Pulse Brain · Growing Health Evidence Index
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): 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, Miriam Hegemann, 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, 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 Hovey, Timothy Clay, Siobhan Ng, Annemie Rutten, Jean‐Pascal Machiels, Herlinde Dumez, Susanna Y. Cheng, Kim Nguyen, Cristiano Ferrario, Lisa Sengeloev, Niels Viggo Jensen, Constance Thibault, Brigitte Laguerre, Fredrik Laestadius, Florence Joly, Aude Fléchon, Stéphane Culine, Catherine Becht, Günter Niegisch, Michael Stöckle, Marc‐Oliver Grimm, Georgios Gakis, Wolfgang Schultze‐Seemann, Haralambos Kalofonos, Dimitriοs Mavroudis, Christos N. Papandreou, Vasilis Karavasilis, Aristotelis Bamias, János Révész, Lajos Géczi, Eli Rosenbaum, Raya Leibowitz‐Amit, Daniel Kejzman, Avivit Peer, David Sarid, Giorgio V. Scagliotti, Cora N. Sternberg, Giampaolo Tortora, Sergio Bracarda, Andrea Necchi, Francesco Massari, Takahiro Osawa, Naoto Miyajima, Nobuo Shinohara, Fumimasa Fukuta, Chikara Οhyama, Wataru Obara, Shinichi Yamashita, Yoshihiko Tomita, Koji Kawai, Satoshi Fukasawa, Nobuaki Matsubara, Masafumi Oyama, Junji Yonese, Masayoshi Nagata, Motohide Uemura, Kazuo Nishimura, Mutsushi Kawakita, Hiroyuki Tsunemori

The Lancet · 2017

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Summary

This Phase 3 randomised controlled trial, as suggested by the title and publication in The Lancet (2017), evaluated the combination of ramucirumab (a vascular endothelial growth factor receptor 2 inhibitor) with docetaxel chemotherapy versus placebo with docetaxel in patients with advanced or metastatic urothelial carcinoma who had progressed after platinum-based therapy. The trial enrolled a large international cohort and assessed both efficacy endpoints and safety tolerability. Results would inform second-line treatment options for this patient population.

UK applicability

Findings from this trial would be directly applicable to UK clinical practice for managing platinum-refractory urothelial carcinoma, informing National Institute for Health and Care Excellence (NICE) guidance on second-line therapeutic options. UK oncologists would use these results to advise patients on treatment efficacy and side-effect profiles.

Key measures

Overall survival, progression-free survival, objective response rate, duration of response, adverse events

Outcomes reported

The study evaluated efficacy and safety of ramucirumab combined with docetaxel versus placebo combined with docetaxel in patients with locally advanced or metastatic urothelial carcinoma following platinum-based chemotherapy failure. Primary and secondary endpoints likely included overall survival, progression-free survival, response rates, and adverse event profiles.

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/s0140-6736(17)32365-6
Catalogue ID
BFmor3gded-cq7db3

Topic tags

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