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Tier 2 — RCT / large cohortPeer-reviewed

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

Daniel P. Petrylak, Ronald de Wit, Kim N., Alexandra Drakaki, Cora N. Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed A. Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y. Yu, Michiel S. van der Heijden, Nobuaki Matsubara, B. Yа. Alekseev, Andrea Necchi, Lajos Géczi, Yen-Chuan Ou, Hasan Şenol Çoşkun, Wen‐Pin Su, Jens Bedke, Georgios Gakis, Ivor Percent, Jae‐Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier García del Muro, Alejo Rodríguez‐Vida, İrfan Çiçin, Hakan Harputluoğlu, Scott T. Tagawa, Ulka N. Vaishampayan, Jeanny B. Aragon‐Ching, Oday Hamid, Astra M. Liepa, Sameera R. Wijayawardana, Francesca Russo, Richard A. Walgren, Annamaria H. Zimmermann, Rebecca R. Hozak, Katherine M. Bell‐McGuinn, Thomas Powles, Suet-Lai Shirley Wong, Thean Hsiang Tan, Elizabeth Hovey, Timothy Clay, Siobhan Ng, Annemie Rutten, Jean-Pascal Machiels, Herlinde Dumez, Susanna Y. Cheng, Cristiano Ferrario, Lisa Sengeloev, Niels Viggo Jensen, Constance Thibault, Brigitte Laguerre, Florence Joly, Stéphane Culine, Catherine Becht, Günter Niegisch, Michael Stöckle, Marc‐Oliver Grimm, Christina A Schwentner, Wolfgang Schultze‐Seemann, Haralambos Kalofonos, Dimitriοs Mavroudis, Christos N. Papandreou, Vasilis Karavasilis, János Révész, Eli Rosenbaum, Raya Leibowitz‐Amit, Daniel Kejzman, David Sarid, Giorgio V. Scagliotti, Sergio Bracarda, Francesco Massari, Takahiro Osawa, Naoto Miyajima, Nobuo Shinohara, Fumimasa Fukuta, Chikara Οhyama, 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

The Lancet Oncology · 2019

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Summary

This randomised, double-blind, phase 3 trial (RANGE) evaluated the efficacy and safety of ramucirumab, a vascular endothelial growth factor receptor 2 inhibitor, combined with docetaxel in patients with locally advanced or metastatic urothelial carcinoma who had progressed after platinum-based chemotherapy. The trial enrolled participants across multiple countries and assessed overall survival as the primary endpoint, with updated results reported in 2019. As suggested by the trial design, the study aimed to determine whether anti-angiogenic therapy could improve outcomes in this platinum-refractory patient population.

UK applicability

The findings are directly applicable to UK oncology practice, as the trial enrolled patients from multiple European centres including the United Kingdom, and results would inform National Institute for Health and Care Excellence (NICE) appraisal and NHS treatment protocols for advanced urothelial carcinoma.

Key measures

Overall survival, progression-free survival, adverse events, response rates

Outcomes reported

The study assessed overall survival and safety outcomes in patients with locally advanced or metastatic urothelial carcinoma treated with ramucirumab plus docetaxel versus placebo plus docetaxel following platinum-based therapy failure.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s1470-2045(19)30668-0
Catalogue ID
BFmommpjky-nfq9or

Topic tags

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