Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Autor: Thomas Powles, Michiel S van der Heijden, Daniel Castellano, Matthew D Galsky, Yohann Loriot, Daniel P Petrylak, Osamu Ogawa, Se Hoon Park, Jae-Lyun Lee, Ugo De Giorgi, Martin Bögemann, Aristotelis Bamias, Bernhard J Eigl, Howard Gurney, Som D Mukherjee, Yves Fradet, Iwona Skoneczna, Marinos Tsiatas, Andrey Novikov, Cristina Suárez, André P Fay, Ignacio Duran, Andrea Necchi, Sophie Wildsmith, Philip He, Natasha Angra, Ashok K Gupta, Wendy Levin, Joaquim Bellmunt, Michiel S. van der Heijden, Jae Lyun Lee, Bernhard J. Eigl, Som D. Mukherjee, Cristina Suarez, Hans Westgeest, Aude Flechon, Yen-Chuan Ou, Inkeun Park, Vsevolod Matveev, Begoña Pérez-Valderrama, Susanna Cheng, Stephen Frank, Urbano Anido, Alketa Hamzaj, Margitta Retz, Srikala Sridhar, Giorgio Vittorio Scagliotti, Jens Voortman, Boris Alekseev, Anna Alyasova, Boris Komyakov, Herlinde Dumez, Michel Pavic, Go Kimura, Atsushi Mizokami, Susanne Osanto, Jose Angel Arranz, Djura Piersma, Sang Joon Shin, Oleg Karyakin, Ignacio Delgado, Jose Luis Gonzalez, See-Tong Pang, Anna Tran, Oleg Lipatov, Wen-Pin Su, Thomas Flaig, Ajjai Alva, Hwa Park Kyong, Evgeny Kopyltsov, Elena Almagro, Monserrat Domenech, Yen-Hwa Chang, Brieuc Sautois, Andre Ravaux, Gerasimos Aravantinos, Vasileios Georgoulias, Sasja Mulder, Yu Jung Kim, Fabio Kater, Christine Chevreau, Scott Tagawa, Pawel Zalewski, Florence Joly, Gencay Hatiboglu, Luca Gianni, Franco Morelli, Rosa Tambaro, Yasuhiro Hashimoto, Alexander Nosov, Albert Font, Alejo M. Rodriguez-Vida, Robert Jones, Naveen Vasudev, Sandhya Srinivas, Jingsong Zhang, Thierry Gil, Daygen Finch, Marc-Oliver Grimm, Yu-Li Su, Simon Chowdhury, Christopher Hocking, Eugen Plas, Scott North, Niels Viggo Jensen, Christine Theodore, Florian Imkamp, Avivit Peer, Takashi Kobayashi, Hideki Sakai, Naoto Sassa, Kazuhiro Yoshimura, Maureen Aarts, Ana Ferreira Castro, Marlen Topuzov, Juan Francisco Rodriguez, Federico Jose Vazquez, Yu-Chieh Tsai, Simon Crabb, Syed Hussain, Johanna Bendell, Marine Gross-Goupil, Gravis Gwenaelle, Raanan Berger, Galina Statsenko, Linda Evans, Alexandra Drakaki, Bradley Somer, Ian Davis, James Lynam, Giuliano Borges, Aldo Dettino, André P. Fay, Graziella Martins, Luis Eduardo Zucca, Mads Agerbaek, Haralambos Kalofonos, Eli Rosenbaum, Hideki Enokida, Hiroaki Kikukawa, Kazuo Nishimura, Satoshi Tamada, Motohide Uemura, Yamil Lopez, Jourik Gietema, Marcin Slojewski, Isabel Fernandes, Alexey Smolin, Danish Mazhar, Arash Rezazadeh Kalebasty, Bradley Carthon, Wolfgang Loidl, Fabio Franke, Gustavo Girotto, Nimira Alimohamed, Robyn Macfarlane, Helle Pappot, Guenter Niegisch, Dimitrios Mavroudis, Avishay Sella, Camillo Porta, Shin Ebara, Motonobu Nakamura, Wataru Obara, Norihiko Okuno, Nobuo Shinohara, Mikio Sugimoto, Akitaka Suzuki, Noriaki Tokuda, Hiroji Uemura, Akito Yamaguchi, Francisco Ramirez, Pawel Rozanowski, Pawel Wiechno, Bhumsuk Keam, Nikolay Kislov, Denis Plaksin, Irfan Cicin, Satish Kumar, Matthew D. Galsky, Daniel P. Petrylak, Joseph Rosales, Ulka Vaishampayan, Stephane Culine, Christos Papandreou, Taketoshi Nara, Mustafa Erman, Laurence Kreiger, Juliana Janoski, Diogo Rosa, Mariana Siqueira, Christina Canil, Lisa Sengelov, Jean-Marc Tourani, Gaku Arai, Katsuyoshi Hashine, Mutsushi Kawakita, Noboru Nakaigawa, Hayahito Nomi, Hiroaki Shiina, Hiroyoshi Suzuki, Junji Yonese, Roberto Kuri, Eleazar Macedo, Samuel Rivera, Alberto Villalobos Prieto, Anna Polakiewicz-Gilowska, Renata Zaucha, Fabio Lopes, Roman Ponomarev, Mark Pomerantz, Shahrokh Shariat, Cynthia Luk, Krzysztof Lesniewski-Kmak

