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1. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Wan Ng, Siobhan Su, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Joly, Florence, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Schwentner, Christina A, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Révész, Janos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Sarid, David, Scagliotti, Giorgio Vittorio, Bracarda, Sergio, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Vazquez Cortés, Leticia, Lorena Urzua Flores, Claudia, Blaisse, Reinoud J.B., Erdkamp, Fransiscus L.G., Aarts, Maureen J.B., Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Fomkin, Roman, Gajate Borau, Pablo, Grande, Enrique, Delgado Mignorance, Juan Ignacio, Su, Yu-Li, Li, Jian-Ri, Lin, Chien-Liang, Lin, Chia-Chi, Yeh, Su-Peng, Erman, Mustafa, Urun, Yuksel, Golovko, Yuriy, Bondarenko, Igor, Sinielnikov, Ivan, Crabb, Simon J., Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Flaig, Thomas W., Pan, Chong Xian, Schwarz, James K., Cultrera, Jennifer Lyn, Acs, Peter Istvan, Hainsworth, John D., Herms, Benjamin T., Lawler, William Eyre, Lowe, Thomas Eugene, Petrylak, Daniel P, de Wit, Ronald, Chi, Kim N, Drakaki, Alexandra, Sternberg, Cora N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan Y, van der Heijden, Michiel S, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan Senol, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor J, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Hamid, Oday, Liepa, Astra M, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard A, Zimmermann, Annamaria H, Hozak, Rebecca R, Bell-McGuinn, Katherine M, and Powles, Thomas

Published
2020
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2. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Ng, Siobhan Su Wan, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Chi, Kim Nguyen, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Laestadius, Fredrik, Joly, Florence, Flechon, Aude, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Gakis, Georgios, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Bamias, Aristotelis, Révész, Janos, Geczi, Lajos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Peer, Avivit, Sarid, David, Scagliotti, Giorgio Vittorio, Sternberg, Cora N, Tortora, Giampaolo, Bracarda, Sergio, Necchi, Andrea, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Matsubara, Nobuaki, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Jae-Lyun, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Cortés, Leticia Vazquez, Flores, Claudia Lorena Urzua, Blaisse, Reinoud J B, van der Heijden, Michiel S, de Wit, Ronald, Erdkamp, Fransiscus L G, Aarts, Maureen J B, Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Safina, Sufia Z, Alekseev, Boris, Semenov, Andrey, Fomkin, Roman, Pulido, Enrique Grande, Del Muro, F Xavier García, Mignorance, Juan Ignacio Delgado, Gauna, Daniel Castellano, Rodríguez-Vida, Alejo, Su, Yu-Li, Ou, Yen-Chuan, Lin, Chien-Liang, Su, Wen-Pin, Lin, Chia-Chi, Yeh, Su-Peng, Çiçin, Irfan, Harputluoglu, Hakan, Erman, Mustafa, Coskun, Hasan Senol, Urun, Yuksel, Golovko, Yurii, Bondarenko, Igor, Sinielnikov, Ivan, Powles, Thomas, Crabb, Simon, Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Drakaki, Alexandra, Flaig, Thomas, Pan, Chong Xian, Petrylak, Daniel, Schwarz, James, Percent, Ivor, Cultrera, Jennifer, Hainsworth, John, Herms, Benjamin, Lawler, William, Lowe, Thomas, Tagawa, Scott, Aragon-Ching, Jeanny, Vaishampayan, Ulka, Petrylak, Daniel P, Chi, Kim N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Yu, Evan Y, Géczi, Lajos, Hegemann, Miriam, Percent, Ivor J, Tucci, Marcello, Safina, Sufia, del Muro, Xavier Garcia, Rodriguez-Vida, Alejo, Cicin, Irfan, Widau, Ryan C, Liepa, Astra M, Walgren, Richard A, Hamid, Oday, Zimmermann, Annamaria H, and Bell-McGuinn, Katherine M

