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 evaluated ramucirumab, a VEGF receptor-2 antagonist, combined with docetaxel against placebo plus docetaxel as second-line therapy for patients with locally advanced or metastatic urothelial carcinoma refractory to platinum-based chemotherapy. The multicentre international study measured survival and safety outcomes to inform treatment options for this advanced cancer population. Published in The Lancet in 2017, the trial contributes evidence on targeted combination therapy efficacy in post-platinum urothelial cancer.

UK applicability

Findings from this international phase 3 trial are directly applicable to UK oncology practice, informing treatment decisions for eligible patients with platinum-refractory urothelial carcinoma within NHS cancer centres. UK participation in the trial and alignment with international standards suggest relevance to current National Institute for Health and Care Excellence (NICE) appraisal of second-line therapies.

Key measures

Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events

Outcomes reported

The study measured overall survival, progression-free survival, and safety outcomes in patients with locally advanced or metastatic urothelial carcinoma treated with ramucirumab plus docetaxel versus placebo plus docetaxel.

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
BFmovbmm16-nokyhm

Topic tags

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