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1. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Akce, Mehmet, Ales Diaz, Inmaculada, Alves, Gustavo, Anand, Sumitra, Arslan, Cagatay, Asselah, Jamil, Assenat, Eric, Aubin, Francine, Bai, Li-Yuan, Bai, Yuxian, Barajas, Olga, Bates, Susan, Begbie, Stephen, Ben-Aharon, Irit, Beri, Nina, Berres, Marie-Luise, Blanc, Jean-Frederic, Borbath, Ivan, Bordonaro, Robert, Bouattour, Mohamed, Brandi, Giovanni, Burgoyne, Adam, Butthongkomvong, Kritiya, Camandaroba, Marcos, Cao, Ke, Carballido, Marcela, Chan, Stephan Lam, Chen, Jen-Shi, Chen, Ming-Huang, Chen, Xiaoming, Cheng, Ashley, Chiu, Tai-Jan, Choi, Hye Jin, Chon, Hong Jae, Collignon, Joelle, Cubillo Gracian, Antonio, Davis, Sarah, de Carvalho, Ricardo Saraiva, de Groot, D.J.A., Demols, Anne, De Vos, Judith, Diab, Maria, Easaw, Jacob, Eatock, Martin, Edeline, Julien, Elias, Rawad, Eskens, Fredericus, Falcone, Alfredo, Fernandez, Plinio, Finn, Richard, Franke, Fabio, Furukawa, Masayuki, Furuse, Junji, Gbolahan, Olumide, Geboes, Karen, Geneser, Keri-Lee, Geng, Zhimin, Geva, Ravit, Gillmore, Roopinder, Goetze, Thorsten, Gou, Hongfeng, Grasselli, Julieta, Gu, Shanzhi, Gumus, Mahmut, Haj Mohammad, Nadia, Hao, Chunyi, Harputluoglu, Hakan, Hatoum, Hassan, Heinemann, Volker, Ho, Wang Kwong, Hsu, Chiun, Hubert, Ayala, Hwang, Juneul, Inanc, Mevlude, Iseas, Soledad, Jeyasingam, Vaishnavi, Jimenez Fonseca, Paula, Joubert, Warren, Juengsamarn, Jitlada, Kaen, Diego, Kanai, Masashi, Kasper-Virchow, Stefan, Kazemi, Ghazaleh, Kelleher, Fergal, Kelley, Robin, Kim, Jin Won, Kim, Jong Gwang, Kinupe Abrahao, Ana Beatriz, Klumpen, Heinz, Kochenderfer, Mark, Kose, Fatih, Lam, Ho Ching, Lee, Choong-kun, Lee, Hyun Woo, Lee, Margaret, Lee, Myung Ah, Lee, Wai Man Sarah, Le Sourd, Samuel, Li, Dongliang, Li, Wei, Liang, Houjie, Liang, Tingbo, Lim, Chun Sen, Lingerfelt, Brian, Lopez, Charles, Low, John, Macarulla Mercade, Teresa, Malka, David, Mao, Yimin, Masi, Gianluca, McCune, Steven, McDermott, Ray, McWhirter, Elaine, Mendez, Guillermo, Milella, Michele, Mizuno, Nobumasa, Mizutani, Tomonori, Moniz, Camila, Morales, Luisa, Munoz Martin, Andres Jesús, Nervi, Bruno, Ngamphaiboon, Nuttapong, Oh, Sang Cheul, Oksuzoglu, Berna, Outlaw, Darryl, Ozaka, Masato, Ozguroglu, Mustafa, Ozyilkan, Ozgur, Painemal, Claudio, Pan, Yueyin, Park, Joon Oh, Pelzer, Uwe, Peng, Chuang, Petorin, Caroline, Pezet, Denis, Power, Derek, Qin, Shukui, Ren, Zhenggang, Roohullah, Aflah, Ryu, Hyewon, Salman, Pamela, Sasaki, Mitsuhito, Sasidharan, Rita, Satoh, Taroh, Schulze, Kornelius, Scott-Brown, Martin, Segovia, Ruben, Seufferlein, Thomas, Siena, Salvatore, Sinapi, Isabelle, Smolenschi, Cristina, Song, Tianqiang, Sookprasert, Aumkhae, Soparattanapaisarn, Nopadol, Starling, Naureen, Stein, Stacey, Stemmer, Salomon, Su, Haichuan, Sugimoto, Rie, Suksombooncharoen, Thatthan, Tam, Vincent, Tan, Ai Lian, Tan, Chih Kiang, Tanasanvimon, Suebpong, Tonini, Giuseppe, Tortora, Giampaolo, Tsuji, Akihito, Ueno, Makoto, Uribe, Rodrigo, Venerito, Marino, Verdaguer Mata, Helena, Verslype, Chris, Victorino, Ana Paula, Vogel, Arndt, Wade, James, Waldschmidt, Dirk Thomas, Wang, Lu, Wan Isahk, Wan Zamaniah, Wasan, Harpeet, Weschenfelder, Rui, Wong, Chun Yin, Wong, Yoke Fui, Yalcin, Suayib, Yanez Weber, Patricio, Yang, Xuezhong, Yasui, Hisateru, Yau, Thomas, Yazici, Ozan, Yen, Chia-Jui, Ying, Jieer, Yoo, Changhoon, Yu, Wenchang, Zhao, Haitao, Kelley, Robin Kate, Finn, Richard S, Klümpen, Heinz-Josef, Chan, Stephen L, Valle, Juan W, Yu, Li, Malhotra, Usha, and Siegel, Abby B

Published
2023
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2. Durable Response With Sequential Tyrosine Kinase Inhibitor Treatment in a Patient With ROS1 Fusion–Positive Pancreatic Adenocarcinoma: A Case Report

Author

Reutter, Theresa, Fassunke, Jana, Püsken, Michael, Weber, Jan-Phillip, Binot, Elke, Eisert, Anna, Fischer, Rieke, Nogova, Lucia, Riedel, Richard, Schaufler, Diana, Scharpenseel, Heather, Scheffler, Matthias, Schulz, Holger, Waldschmidt, Dirk‐Thomas, Zander, Thomas, Merkelbach-Bruse, Sabine, Schirmacher, Peter, Büttner, Reinhard, Wolf, Jürgen, and Michels, Sebastian

Published
2023
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3. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study

Author

Javle, Milind, Roychowdhury, Sameek, Kelley, Robin Kate, Sadeghi, Saeed, Macarulla, Teresa, Weiss, Karl Heinz, Waldschmidt, Dirk-Thomas, Goyal, Lipika, Borbath, Ivan, El-Khoueiry, Anthony, Borad, Mitesh J, Yong, Wei Peng, Philip, Philip A, Bitzer, Michael, Tanasanvimon, Surbpong, Li, Ai, Pande, Amit, Soifer, Harris S, Shepherd, Stacie Peacock, Moran, Susan, Zhu, Andrew X, Bekaii-Saab, Tanios S, and Abou-Alfa, Ghassan K

Published
2021
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4. NASH limits anti-tumour surveillance in immunotherapy-treated HCC

