, additional, Wang, Mengzhao, additional, Yang, Zhixiong, additional, Hu, Jie, additional, Li, Wei, additional, Zhao, Jun, additional, Feng, Jifeng, additional, Ma, Shenglin, additional, Zhou, Xiangdong, additional, Liang, Zongan, additional, Hu, Yi, additional, Chen, Yuan, additional, Bi, Minghong, additional, Shu, Yongqian, additional, Nan, Kejun, additional, Zhou, Jianying, additional, Zhang, Wei, additional, Ma, Rui, additional, Yang, Nong, additional, Lin, Zhong, additional, Wu, Gang, additional, Fang, Jian, additional, Zhang, Helong, additional, Wang, Kai, additional, and Chen, Zhendong, additional

Published
2021
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57. Increasing myocardial contraction and blood pressure in C57BL/6 mice during early postnatal development

Author

Tiemann, Klaus, Weyer, Dirk, Djoufack, P. Chryso, Ghanem, Alexander, Lewalter, Thorsten, Dreiner, Ulrike, Meyer, Rainer, Grohe, Christian, and Fink, Klaus B.

Subjects
Physiology -- Research, Cardiovascular diseases -- Models, Electrocardiogram -- Research, Electrocardiography, Biological sciences
Abstract

Knowledge of the developmental changes of cardiovascular parameters in the genetic background of a mouse strain is important for understanding phenotypic changes in transgenic or knockout mouse models for heart disease. We studied arterial blood pressure and myocardial contractility in mice of the common background strain C57BL/6, aged 21 days [postnatal day 21 (P21)] to 580 days. Heart rate increased during maturation from 396 beats/min at P21 to 551 beats/min at postnatal day 50 (P50), and mean arterial blood pressure increased in parallel from 86 to 110 mmHg and remained constant afterward. Echocardiographically determined left ventricular myocardial wall dimensions (R = 0.79, P < 0.0001) and left ventricular mass calculated using the area-length algorithm correlated strongly with histomorphometrical measurements (R = 0.93, P < 0.001). Sarcomere shortening records from isolated ventricular myocytes used as a measure for myocardial contractility revealed a negative shortening-frequency relation under a pacing frequency of 2 Hz and a positive relation above 2 Hz. Shortening amplitudes recorded from P21 myocytes were smaller, and the shortening-frequency relation was less steep than in adult myocytes. A stimulation pause was followed by a negative 'staircase' at pacing frequency of [less than or equal to] 6 Hz and a positive staircase at [greater than or equal to] 6 Hz. P21 myocytes developed positive staircases at 8 and 10 Hz, and adult myocytes also developed them at 6 Hz. Blood pressure increase during maturation until P50 may originate from increasing single cardiomyocyte contractility. cardiovascular disease models; electrocardiography; echocardiography; sarcomere shortening

Published
2003

58. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia

Author

File, Thomas M., Jr, Low, Donald E., Eckburg, Paul B., Talbot, George H., Friedland, H. David, Lee, Jon, Llorens, Lily, Critchley, Ian A., Thye, Dirk A., Pullman, John, Giordano, Philip, Welker, James, Manos, Paul, Mehra, Purvi, File, Thomas, Jr, De Santo, Joseph, Venkateswaralu, Bhaskar, Gerald Schrock, Christian, Tillis, William, Winetz, Jan Alan, Gonzalez, J. Mario, Ramage, Anthony, Eisenhower, Dwight D., Koegelenberg, Coenie, Engelbrecht, Ingrid, Jurgens, Jaco, Mitha, Ishmail, Breedt, Johannes, Gani, Mashra, Roos, Johannes, Basson, Matthys, Van Zyl, Louis, Meeding, Ronel, Fulat, Muhammed, Le Roux, Marius, Bonvehi, Pablo Eduardo, Ganaha, Maria Cristina, Gurini, Ana Leticia, Daniel Lopardo, Gustavo, Cristina, Lucia, Edwardo Prieto, Sergio, Rodiguez, Claudia Gabriela, Augusto Teijeiro, Ricardo, Carmen Pallone, Elida, Pryluka, Daniel Horacio, da Cunha, Clovis Arns, da Silva, Nilton Brandao, de Faria Freire, Antonio Tarcisio, Ferreira Starling, Carlos Ernesto, Costa Fiterman, Jussara, Góngora Rubio, Fernando, Carlos Losso, Luis, Patelli, Maria, Souza Lima, Juliani, Zimermann Teixeira, Paulo José, Carmo Moreira, Maria Auxiliadora, Abreu de Oliveira, Julio César, Roudas, Vsevolod, Gamal, Evgeny A., Leschenko, Igor, Rudnov, Vladimir A., Yevdokimova, Anna G., Vertkin, Arkadiy L., Ambalov, Yuriy M., Dvoryashina, Irina V., Zilber, Elmira, Khamitov, Rustem F., Galustyan, Anna N., Reshetko, Olga V., Senior, Victoria Arama, Grosan, Mihaela Flavia, Jimborean, Gabriela, Lupse, Mihaela, Aron, Gheorgita, Olteanu, Dan, Puschita, Maria, Gavris, Claudia, Tudorache, Voicu Mircea, Youroukova, Vania, Petkova, Mila, Troshanova, Evelina, Dzhabalyan, Mari, Kavtaradze, George, Makhviladze, Manana, Tabukashvili, Revaz, Pons, Marco, Garbino, Jorge, Genne, Daniel, Rothen, Madeleine, de Saracho, Juan Oriz, Capelastegui, Alberto, Menendez, Rosario, Torres, Antoni, Shum, Conrado, Falco, Vincenç, Bouza, Emilio, Bru, Jean-Pierre, Misset, Benoit, Megarbane, Bruno, Sollet, Jean Pierre, Molina, Jean-Michel, Dalhoff, Klaus, Lorenz, Joachim, Petermann, Wolfgang, Rohde, Gernot, Schumann, Christian, Tasci, Selcuk, Zerbst, Joachim, Auch-Schwelk, Wolfgang, Suttorp, Norbert, Henrich, Rolf, Fertl, Andreas, Grohe, Christian, Jakobeit, Christian, Deppermann, Karl-Matthius, Batura-Gabryel, Halina, Pupek-Musialik, Danuta, Piotrowicz, Pawe, Marcisz, Czeslaw, Czarnobilski, Krzysztof, Jankowska, Renata, Janik, Krzysztof, Gutowska-Jablonska, Malgorzata, Hamankiewicz, Maciej, Kus, Jan, Rydzewski, Andrzej, Dulawa, Jan, Ziolko, Ewa, Baranska, Eliza, Wendland, Marian, Trebas-Pietras, Ewa, Tyszkiewic, Ireneusz, Bonelli, Johannes, Balikó, Zoltán, Bisits, Márta, Losonczy, Gyorgy, Mark, Zsuzsa, Albert, Istvan, Francovszky, Eva, Fonay, Karoly, Tetiana Pertseva, Tetiana, Yefimov, Volodymyr, Havrysyuk, Volodymyr, Melnyk, Vasyl, Yashyna, Lyudmyla, Monogarova, Nadiya, Kolchyn, Yuriy, Dutka, Roman, Smolyanyi, Oleksandr, Tryshchuk, Nadiya, Kaydashev, Igor, Rodionova, Victoria, Neyko, Vasyl, Chopey, Ivan, Alekniene, Birute, Kramilius, Ginataras, Naudziunas, Stanislovas, Miliauskas, Skaidrius, Nausediene, Vitalija, Valavicius, Arvydas, Mitic-Milikic, Marija, Celeketic, Dusica, Lazic, Zorica, Milinic, Nikola, Pejcic, Tatjana, Sukles, Kai, Jaanus, Martti, Meriste, Sulev, Ahmad Mahayiddin, Datin Hjh Aziah, Bin Abdul Muttalif, Abdul Pazak, Kuang Kiat, Kiew, Binte, Roslina, Manap, Abdul, bt Tarekh, Noor Aliza, Anekthananon, Thanomsak, Mootsikapun, Piroon, Intalapaporn, Poj, Pothirat, Chaicharn, Horsin, Pinyo, Churchottaworn, Charoen, Wattanathum, Anan, Dukat, Andrej, and Plutinsky, Jan