Published
2017
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3. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Koji Kawai, Satoshi Nagamori, Katherine M Bell-McGuinn, Cristiano Ferrario, Wen Pin Su, Isabel Syndikus, Aude Flechon, Georgios Gakis, Timothy Dudley Clay, Leticia Vazquez Cortés, Ronald de Wit, Florence Joly, Bozena Sikora-Kupis, Sergio Bracarda, Astra M. Liepa, Annemie Rutten, Daniel P. Petrylak, Su Peng Yeh, Annamaria Zimmermann, Sameera R. Wijayawardana, Mutsushi Kawakita, Siobhan Ng, Thean Hsiang Tan, Chikara Ohyama, Yu Jung Kim, Yuriy Golovko, Dimitrios Mavroudis, Jian Ri Li, Reinoud J. B. Blaisse, Mustafa Erman, Francesca Russo, Catherine Becht, Anghel Adrian Udrea, Robert Huddart, Syed A. Hussain, Fransiscus L.G. Erdkamp, Satoshi Fukasawa, Francesco Massari, Motohide Uemura, Boris Alekseev, Irfan Cicin, Se Hoon Park, Marcello Tucci, Lajos Géczi, Maureen J.B. Aarts, Yu Li Su, Fumimasa Fukuta, Hyo Jin Lee, Wolfgang Schultze-Seemann, Alexandra Drakaki, Hakan Harputluoglu, Xavier Garcia del Muro, Santhanam Sundar, Avivit Peer, Herlinde Dumez, William E. Lawler, Juan Ignacio Delgado Mignorance, Naveed Sarwar, Jeanny B. Aragon-Ching, Benjamin T. Herms, Fredrik Laestadius, Nobuaki Matsubara, Ivan Sinielnikov, Cora N. Sternberg, Hiroyuki Nishiyama, Piotr Tomczak, Brigitte Laguerre, Rebecca R. Hozak, Vasilis Karavasilis, Christina A. Schwentner, Hiroyuki Tsunemori, Masayoshi Nagata, Igor Bondarenko, Andrea Necchi, Yen Chuan Ou, Scott T. Tagawa, Constance Thibault, Richard A. Walgren, Akira Yokomizo, Evan Y. Yu, Alejo Rodriguez-Vida, Sufia Safina, Ulka N. Vaishampayan, János Révész, Aristotelis Bamias, Jae-Lyun Lee, Chien Liang Lin, Thomas W. Flaig, Roman Fomkin, Petr Alexandrovich Karlov, Joanna Wojcik-Tomaszewska, Junichi Inokuchi, Wataru Obara, Haralambos Kalofonos, John D. Hainsworth, Marc-Oliver Grimm, Thomas Eugene Lowe, Pablo Gajate Borau, Simon J. Crabb, Lisa Sengeloev, Junji Yonese, Simon Chowdhury, Elizabeth Jane Hovey, Daniel Castellano, Peter Istvan Acs, Chia-Chi Lin, Claudia Lorena Urzua Flores, Jean-Pascal Machiels, Kim N. Chi, Takahiro Osawa, Nobuo Shinohara, Daniel Kejzman, Günter Niegisch, David Sarid, Yuksel Urun, Yun Gyoo Lee, Oday Hamid, Alina Amalia Herzal, Michael Schenker, Eli Rosenbaum, Enrique Grande, Raya Leibowitz-Amit, Naoto Miyajima, Michiel S. van der Heijden, Shinichi Yamashita, Susanna Yee Shan Cheng, Kazuo Nishimura, Sun Young Rha, Thomas Powles, Hasan Şenol Coşkun, Jens Bedke, Ivor J. Percent, Christos Papandreou, James K. Schwarz, Masafumi Oyama, Giorgio V. Scagliotti, Chong-Xian Pan, Yoshihiko Tomita, Giampaolo Tortora, Stéphane Culine, Suet Lai Shirley Wong, Andrey Semenov, Jennifer L. Cultrera, Niels Viggo Jensen, Michael Stöckle, Katsuyoshi Hashine, Medical Oncology, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), Petrylak, Dp, de Wit, R, Chi, Kn, Drakaki, A, Sternberg, Cn, Nishiyama, H, Castellano, D, Hussain, Sa, Flechon, A, Bamias, A, Yu, Ey, van der Heijden, M, Matsubara, N, Alekseev, B, Necchi, A, Geczi, L, Ou, Yc, Coskun, H, Su, Wp, Bedke, J, Gakis, G, Percent, Ij, Lee, Jl, Tucci, M, Semenov, A, Laestadius, F, Peer, A, Tortora, G, Safina, S, del Muro, Xg, Rodriguez-Vida, A, Cicin, I, Harputluoglu, H, Tagawa, St, Vaishampayan, U, Aragon-Ching, Jb, Hamid, O, Liepa, Am, Wijayawardana, S, Russo, F, Walgren, Ra, Zimmermann, Ah, Hozak, Rr, Bell-McGuinn, Km, Powles, T, and Graduate School