Author

Pfister, Dominik, Núñez, Nicolás Gonzalo, Pinyol, Roser, Govaere, Olivier, Pinter, Matthias, Szydlowska, Marta, Gupta, Revant, Qiu, Mengjie, Deczkowska, Aleksandra, Weiner, Assaf, Müller, Florian, Sinha, Ankit, Friebel, Ekaterina, Engleitner, Thomas, Lenggenhager, Daniela, Moncsek, Anja, Heide, Danijela, Stirm, Kristin, Kosla, Jan, Kotsiliti, Eleni, Leone, Valentina, Dudek, Michael, Yousuf, Suhail, Inverso, Donato, Singh, Indrabahadur, Teijeiro, Ana, Castet, Florian, Montironi, Carla, Haber, Philipp K., Tiniakos, Dina, Bedossa, Pierre, Cockell, Simon, Younes, Ramy, Vacca, Michele, Marra, Fabio, Schattenberg, Jörn M., Allison, Michael, Bugianesi, Elisabetta, Ratziu, Vlad, Pressiani, Tiziana, D’Alessio, Antonio, Personeni, Nicola, Rimassa, Lorenza, Daly, Ann K., Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M., Vogel, Arndt, Peck-Radosavljevic, Markus, Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Trojan, Jörg, Schulze, Kornelius, Wege, Henning, Koch, Sandra, Weinmann, Arndt, Bueter, Marco, Rössler, Fabian, Siebenhüner, Alexander, De Dosso, Sara, Mallm, Jan-Philipp, Umansky, Viktor, Jugold, Manfred, Luedde, Tom, Schietinger, Andrea, Schirmacher, Peter, Emu, Brinda, Augustin, Hellmut G., Billeter, Adrian, Müller-Stich, Beat, Kikuchi, Hiroto, Duda, Dan G., Kütting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias Philip, Rahbari, Nuh, Mei, Henrik E., Schulz, Axel Ronald, Ringelhan, Marc, Malek, Nisar, Spahn, Stephan, Bitzer, Michael, Ruiz de Galarreta, Marina, Lujambio, Amaia, Dufour, Jean-Francois, Marron, Thomas U., Kaseb, Ahmed, Kudo, Masatoshi, Huang, Yi-Hsiang, Djouder, Nabil, Wolter, Katharina, Zender, Lars, Marche, Parice N., Decaens, Thomas, Pinato, David J., Rad, Roland, Mertens, Joachim C., Weber, Achim, Unger, Kristian, Meissner, Felix, Roth, Susanne, Jilkova, Zuzana Macek, Claassen, Manfred, Anstee, Quentin M., Amit, Ido, Knolle, Percy, Becher, Burkhard, Llovet, Josep M., and Heikenwalder, Mathias

Published
2021
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5. Validation of the CRAFITY score in patients with hepatocellular carcinoma treated with atezolizumab and bevacizumab

Author

Scheiner, Bernhard, primary, Sartoris, Riccardo, additional, D’Alessio, Antonio, additional, Fulgenzi, Claudia, additional, Pomej, Katharina, additional, Balcar, Lorenz, additional, Bouattour, Mohamed, additional, Sidali, Sabrina, additional, Himmelsbach, Vera, additional, Finkelmeier, Fabian, additional, Schulze, Kornelius, additional, von Felden, Johann, additional, Hucke, Florian, additional, Shmanko, Kateryna, additional, Siebenhüner, Alexander, additional, Mertens, Joachim C., additional, De Dosso, Sara, additional, Ebert, Matthias, additional, Teufel, Andreas, additional, Waldschmidt, Dirk-Thomas, additional, Radu, Iuliana Pompilia, additional, Krall, Anja, additional, Trauner, Michael, additional, Dufour, Jean-François, additional, Wege, Henning, additional, Weinmann, Arndt, additional, Trojan, Jörg, additional, Stauber, Rudolf E., additional, Peck-Radosavljevic, Markus, additional, Hsu, Wei-Fan, additional, Vogel, Arndt, additional, Ronot, Maxime, additional, Pinato, David J., additional, and Pinter, Matthias, additional

Published
2023
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6. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Kelley, Robin Kate, primary, Ueno, Makoto, additional, Yoo, Changhoon, additional, Finn, Richard S, additional, Furuse, Junji, additional, Ren, Zhenggang, additional, Yau, Thomas, additional, Klümpen, Heinz-Josef, additional, Chan, Stephen L, additional, Ozaka, Masato, additional, Verslype, Chris, additional, Bouattour, Mohamed, additional, Park, Joon Oh, additional, Barajas, Olga, additional, Pelzer, Uwe, additional, Valle, Juan W, additional, Yu, Li, additional, Malhotra, Usha, additional, Siegel, Abby B, additional, Edeline, Julien, additional, Vogel, Arndt, additional, Akce, Mehmet, additional, Ales Diaz, Immaculada, additional, Alves, Gustavo, additional, Anand, Sumitra, additional, Arslan, Cagatay, additional, Asselah, Jamil, additional, Assenat, Eric, additional, Aubin, Francine, additional, Bai, Li-Yuan, additional, Bai, Yuxian, additional, Bates, Susan, additional, Begbie, Stephen, additional, Ben-Aharon, Irit, additional, Beri, Nina, additional, Berres, Marie-Luise, additional, Blanc, Jean-Frederic, additional, Borbath, Ivan, additional, Bordonaro, Robert, additional, Brandi, Giovanni, additional, Burgoyne, Adam, additional, Butthongkomvong, Kritiya, additional, Cao, Ke, additional, Carballido, Marcela, additional, Camandaroba, Marcos, additional, Chang, Stephan Lam, additional, Chen, Jen-Shi, additional, Chen, Ming-Huang, additional, Chen, Xiaoming, additional, Cheng, Ashley, additional, Chiu, Tai-Jan, additional, Choi, Hye Jin, additional, Chon, Hong Jae, additional, Collignon, Joelle, additional, Cubillo Gracian, Antonio, additional, Davis, Sarah, additional, de Carvalho, Ricardo Saraiva, additional, de Groot, D.J.A., additional, Demols, Anne, additional, De Vos, Judith, additional, Diab, Maria, additional, Easaw, Jacob, additional, Eatock, Martin, additional, Elias, Rawad, additional, Eskens, Fredericus, additional, Falcone, Alfredo, additional, Fernandez, Plinio, additional, Finn, Richard, additional, Franke, Fabio, additional, Furukawa, Masayuki, additional, Gbolahan, Olumide, additional, Geboes, Karen, additional, Geneser, Keri-Lee, additional, Geng, Zhimin, additional, Geva, Ravit, additional, Gillmore, Roopinder, additional, Goetze, Thorsten, additional, Gou, Hongfeng, additional, Grasselli, Julieta, additional, Gu, Shanzhi, additional, Gumus, Mahmut, additional, Haj Mohammad, Nadia, additional, Hao, Chunyi, additional, Harputluoglu, Hakan, additional, Hatoum, Hassan, additional, Heinemann, Volker, additional, Ho, Wang Kwong, additional, Hsu, Chiun, additional, Hubert, Ayala, additional, Hwang, Juneul, additional, Inanc, Mevlude, additional, Iseas, Soledad, additional, Jeyasingam, Vaishnavi, additional, Jimenez Fonseca, Paula, additional, Joubert, Warren, additional, Juengsamarn, Jitlada, additional, Kaen, Diego, additional, Kanai, Masahi, additional, Kasper-Virchow, Stefan, additional, Kazemi, Ghazaleh, additional, Kelleher, Fergal, additional, Kelley, Robin, additional, Kim, Jin Won, additional, Kim, Jong Gwang, additional, Kinupe Abrahao, Ana Beatriz, additional, Klumpen, Heinz, additional, Kochenderfer, Mark, additional, Kose, Fatih, additional, Lam, Ho Ching, additional, Lee, Choong-kun, additional, Lee, Hyun Woo, additional, Lee, Margaret, additional, Lee, Myung Ah, additional, Lee, Wai Man Sarah, additional, Le Sourd, Samuel, additional, Li, Dongliang, additional, Li, Wei, additional, Liang, Houjie, additional, Liang, Tingbo, additional, Lim, Chun Sen, additional, Lingerfelt, Brian, additional, Lopez, Charles, additional, Low, John, additional, Macarulla Mercade, Teresa, additional, Malka, David, additional, Mao, Yimin, additional, Masi, Gianluca, additional, McCune, Steven, additional, McDermott, Ray, additional, McWhirter, Elaine, additional, Mendez, Guillermo, additional, Milella, Michele, additional, Mizutani, Tomonori, additional, Moniz, Camila, additional, Morales, Luisa, additional, Munoz Martin, Andres Jesús, additional, Nervi, Bruno, additional, Ngamphaiboon, Nuttapong, additional, Oh, Sang Cheul, additional, Oksuzoglu, Berna, additional, Outlaw, Darryl, additional, Ozguroglu, Mustafa, additional, Ozyilkan, Ozgur, additional, Painemeal, Claudio, additional, Pan, Yueyin, additional, Peng, Chuang, additional, Petorin, Caroline, additional, Pezet, Denis, additional, Power, Derek, additional, Qin, Shukui, additional, Roohullah, Aflah, additional, Ryu, Hyewon, additional, Salman, Pamela, additional, Sasidharan, Rita, additional, Satho, Taroh, additional, Schulze, Kornelius, additional, Scott-Brown, Martin, additional, Segovia, Ruben, additional, Seufferlin, Thomas, additional, Siena, Salvatore, additional, Sinapi, Isabelle, additional, Smolenschi, Cristina, additional, Song, Tianqiang, additional, Sookprasert, Aumkhae, additional, Soparattanapaisarn, Nopadol, additional, Starling, Naureen, additional, Stein, Stacey, additional, Stemmer, Salomon, additional, Su, Haichuan, additional, Sugimoto, Rie, additional, Suksombooncharoen, Thatthan, additional, Tam, Vincent, additional, Tan, Ai Lian, additional, Tan, Chih Kiang, additional, Tanasanvimon, Suebpong, additional, Tonini, Giuseppe, additional, Tortora, Giampaolo, additional, Tsuji, Akihito, additional, Uribe, Rodrigo, additional, Venerito, Marino, additional, Verdaguer Mata, Helena, additional, Victorino, Ana Paula, additional, Wade, James, additional, Waldschmidt, Dirk Thomas, additional, Wang, Lu, additional, Wan Isahk, Wan Zamaniah, additional, Wasan, Harpeet, additional, Weschenfelder, Rui, additional, Wong, Chun Yin, additional, Wong, Yoke Fui, additional, Yalcin, Suayib, additional, Yanez Weber, Patricio, additional, Yang, Xuezhong, additional, Yasui, Hisateru, additional, Yazici, Ozan, additional, Yen, Chia-Jui, additional, Ying, Jieer, additional, Yu, Wenchang, additional, and Zhao, Haitao, additional