Published
2011
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59. Osimertinib in ResectedEGFR-Mutated Non–Small-Cell Lung Cancer

Author

Wu, Yi-Long, primary, Tsuboi, Masahiro, additional, He, Jie, additional, John, Thomas, additional, Grohe, Christian, additional, Majem, Margarita, additional, Goldman, Jonathan W., additional, Laktionov, Konstantin, additional, Kim, Sang-We, additional, Kato, Terufumi, additional, Vu, Huu-Vinh, additional, Lu, Shun, additional, Lee, Kye-Young, additional, Akewanlop, Charuwan, additional, Yu, Chong-Jen, additional, de Marinis, Filippo, additional, Bonanno, Laura, additional, Domine, Manuel, additional, Shepherd, Frances A., additional, Zeng, Lingmin, additional, Hodge, Rachel, additional, Atasoy, Ajlan, additional, Rukazenkov, Yuri, additional, and Herbst, Roy S., additional

Published
2020
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60. Abstract CT214: CANOPY-1: Safety run-in results from phase (ph) 3 study of canakinumab (CAN) or placebo (PBO) in combination (comb) with pembrolizumab (PEM) plus platinum-based doublet chemotherapy (Ctx) as 1st line therapy in patients (pts) with advanced or metastatic NSCLC

Author

Johnson, Bruce E., primary, Kim, Tae Min, additional, Hiltermann, T. Jeroen N., additional, Barlesi, Fabrice, additional, Grohe, Christian, additional, Goto, Yasushi, additional, Gunnarsson, Orvar, additional, Overbeck, Tobias, additional, Reguart, Noemi, additional, Wermke, Martin, additional, Castro, Gilberto Castro, additional, Felip, Enriqueta, additional, Greystoke, Alastair, additional, Solomon, Benjamin J., additional, Deudon, Stephanie, additional, Louveau, Anne-Laure, additional, Passos, Vanessa, additional, and Tan, Daniel SW, additional

Published
2020
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61. Abstract C100: Safety run-in results from phase 3 study of canakinumab (CAN) or placebo in combination with pembrolizumab (PEM) plus platinum-based doublet chemotherapy (Ctx) as 1stline therapy in patients (pts) with advanced or metastatic NSCLC (CANOPY-1)

Author

Johnson, Bruce E., primary, Kim, Tae Min, additional, Hiltermann, T. Jeroen N., additional, Barlesi, Fabrice, additional, Grohe, Christian, additional, Goto, Yasushi, additional, Gunnarsson, Orvar, additional, Overbeck, Tobias, additional, Reguart, Noemi, additional, Wermke, Martin, additional, Castro, Gilberto, additional, Felip, Enriqueta, additional, Greystoke, Alastair, additional, Solomon, Benjamin J., additional, Nebot, Noelia, additional, Deudon, Stephanie, additional, Louveau, Anne-Laure, additional, Passos, Vanessa Q., additional, and Tan, Daniel SW, additional

Published
2019
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62. Nintedanib plus docetaxel after progression on immune checkpoint inhibitor therapy: insights from VARGADO, a prospective study in patients with lung adenocarcinoma

Author

Grohe, Christian, Gleiber, Wolfgang, Haas, Siegfried, Losem, Christoph, Mueller-Huesmann, Harald, Schulze, Mathias, Franke, Christian, Basara, Nadezda, Atz, Judith, and Kaiser, Rolf

Subjects
ddc:610
Abstract

Aim: To assess outcomes in patients with advanced adenocarcinoma non-small-cell lung cancer who received nintedanib plus docetaxel after progression on prior chemotherapy followed by immune checkpoint inhibitor (ICI) therapy. Patients & methods: VARGADO is a prospective, noninterventional study. We describe initial data from a cohort of 22 patients who received nintedanib plus docetaxel after chemotherapy and ICI therapy. Results: Median progression-free survival with nintedanib plus docetaxel was 5.5 months (95% CI: 1.9–8.7 months). The objective response rate was 7/12 (58%) and the disease control rate was 10/12 (83%). Data for overall survival rate 12 months after the start of treatment (primary end point) are not yet mature and are not reported. Of 22 patients, 73% experienced drug-related adverse events; adverse events led to treatment discontinuation in 32% of patients. Conclusion: These data highlight the potential clinical benefit of nintedanib plus docetaxel in patients who failed prior ICI therapy. Trial registration number: NCT02392455

