Apalutamide and Overall Survival in Prostate Cancer

Matthew R. Smith, Fred Saad, Simon Chowdhury, Stéphane Oudard, Boris A. Hadaschik, Julie N. Graff, David Olmos, Paul N. Mainwaring, Ji Youl Lee, Hiroji Uemura, Peter De Porre, Andressa A. Smith, Sabine D. Brookman-May, Susan Li, Ke Zhang, Brendan Rooney, Angela Lopez-Gitlitz, Eric J. Small

Research output: Contribution to journalArticlepeer-review

201 Scopus citations

Abstract

Apalutamide increased overall survival and delayed time to initiation of cytotoxic chemotherapy versus placebo in patients with nonmetastatic castration-resistant prostate cancer. Prior analyses had demonstrated clinically impactful improvement in metastasis-free survival, time to symptomatic progression, and second progression-free survival with apalutamide.

Original languageEnglish
Pages (from-to)150-158
Number of pages9
JournalEuropean Urology
Volume79
Issue number1
DOIs
StatePublished - Jan 2021

Bibliographical note

Funding Information:
Funding/Support and role of the sponsor : The trial was designed by two of the academic authors and representatives of the Aragon Pharmaceuticals. The sponsor commissioned an independent data and safety monitoring committee to review safety data the results of the primary efficacy analysis before unblinding. Data were transcribed, by trial personnel at each clinical site, from source documents into electronic case-report forms prepared by the sponsor. All the authors had access to the data, drafted the manuscript with input from the sponsor (Janssen), reviewed and approved the manuscript before submission, and made the decision to submit the manuscript for publication. The SPARTAN study was funded by Janssen Research & Development . Janssen Global Services, LLC provided funding for editorial assistance.

Publisher Copyright:
© 2020 The Authors

Keywords

  • Apalutamide
  • Nonmetastatic castration-resistant prostate cancer
  • Overall survival
  • Subsequent therapy
  • Time to cytotoxic chemotherapy

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