Published
2023
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7. OS-079-YI Development and validation of the CABLE score to estimate individual prognosis of patients with hepatocellular carcinoma treated with 1L atezolizumab and bevacizumab

Author

Gairing, Simon Johannes, Mildenberger, Philipp, Gile, Jennifer, Artusa, Fabian, Scheiner, Bernhard, Leyh, Catherine, Lieb, Sabine, Sinner, Friedrich, Jörg, Vincent, Fruendt, Thorben, Himmelsbach, Vera, Abedin, Nada, Sahin, Cennet, Boettcher, Katrin, Schuhbaur, Jasmin, Labuhn, Simon, Korolewicz, James, Fulgenzi, Claudia, D'Alessio, Antonio, Zanuso, Valentina, Hucke, Florian, Röhlen, Natascha, Khaled, Najib Ben, Ramadori, Eleonora, Müller, Lukas, Weinmann, Arndt, Kloeckner, Roman, Galle, Peter R., Tran, Nguyen H., Venkatesh, Sudhakar, Teufel, Andreas, de Toni, Enrico, Waldschmidt, Dirk-Thomas, Marquardt, Jens U., Bettinger, Dominik, Peck-Radosavljevic, Markus, Geier, Andreas, Reiter, Florian P, Rimassa, Lorenza, Pinato, David J., Roderburg, Christoph, Ettrich, Thomas, Bitzer, Michael, Scheble, Veit, Ehmer, Ursula, Berres, Marie-Luise, Finkelmeier, Fabian, Gonzalez-Carmona, Maria Angeles, von Felden, Johann, Schulze, Kornelius, Venerito, Marino, van Bömmel, Florian, Jochheim, Leonie, Pinter, Matthias, Mohr, Raphael, Ilyas, Sumera I., Schmidtmann, Irene, and Foerster, Friedrich

Published
2024
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8. Prognosis of patients with hepatocellular carcinoma treated with immunotherapy - development and validation of the CRAFITY score

Author

Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M., Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Himmelsbach, Vera, Schulze, Kornelius, von Felden, Johann, Frundt, Thorben W., Stadler, Marc, Heinzl, Harald, Shmanko, Kateryna, Spahn, Stephan, Radu, Pompilia, Siebenhuener, Alexander R., Mertens, Joachim C., Rahbari, Nuh N., Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias P., Teufel, Andreas, De Dosso, Sara, Pinato, David J., Pressiani, Tiziana, Meischl, Tobias, Balcar, Lorenz, Mueller, Christian, Mandorfer, Mattias, Reiberger, Thomas, Trauner, Michael, Personeni, Nicola, Rimassa, Lorenza, Bitzer, Michael, Trojan, Joerg, Weinmann, Arndt, Wege, Henning, Dufour, Jean-Francois, Peck-Radosavljevic, Markus, Vogel, Arndt, Pinter, Matthias, Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M., Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Himmelsbach, Vera, Schulze, Kornelius, von Felden, Johann, Frundt, Thorben W., Stadler, Marc, Heinzl, Harald, Shmanko, Kateryna, Spahn, Stephan, Radu, Pompilia, Siebenhuener, Alexander R., Mertens, Joachim C., Rahbari, Nuh N., Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias P., Teufel, Andreas, De Dosso, Sara, Pinato, David J., Pressiani, Tiziana, Meischl, Tobias, Balcar, Lorenz, Mueller, Christian, Mandorfer, Mattias, Reiberger, Thomas, Trauner, Michael, Personeni, Nicola, Rimassa, Lorenza, Bitzer, Michael, Trojan, Joerg, Weinmann, Arndt, Wege, Henning, Dufour, Jean-Francois, Peck-Radosavljevic, Markus, Vogel, Arndt, and Pinter, Matthias

Abstract

Background & Aims: Immunotherapy with atezolizumab plus bevacizumab represents the new standard of care in systemic front-line treatment of hepatocellular carcinoma (HCC). However, biomarkers that predict treatment success and survival remain an unmet need. Methods: Patients with HCC put on PD-(L)1-based immunotherapy were included in a training set (n = 190; 6 European centers) and a validation set (n = 102; 8 European centers). We investigated the prognostic value of baseline variables on overall survival using a Cox model in the training set and developed the easily applicable CRAFITY (CRP and AFP in ImmunoTherapY) score. The score was validated in the independent, external cohort, and evaluated in a cohort of patients treated with sor- afenib (n = 204). Results: Baseline serum alpha-fetoprotein >= 100 ng/ml (hazard ratio [HR] 1.7; p = 0.007) and C-reactive protein >= 1 mg/dl (HR, 1.7; p = 0.007) were identified as independent prognostic factors in multivariable analysis and were used to develop the CRAFITY score. Patients who fulfilled no criterion (0 points; CRAFITY-low) had the longest median overall survival (27.6 (95% CI 19.5-35.8) months), followed by those fulfilling 1 criterion (1 point; CRAFITY-intermediate; 11.3 (95% CI 8.0-14.6) months), and patients meeting both criteria (2 points; CRAFITY-high; 6.4 (95% CI 4.8-8.1) months; p <0.001). Additionally, best radiological response (complete response/partial response/stable disease/ progressive disease) was significantly better in patients with lower CRAFITY score (CRAFITY-low: 9%/20%/52%/20% vs. CRAFITY-intermediate: 3%/25%/36%/36% vs. CRAFITY-high: 2%/ 15%/22%/61%; p = 0.003). These results were confirmed in the independent validation set and in different subgroups, including Child-Pugh A and B, performance status 0 and >= 1 and first-line and later lines. In the sorafenib cohort, CRAFITY was associated with survival, but not radiological response. Conclusions: The CRAFITY score is associated with survival

Published
2022

9. Prognosis of patients with hepatocellular carcinoma treated with immunotherapy – development and validation of the CRAFITY score

Author

Scheiner, Bernhard, primary, Pomej, Katharina, additional, Kirstein, Martha M., additional, Hucke, Florian, additional, Finkelmeier, Fabian, additional, Waidmann, Oliver, additional, Himmelsbach, Vera, additional, Schulze, Kornelius, additional, von Felden, Johann, additional, Fründt, Thorben W., additional, Stadler, Marc, additional, Heinzl, Harald, additional, Shmanko, Kateryna, additional, Spahn, Stephan, additional, Radu, Pompilia, additional, Siebenhüner, Alexander R., additional, Mertens, Joachim C., additional, Rahbari, Nuh N., additional, Kütting, Fabian, additional, Waldschmidt, Dirk-Thomas, additional, Ebert, Matthias P., additional, Teufel, Andreas, additional, De Dosso, Sara, additional, Pinato, David J., additional, Pressiani, Tiziana, additional, Meischl, Tobias, additional, Balcar, Lorenz, additional, Müller, Christian, additional, Mandorfer, Mattias, additional, Reiberger, Thomas, additional, Trauner, Michael, additional, Personeni, Nicola, additional, Rimassa, Lorenza, additional, Bitzer, Michael, additional, Trojan, Jörg, additional, Weinmann, Arndt, additional, Wege, Henning, additional, Dufour, Jean-François, additional, Peck-Radosavljevic, Markus, additional, Vogel, Arndt, additional, and Pinter, Matthias, additional

Published
2022
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10. Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement.