Published
2019

64. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial

Author

Paz-Ares, Luis, primary, Dvorkin, Mikhail, additional, Chen, Yuanbin, additional, Reinmuth, Niels, additional, Hotta, Katsuyuki, additional, Trukhin, Dmytro, additional, Statsenko, Galina, additional, Hochmair, Maximilian J, additional, Özgüroğlu, Mustafa, additional, Ji, Jun Ho, additional, Voitko, Oleksandr, additional, Poltoratskiy, Artem, additional, Ponce, Santiago, additional, Verderame, Francesco, additional, Havel, Libor, additional, Bondarenko, Igor, additional, Kazarnowicz, Andrzej, additional, Losonczy, György, additional, Conev, Nikolay V, additional, Armstrong, Jon, additional, Byrne, Natalie, additional, Shire, Norah, additional, Jiang, Haiyi, additional, Goldman, Jonathan W, additional, Batagelj, Emilio, additional, Casarini, Ignacio, additional, Pastor, Anea Viviana, additional, Sena, Susana Noemi, additional, Zarba, Juan Jose, additional, Burghuber, Otto, additional, Hartl, Sylvia, additional, Lamprecht, Bernd, additional, Studnicka, Michael, additional, Alberto Schlittler, Luis, additional, Augusto Martinelli de Oliveira, Fabricio, additional, Calabrich, Aknar, additional, Colagiovanni Girotto, Gustavo, additional, Dos Reis, Peo, additional, Fausto Nino Gorini, Carlos, additional, Rafael Martins De Marchi, Peo, additional, Serodio da Rocha Baldotto, Clarissa, additional, Sette, Claudia, additional, Zukin, Mauro, additional, Dudov, Assen, additional, Ilieva, Rumyana, additional, Koynov, Krassimir, additional, Krasteva, Rositsa, additional, Tonev, Ivan, additional, Valev, Spartak, additional, Venkova, Violetka, additional, Bi, Minghong, additional, Chen, Chengshui, additional, Chen, Yuan, additional, Chen, Zhendong, additional, Fang, Jian, additional, Feng, Jifeng, additional, Han, Zhigang, additional, Hu, Jie, additional, Hu, Yi, additional, Li, Wei, additional, Liang, Zongan, additional, Lin, Zhong, additional, Ma, Rui, additional, Ma, Shenglin, additional, Nan, Kejun, additional, Shu, Yongqian, additional, Wang, Kai, additional, Wang, Mengzhao, additional, Wu, Gang, additional, Yang, Nong, additional, Yang, Zhixiong, additional, Zhang, Helong, additional, Zhang, Wei, additional, Zhao, Jun, additional, Zhao, Yanqiu, additional, Zhou, Caicun, additional, Zhou, Jianying, additional, Zhou, Xiangdong, additional, Kolek, Vitezslav, additional, Koubkova, Leona, additional, Roubec, Jaromir, additional, Skrickova, Jana, additional, Zemanova, Milada, additional, Chouaid, Christos, additional, Hilgers, Werner, additional, Lena, Hervé, additional, Moro-Sibilot, Denis, additional, Robinet, Gilles, additional, Souquet, Pierre-Jean, additional, Alt, Jürgen, additional, Bischoff, Helge, additional, Grohe, Christian, additional, Laack, Eckart, additional, Lang, Susanne, additional, Panse, Jens, additional, Schulz, Christian, additional, Bogos, Krisztina, additional, Csánky, Eszter, additional, Fülöp, Anea, additional, Horváth, Zsolt, additional, Kósa, Judit, additional, Laczó, Ibolya, additional, Pajkos, Gábor, additional, Pápai, Zsuzsanna, additional, Pápai Székely, Zsolt, additional, Sárosi, Veronika, additional, Somfay, Attila, additional, Somogyiné Ezer, Éva, additional, Telekes, Anás, additional, Bar, Jair, additional, Gottfried, Maya, additional, Heching, Norman Isaac, additional, Zer Kuch, Alona, additional, Bartolucci, Roberta, additional, Bettini, Anna Cecilia, additional, Delmonte, Angelo, additional, Garassino, Marina Chiara, additional, Minelli, Mauro, additional, Roila, Fausto, additional, Atagi, Shinji, additional, Azuma, Koichi, additional, Goto, Hisatsugu, additional, Goto, Koichi, additional, Hara, Yu, additional, Hayashi, Hidetoshi, additional, Hida, Toyoaki, additional, Kanazawa, Kenya, additional, Kanda, Shintaro, additional, Kim, Young Hak, additional, Kuyama, Shoichi, additional, Maeda, Tadashi, additional, Morise, Masahiro, additional, Nakahara, Yasuharu, additional, Nishio, Makoto, additional, Nogami, Naoyuki, additional, Okamoto, Isamu, additional, Saito, Haruhiro, additional, Shinoda, Masahiro, additional, Umemura, Shigeki, additional, Yoshida, Tatsuya, additional, Claessens, Niels, additional, Cornelissen, Robin, additional, Heniks, Lizza, additional, Hiltermann, Jeroen, additional, Smit, Egbert, additional, Staal van den Brekel, Agnes, additional, Kowalski, Dariusz, additional, Mańdziuk, Slawomir, additional, Mróz, Robert, additional, Wojtukiewicz, Marek, additional, Ciuleanu, Tudor, additional, Ganea, Doina, additional, Ungureanu, Anei, additional, Luft, Alexander, additional, Moiseenko, Vladimir, additional, Sakaeva, Dina, additional, Smolin, Alexey, additional, Vasilyev, Alexander, additional, Vladimirova, Lyubov, additional, Anasina, Igor, additional, Chovanec, Jozef, additional, Demo, Pavol, additional, Godal, Robert, additional, Kasan, Peter, additional, Stresko, Marian, additional, Urda, Michal, additional, Cho, Eun Kyung, additional, Kim, Joo-Hang, additional, Kim, Sang-We, additional, Lee, Gyeong-Won, additional, Lee, Jong-Seok, additional, Lee, Ki Hyeong, additional, Lee, Kyung Hee, additional, Lee, Yun Gyoo, additional, Amelia Insa Molla, Maria, additional, Domine Gomez, Manuel, additional, Ignacio Delgado Mingorance, Juan, additional, Isla Casado, Dolores, additional, Lopez Brea, Marta, additional, Majem Tarruella, Margarita, additional, Morán Bueno, Teresa, additional, Navarro Mendivil, Alejano, additional, Paz-Ares Rodríguez, Luis, additional, Ponce Aix, Santiago, additional, Rosario Garcia Campelo, Maria, additional, Chang, Gee-Chen, additional, Chen, Yen-Hsun, additional, Chiu, Chao-Hua, additional, Hsia, Te-Chun, additional, Lee, Kang-Yun, additional, Li, Chien-Te, additional, Wang, Chin-Chou, additional, Wei, Yu-Feng, additional, Wu, Shang-Yin, additional, Alacacıoğlu, Ahmet, additional, Çiçin, Irfan, additional, Demirkazik, Ahmet, additional, Erman, Mustafa, additional, Göksel, Tuncay, additional, Adamchuk, Hryhoriy, additional, Kolesnik, Oleksii, additional, Kryzhanivska, Anna, additional, Ostapenko, Yuriv, additional, Shevnia, Serhii, additional, Shparyk, Yaroslav, additional, Ursol, Grygorii, additional, Voitko, Nataliia, additional, Vynnychenko, Ihor, additional, Babu, Sunil, additional, Chiang, Anne, additional, Chua, Winston, additional, Dakhil, Shaker, additional, Dowlati, Afshin, additional, Haque, Basir, additional, Jamil, Rodney, additional, Knoble, Jeanna, additional, Lakhanpal, Shailena, additional, Mi, Kailhong, additional, Nikolinakos, Petros, additional, Powell, Steven, additional, Ross, Helen, additional, Schaefer, Eric, additional, Schneider, Jeffrey, additional, Spahr, Joseph, additional, Spigel, David, additional, Stilwill, Joseph, additional, Sumey, Christopher, additional, and Williamson, Michael, additional

Published
2019
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65. Late Breaking Abstract - Exploring Efficacy and Safety of oral Pirfenidone for progressive, non-IPF Lung Fibrosis (RELIEF)

Author

Guenther, Andreas, primary, Prasse, Antje, additional, Kreuter, Michael, additional, Neuser, Petra, additional, Rabe, Klaus, additional, Bonella, Francesco, additional, Bonnet, Reiner, additional, Grohe, Christian, additional, Held, Matthias, additional, Wilkens, Heinrike, additional, Hammerl, Peter, additional, Koschel, Dirk, additional, Blaas, Stefan, additional, Wirtz, Hubert, additional, Ficker, Joachim, additional, Neumeister, Wolfgang, additional, Schönfeld, Nicolaus, additional, Claussen, Martin, additional, Kneidinger, Nikolaus, additional, Frankenberger, Marion, additional, Hummler, Simone, additional, Kahn, Nicolas, additional, Tello, Silke, additional, Freise, Julia, additional, Welte, Tobias, additional, Schade-Brittinger, Carmen, additional, and Behr, Jürgen, additional

Published
2019
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66. Crizotinib in patients with advanced or metastatic ROS1-rearranged lung cancer (EUCROSS): A European phase II clinical trial–Updated report on progression-free and overall survival.