Subjects
Male, 0301 basic medicine, MULTICENTER, Docetaxel, Gastroenterology, ANGIOGENESIS, VINFLUNINE, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Neoplasm Metastasis, education.field_of_study, CHEMOTHERAPY, Middle Aged, OPEN-LABEL, Prognosis, Survival Rate, Oncology, 030220 oncology & carcinogenesis, Female, medicine.drug, EXPRESSION, Urologic Neoplasms, medicine.medical_specialty, BEVACIZUMAB, Population, BLADDER-CANCER, Neutropenia, Antibodies, Monoclonal, Humanized, Placebo, Ramucirumab, 03 medical and health sciences, Double-Blind Method, Internal medicine, medicine, Humans, Neoplasm Invasiveness, education, Survival rate, Aged, Platinum, Salvage Therapy, Carcinoma, Transitional Cell, business.industry, medicine.disease, ATEZOLIZUMAB, 030104 developmental biology, ENDOTHELIAL GROWTH-FACTOR, business, Febrile neutropenia, Follow-Up Studies
Abstract

Background Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonistplus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial.Methods We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m 2 (60 mg/m 2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues.Findings Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7.4 months (IQR 3.5-13.9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4.1 months [95% CI 3.3-4.8] vs 2.8 months [2.6-2.9]; HR 0.696 [95% CI 0.573-0.845]; p=0.0002). Median overall survival was 9.4 months (95% CI 7.9-11.4) in the ramucirumab group versus 7.9 months (7.0-9.3) in the placebo group (stratified HR 0.887 [95% CI 0.724-1.086]; p=0.25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group.Interpretation Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Published
2020

5. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Petrylak, Daniel P, primary, de Wit, Ronald, additional, Chi, Kim N, additional, Drakaki, Alexandra, additional, Sternberg, Cora N, additional, Nishiyama, Hiroyuki, additional, Castellano, Daniel, additional, Hussain, Syed A, additional, Fléchon, Aude, additional, Bamias, Aristotelis, additional, Yu, Evan Y, additional, van der Heijden, Michiel S, additional, Matsubara, Nobuaki, additional, Alekseev, Boris, additional, Necchi, Andrea, additional, Géczi, Lajos, additional, Ou, Yen-Chuan, additional, Coskun, Hasan Senol, additional, Su, Wen-Pin, additional, Bedke, Jens, additional, Gakis, Georgios, additional, Percent, Ivor J, additional, Lee, Jae-Lyun, additional, Tucci, Marcello, additional, Semenov, Andrey, additional, Laestadius, Fredrik, additional, Peer, Avivit, additional, Tortora, Giampaolo, additional, Safina, Sufia, additional, Garcia del Muro, Xavier, additional, Rodriguez-Vida, Alejo, additional, Cicin, Irfan, additional, Harputluoglu, Hakan, additional, Tagawa, Scott T, additional, Vaishampayan, Ulka, additional, Aragon-Ching, Jeanny B, additional, Hamid, Oday, additional, Liepa, Astra M, additional, Wijayawardana, Sameera, additional, Russo, Francesca, additional, Walgren, Richard A, additional, Zimmermann, Annamaria H, additional, Hozak, Rebecca R, additional, Bell-McGuinn, Katherine M, additional, Powles, Thomas, additional, Wong, Suet-Lai Shirley, additional, Tan, Thean Hsiang, additional, Hovey, Elizabeth Jane, additional, Clay, Timothy Dudley, additional, Wan Ng, Siobhan Su, additional, Rutten, Annemie, additional, Machiels, Jean-Pascal, additional, Dumez, Herlinde, additional, Cheng, Susanna Yee-Shan, additional, Ferrario, Cristiano, additional, Sengeloev, Lisa, additional, Jensen, Niels Viggo, additional, Thibault, Constance, additional, Laguerre, Brigitte, additional, Joly, Florence, additional, Culine, Stéphane, additional, Becht, Catherine, additional, Niegisch, Günter, additional, Stöckle, Michael, additional, Grimm, Marc-Oliver, additional, Schwentner, Christina A, additional, Schultze-Seemann, Wolfgang, additional, Kalofonos, Haralambos, additional, Mavroudis, Dimitrios, additional, Papandreou, Christos, additional, Karavasilis, Vasilis, additional, Révész, Janos, additional, Rosenbaum, Eli, additional, Leibowitz-Amit, Raya, additional, Kejzman, Daniel, additional, Sarid, David, additional, Scagliotti, Giorgio Vittorio, additional, Bracarda, Sergio, additional, Massari, Francesco, additional, Osawa, Takahiro, additional, Miyajima, Naoto, additional, Shinohara, Nobuo, additional, Fukuta, Fumimasa, additional, Ohyama, Chikara, additional, Obara, Wataru, additional, Yamashita, Shinichi, additional, Tomita, Yoshihiko, additional, Kawai, Koji, additional, Fukasawa, Satoshi, additional, Oyama, Masafumi, additional, Yonese, Junji, additional, Nagata, Masayoshi, additional, Uemura, Motohide, additional, Nishimura, Kazuo, additional, Kawakita, Mutsushi, additional, Tsunemori, Hiroyuki, additional, Hashine, Katsuyoshi, additional, Inokuchi, Junichi, additional, Yokomizo, Akira, additional, Nagamori, Satoshi, additional, Lee, Hyo Jin, additional, Park, Se Hoon, additional, Rha, Sun Young, additional, Kim, Yu Jung, additional, Lee, Yun-Gyoo, additional, Vazquez Cortés, Leticia, additional, Lorena Urzua Flores, Claudia, additional, Blaisse, Reinoud J.B., additional, Erdkamp, Fransiscus L.G., additional, Aarts, Maureen J.B., additional, Wojcik-Tomaszewska, Joanna, additional, Tomczak, Piotr, additional, Sikora-Kupis, Bozena, additional, Schenker, Michael, additional, Herzal, Alina Amalia, additional, Udrea, Anghel Adrian, additional, Karlov, Petr, additional, Fomkin, Roman, additional, Gajate Borau, Pablo, additional, Grande, Enrique, additional, Delgado Mignorance, Juan Ignacio, additional, Su, Yu-Li, additional, Li, Jian-Ri, additional, Lin, Chien-Liang, additional, Lin, Chia-Chi, additional, Yeh, Su-Peng, additional, Erman, Mustafa, additional, Urun, Yuksel, additional, Golovko, Yuriy, additional, Bondarenko, Igor, additional, Sinielnikov, Ivan, additional, Crabb, Simon J., additional, Syndikus, Isabel, additional, Huddart, Robert, additional, Sundar, Santhanam, additional, Chowdhury, Simon, additional, Sarwar, Naveed, additional, Flaig, Thomas W., additional, Pan, Chong Xian, additional, Schwarz, James K., additional, Cultrera, Jennifer Lyn, additional, Acs, Peter Istvan, additional, Hainsworth, John D., additional, Herms, Benjamin T., additional, Lawler, William Eyre, additional, and Lowe, Thomas Eugene, additional