Author

Javle, Milind M., Roychowdhury, Sameek, Kelley, Robin Kate, Sadeghi, Saeed, Macarulla, Teresa, Waldschmidt, Dirk Thomas, Goyal, Lipika, Borbath, Ivan, El-Khoueiry, Anthony B., Yong, Wei-Peng, Philip, Philip Agop, Bitzer, Michael, Tanasanvimon, Suebpong, Pande, Amit, Shepherd, Stacie Peacock, Moran, Susan, Abou-Alfa, Ghassan K., Javle, Milind M., Roychowdhury, Sameek, Kelley, Robin Kate, Sadeghi, Saeed, Macarulla, Teresa, Waldschmidt, Dirk Thomas, Goyal, Lipika, Borbath, Ivan, El-Khoueiry, Anthony B., Yong, Wei-Peng, Philip, Philip Agop, Bitzer, Michael, Tanasanvimon, Suebpong, Pande, Amit, Shepherd, Stacie Peacock, Moran, Susan, and Abou-Alfa, Ghassan K.

Published
2021

11. Cabozantinib in Advanced Hepatocellular Carcinoma: Efficacy and Safety Data from an International Multicenter Real-Life Cohort

Author

Finkelmeier, Fabian, Scheiner, Bernhard, Leyh, Catherine, Best, Jan, Fruendt, Thorben Wilhelm, Czauderna, Carolin, Beutel, Alica, Bettinger, Dominik, WeiSS, Johannes, Meischl, Tobias, Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Radu, Pompilia, Schultheiss, Michael, Peiffer, Kai-Henrik, Ettrich, Thomas J., Weinmann, Arndt, Wege, Henning, Venerito, Marino, Dufour, Jean-Francois, Lange, Christian M., Pinter, Matthias, Waidmann, Oliver, Finkelmeier, Fabian, Scheiner, Bernhard, Leyh, Catherine, Best, Jan, Fruendt, Thorben Wilhelm, Czauderna, Carolin, Beutel, Alica, Bettinger, Dominik, WeiSS, Johannes, Meischl, Tobias, Kuetting, Fabian, Waldschmidt, Dirk-Thomas, Radu, Pompilia, Schultheiss, Michael, Peiffer, Kai-Henrik, Ettrich, Thomas J., Weinmann, Arndt, Wege, Henning, Venerito, Marino, Dufour, Jean-Francois, Lange, Christian M., Pinter, Matthias, and Waidmann, Oliver

Abstract

Background and Aims: The multikinase inhibitor cabozantinib has been approved for hepatocellular carcinoma (HCC) previously treated with sorafenib. We report safety and efficacy data of an international, multicenter, real-life cohort of patients with advanced HCC treated with cabozantinib. Methods: Patients with HCC who were treated with cabozantinib were retrospectively identified across 11 centers in Austria, Switzerland, and Germany. Patients' characteristics, adverse events, duration of treatment and overall survival (OS) data were analyzed until April 1, 2020. Results: Eighty-eight patients from 11 centers were included. The predominant underlying liver diseases were NAFLD/NASH in 26 (30%) and hepatitis C infection in 21 (24%) patients. Seventy-eight patients (89%) were classified as Barcelona clinic liver cancer (BCLC) stage C. Sixty patients (68%) were Child-Pugh A, whereas 22 (25%) were Child-Pugh B, respectively. Cabozantinib was used as systemic second- and third-line or later treatment in 41 (47%) and 46 (52%) patients, respectively. The following best responses under cabozantinib were documented: partial response in 6 (7%), stable disease in 28 (32%), and progressive disease in 28 (32%) patients, respectively. Fifty-two patients (59%) died during follow-up. The median OS from start of cabozantinib treatment was 7.0 months in the entire cohort and 9.7 months in Child-Pugh A patients, while Child-Pugh B patients had a median OS of 3.4 months, respectively. Thirty-seven (42%) patients fulfilled the CELESTIAL inclusion and exclusion criteria, showing a median OS of 11.1 months. Most common adverse events were fatigue (15.6%) and diarrhea (15.6%). Conclusion: Cabozantinib treatment was effective, safe, and feasible in patients with advanced HCC in patients with compensated cirrhosis. Patients in the real-life setting had more advanced liver disease - in which 25% of patients were Child-Pugh B. However, OS in patients with Child-Pugh A cirrhosis was similar to

Published
2021

12. Results of a phase Ib study of regorafenib (REG) 80 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC).

Author

Kim, Richard D., Harris, William P., Sung, Max W., Waldschmidt, Dirk Thomas, Cabrera, Roniel, Mueller, Udo, Menezes, Flavia, Ishida, Tatiane, Galle, Peter R., El-Khoueiry, Anthony B., Kim, Richard D., Harris, William P., Sung, Max W., Waldschmidt, Dirk Thomas, Cabrera, Roniel, Mueller, Udo, Menezes, Flavia, Ishida, Tatiane, Galle, Peter R., and El-Khoueiry, Anthony B.

Published
2021

13. FRI-273 - Validation of the CRAFITY score in patients with hepatocellular carcinoma treated with atezolizumab and bevacizumab

Author

Scheiner, Bernhard, Sartoris, Riccardo, D’Alessio, Antonio, Fulgenzi, Claudia, Pomej, Katharina, Balcar, Lorenz, Bouattour, Mohamed, Sidali, Sabrina, Himmelsbach, Vera, Finkelmeier, Fabian, Schulze, Kornelius, von Felden, Johann, Hucke, Florian, Shmanko, Kateryna, Siebenhüner, Alexander, Mertens, Joachim C., De Dosso, Sara, Ebert, Matthias, Teufel, Andreas, Waldschmidt, Dirk-Thomas, Radu, Iuliana Pompilia, Krall, Anja, Trauner, Michael, Dufour, Jean-François, Wege, Henning, Weinmann, Arndt, Trojan, Jörg, Stauber, Rudolf E., Peck-Radosavljevic, Markus, Hsu, Wei-Fan, Vogel, Arndt, Ronot, Maxime, Pinato, David J., and Pinter, Matthias

Published
2023
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14. Structured Reporting of Solid and Cystic Pancreatic Lesions in CT and MRI: Consensus-Based Structured Report Templates of the German Society of Radiology (DRG)

Author

Persigehl, Thorsten, Baumhauer, Matthias, Baessler, Bettina, Beyer, Lukas Philipp, Bludau, Marc, Bruns, Christiane, Bunck, Alexander Christian, Germer, Christoph-Thomas, Grenacher, Lars, Hacklaender, Thomas, Haneder, Stefan, Heinrich, Stefan, Heusch, Philipp, Hoffmann, Matthias, Juchems, Markus S., Kroeger, Jan Robert, Kotter, Elmar, Layer, Guenter, Maintz, David, Menke, Jan, Palmowski, Moritz, Pantelis, Dimitrios, dos Santos, Daniel Pinto, Popp, Felix Christoph, Schaefer, Nico, Schlemmer, Heinz-Peter, Schreyer, Andreas G., Siedek, Florian, Stippel, Dirk, Voelker, Martin, Waldschmidt, Dirk Thomas, Weber, Tim Frederik, von Winterfeld, Moritz, Wybranski, Christian, Zander, Thomas, Wessling, Johannes, Persigehl, Thorsten, Baumhauer, Matthias, Baessler, Bettina, Beyer, Lukas Philipp, Bludau, Marc, Bruns, Christiane, Bunck, Alexander Christian, Germer, Christoph-Thomas, Grenacher, Lars, Hacklaender, Thomas, Haneder, Stefan, Heinrich, Stefan, Heusch, Philipp, Hoffmann, Matthias, Juchems, Markus S., Kroeger, Jan Robert, Kotter, Elmar, Layer, Guenter, Maintz, David, Menke, Jan, Palmowski, Moritz, Pantelis, Dimitrios, dos Santos, Daniel Pinto, Popp, Felix Christoph, Schaefer, Nico, Schlemmer, Heinz-Peter, Schreyer, Andreas G., Siedek, Florian, Stippel, Dirk, Voelker, Martin, Waldschmidt, Dirk Thomas, Weber, Tim Frederik, von Winterfeld, Moritz, Wybranski, Christian, Zander, Thomas, and Wessling, Johannes