Author

Michels, Sebastian Yves Friedrich, primary, Franklin, Jeremy, additional, Massuti, Bartomeu, additional, Sebastian, Martin, additional, Schildhaus, Hans-Ulrich, additional, Felip, Enriqueta, additional, Grohe, Christian, additional, Rodriguez-Abreu, Delvys, additional, Bischoff, Helge, additional, Carcereny, Enric, additional, Corral, Jesús, additional, Dingemans, Anne-Marie C., additional, Insa, Amelia, additional, Reck, Martin, additional, Rothschild, Sacha, additional, Smit, Egbert F., additional, Provencio, Mariano, additional, Büttner, Reinhard, additional, Rosell, Rafael, additional, and Wolf, Juergen, additional

Published
2019
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68. Preliminary Phase II results of a multicenter, open-label study of nazartinib (EGF816) in adult patients with treatment-naive EGFR-mutant non-small cell lung cancer (NSCLC).

Author

Kim, Dong-Wan, Tan, Daniel Shao-Weng, Aix, Santiago Ponce, Sequist, Lecia V., Smit, Egbert F., Hida, Toyoaki, Yang, James Chih-Hsin, Felip, Enriqueta, Seto, Takashi, Grohe, Christian, Wolf, Juergen, Ko, Jinnie, Diallo, Mariama, Pultar, Philippe, Giovannini, Monica, Kim, Sang-We, Kim, Dong-Wan, Tan, Daniel Shao-Weng, Aix, Santiago Ponce, Sequist, Lecia V., Smit, Egbert F., Hida, Toyoaki, Yang, James Chih-Hsin, Felip, Enriqueta, Seto, Takashi, Grohe, Christian, Wolf, Juergen, Ko, Jinnie, Diallo, Mariama, Pultar, Philippe, Giovannini, Monica, and Kim, Sang-We

Published
2018

69. Epigenomic profiling of non-small cell lung cancer xenografts uncover LRP12 DNA methylation as predictive biomarker for carboplatin resistance

Author

Grasse, Sabrina, Lienhard, Matthias, Frese, Steffen, Kerick, Martin, Steinbach, Anne, Grimm, Christina, Hussong, Michelle, Rolff, Jana, Becker, Michael, Dreher, Felix, Schirmer, Uwe, Boerno, Stefan, Ramisch, Anna, Leschber, Gunda, Timmermann, Bernd, Grohe, Christian, Lueders, Heike, Vingron, Martin, Fichtner, Iduna, Klein, Sebastian, Odenthal, Margarete, Buettner, Reinhard, Lehrach, Hans, Sueltmann, Holger, Herwig, Ralf, Schweiger, Michal R., Grasse, Sabrina, Lienhard, Matthias, Frese, Steffen, Kerick, Martin, Steinbach, Anne, Grimm, Christina, Hussong, Michelle, Rolff, Jana, Becker, Michael, Dreher, Felix, Schirmer, Uwe, Boerno, Stefan, Ramisch, Anna, Leschber, Gunda, Timmermann, Bernd, Grohe, Christian, Lueders, Heike, Vingron, Martin, Fichtner, Iduna, Klein, Sebastian, Odenthal, Margarete, Buettner, Reinhard, Lehrach, Hans, Sueltmann, Holger, Herwig, Ralf, and Schweiger, Michal R.

Abstract

Background: Non-small cell lung cancer (NSCLC) is the most common cause of cancer-related deaths worldwide and is primarily treated with radiation, surgery, and platinum-based drugs like cisplatin and carboplatin. The major challenge in the treatment of NSCLC patients is intrinsic or acquired resistance to chemotherapy. Molecular markers predicting the outcome of the patients are urgently needed. Methods: Here, we employed patient-derived xenografts (PDXs) to detect predictive methylation biomarkers for platin-based therapies. We used MeDIP-Seq to generate genome-wide DNA methylation profiles of 22 PDXs, their parental primary NSCLC, and their corresponding normal tissues and complemented the data with gene expression analyses of the same tissues. Candidate biomarkers were validated with quantitative methylation-specific PCRs (qMSP) in an independent cohort. Results: Comprehensive analyses revealed that differential methylation patterns are highly similar, enriched in PDXs and lung tumor-specific when comparing differences in methylation between PDXs versus primary NSCLC. We identified a set of 40 candidate regions with methylation correlated to carboplatin response and corresponding inverse gene expression pattern even before therapy. This analysis led to the identification of a promoter CpG island methylation of LDL receptor-related protein 12 (LRP12) associated with increased resistance to carboplatin. Validation in an independent patient cohort (n = 35) confirmed that LRP12 methylation status is predictive for therapeutic response of NSCLC patients to platin therapy with a sensitivity of 80% and a specificity of 84% (p < 0.01). Similarly, we find a shorter survival time for patients with LRP12 hypermethylation in the TCGA data set for NSCLC (lung adenocarcinoma). Conclusions: Using an epigenome-wide sequencing approach, we find differential methylation patterns from primary lung cancer and PDX-derived cancers to be very similar, albeit with a lower degree of dif

Published
2018

70. Neuroendocrine Neoplasia within the German NET Registry

Author

Maasberg, Sebastian, Pape, Ulrich-Frank, Fottner, Christian, Goretzki, Peter E., Anlauf, Martin, Hoersch, Dieter, Cremer, Birgit, Schulte, Dominik M., Quietzsch, Detlef, Scheerer, Frank, Poeppel, Gabriele, Poeppel, Thorsten D., Begum, Nehara, Grohe, Christian, Rinke, Anja, Maasberg, Sebastian, Pape, Ulrich-Frank, Fottner, Christian, Goretzki, Peter E., Anlauf, Martin, Hoersch, Dieter, Cremer, Birgit, Schulte, Dominik M., Quietzsch, Detlef, Scheerer, Frank, Poeppel, Gabriele, Poeppel, Thorsten D., Begum, Nehara, Grohe, Christian, and Rinke, Anja

Abstract

Neuroendocrine neoplasias (NEN) comprise a rare tumor entity with heterogeneous biology, prognosis and therapeutic options. Together with the recent publication of the first German guidelines on diagnostics and therapy of NEN, an analysis of the German NET-registry cohort of the German Society of Endocrinology (DGE) was performed. For this purpose, 2686 cases were extracted and their patient characteristics (e. g., age, sex, histopathological characterization, grading and staging) were displayed and outcomes were calculated. Additionally, the systemic treatment reality in the two largest subgroups, small intestinal and pancreatic NEN, was analyzed within metastatic patients. Distribution of primary tumor localization, histopathological classification, disease stage and overall survival was comparable with results from international registry studies. In concordance with current guidelines, somatostatin analogues (SSA) and peptide-receptor-radionuclide-therapy (PRRT) were the most common therapeutic modalities in small intestinal NEN. In pancreatic NEN, chemotherapy was used in first line as often as SSA. In second line, chemotherapy was used as often as PRRT. WHO-classification of 2010 and TNM staging proved to be of prognostic relevance. The current analysis of the German NET-registry characterizes a multicentric, interdisciplinary cohort of NEN patients throughout Germany and it describes the applied systemic treatment modalities and overall outcome as well as the prognostic value of the WHO classification of 2010 and TNM staging.