Published
2020
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7. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Daniel P Petrylak, Ronald de Wit, Kim N Chi, Alexandra Drakaki, Cora N Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y Yu, Michiel S van der Heijden, Nobuaki Matsubara, Boris Alekseev, Andrea Necchi, Lajos Géczi, Yen-Chuan Ou, Hasan Senol Coskun, Wen-Pin Su, Miriam Hegemann, Ivor J Percent, Jae-Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier Garcia del Muro, Alejo Rodriguez-Vida, Irfan Cicin, Hakan Harputluoglu, Ryan C Widau, Astra M Liepa, Richard A Walgren, Oday Hamid, Annamaria H Zimmermann, Katherine M Bell-McGuinn, Thomas Powles, Suet-Lai Shirley Wong, Thean Hsiang Tan, Elizabeth Jane Hovey, Timothy Dudley Clay, Siobhan Su Wan Ng, Annemie Rutten, Jean-Pascal Machiels, Herlinde Dumez, Susanna Yee-Shan Cheng, Kim Nguyen Chi, Cristiano Ferrario, Lisa Sengeloev, Niels Viggo Jensen, Constance Thibault, Brigitte Laguerre, Florence Joly, Aude Flechon, Stéphane Culine, Catherine Becht, Günter Niegisch, Michael Stöckle, Marc-Oliver Grimm, Georgios Gakis, Wolfgang Schultze-Seemann, Haralambos Kalofonos, Dimitrios Mavroudis, Christos Papandreou, Vasilis Karavasilis, Janos Révész, Lajos Geczi, Eli Rosenbaum, Raya Leibowitz-Amit, Daniel Kejzman, David Sarid, Giorgio Vittorio Scagliotti, Sergio Bracarda, Francesco Massari, Takahiro Osawa, Naoto Miyajima, Nobuo Shinohara, Fumimasa Fukuta, Chikara Ohyama, Wataru Obara, Shinichi Yamashita, Yoshihiko Tomita, Koji Kawai, Satoshi Fukasawa, Masafumi Oyama, Junji Yonese, Masayoshi Nagata, Motohide Uemura, Kazuo Nishimura, Mutsushi Kawakita, Hiroyuki Tsunemori, Katsuyoshi Hashine, Junichi Inokuchi, Akira Yokomizo, Satoshi Nagamori, Hyo Jin Lee, Se Hoon Park, Sun Young Rha, Yu Jung Kim, Yun-Gyoo Lee, Leticia Vazquez Cortés, Claudia Lorena Urzua Flores, Reinoud J B Blaisse, Fransiscus L G Erdkamp, Maureen J B Aarts, Joanna Wojcik-Tomaszewska, Piotr Tomczak, Bozena Sikora-Kupis, Michael Schenker, Alina Amalia Herzal, Anghel Adrian Udrea, Petr Karlov, Sufia Z Safina, Roman Fomkin, Enrique Grande Pulido, F Xavier García Del Muro, Juan Ignacio Delgado Mignorance, Daniel Castellano Gauna, Alejo Rodríguez-Vida, Yu-Li Su, Chien-Liang Lin, Chia-Chi Lin, Su-Peng Yeh, Irfan Çiçin, Mustafa Erman, Yuksel Urun, Yurii Golovko, Igor Bondarenko, Ivan Sinielnikov, Simon Crabb, Isabel Syndikus, Robert Huddart, Santhanam Sundar, Simon Chowdhury, Naveed Sarwar, Thomas Flaig, Chong Xian Pan, Daniel Petrylak, James Schwarz, Ivor Percent, Jennifer Cultrera, John Hainsworth, Benjamin Herms, William Lawler, Thomas Lowe, Scott Tagawa, Jeanny Aragon-Ching, Ulka Vaishampayan, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'oncologie médicale, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), Petrylak, Dp, de Wit, R, Chi, Kn, Drakaki, A, Sternberg, Cn, Nishiyama, H, Castellano, D, Hussain, S, Flechon, A, Bamias, A, Yu, Ey, van der Heijden, M, Matsubara, N, Alekseev, B, Necchi, A, Geczi, L, Ou, Yc, Coskun, H, Su, Wp, Hegemann, M, Percent, Ij, Lee, Jl, Tucci, M, Semenov, A, Laestadius, F, Peer, A, Tortora, G, Safina, S, del Muro, Xg, Rodriguez-Vida, A, Cicin, I, Harputluoglu, H, Widau, Rc, Liepa, Am, Walgren, Ra, Hamid, O, Zimmermann, Ah, Bell-McGuinn, Km, Powles, T, and Medical Oncology