Abstract

Background Radiological reports of pancreatic lesions are currently widely formulated as free texts. However, for optimal characterization, staging and operation planning, a wide range of information is required but is sometimes not captured comprehensively. Structured reporting offers the potential for improvement in terms of completeness, reproducibility and clarity of interdisciplinary communication. Method Interdisciplinary consensus finding of structured report templates for solid and cystic pancreatic tumors in computed tomography (CT) and magnetic resonance imaging (MRI) with representatives of the German Society of Radiology (DRG), German Society for General and Visceral Surgery (DGAV), working group Oncological Imaging (ABO) of the German Cancer Society (DKG) and other radiologists, oncologists and surgeons. Results Among experts in the field of pancreatic imaging, oncology and pancreatic surgery, as well as in a public online survey, structured report templates were developed by consensus. These templates are available on the DRG homepage under www.befundung.drg.de and will be regularly revised to the current state of scientific knowledge by the participating specialist societies and responsible working groups. Conclusion This article presents structured report templates for solid and cystic pancreatic tumors to improve clinical staging (cTNM, ycTNM) in everyday radiology. Key Points: Structured report templates offer the potential of optimized radiological reporting with regard to completeness, reproducibility and differential diagnosis. This article presents consensus-based, structured reports for solid and cystic pancreatic lesions in CT and MRI. These structured reports are available open source on the homepage of the German Society of Radiology (DRG) under www.befundung. drg.de.

Published
2020

15. Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement.

Author

Javle, Milind M., primary, Roychowdhury, Sameek, additional, Kelley, Robin Kate, additional, Sadeghi, Saeed, additional, Macarulla, Teresa, additional, Waldschmidt, Dirk Thomas, additional, Goyal, Lipika, additional, Borbath, Ivan, additional, El-Khoueiry, Anthony B., additional, Yong, Wei-Peng, additional, Philip, Philip Agop, additional, Bitzer, Michael, additional, Tanasanvimon, Suebpong, additional, Li, Ai, additional, Pande, Amit, additional, Shepherd, Stacie Peacock, additional, Moran, Susan, additional, and Abou-Alfa, Ghassan K., additional

Published
2021
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16. Results of a phase Ib study of regorafenib (REG) 80 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC).

Author

Kim, Richard D., primary, Harris, William P., additional, Sung, Max W., additional, Waldschmidt, Dirk Thomas, additional, Cabrera, Roniel, additional, Mueller, Udo, additional, Menezes, Flavia, additional, Ishida, Tatiane, additional, Galle, Peter R., additional, and El-Khoueiry, Anthony B., additional

Published
2021
Full Text
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17. Cabozantinib in Advanced Hepatocellular Carcinoma: Efficacy and Safety Data from an International Multicenter Real-Life Cohort

Author

Finkelmeier, Fabian, primary, Scheiner, Bernhard, additional, Leyh, Catherine, additional, Best, Jan, additional, Fründt, Thorben Wilhelm, additional, Czauderna, Carolin, additional, Beutel, Alica, additional, Bettinger, Dominik, additional, Weiß, Johannes, additional, Meischl, Tobias, additional, Kütting, Fabian, additional, Waldschmidt, Dirk-Thomas, additional, Radu, Pompilia, additional, Schultheiß, Michael, additional, Peiffer, Kai-Henrik, additional, Ettrich, Thomas J., additional, Weinmann, Arndt, additional, Wege, Henning, additional, Venerito, Marino, additional, Dufour, Jean-Francois, additional, Lange, Christian M., additional, Pinter, Matthias, additional, and Waidmann, Oliver, additional

Published
2021
Full Text
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18. Structured Reporting of Solid and Cystic Pancreatic Lesions in CT and MRI: Consensus-Based Structured Report Templates of the German Society of Radiology (DRG)

Author

Persigehl, Thorsten, additional, Baumhauer, Matthias, additional, Baeßler, Bettina, additional, Beyer, Lukas Philipp, additional, Bludau, Marc, additional, Bruns, Christiane, additional, Bunck, Alexander Christian, additional, Germer, Christoph-Thomas, additional, Grenacher, Lars, additional, Hackländer, Thomas, additional, Haneder, Stefan, additional, Heinrich, Stefan, additional, Heusch, Philipp, additional, Hoffmann, Matthias, additional, Juchems, Markus S., additional, Kröger, Jan Robert, additional, Kotter, Elmar, additional, Layer, Günter, additional, Maintz, David, additional, Menke, Jan, additional, Palmowski, Moritz, additional, Pantelis, Dimitrios, additional, Pinto dos Santos, Daniel, additional, Popp, Felix Christoph, additional, Schäfer, Nico, additional, Schlemmer, Heinz-Peter, additional, Schreyer, Andreas G., additional, Siedek, Florian, additional, Stippel, Dirk, additional, Völker, Martin, additional, Waldschmidt, Dirk Thomas, additional, Weber, Tim Frederik, additional, von Winterfeld, Moritz, additional, Wybranski, Christian, additional, Zander, Thomas, additional, and Wessling, Johannes, additional

Published
2020
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19. Implementing a novel method to estimate the "Burden of Therapy" (BOTh) for patients with metastatic pancreatic cancer treated with gemcitabine plus afatinib vs. gemcitabine in the AIO ACCEPT trial.

Author

Haas, Michael, primary, Abdul-Ahad, Ayad, additional, Snijder, Robert, additional, Waldschmidt, Dirk Thomas, additional, Stahl, Michael, additional, Reinacher-Schick, Anke C., additional, Freiberg-Richter, Jens, additional, Kaiser, Florian, additional, Kanzler, Stephan, additional, Frickhofen, Norbert, additional, Seufferlein, Thomas, additional, Dechow, Tobias Nicolaas, additional, Mahlberg, Rolf, additional, Malfertheiner, Peter, additional, Illerhaus, Gerald, additional, Kubicka, Stefan, additional, Held, Swantje, additional, Boeck, Stefan Hubert, additional, von Bergwelt-Baildon, Michael, additional, and Heinemann, Volker, additional

Published
2020
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20. Cabozantinib in advanced hepatocellular carcinoma: Efficacy and safety data from an international multicenter real-world cohort.

Author

Finkelmeier, Fabian, primary, Scheiner, Bernhard, additional, Leyh, Catherine, additional, Best, Jan, additional, Fründt, Thorben Wilhelm, additional, Czauderna, Carolin, additional, Beutel, Alica, additional, Bettinger, Dominik, additional, Weiß, Johannes, additional, Meischl, Tobias, additional, Kuetting, Fabian, additional, Waldschmidt, Dirk Thomas, additional, Schultheiß, Michael, additional, Ettrich, Thomas Jens, additional, Weinmann, Arndt, additional, Wege, Henning, additional, Venerito, Marino, additional, Lange, Christian, additional, Pinter, Matthias, additional, and Waidmann, Oliver, additional

Published
2020
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21. Leitlinie - ICD-10 C25 : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Waldschmidt, Dirk Thomas, Bauernhofer, Thomas, Pritzkuleit, Ron, Schweizerische Gesellschaft Für Hämatologie, Wörmann, Bernhard, Schweizerische Gesellschaft Für Medizinische Onkologie, Deutsche Krebsgesellschaft. Arbeitsgemeinschaft Für Internistische Onkologie, Fietkau, Rainer, Heinemann, Volker, Borner, Markus M., Neumann, Ulf Peter, Österreichische Gesellschaft Für Hämatologie & Medizinische Onkologie, Oettle, Helmut, Faber, Gerhard, Sinn, Marianne, and Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie

Subjects
Medizin und Gesundheit
Published
2018
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22. Sequence therapy in metastatic pancreatic cancer

Author

Waidmann, Oliver, Pelzer, Uwe, Boeck, Stefan, Waldschmidt, Dirk-Thomas, Waidmann, Oliver, Pelzer, Uwe, Boeck, Stefan, and Waldschmidt, Dirk-Thomas

Abstract

Pancreatic cancer is one of the most lethal cancer diseases. For years, gemcitabine has been the standard of care and the only therapeutic option in patients with metastatic pancreatic cancer. Within the last years, new combination therapies have been established for first-line treatment, which significantly improve overall survival in comparison to gemcitabine monotherapy. Furthermore, new second-line therapies have been identified, which significantly improve overall survival. The current manuscript summarizes briefly standard of care first- and second-line chemotherapies and discusses possible treatment sequences.