Published
2018

71. Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations from the Cologne Consensus Conference 2018

Author

Wilkens, Heinrike, Konstantinides, Stavros, Lang, Irene M., Bunck, Alexander C., Gerges, Mario, Gerhardt, Felix, Grgic, Aleksandar, Grohe, Christian, Guth, Stefan, Held, Matthias, Hinrichs, Jan B., Hoeper, Marius M., Klepetko, Walter, Kramm, Thorsten, Krueger, Ulrich, Lankeit, Mareike, Meyer, Bernhard C., Olsson, Karen M., Schaefers, Hans-Joachim, Schmidt, Matthias, Seyfarth, Hans-J, Ulrich, Silvia, Wiedenroth, Christoph B., Mayer, Eckhard, Wilkens, Heinrike, Konstantinides, Stavros, Lang, Irene M., Bunck, Alexander C., Gerges, Mario, Gerhardt, Felix, Grgic, Aleksandar, Grohe, Christian, Guth, Stefan, Held, Matthias, Hinrichs, Jan B., Hoeper, Marius M., Klepetko, Walter, Kramm, Thorsten, Krueger, Ulrich, Lankeit, Mareike, Meyer, Bernhard C., Olsson, Karen M., Schaefers, Hans-Joachim, Schmidt, Matthias, Seyfarth, Hans-J, Ulrich, Silvia, Wiedenroth, Christoph B., and Mayer, Eckhard

Abstract

Chronic thromboembolic pulmonary hypertension (CTEPH) is a subgroup of pulmonary hypertension that differs fromall other forms of PHin terms of its pathophysiology, patient characteristics and treatment. For implementation of the European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension in Germany, the Cologne Consensus Conference 2016 was held and last updated in spring of 2018. One of the working groups was dedicated to CTEPH, practical and controversial issues were commented and updated. In every patient with suspected PH, CTEPH or chronic thromboembolic disease (CTED, i.e. symptomatic residual vasculopathy without pulmonary hypertension) should be excluded. Primary treatment is surgical pulmonary endarterectomy (PEA) in a multidisciplinary CTEPH centre. Inoperable patients or patients with persistent or recurrent CTEPH after PEA are candidates for targeted drug therapy. There is increasing experience with balloon pulmonary angioplasty (BPA) for inoperable patients; this option, like PEA, is reserved for specialised centres with expertise in this treatment method. (c) 2018 Published by Elsevier B.V.

Published
2018

73. Clinicopathological Characteristics of RET Rearranged Lung Cancer in European Patients

Author

Michels, Sebastian, Scheel, Andreas Hans, Scheffler, Matthias, Schultheis, Anne Maria, Gautschi, Oliver, Aebersold, Franziska, Diebold, Joachim, Pall, Georg, Rothschild, Sacha, Bubendorf, Lukas, Hartmann, Wolfgang, Heukamp, Lukas, Schildhaus, Hans-Ulrich, Fassunke, Jana, Ihle, Michaela Angelika, Künstlinger, Helen, Heydt, Carina, Fischer, Rieke, Nogovà, Lucia, Mattonet, Christian, Hein, Rebecca, Adams, Anne, Gerigk, Ulrich, Schulte, Wolfgang, Lüders, Heike, Grohé, Christian, Graeven, Ullrich, Müller-Naendrup, Clemens, Draube, Andreas, Kambartel, Karl-Otto, Krüger, Stefan, Schulze-Olden, Susanne, Serke, Monika, Engel-Riedel, Walburga, Kaminsky, Britta, Randerath, Winfried, Merkelbach-Bruse, Sabine, Büttner, Reinhard, and Wolf, Jürgen

Published
2016
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74. Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA) : an open-label, multicentre, randomised, phase 2 trial

Author

Ferolla, Piero, Brizzi, Maria Pia, Meyer, Tim, Mansoor, Wasat, Mazieres, Julien, Do Cao, Christine, Lena, Herve, Berruti, Alfredo, Damiano, Vincenzo, Buikhuisen, Wieneke, Gronbaek, Henning, Lombard-Bohas, Catherine, Grohe, Christian, Minotti, Vincenzo, Tiseo, Marcello, De Castro, Javier, Reed, Nicholas, Gislimberti, Gabriella, Singh, Neha, Stankovic, Miona, Öberg, Kjell, Baudin, Eric, Ferolla, Piero, Brizzi, Maria Pia, Meyer, Tim, Mansoor, Wasat, Mazieres, Julien, Do Cao, Christine, Lena, Herve, Berruti, Alfredo, Damiano, Vincenzo, Buikhuisen, Wieneke, Gronbaek, Henning, Lombard-Bohas, Catherine, Grohe, Christian, Minotti, Vincenzo, Tiseo, Marcello, De Castro, Javier, Reed, Nicholas, Gislimberti, Gabriella, Singh, Neha, Stankovic, Miona, Öberg, Kjell, and Baudin, Eric

Abstract

Background There are no data from prospective studies focused exclusively on patients with advanced lung and thymic carcinoids. We aimed to assess the efficacy and safety of long-acting pasireotide and everolimus, administered alone or in combination, in patients with advanced carcinoids of the lung or thymus. Methods LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus, with radiological progression within 12 months before randomisation, and a WHO performance status of 0–2. At each centre, the investigator or their designee registered each patient using an interactive voice recognition system into one of the three treatment groups. The randomisation allocation sequence was generated by an external company; patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days), everolimus (10 mg orally once daily), or both in combination, for the core 12-month treatment period. Patients were stratified by carcinoid type (typical vs atypical) and line of study treatment (first line vs others). The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1.1, assessed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. The trial is registered with ClinicalTrials.gov, number NCT01563354. The extension phase of the study is ongoing. Findings Between Aug 16, 2013, and Sept 30, 2014, 124 patients were enrolled from 36 centres in nine countries: 41 were allocated to the long-acting pasireotide group, 42

Published
2017
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75. EUCROSS: A European Phase II Trial of Crizotinib in Advanced Adenocarcinoma of the Lung Harboring ROS1 Rearrangements - Preliminary Results

Author

Michels, Sebastian, Gardizi, Masyar, Schmalz, Petra, Thurat, Meike, Pereira, Eva, Sebastian, Martin, Carcereny, Enric, Corral, Jesus, Paz-Ares, Luis, Felip, Enriqueta, Grohe, Christian, Rodriguez Abreu, Delvys, Insa Molla, Amelia, Bischoff, Helge, Reck, Martin, Karachaliou, Niki, Scheel, Andreas, Brandes, Vanessa, Rieke, Fischer, Nogova, Lucia, Scheffler, Matthias, Franklin, Jeremy, Hellmich, Martin, Massuti, Bartomeu, Buettner, Reinhard, Rosell, Rafael, Wolf, Juergen, Michels, Sebastian, Gardizi, Masyar, Schmalz, Petra, Thurat, Meike, Pereira, Eva, Sebastian, Martin, Carcereny, Enric, Corral, Jesus, Paz-Ares, Luis, Felip, Enriqueta, Grohe, Christian, Rodriguez Abreu, Delvys, Insa Molla, Amelia, Bischoff, Helge, Reck, Martin, Karachaliou, Niki, Scheel, Andreas, Brandes, Vanessa, Rieke, Fischer, Nogova, Lucia, Scheffler, Matthias, Franklin, Jeremy, Hellmich, Martin, Massuti, Bartomeu, Buettner, Reinhard, Rosell, Rafael, and Wolf, Juergen

