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) compared ramucirumab plus docetaxel with placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma resistant to or relapsed after platinum-based therapy. The trial reports updated overall survival data and safety outcomes from an international, multi-centre patient cohort, as suggested by the 2019 publication date and extensive investigator network.

UK applicability

This oncology trial's findings on targeted immunotherapy with angiogenesis inhibition may inform UK cancer treatment guidelines and NHS commissioning decisions for urothelial carcinoma, though applicability depends on UK-specific cost-effectiveness and patient population characteristics.

Key measures

Overall survival, progression-free survival, response rate, safety and tolerability outcomes

Outcomes reported

The study evaluated overall survival and clinical outcomes in patients with locally advanced or metastatic urothelial carcinoma treated with ramucirumab plus docetaxel versus placebo plus docetaxel following platinum-based chemotherapy.

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: BFmovi2888-3am3y7

Topic tags

urothelial carcinoma ramucirumab docetaxel phase 3 trial overall survival platinum-resistant

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