Published
2018

23. Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study

Author

Javle, Milind, Roychowdhury, Sameek, Kelley, Robin Kate, Sadeghi, Saeed, Macarulla, Teresa, Weiss, Karl Heinz, Waldschmidt, Dirk-Thomas, Goyal, Lipika, Borbath, Ivan, El-Khoueiry, Anthony, Borad, Mitesh J, Yong, Wei Peng, Philip, Philip A, Bitzer, Michael, Tanasanvimon, Surbpong, Li, Ai, Pande, Amit, Soifer, Harris S, Shepherd, Stacie Peacock, Moran, Susan, Zhu, Andrew X, Bekaii-Saab, Tanios S, and Abou-Alfa, Ghassan K

Abstract

Treatment options are sparse for patients with advanced cholangiocarcinoma after progression on first-line gemcitabine-based therapy. FGFR2fusions or rearrangements occur in 10–16% of patients with intrahepatic cholangiocarcinoma. Infigratinib is a selective, ATP-competitive inhibitor of fibroblast growth factor receptors. We aimed to evaluate the antitumour activity of infigratinib in patients with locally advanced or metastatic cholangiocarcinoma, FGFR2alterations, and previous gemcitabine-based treatment.

Published
2021
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24. Leitlinie - ICD-10 C25 : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Waldschmidt, Dirk Thomas, Bauernhofer, Thomas, Pritzkuleit, Ron, Wörmann, Bernhard, Schweizerische Gesellschaft Für Medizinische Onkologie, Fietkau, Rainer, Heinemann, Volker, Borner, Markus M., Neumann, Ulf Peter, Österreichische Gesellschaft Für Hämatologie & Medizinische Onkologie, Oettle, Helmut, Faber, Gerhard, Sinn, Marianne, and Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie

Subjects
Medizin und Gesundheit
Published
2017
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26. FOOTPATH: A randomized, open-label phase-2 study of liposomal irinotecan + 5-FU and folinic acid (NAPOLI) versus sequential NAPOLI and mFOLFOX6 versus gemcitabine/nab-paclitaxel in treatment-naïve metastatic pancreatic cancer (mPDAC).

Author

Westphalen, Benedikt, Gaska, Tobias, Reichert, Maximilian, Quante, Michael, Oettle, Helmut, Waldschmidt, Dirk Thomas, Schlenska-Lange, Anke, Angermeier, Stefan, Fischer von Weikersthal, Ludwig, Bohle, Wolfram, Vehling-Kaiser, Ursula, Stahler, Arndt, Kanzler, Stephan, Lamberti, Christof, Pelzer, Uwe, Sinn, Marianne, Blau, Wolfgang, Boeck, Stefan Hubert, Held, Swantje, and Heinemann, Volker

Published
2023
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27. Leitlinie : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Bertz, Hartmut, Waldschmidt, Dirk Thomas, Karthaus, Meinolf, Penack, Olaf, Salwender, Hans, Krüger, William H., Sandherr, Michael, Wolf, Hans-Heinrich, Kiehl, Michael G., Buchheidt, Dieter, Egerer, Gerlinde, Reuter, Stefan, Cornely, Oliver Andreas, Auner, Holger, Ruhnke, Markus, Weißinger, Florian, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, Ullmann, Andrew, and Heinz, Werner

Subjects
Medizin und Gesundheit
Published
2012
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28. NASH limits anti-tumour surveillance in immunotherapy-treated HCC

Author

Pfister, Dominik, Núñez, Nicolás Gonzalo, Pinyol, Roser, Govaere, Olivier, Pinter, Matthias, Szydlowska, Marta, Gupta, Revant, Qiu, Mengjie, Deczkowska, Aleksandra, Weiner, Assaf, Müller, Florian, Sinha, Ankit, Friebel, Ekaterina, Engleitner, Thomas, Lenggenhager, Daniela, Moncsek, Anja, Heide, Danijela, Stirm, Kristin, Kosla, Jan, Kotsiliti, Eleni, Leone, Valentina, Dudek, Michael, Yousuf, Suhail, Inverso, Donato, Singh, Indrabahadur, Teijeiro, Ana, Castet, Florian, Montironi, Carla, Haber, Philipp K, Tiniakos, Dina, Bedossa, Pierre, Cockell, Simon, Younes, Ramy, Vacca, Michele, Marra, Fabio, Schattenberg, Jörn M, Allison, Michael, Bugianesi, Elisabetta, Ratziu, Vlad, Pressiani, Tiziana, D'Alessio, Antonio, Personeni, Nicola, Rimassa, Lorenza, Daly, Ann K, Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M, Vogel, Arndt, Peck-Radosavljevic, Markus, Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Trojan, Jörg, Schulze, Kornelius, Wege, Henning, Koch, Sandra, Weinmann, Arndt, Bueter, Marco, Rössler, Fabian, Siebenhüner, Alexander, De Dosso, Sara, Mallm, Jan-Philipp, Umansky, Viktor, Jugold, Manfred, Luedde, Tom, Schietinger, Andrea, Schirmacher, Peter, Emu, Brinda, Augustin, Hellmut G, Billeter, Adrian, Müller-Stich, Beat, Kikuchi, Hiroto, Duda, Dan G, Kütting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias Philip, Rahbari, Nuh, Mei, Henrik E, Schulz, Axel Ronald, Ringelhan, Marc, Malek, Nisar, Spahn, Stephan, Bitzer, Michael, Ruiz De Galarreta, Marina, Lujambio, Amaia, Dufour, Jean-Francois, Marron, Thomas U, Kaseb, Ahmed, Kudo, Masatoshi, Huang, Yi-Hsiang, Djouder, Nabil, Wolter, Katharina, Zender, Lars, Marche, Parice N, Decaens, Thomas, Pinato, David J, Rad, Roland, Mertens, Joachim C, Weber, Achim, Unger, Kristian, Meissner, Felix, Roth, Susanne, Jilkova, Zuzana Macek, Claassen, Manfred, Anstee, Quentin M, Amit, Ido, Knolle, Percy, Becher, Burkhard, Llovet, Josep M, and Heikenwalder, Mathias

Subjects
Male, Carcinoma, Hepatocellular, Carcinogenesis, Tumor Necrosis Factor-alpha, Liver Neoplasms, Programmed Cell Death 1 Receptor, CD8-Positive T-Lymphocytes, digestive system diseases, B7-H1 Antigen, 3. Good health, Mice, Liver, Non-alcoholic Fatty Liver Disease, Disease Progression, Animals, Humans, Immunotherapy
Abstract

Hepatocellular carcinoma (HCC) can have viral or non-viral causes1-5. Non-alcoholic steatohepatitis (NASH) is an important driver of HCC. Immunotherapy has been approved for treating HCC, but biomarker-based stratification of patients for optimal response to therapy is an unmet need6,7. Here we report the progressive accumulation of exhausted, unconventionally activated CD8+PD1+ T cells in NASH-affected livers. In preclinical models of NASH-induced HCC, therapeutic immunotherapy targeted at programmed death-1 (PD1) expanded activated CD8+PD1+ T cells within tumours but did not lead to tumour regression, which indicates that tumour immune surveillance was impaired. When given prophylactically, anti-PD1 treatment led to an increase in the incidence of NASH-HCC and in the number and size of tumour nodules, which correlated with increased hepatic CD8+PD1+CXCR6+, TOX+, and TNF+ T cells. The increase in HCC triggered by anti-PD1 treatment was prevented by depletion of CD8+ T cells or TNF neutralization, suggesting that CD8+ T cells help to induce NASH-HCC, rather than invigorating or executing immune surveillance. We found similar phenotypic and functional profiles in hepatic CD8+PD1+ T cells from humans with NAFLD or NASH. A meta-analysis of three randomized phase III clinical trials that tested inhibitors of PDL1 (programmed death-ligand 1) or PD1 in more than 1,600 patients with advanced HCC revealed that immune therapy did not improve survival in patients with non-viral HCC. In two additional cohorts, patients with NASH-driven HCC who received anti-PD1 or anti-PDL1 treatment showed reduced overall survival compared to patients with other aetiologies. Collectively, these data show that non-viral HCC, and particularly NASH-HCC, might be less responsive to immunotherapy, probably owing to NASH-related aberrant T cell activation causing tissue damage that leads to impaired immune surveillance. Our data provide a rationale for stratification of patients with HCC according to underlying aetiology in studies of immunotherapy as a primary or adjuvant treatment.