Published
2017

76. Euvolemic hyponatremia in cancer patients. Report of the Hyponatremia Registry: an observational multicenter international study

Author

Burst, Volker, Grundmann, Franziska, Kubacki, Torsten, Greenberg, Arthur, Rudolf, Despina, Salahudeen, Abdulla, Verbalis, Joseph, Grohe, Christian, Burst, Volker, Grundmann, Franziska, Kubacki, Torsten, Greenberg, Arthur, Rudolf, Despina, Salahudeen, Abdulla, Verbalis, Joseph, and Grohe, Christian

Abstract

Hyponatremia secondary to SIADH is frequent in cancer patients and potentially deleterious. The aim of this sub-analysis of the Hyponatremia Registry database is to analyze current diagnostic and therapeutic management practices in cancer patients with SIADH. We analyzed 358 cancer patients who had serum sodium concentration ([Na+]) <= 130 mEq/L and a clinical diagnosis of SIADH from 225 sites in the USA and EU. Precise diagnostic testing was performed in only 46%. Almost 12% of all patients did not receive any hyponatremia treatment. The most frequent therapies were fluid restriction (20%), isotonic saline (14%), fluid restriction/isotonic saline (7%), tolvaptan (8%), and salt tablets (7%). Hypertonic saline was used in less than 3%. Tolvaptan produced the greatest median rate of [Na+] change (IQR) (3.0 (4.7) mEq/L/day), followed by hypertonic saline (2.0(7.0) mEq/L/day), and fluid restriction/isotonic saline (1.9(3.2) mEq/L/day). Both fluid restriction and isotonic saline monotherapies were significantly less effective (0.8(2.0) mEq/L/day and 1.3(3.0) mEq/L/day, respectively) and were associated with clinically relevant rates of treatment failure. Only 46% of patients were discharged with [Na+] >= 130 mEq/L. Overly rapid correction of hyponatremia occurred in 11.7%. Although essential for successful hyponatremia management, appropriate diagnostic testing is not routinely performed in current practice. The most frequently employed monotherapies were often ineffective and sometimes even aggravated hyponatremia. Tolvaptan was used less often but showed significantly greater effectiveness. Despite clear evidence that hyponatremia is associated with poor outcome in oncology patients, most patients were discharged still hyponatremic. Further studies are needed to assess the beneficial impact of hyponatremia correction with effective therapies.

Published
2017

77. Gender associated Differences in Patients with IPF based on the Analysis of the INSIGHTS-IPF Registry Data

Author

Prasse, Antje, primary, Kreuter, Michael, additional, Klotsche, Jens, additional, Koschel, Dirk, additional, Frankenberger, Marion, additional, Neurohr, Claus, additional, Schwaiblmair, Martin, additional, Skowasch, Dirk, additional, Claussen, Martin, additional, Gläser, Sven, additional, Wilkens, Henrike, additional, Grohe, Christian, additional, Hagmeier, Lars, additional, Kirschner, Joachim, additional, Andreas, Stefan, additional, Wirtz, Hubert, additional, Pittrow, David, additional, Behr, Jürgen, additional, and Geier, Silke, additional

Published
2017
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80. Detection of actionable genome alterations using hybrid capture based next generation sequencing technology: NEOplus and NEOliquid.

Author

Heukamp, Lukas C., primary, Menon, Roopika, additional, Mueller, Judith, additional, Lakis, Sotirios, additional, Schulte, Johannes, additional, Wiest, Gunther, additional, Griesinger, Frank, additional, Salat, Christoph, additional, Dziadziuszko, Rafal, additional, Gautschi, Oliver, additional, Grohe, Christian, additional, Crown, John, additional, and Heuckmann, Johannes, additional

Published
2016
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81. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

Author

Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Horn, Leora, Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Souquet, Pierre-Jean, Baldini, Editta, Cappuzzo, Federico, Chouaid, Christos, Dowlati, Afshin, Sanborn, Rachel, Lopez-Chavez, Ariel, Grohe, Christian, Huber, Rudolf M., Harbison, Christopher T., Baudelet, Christine, Lestini, Brian J., Ramalingam, Suresh S., Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Horn, Leora, Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Souquet, Pierre-Jean, Baldini, Editta, Cappuzzo, Federico, Chouaid, Christos, Dowlati, Afshin, Sanborn, Rachel, Lopez-Chavez, Ariel, Grohe, Christian, Huber, Rudolf M., Harbison, Christopher T., Baudelet, Christine, Lestini, Brian J., and Ramalingam, Suresh S.

Abstract

Background Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer. Methods We did this phase 2, single-arm trial at 27 sites (academic, hospital, and private cancer centres) in France, Germany, Italy, and USA. Patients who had received two or more previous treatments received intravenous nivolumab (3 mg/kg) every 2 weeks until progression or unacceptable toxic effects. The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee. We included all treated patients in the analyses. This study is registered with ClinicalTrials. gov, number NCT01721759. Findings Between Nov 16, 2012, and July 22, 2013, we enrolled and treated 117 patients. 17 (14.5%, 95% CI 8.7-22.2) of 117 patients had an objective response as assessed by an independent radiology review committee. Median time to response was 3 . 3 months (IQR 2.2-4.8), and median duration of response was not reached (95% CI 8 . 31-not applicable); 13 (77%) of 17 of responses were ongoing at the time of analysis. 30 (26%) of 117 patients had stable disease (median duration 6 . 0 months, 95% CI 4.7-10.9). 20 (17%) of 117 patients reported grade 3-4 treatmentrelated adverse events, including: fatigue (five [4%] of 117 patients), pneumonitis (four [3%]), and diarrhoea (three [3%]). There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease. Interpretation Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non-small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled

Published
2015

82. P1.07-003 A Phase II Study Evaluating the Combination of Everolimus with Carboplatin/Paclitaxel as 1st Line Treatment in Patients with Advanced LCNEC: Topic: Drug Treatment Alone and in Combination with Radiotherapy

Author

Grohé, Christian, Engel-Riedel, Walburga, Kropf-Sanchen, Cornelia, Joachim, Von Pawel, Gütz, Sylvia, Kollmeier, Jens, Eberhardt, Wilfried, Christopoulos, Petros, Nimmrich, Inko, Sieder, Christian, Baum, Volker, Serke, Monika, and Thomas, Michael

Published
2017
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83. MA07.05 EUCROSS: A European Phase II Trial of Crizotinib in Advanced Adenocarcinoma of the Lung Harboring ROS1 Rearrangements - Preliminary Results

Author

Michels, Sebastian, Gardizi, Masyar, Schmalz, Petra, Thurat, Meike, Pereira, Eva, Sebastian, Martin, Carcereny, Enric, Corral, Jesus, Paz-Ares, Luis, Felip, Enriqueta, Grohé, Christian, Abreu, Delvys Rodriguez, Molla, Amelia Insa, Bischoff, Helge, Reck, Martin, Karachaliou, Niki, Scheel, Andreas, Brandes, Vanessa, Rieke, Fischer, Nogova, Lucia, Scheffler, Matthias, Franklin, Jeremy, Hellmich, Martin, Massuti, Bartomeu, Buettner, Reinhard, Rosell, Rafael, and Wolf, Jürgen