Publikováno v: lancet oncology, 21(12), 1574-1588. Lancet Publishing Group
Lancet Oncology, 21(12), 1574-1588. Lancet Publishing Group
DANUBE study investigators & Voortman, J 2020, ' Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE) : a randomised, open-label, multicentre, phase 3 trial ', Lancet Oncology, vol. 21, no. 12, pp. 1574-1588 . https://doi.org/10.1016/S1470-2045(20)30541-6
The Lancet Oncology, 21(12), 1574-1588. ELSEVIER SCIENCE INC

Background: Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6d1a55ae19ca8e730510c641cbd9a05a
https://pubmed.ncbi.nlm.nih.gov/33387509

Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study

Autor: Joshua J. McFarlane, Mark D. Kochenderfer, Mark R. Olsen, Todd M. Bauer, Ana Molina, Ralph J. Hauke, James A. Reeves, Sunil Babu, Peter Van Veldhuizen, Bradley Somer, Vijay Gunuganti, Ian Schnadig, Saby George, Ray D. Page, Edward Arrowsmith, Rohit K. Jain, Joshua Zhang, M. Brent McHenry, Jennifer L. Johansen, Nicholas J. Vogelzang

Publikováno v: Clinical genitourinary cancer. 18(6)

The open-label, phase IIIb/IV CheckMate 374 study (NCT02596035) was conducted to validate the safety and efficacy of flat-dose nivolumab monotherapy 240 mg every 2 weeks (Q2W) in previously treated advanced/metastatic renal cell carcinoma (RCC). Thre

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ed41ec63369ca702699a2d70a008c2ee
https://pubmed.ncbi.nlm.nih.gov/32641261

Adjuvant vemurafenib in resected, BRAF V600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