Subjects
0301 basic medicine, Male, Internationality, medicine.medical_treatment, Phases of clinical research, Docetaxel, Kaplan-Meier Estimate, Gastroenterology, 2ND-LINE THERAPY, 0302 clinical medicine, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Medicine, ramucirab, Medicine (all), Antibodies, Monoclonal, General Medicine, Middle Aged, OPEN-LABEL, Prognosis, Neoadjuvant Therapy, Treatment Outcome, 030220 oncology & carcinogenesis, Female, Taxoids, medicine.drug, Adult, medicine.medical_specialty, Metastatic Urothelial Carcinoma, Urology, Locally advanced, BLADDER-CANCER, Placebo, Antibodies, Monoclonal, Humanized, Risk Assessment, Ramucirumab, Antibodies, Disease-Free Survival, Double blind, II TRIAL, 03 medical and health sciences, LUNG-CANCER, Aged, Carcinoma, Transitional Cell, Double-Blind Method, Humans, Neoplasm Invasiveness, Neoplasm Staging, Proportional Hazards Models, Survival Analysis, Urinary Bladder Neoplasms, Internal medicine, BREAST-CANCER, In patient, Adverse effect, Platinum, Chemotherapy, FACTOR RECEPTOR-2, Settore MED/06 - ONCOLOGIA MEDICA, business.industry, Carcinoma, TRANSITIONAL-CELL-CARCINOMA, Surgery, Discontinuation, Regimen, Ramucirumab, docetaxel, 030104 developmental biology, ENDOTHELIAL GROWTH-FACTOR, Transitional Cell, business, FOLLOW-UP
Abstract

Summary Background Few treatments with a distinct mechanism of action are available for patients with platinum-refractory advanced or metastatic urothelial carcinoma. We assessed the efficacy and safety of treatment with docetaxel plus either ramucirumab—a human IgG1 VEGFR-2 antagonist—or placebo in this patient population. Methods We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 sites in 23 countries. Previous treatment with one immune-checkpoint inhibitor was permitted. Patients were randomised (1:1) using an interactive web response system to receive intravenous docetaxel 75 mg/m 2 plus either intravenous ramucirumab 10 mg/kg or matching placebo on day 1 of repeating 21-day cycles, until disease progression or other discontinuation criteria were met. The primary endpoint was investigator-assessed progression-free survival, analysed by intention-to-treat in the first 437 randomised patients. This study is registered with ClinicalTrials.gov, number NCT02426125. Findings Between July, 2015, and April, 2017, 530 patients were randomly allocated either ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267). Progression-free survival was prolonged significantly in patients allocated ramucirumab plus docetaxel versus placebo plus docetaxel (median 4·07 months [95% CI 2·96–4·47] vs 2·76 months [2·60–2·96]; hazard ratio [HR] 0·757, 95% CI 0·607–0·943; p=0·0118). A blinded independent central analysis was consistent with these results. An objective response was achieved by 53 (24·5%, 95% CI 18·8–30·3) of 216 patients allocated ramucirumab and 31 (14·0%, 9·4–18·6) of 221 assigned placebo. The most frequently reported treatment-emergent adverse events, regardless of causality, in either treatment group (any grade) were fatigue, alopecia, diarrhoea, decreased appetite, and nausea. These events occurred predominantly at grade 1–2 severity. The frequency of grade 3 or worse adverse events was similar for patients allocated ramucirumab and placebo (156 [60%] of 258 vs 163 [62%] of 265 had an adverse event), with no unexpected toxic effects. 63 (24%) of 258 patients allocated ramucirumab and 54 (20%) of 265 assigned placebo had a serious adverse event that was judged by the investigator to be related to treatment. 38 (15%) of 258 patients allocated ramucirumab and 43 (16%) of 265 assigned placebo died on treatment or within 30 days of discontinuation, of which eight (3%) and five (2%) deaths were deemed related to treatment by the investigator. Sepsis was the most common adverse event leading to death on treatment (four [2%] vs none [0%]). One fatal event of neutropenic sepsis was reported in a patient allocated ramucirumab. Interpretation To the best of our knowledge, ramucirumab plus docetaxel is the first regimen in a phase 3 study to show superior progression-free survival over chemotherapy in patients with platinum-refractory advanced urothelial carcinoma. These data validate inhibition of VEGFR-2 signalling as a potential new therapeutic treatment option for patients with urothelial carcinoma. Funding Eli Lilly and Company.

