Udskriv Udskriv
Switch language
Rigshospitalet - en del af Københavns Universitetshospital

Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review


  1. Menopausal hormone therapy prior to the diagnosis of ovarian cancer is associated with improved survival

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Incidence of vulvar high-grade precancerous lesions and cancer in Denmark before and after introduction of HPV vaccination

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Non-epithelial ovarian cancer in Denmark - Incidence and survival over nearly 40 years

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • I Vergote
  • A du Bois
  • A Floquet
  • J Rau
  • J-W Kim
  • J M Del Campo
  • M Friedlander
  • S Pignata
  • K Fujiwara
  • N Colombo
  • M R Mirza
  • B J Monk
  • I Tsibulak
  • P M Calvert
  • T J Herzog
  • L C Hanker
  • J Meunier
  • J-Y Lee
  • A Bologna
  • M J Carrasco-Alfonso
  • P Harter
Vis graf over relationer

OBJECTIVE: The AGO-OVAR16 study was designed to test the efficacy, safety, and tolerability of pazopanib maintenance after first-line chemotherapy in patients with newly diagnosed advanced ovarian cancer (AOC).

METHODS: Nine hundred and forty patients with histologically confirmed AOC, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV, were randomized in a 1:1 ratio to receive either 800 mg pazopanib once daily or placebo for up to 24 months, unless there was disease progression, toxicity, withdrawal of consent, or death. The primary endpoint (investigator-assessed progression-free survival [PFS]) was met and previously reported. The results of final analyses of overall survival (OS) are reported here.

RESULTS: A third OS interim analysis showed futility and led to study closure and a final OS analysis after last patient last visit. At the time of the final OS analysis, 494 (89.7% of the planned 551) events had occurred. No difference was observed in OS between pazopanib and placebo. The hazard ratio (HR) was 0.960 (95% confidence interval [CI]: 0.805-1.145), and the median OS from randomization was 59.1 months in pazopanib and 64.0 months in placebo arms. For the East Asian patients, similar to the first three interim OS analyses, a numerical negative trend was observed favoring placebo (HR, 1.332; 95% CI: 0.863-2.054). Exploratory analyses showed a trend for a longer time to first subsequent anti-cancer therapy or death with pazopanib over placebo (HR, 0.829; 95% CI: 0.713-0.965), with a median estimate of 19.0 and 14.5 months, respectively. No new safety signals were observed.

CONCLUSION: Although pazopanib prolonged PFS, this was not associated with improvement in median OS.


TidsskriftGynecologic Oncology
Udgave nummer2
Sider (fra-til)186-191
Antal sider6
StatusUdgivet - nov. 2019

Bibliografisk note

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

ID: 59076616