Autor: Michele Maio, Karl Lewis, Lev Demidov, Mario Mandalà, Igor Bondarenko, Paolo A Ascierto, Christopher Herbert, Andrzej Mackiewicz, Piotr Rutkowski, Alexander Guminski, Grant R Goodman, Brian Simmons, Chenglin Ye, Yibing Yan, Dirk Schadendorf, Gabriela Cinat, Luis Enrique Fein, Michael Brown, Andrew Haydon, Adnan Khattak, Catriona McNeil, Phillip Parente, Jeremy Power, Rachel Roberts-Thomson, Shahneen Sandhu, Craig Underhill, Suresh Varma, Thomas Berger, Ahmad Awada, Nathalie Blockx, Veronique Buyse, Jeroen Mebis, Fábio André Franke, Sérgio Jobim de Azevedo, Nicolas Silva Lazaretti, Rahima Jamal, Catalin Mihalcioiu, Teresa Petrella, Kerry Savage, Xinni Song, Ralph Wong, Nina Dabelic, Stjepko Plestina, Zeljko Vojnovic, Petr Arenberger, Ivo Kocak, Ivana Krajsova, Eugen Kubala, Bohuslav Melichar, Yvetta Vantuchova, Kadri Putnik, Brigitte Dreno, Caroline Dutriaux, Jean-Jacques Grob, Pascal Joly, Jean-Philippe Lacour, Nicolas Meyer, Laurent Mortier, Luc Thomas, Michael Fluck, Thilo Gambichler, Jessica Hassel, Axel Hauschild, Paul Donnellan, John McCaffrey, Derek Power, Samuel Ariad, Gil Bar-Sela, Daniel Hendler, Ilan Ron, Jacob Schachter, Paolo Ascierto, Alfredo Berruti, Luca Bianchi, Vanna Chiarion Sileni, Francesco Cognetti, Riccardo Danielli, Anna Maria Di Giacomo, Luca Gianni, Aron Goldhirsch, Michele Guida, Paolo Marchetti, Paola Queirolo, Armando Santoro, Ellen Kapiteijn, Paula Ferreira, Georgy Gafton, Yulia Makarova, Zoran Andric, Nada Babovic, Darjana Jovanovic, Lidija Kandolf Sekulovic, Graham Cohen, Lydia Dreosti, Daniel Vorobiof, Maria Teresa Curiel Garcia, Roberto Diaz Beveridge, Margarita Majem Tarruella, Ivan Marquez Rodas, Jose-M Puliats Rodriguez, Antonio Rueda Dominguez, Marianne Maroti, Karin Papworth, Olivier Michielin, Ewan Brown, Pippa Corrie, Mark Harries, Satish Kumar, Agustin Martin-Clavijo, Mark Middleton, Poulam Patel, Toby Talbot, Sanjiv Agarwala, Paul Chapman, Robert Conry, Gary Doolittle, Tara Gangadhar, Sigrun Hallmeyer, Omid Hamid, Leonel Hernandez-Aya, Douglas Johnson, Frederic Kass, Tatjana Kolevska, Scott Lunin, April Salama, Branimir Sikic, Bradley Somer, David Spigel, Eric Whitman

Summary Background Systemic adjuvant treatment might mitigate the high risk of disease recurrence in patients with resected stage IIC–III melanoma. The BRIM8 study evaluated adjuvant vemurafenib monotherapy in patients with resected, BRAF V600 muta

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5ca377ad3c682462789b57095f06c16
http://hdl.handle.net/11379/501841

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Autor: Seth Keller, Michael Nelson, William H. Frishman, Bradley Somer, Christos P. Carvounis, Sylvia Wassertheil-Smoller, Miriam Aronson, Donald A. Feinfeld

Publikováno v: Geriatric Nephrology and Urology. 8:131-135

In a population of 141 very elderly subjects, there was a small but significant decline in BUN and creatinine at 3 years, which persisted at 6 years although partially attenuated. A similar pattern of falling BUN and creatinine was seen in the 31 sub

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2095a892183c60fb38755008efed2544
https://doi.org/10.1023/a:1008370126227

Oral enzastaurin in prostate cancer: a two-cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy for castrate metastatic disease

Autor: Brian I. Rini, Sandy Srinivas, Nicholas J. Vogelzang, Derek Raghavan, Maha Hussain, Bradley Somer, Marek Kania, Yan D. Zhao, Jorge A. Garcia, Robert Dreicer

Publikováno v: Investigational new drugs. 29(6)

Purpose: Enzastaurin is an oral serine/threonine kinase inhibitor of the beta isoform of protein kinase C that may have therapeutic activity in prostate cancer. We explored the efficacy of enzastaurin on two cohorts of patients with prostate cancer p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::935341b727c4f98e9b9b982e0deb1318
https://pubmed.ncbi.nlm.nih.gov/20369375