Published
2017

9. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Petrylak, Daniel P, primary, de Wit, Ronald, additional, Chi, Kim N, additional, Drakaki, Alexandra, additional, Sternberg, Cora N, additional, Nishiyama, Hiroyuki, additional, Castellano, Daniel, additional, Hussain, Syed, additional, Fléchon, Aude, additional, Bamias, Aristotelis, additional, Yu, Evan Y, additional, van der Heijden, Michiel S, additional, Matsubara, Nobuaki, additional, Alekseev, Boris, additional, Necchi, Andrea, additional, Géczi, Lajos, additional, Ou, Yen-Chuan, additional, Coskun, Hasan Senol, additional, Su, Wen-Pin, additional, Hegemann, Miriam, additional, Percent, Ivor J, additional, Lee, Jae-Lyun, additional, Tucci, Marcello, additional, Semenov, Andrey, additional, Laestadius, Fredrik, additional, Peer, Avivit, additional, Tortora, Giampaolo, additional, Safina, Sufia, additional, del Muro, Xavier Garcia, additional, Rodriguez-Vida, Alejo, additional, Cicin, Irfan, additional, Harputluoglu, Hakan, additional, Widau, Ryan C, additional, Liepa, Astra M, additional, Walgren, Richard A, additional, Hamid, Oday, additional, Zimmermann, Annamaria H, additional, Bell-McGuinn, Katherine M, additional, Powles, Thomas, additional, Wong, Suet-Lai Shirley, additional, Tan, Thean Hsiang, additional, Hovey, Elizabeth Jane, additional, Clay, Timothy Dudley, additional, Ng, Siobhan Su Wan, additional, Rutten, Annemie, additional, Machiels, Jean-Pascal, additional, Dumez, Herlinde, additional, Cheng, Susanna Yee-Shan, additional, Chi, Kim Nguyen, additional, Ferrario, Cristiano, additional, Sengeloev, Lisa, additional, Jensen, Niels Viggo, additional, Thibault, Constance, additional, Laguerre, Brigitte, additional, Joly, Florence, additional, Flechon, Aude, additional, Culine, Stéphane, additional, Becht, Catherine, additional, Niegisch, Günter, additional, Stöckle, Michael, additional, Grimm, Marc-Oliver, additional, Gakis, Georgios, additional, Schultze-Seemann, Wolfgang, additional, Kalofonos, Haralambos, additional, Mavroudis, Dimitrios, additional, Papandreou, Christos, additional, Karavasilis, Vasilis, additional, Révész, Janos, additional, Geczi, Lajos, additional, Rosenbaum, Eli, additional, Leibowitz-Amit, Raya, additional, Kejzman, Daniel, additional, Sarid, David, additional, Scagliotti, Giorgio Vittorio, additional, Bracarda, Sergio, additional, Massari, Francesco, additional, Osawa, Takahiro, additional, Miyajima, Naoto, additional, Shinohara, Nobuo, additional, Fukuta, Fumimasa, additional, Ohyama, Chikara, additional, Obara, Wataru, additional, Yamashita, Shinichi, additional, Tomita, Yoshihiko, additional, Kawai, Koji, additional, Fukasawa, Satoshi, additional, Oyama, Masafumi, additional, Yonese, Junji, additional, Nagata, Masayoshi, additional, Uemura, Motohide, additional, Nishimura, Kazuo, additional, Kawakita, Mutsushi, additional, Tsunemori, Hiroyuki, additional, Hashine, Katsuyoshi, additional, Inokuchi, Junichi, additional, Yokomizo, Akira, additional, Nagamori, Satoshi, additional, Lee, Hyo Jin, additional, Park, Se Hoon, additional, Rha, Sun Young, additional, Kim, Yu Jung, additional, Lee, Yun-Gyoo, additional, Cortés, Leticia Vazquez, additional, Flores, Claudia Lorena Urzua, additional, Blaisse, Reinoud J B, additional, Erdkamp, Fransiscus L G, additional, Aarts, Maureen J B, additional, Wojcik-Tomaszewska, Joanna, additional, Tomczak, Piotr, additional, Sikora-Kupis, Bozena, additional, Schenker, Michael, additional, Herzal, Alina Amalia, additional, Udrea, Anghel Adrian, additional, Karlov, Petr, additional, Safina, Sufia Z, additional, Fomkin, Roman, additional, Pulido, Enrique Grande, additional, Del Muro, F Xavier García, additional, Mignorance, Juan Ignacio Delgado, additional, Gauna, Daniel Castellano, additional, Rodríguez-Vida, Alejo, additional, Su, Yu-Li, additional, Lin, Chien-Liang, additional, Lin, Chia-Chi, additional, Yeh, Su-Peng, additional, Çiçin, Irfan, additional, Erman, Mustafa, additional, Urun, Yuksel, additional, Golovko, Yurii, additional, Bondarenko, Igor, additional, Sinielnikov, Ivan, additional, Crabb, Simon, additional, Syndikus, Isabel, additional, Huddart, Robert, additional, Sundar, Santhanam, additional, Chowdhury, Simon, additional, Sarwar, Naveed, additional, Flaig, Thomas, additional, Pan, Chong Xian, additional, Petrylak, Daniel, additional, Schwarz, James, additional, Percent, Ivor, additional, Cultrera, Jennifer, additional, Hainsworth, John, additional, Herms, Benjamin, additional, Lawler, William, additional, Lowe, Thomas, additional, Tagawa, Scott, additional, Aragon-Ching, Jeanny, additional, and Vaishampayan, Ulka, additional