29. NASH limits anti-tumour surveillance in immunotherapy-treated HCC

Author

Pfister, Dominik, Núñez, Nicolás Gonzalo, Pinyol, Roser, Govaere, Olivier, Pinter, Matthias, Szydlowska, Marta, Gupta, Revant, Qiu, Mengjie, Deczkowska, Aleksandra, Weiner, Assaf, Müller, Florian, Sinha, Ankit, Friebel, Ekaterina, Engleitner, Thomas, Lenggenhager, Daniela, Moncsek, Anja, Heide, Danijela, Stirm, Kristin, Kosla, Jan, Kotsiliti, Eleni, Leone, Valentina, Dudek, Michael, Yousuf, Suhail, Inverso, Donato, Singh, Indrabahadur, Teijeiro, Ana, Castet, Florian, Montironi, Carla, Haber, Philipp K, Tiniakos, Dina, Bedossa, Pierre, Cockell, Simon, Younes, Ramy, Vacca, Michele, Marra, Fabio, Schattenberg, Jörn M, Allison, Michael, Bugianesi, Elisabetta, Ratziu, Vlad, Pressiani, Tiziana, D'Alessio, Antonio, Personeni, Nicola, Rimassa, Lorenza, Daly, Ann K, Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M, Vogel, Arndt, Peck-Radosavljevic, Markus, Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Trojan, Jörg, Schulze, Kornelius, Wege, Henning, Koch, Sandra, Weinmann, Arndt, Bueter, Marco, Rössler, Fabian, Siebenhüner, Alexander, De Dosso, Sara, Mallm, Jan-Philipp, Umansky, Viktor, Jugold, Manfred, Luedde, Tom, Schietinger, Andrea, Schirmacher, Peter, Emu, Brinda, Augustin, Hellmut G, Billeter, Adrian, Müller-Stich, Beat, Kikuchi, Hiroto, Duda, Dan G, Kütting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias Philip, Rahbari, Nuh, Mei, Henrik E, Schulz, Axel Ronald, Ringelhan, Marc, Malek, Nisar, Spahn, Stephan, Bitzer, Michael, Ruiz de Galarreta, Marina, Lujambio, Amaia, Dufour, Jean-François, Marron, Thomas U, Kaseb, Ahmed, Kudo, Masatoshi, Huang, Yi-Hsiang, Djouder, Nabil, Wolter, Katharina, Zender, Lars, Marche, Parice N, Decaens, Thomas, Pinato, David J, Rad, Roland, Mertens, Joachim C, Weber, Achim, Unger, Kristian, Meissner, Felix, Roth, Susanne, Jilkova, Zuzana Macek, Claassen, Manfred, Anstee, Quentin M, Amit, Ido, Knolle, Percy, Becher, Burkhard, Llovet, Josep M, and Heikenwalder, Mathias

Subjects
610 Medicine & health, digestive system diseases, 3. Good health
Abstract

Hepatocellular carcinoma (HCC) can have viral or non-viral causes1-5. Non-alcoholic steatohepatitis (NASH) is an important driver of HCC. Immunotherapy has been approved for treating HCC, but biomarker-based stratification of patients for optimal response to therapy is an unmet need6,7. Here we report the progressive accumulation of exhausted, unconventionally activated CD8+PD1+ T cells in NASH-affected livers. In preclinical models of NASH-induced HCC, therapeutic immunotherapy targeted at programmed death-1 (PD1) expanded activated CD8+PD1+ T cells within tumours but did not lead to tumour regression, which indicates that tumour immune surveillance was impaired. When given prophylactically, anti-PD1 treatment led to an increase in the incidence of NASH-HCC and in the number and size of tumour nodules, which correlated with increased hepatic CD8+PD1+CXCR6+, TOX+, and TNF+ T cells. The increase in HCC triggered by anti-PD1 treatment was prevented by depletion of CD8+ T cells or TNF neutralization, suggesting that CD8+ T cells help to induce NASH-HCC, rather than invigorating or executing immune surveillance. We found similar phenotypic and functional profiles in hepatic CD8+PD1+ T cells from humans with NAFLD or NASH. A meta-analysis of three randomized phase III clinical trials that tested inhibitors of PDL1 (programmed death-ligand 1) or PD1 in more than 1,600 patients with advanced HCC revealed that immune therapy did not improve survival in patients with non-viral HCC. In two additional cohorts, patients with NASH-driven HCC who received anti-PD1 or anti-PDL1 treatment showed reduced overall survival compared to patients with other aetiologies. Collectively, these data show that non-viral HCC, and particularly NASH-HCC, might be less responsive to immunotherapy, probably owing to NASH-related aberrant T cell activation causing tissue damage that leads to impaired immune surveillance. Our data provide a rationale for stratification of patients with HCC according to underlying aetiology in studies of immunotherapy as a primary or adjuvant treatment.

30. NASH limits anti-tumour surveillance in immunotherapy-treated HCC

Author

Pfister, Dominik, Núñez, Nicolás Gonzalo, Pinyol, Roser, Govaere, Olivier, Pinter, Matthias, Szydlowska, Marta, Gupta, Revant, Qiu, Mengjie, Deczkowska, Aleksandra, Weiner, Assaf, Müller, Florian, Sinha, Ankit, Friebel, Ekaterina, Engleitner, Thomas, Lenggenhager, Daniela, Moncsek, Anja, Heide, Danijela, Stirm, Kristin, Kosla, Jan, Kotsiliti, Eleni, Leone, Valentina, Dudek, Michael, Yousuf, Suhail, Inverso, Donato, Singh, Indrabahadur, Teijeiro, Ana, Castet, Florian, Montironi, Carla, Haber, Philipp K., Tiniakos, Dina, Bedossa, Pierre, Cockell, Simon, Younes, Ramy, Vacca, Michele, Marra, Fabio, Schattenberg, Jörn M., Allison, Michael, Bugianesi, Elisabetta, Ratziu, Vlad, Pressiani, Tiziana, D’Alessio, Antonio, Personeni, Nicola, Rimassa, Lorenza, Daly, Ann K., Scheiner, Bernhard, Pomej, Katharina, Kirstein, Martha M., Vogel, Arndt, Peck-Radosavljevic, Markus, Hucke, Florian, Finkelmeier, Fabian, Waidmann, Oliver, Trojan, Jörg, Schulze, Kornelius, Wege, Henning, Koch, Sandra, Weinmann, Arndt, Bueter, Marco, Rössler, Fabian, Siebenhüner, Alexander, De Dosso, Sara, Mallm, Jan-Philipp, Umansky, Viktor, Jugold, Manfred, Luedde, Tom, Schietinger, Andrea, Schirmacher, Peter, Emu, Brinda, Augustin, Hellmut G., Billeter, Adrian, Müller-Stich, Beat, Kikuchi, Hiroto, Duda, Dan G., Kütting, Fabian, Waldschmidt, Dirk-Thomas, Ebert, Matthias Philip, Rahbari, Nuh, Mei, Henrik E., Schulz, Axel Ronald, Ringelhan, Marc, Malek, Nisar, Spahn, Stephan, Bitzer, Michael, Ruiz De Galarreta, Marina, Lujambio, Amaia, Dufour, Jean-Francois, Marron, Thomas U., Kaseb, Ahmed, Kudo, Masatoshi, Huang, Yi-Hsiang, Djouder, Nabil, Wolter, Katharina, Zender, Lars, Marche, Parice N., Decaens, Thomas, Pinato, David J., Rad, Roland, Mertens, Joachim C., Weber, Achim, Unger, Kristian, Meissner, Felix, Roth, Susanne, Jilkova, Zuzana Macek, Claassen, Manfred, Anstee, Quentin M., Amit, Ido, Knolle, Percy, Becher, Burkhard, Llovet, Josep M., and Heikenwalder, Mathias