Published
2017
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84. Adressen

Author

Ludwig, Malte, Benckert, Julia, Berg, Thomas, Bornstein, Stefan, Breitkreutz, Christian, Engelmann, Cornelius, Frank, Helga, Fritzsche, Carlos, Graf, Nicolas, Grohé, Christian, Gruber, Matthias, Hering, Thomas, Humboldt, Tim, Junge, Tanja, Kluge, Stefan, Kochanek, Matthias, Koerfer, Peter, Kühl, Uwe, Labenz, Joachim, Lawall, Holger, Lepper, Wolfgang, Löbermann, Micha, Möhlenkamp, Stefan, Möller, Lars, Müller, Karin A.L., Neumann, Till, Patschan, Susann A., Pletz, Mathias W., Reising, Kurt D., Reisinger, Emil C., Rünzi, Michael, Sander, Dirk, Schindler, Ralf, Schleenvoigt, Benjamin T., Schmidmaier, Ralf, Schmitz, Udo, Schobel, Hans-Paul, Scholze, Jürgen E., Schwartz, Stefan, Sefrin, Peter, Serke, Monika, Sieber, Dirk K.C., Spannagl, Michael, Specker, Christof, Stiegler, Hubert, Straka, Christian, Tschöpe, Carsten, Volkmann, Hans-Jürgen, Weber, Michael, Klütsch, Klaus, Tischer, Katja, von Weizsäcker, Fritz, Worth, Heinrich, and Zöpf, Thomas

Published
2017
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86. Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations of the Cologne Consensus Conference 2011

Author

Wilkens, Heinrike, Lang, Irene, Behr, Juergen, Berghaus, Thomas, Grohe, Christian, Guth, Stefan, Hoeper, Marius M., Kramm, Thorsten, Krueger, Ulrich, Langer, Frank, Rosenkranz, Stephan, Schaefers, Hans-Joachim, Schmidt, Matthias, Seyfarth, Hans-Juergen, Wahlers, Thorsten, Worth, Heinrich, Mayer, Eckhard, Wilkens, Heinrike, Lang, Irene, Behr, Juergen, Berghaus, Thomas, Grohe, Christian, Guth, Stefan, Hoeper, Marius M., Kramm, Thorsten, Krueger, Ulrich, Langer, Frank, Rosenkranz, Stephan, Schaefers, Hans-Joachim, Schmidt, Matthias, Seyfarth, Hans-Juergen, Wahlers, Thorsten, Worth, Heinrich, and Mayer, Eckhard

Abstract

In the 2009 European Guidelines on the diagnosis and treatment of pulmonary hypertension (PH), one section covers aspects of pathophysiology, diagnosis and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). The practical implementation of the guidelines for this disease is of crucial importance, because CTEPH is a subset of PH which can potentially be cured by pulmonary endarterectomy (PEA). Nowadays, CTEPH is commonly underdiagnosed and not properly managed. Any patient with unexplained PH should be evaluated for the presence of CTEPH, and a ventilation/perfusion (V/Q) lung scan is recommended as screening method of choice. If the V/Q scan or CT angiography reveals signs of CTEPH, the patient should be referred to a specialized center with expertise in the medical and surgical management of this disease. Every case has to be reviewed by an experienced PEA surgeon for the assessment of operability. In this updated recommendation, important contents of the European guidelines were commented, and more recent information regarding diagnosis and treatment was added. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

Published
2011

88. Die Rolle des Transkriptionsfaktors NF-κB bei der mechanischen Dehnung von pulmonalen Strukturzellen

Author

Kuhn, Hartmut, Grohe, Christian, Universität Leipzig, Maser, Franziska, Kuhn, Hartmut, Grohe, Christian, Universität Leipzig, and Maser, Franziska

Abstract

Obwohl die künstliche bzw. mechanische Beatmung bei der Therapie von ALI / ARDS eine wichtige und bedeutende Rolle spielt, kann sie selbst eine akute Lungen-schädigung auslösen oder bestehende pulmonale Beeinträchtigungen verstärken. Zentraler Schädigungsmechanismus ist die alveoläre Überdehnung durch hohe Ti-dalvolumina. Selbst bei der Anwendung kleiner, protektiver Tidalvolumina in Lungen mit einem nur geringen Anteil belüfteter Alveolen kann es in diesen zu alveolärer Überdehnung kommen. Diese Überdehnung führt einerseits zu mechanisch induzier-te Apoptose sowie Nekrose und andererseits zu einer mechanisch induzierten Ver-änderung der Mediatorenfreisetzung hin zu einem pro-inflammatorischen Muster. Da der Transkriptionsfaktor NF-κB zahlreiche Mediatoren aktiviert bzw. von ihnen beeinf-lusst werden kann, nimmt er in diesem Geschehen eine ganz besondere Schlüssel-position ein. In der vorliegenden Arbeit wird der Hypothese nachgegangen, ob die NF-κB-Aktivierung bei der mechanischen Dehnung und dem daraus resultierenden inflam-matorischen Verhalten von pulmonalen Strukturzellen verändert wird und in wie weit ein Zusammenhang zwischen Dehnung, Zellschädigung und NF-κB besteht. Dafür wurden sowohl frisch isolierte alveoläre Ratten-Typ-II Zellen, Zellen der hu-man-alveolaren Epithelzelllinie A549 sowie Lungen- Fibroblasten der Zell-Linie Wi 38 untersucht. Alle drei Zellarten wurden auf einem speziellen elastischen Silikonboden von 6er-Well-Platten inkubiert, wo sie mit Hilfe des Flexercell-Stretch-Gerätes (FX 3000) als Zellmonolayer equibiaxial für 24 Stunden gedehnt wurden. Auch die zeitliche Abhängigkeit der NF-κB-Expression von der mechanischen Deh-nung wurde untersucht. Dabei konnte festgestellt werden, dass ein Zusammenhang zwischen NF-κB-Aktivierung, Zellschädigung und mechanischer Dehnung existiert. Wobei bei unter-schiedlichen Zellarten auch variierende Ergebnisse beobachtet werden konnten. Im Zusammenhang mit anderen aus unserer Forschungsgruppe und in der Lite

Published
2010

89. Die Rolle des Transkriptionsfaktors NF-κB bei der mechanischen Dehnung von pulmonalen Strukturzellen

Author

Wirtz, Hubert, Kuhn, Hartmut, Grohe, Christian, Universität Leipzig, Maser, Franziska, Wirtz, Hubert, Kuhn, Hartmut, Grohe, Christian, Universität Leipzig, and Maser, Franziska