Published
2017
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10. So you want to be a comedian, eh?

Author

Lai, Shirley

Subjects
Popular culture -- Personal narratives, Comedians -- Behavior, Stand-up comedy -- Personal narratives, Arts, visual and performing, Behavior, Personal narratives
Abstract

In a land filled with thousands of miles of glass-encased strip malls, countless donut shops and ridiculously cold winters, it's no wonder Canada turns out some of the funniest people [...]

Published
1996

23. See me

Author

Lai, Shirley

Subjects
Ross, Tyley, The Who's Tommy (Opera) -- Personalities, Actors -- Biography -- Interviews, Actresses, Arts, visual and performing, Personalities
Abstract

Tired and breathless from running into his apartment after a night of intense rehearsal, 24 year-old Tyley Ross gently asks if he can phone me back after he finishes brewing [...]

Published
1995

25. Growing giant

Author

Lai, Shirley

Subjects
Information services industry -- Taiwan, Computer industry -- Taiwan, Business, Business, international
Abstract

Taiwan's information industry has become the cornerstone of its national economic success, thanks in large part to agility and the ability to innovate at the market's fast pace. Its overall contribution to GNP in 1995 will be about $15 billion, or 6% of the total. Industry leader Compaq Computer will buy $1.5 billion in Taiwan-made inputs in 1995, up from $460 million in 1994 and 350% above 1992 figures. Overall 1994 shipments made Taiwan the world's fourth-largest exporter of computer products, and it will be No 3 in 1995.

Published
1995

26. Taiwan contracts take wing

Author

Lai, Shirley and Curtain, Matthew

Subjects
Taiwan -- Securities, Derivatives (Financial instruments) -- Analysis, Stock index futures -- Analysis, Business, Business, international
Published
1997

27. So you want to be a comedian, eh?

Author

Lai, Shirley

Subjects
*STAND-up comedy, *COMEDIANS
Abstract

Focuses on professional comedy and comedians in Canada. Includes Kedar Brown; Marla Lukofsky; Frank Van Keeken; Importance of hard work, dedication and self sacrifice.

Published
1995

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