Subjects
631/67, article, 631/250/251, digestive system diseases, 3. Good health, 13/31, 13/2, 14/32, 13/1, 14/34, 13/21, 13/51, 14/63, 59/57, 64/60, 14/19, 14/35
Abstract

Hepatocellular carcinoma (HCC) can have viral or non-viral causes1–5. Non-alcoholic steatohepatitis (NASH) is an important driver of HCC. Immunotherapy has been approved for treating HCC, but biomarker-based stratification of patients for optimal response to therapy is an unmet need6, 7. Here we report the progressive accumulation of exhausted, unconventionally activated CD8+PD1+ T cells in NASH-affected livers. In preclinical models of NASH-induced HCC, therapeutic immunotherapy targeted at programmed death-1 (PD1) expanded activated CD8+PD1+ T cells within tumours but did not lead to tumour regression, which indicates that tumour immune surveillance was impaired. When given prophylactically, anti-PD1 treatment led to an increase in the incidence of NASH–HCC and in the number and size of tumour nodules, which correlated with increased hepatic CD8+PD1+CXCR6+, TOX+, and TNF+ T cells. The increase in HCC triggered by anti-PD1 treatment was prevented by depletion of CD8+ T cells or TNF neutralization, suggesting that CD8+ T cells help to induce NASH–HCC, rather than invigorating or executing immune surveillance. We found similar phenotypic and functional profiles in hepatic CD8+PD1+ T cells from humans with NAFLD or NASH. A meta-analysis of three randomized phase III clinical trials that tested inhibitors of PDL1 (programmed death-ligand 1) or PD1 in more than 1,600 patients with advanced HCC revealed that immune therapy did not improve survival in patients with non-viral HCC. In two additional cohorts, patients with NASH-driven HCC who received anti-PD1 or anti-PDL1 treatment showed reduced overall survival compared to patients with other aetiologies. Collectively, these data show that non-viral HCC, and particularly NASH–HCC, might be less responsive to immunotherapy, probably owing to NASH-related aberrant T cell activation causing tissue damage that leads to impaired immune surveillance. Our data provide a rationale for stratification of patients with HCC according to underlying aetiology in studies of immunotherapy as a primary or adjuvant treatment.

31. Efficacy, safety and differential outcomes of immune-chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort.

Author

Mitzlaff K, Kirstein MM, Müller C, Venerito M, Olkus A, Dill MT, Weinmann A, Kocheise L, Busch A, Schulze K, Allo G, Waldschmidt DT, Barsch M, Bengsch B, Quante M, Gonzalez-Carmona MA, Himmelsbach V, Finkelmeier F, Kloeckner R, Schirmacher P, Marquardt JU, and Zimpel C

Abstract

Background: Combined Immuno-chemotherapy consisting of gemcitabine, cisplatin and the programmed death-ligand one inhibitor durvalumab (GCD) is the new standard of care for patients with biliary tract cancers (BTC) based on positive results of the TOPAZ-1 study., Objective: We here evaluated the efficacy and safety of GCD for BTC in a German multicenter real-world patient cohort., Methods: Patients with BTC treated with GCD from 9 German centers were included. Clinicopathological baseline parameters, overall survival (OS), response rate and adverse events (AEs) were retrospectively analyzed. The prognostic impact was determined by Kaplan-Meier analyses and Cox regression models., Results: A total of 165 patients treated with GCD between 2021 and 2024 were included in the study. Median OS and median progression-free survival were 14 months (95% CI 10.3-17.7) and 8 months (95% CI 6.8-9.2), respectively. The best overall response rate was 28.5% and disease control rate was 65.5%. While extrahepatic and intrahepatic BTC showed similar outcomes, mOS was significantly shorter in patients with gall bladder cancer (GB-CA) with 9 months (95% CI 5.5-12.4; p = 0.02). In univariate analyses age ≥70 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥1, status post cholecystectomy, GB-CA and high baseline CRP values were significantly associated with OS. ECOG PS ≥ 1 and GB-CA remained independent prognostic factors for OS in multivariable cox regression analysis. AEs have been reported in 130 patients (78.8%), including 149 grade 3-4 AEs (25.5%). One patient died of severe infectious pneumonia. Immune-related (ir)AEs occurred in 17 patients (10.3%), including 9 grade 3-4 irAEs (2.2%), which led to treatment interruption in 4 patients., Conclusions: Immuno-chemotherapy in patients with BTC was feasible, effective and safe in a real-life scenario. Our results were comparable to the phase 3 clinical trial results (TOPAZ-1). Reduced efficacy was noted in patients with GB-CA and/or a reduced performance status that warrants further investigation., (© 2024 The Author(s). United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Published
2024
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32. Structured Reporting of Solid and Cystic Pancreatic Lesions in CT and MRI: Consensus-Based Structured Report Templates of the German Society of Radiology (DRG).

Author

Persigehl T, Baumhauer M, Baeßler B, Beyer LP, Bludau M, Bruns C, Bunck AC, Germer CT, Grenacher L, Hackländer T, Haneder S, Heinrich S, Heusch P, Hoffmann M, Juchems MS, Kröger JR, Kotter E, Layer G, Maintz D, Menke J, Palmowski M, Pantelis D, Pinto Dos Santos D, Popp FC, Schäfer N, Schlemmer HP, Schreyer AG, Siedek F, Stippel D, Völker M, Waldschmidt DT, Weber TF, von Winterfeld M, Wybranski C, Zander T, and Wessling J

Subjects
Germany, Humans, Radiology, Societies, Medical, Magnetic Resonance Imaging methods, Pancreatic Cyst diagnostic imaging, Pancreatic Diseases diagnostic imaging, Pancreatic Neoplasms diagnostic imaging, Radiology Information Systems, Research Design, Tomography, X-Ray Computed methods
Abstract

Background:  Radiological reports of pancreatic lesions are currently widely formulated as free texts. However, for optimal characterization, staging and operation planning, a wide range of information is required but is sometimes not captured comprehensively. Structured reporting offers the potential for improvement in terms of completeness, reproducibility and clarity of interdisciplinary communication., Method:  Interdisciplinary consensus finding of structured report templates for solid and cystic pancreatic tumors in computed tomography (CT) and magnetic resonance imaging (MRI) with representatives of the German Society of Radiology (DRG), German Society for General and Visceral Surgery (DGAV), working group Oncological Imaging (ABO) of the German Cancer Society (DKG) and other radiologists, oncologists and surgeons., Results:  Among experts in the field of pancreatic imaging, oncology and pancreatic surgery, as well as in a public online survey, structured report templates were developed by consensus. These templates are available on the DRG homepage under www.befundung.drg.de and will be regularly revised to the current state of scientific knowledge by the participating specialist societies and responsible working groups., Conclusion:  This article presents structured report templates for solid and cystic pancreatic tumors to improve clinical staging (cTNM, ycTNM) in everyday radiology., Key Points:   · Structured report templates offer the potential of optimized radiological reporting with regard to completeness, reproducibility and differential diagnosis.. · This article presents consensus-based, structured reports for solid and cystic pancreatic lesions in CT and MRI.. · These structured reports are available open source on the homepage of the German Society of Radiology (DRG) under www.befundung.drg.de.., Citation Format: · Persigehl T, Baumhauer M, Baeßler B et al. Structured Reporting of Solid and Cystic Pancreatic Lesions in CT and MRI: Consensus-Based Structured Report Templates of the German Society of Radiology (DRG). Fortschr Röntgenstr 2020; 192: 641 - 655., Competing Interests: The authors declare that they have no conflict of interest., (© Georg Thieme Verlag KG Stuttgart · New York.)

Published
2020
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