Abstract

Obwohl die künstliche bzw. mechanische Beatmung bei der Therapie von ALI / ARDS eine wichtige und bedeutende Rolle spielt, kann sie selbst eine akute Lungen-schädigung auslösen oder bestehende pulmonale Beeinträchtigungen verstärken. Zentraler Schädigungsmechanismus ist die alveoläre Überdehnung durch hohe Ti-dalvolumina. Selbst bei der Anwendung kleiner, protektiver Tidalvolumina in Lungen mit einem nur geringen Anteil belüfteter Alveolen kann es in diesen zu alveolärer Überdehnung kommen. Diese Überdehnung führt einerseits zu mechanisch induzier-te Apoptose sowie Nekrose und andererseits zu einer mechanisch induzierten Ver-änderung der Mediatorenfreisetzung hin zu einem pro-inflammatorischen Muster. Da der Transkriptionsfaktor NF-κB zahlreiche Mediatoren aktiviert bzw. von ihnen beeinf-lusst werden kann, nimmt er in diesem Geschehen eine ganz besondere Schlüssel-position ein. In der vorliegenden Arbeit wird der Hypothese nachgegangen, ob die NF-κB-Aktivierung bei der mechanischen Dehnung und dem daraus resultierenden inflam-matorischen Verhalten von pulmonalen Strukturzellen verändert wird und in wie weit ein Zusammenhang zwischen Dehnung, Zellschädigung und NF-κB besteht. Dafür wurden sowohl frisch isolierte alveoläre Ratten-Typ-II Zellen, Zellen der hu-man-alveolaren Epithelzelllinie A549 sowie Lungen- Fibroblasten der Zell-Linie Wi 38 untersucht. Alle drei Zellarten wurden auf einem speziellen elastischen Silikonboden von 6er-Well-Platten inkubiert, wo sie mit Hilfe des Flexercell-Stretch-Gerätes (FX 3000) als Zellmonolayer equibiaxial für 24 Stunden gedehnt wurden. Auch die zeitliche Abhängigkeit der NF-κB-Expression von der mechanischen Deh-nung wurde untersucht. Dabei konnte festgestellt werden, dass ein Zusammenhang zwischen NF-κB-Aktivierung, Zellschädigung und mechanischer Dehnung existiert. Wobei bei unter-schiedlichen Zellarten auch variierende Ergebnisse beobachtet werden konnten. Im Zusammenhang mit anderen aus unserer Forschungsgruppe und in der Lite

Published
2010

90. International tailored chemotherapy adjuvant trial: Itaca trial.

Author

Novello, Silvia, primary, Manegold, Christian, additional, Grohe, Christian, additional, Colantonio, Ida, additional, Serke, Monika Heidi, additional, Geissler, Michael, additional, Valmadre, Giuseppe, additional, Schuette, Wolfgang, additional, Stoelben, Erich, additional, Bria, Emilio, additional, Monica, Valentina, additional, Torri, Valter, additional, and Scagliotti, Giorgio, additional

Published
2012
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91. Chronic thromboembolic pulmonary hypertension (CTEPH): Updated Recommendations of the Cologne Consensus Conference 2011

Author

Wilkens, Heinrike, primary, Lang, Irene, additional, Behr, Jürgen, additional, Berghaus, Thomas, additional, Grohe, Christian, additional, Guth, Stefan, additional, Hoeper, Marius M., additional, Kramm, Thorsten, additional, Krüger, Ulrich, additional, Langer, Frank, additional, Rosenkranz, Stephan, additional, Schäfers, Hans-Joachim, additional, Schmidt, Matthias, additional, Seyfarth, Hans-Jürgen, additional, Wahlers, Thorsten, additional, Worth, Heinrich, additional, and Mayer, Eckhard, additional

Published
2011
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93. 17β-Estradiol Reduces Cardiomyocyte Apoptosis In Vivo and In Vitro via Activation of Phospho-Inositide-3 Kinase/Akt Signaling

Author

Patten, Richard D., primary, Pourati, Isaac, additional, Aronovitz, Mark J., additional, Baur, Jason, additional, Celestin, Flore, additional, Chen, Xin, additional, Michael, Ashour, additional, Haq, Syed, additional, Nuedling, Simone, additional, Grohe, Christian, additional, Force, Thomas, additional, Mendelsohn, Michael E., additional, and Karas, Richard H., additional

Published
2004
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95. Autoren

Author

Benckert, Julia, Berg, Thomas, Bornstein, Stefan, Breitkreutz, Christian, Engelmann, Cornelius, Frank, Helga, Fritzsche, Carlos, Graf, Nicolas, Grohé, Christian, Gruber, Matthias, Hering, Thomas, Humboldt, Tim, Junge, Tanja, Kluge, Stefan, Kochanek, Matthias, Koerfer, Peter, Labenz, Joachim, Lawall, Holger, Lepper, Wolfgang, Löbermann, Micha, Möhlenkamp, Stefan, Möller, Lars, Müller, Karin A.L., Neumann, Till, Patschan, Susann A., Pletz, Mathias W., Reising, Kurt D., Reisinger, Emil C., Rünzi, Michael, Sander, Dirk, Schindler, Ralf, Schleenvoigt, Benjamin T., Schmidmaier, Ralf, Schmitz, Udo, Schobel, Hans-Paul, Scholze, Jürgen E., Schwartz, Stefan, Sefrin, Peter, Serke, Monika, Sieber, Dirk K.C., Spannagl, Michael, Specker, Christof, Stiegler, Hubert, Straka, Christian, Tschöpe, Carsten, Volkmann, Hans-Jürgen, Weber, Michael, Klütsch, Klaus, Tischer, Katja, Weizsäcker, Fritz von, Worth, Heinrich, and Zöpf, Thomas

Published
2014
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97. 17Β-Estradiol regulates the expression of endothelin receptor type B in the heart.

Author

Nuedling, Simone, van Eickels, Martin, Allera, Axel, Doevendans, Pieter, Meyer, Rainer, Vetter, Hans, and Grohe, Christian

Subjects
ENDOTHELINS, VASCULAR endothelium, ESTRADIOL, LABORATORY rats
Abstract

Investigates the regulation of proteins of the endothelin system in the hearts of female spontaneously hypertensive rats. Effect of ovariectomy on endothelin receptor protein regulation; Interaction between 17-beta estradiol and vasoactive endothelial system; Implications on gender-based differences found in cardiovascular disease.

Published
2003
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98. Estrogenic hormone action in the heart: regulatory network and function

Author

Babiker, Fawzi A., De Windt, Leon J., van Eickels, Martin, Grohe, Christian, Meyer, Rainer, and Doevendans, Pieter A.

Subjects
ESTROGEN, ANGIOTENSIN converting enzyme, CARDIOVASCULAR diseases
Abstract

Cardiovascular diseases are the leading cause of death in the industrialised countries and display significant gender-based differences. Estrogen plays an important role in the pathogenesis of heart disease and is able to modulate the progression of cardiovascular disease. The focus on the beneficial influence of estrogen is gradually shifting from the vascular system to the myocardium. The presence of functional estrogen receptors in the myocardium has been demonstrated. Estrogen is important for cardiovascular baseline physiology and modulates the myocardial response under pathological conditions. Here we summarise the current knowledge of the regulatory network of estrogenic action in the myocardium and its effects on cardiovascular function. [Copyright &y& Elsevier]

Published
2002
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100. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC

Author

Wu, Yi-Long, John, Thomas, Grohe, Christian, Majem, Margarita, Goldman, Jonathan W., Kim, Sang-We, Kato, Terufumi, Laktionov, Konstantin, Vu, Huu Vinh, Wang, Zhijie, Lu, Shun, Lee, Kye Young, Akewanlop, Charuwan, Yu, Chong-Jen, de Marinis, Filippo, Bonanno, Laura, Domine, Manuel, Shepherd, Frances A., Zeng, Lingmin, Atasoy, Ajlan, Herbst, Roy S., and Tsuboi, Masahiro

Abstract

Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a statistically significant improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA.

Published
2021
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