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: Gynecologic Oncology

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-AlfonsoP. Harter

Research output: Contribution to journalArticle

Abstract

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. Clinical trial information. ClinicalTrials.gov: NCT00866697. © 2019 The Authors
Original languageEnglish
Pages (from-to)186-191
Number of pages6
JournalGynecol. Oncol.
Volume155
Issue number2
DOIs
Publication statusPublished - 2019

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Keywords

  • Ovarian cancer
  • Pazopanib
  • Targeted therapy
  • Taxane‑platinum–based chemotherapy
  • pazopanib
  • placebo
  • angiogenesis inhibitor
  • pyrimidine derivative
  • sulfonamide
  • advanced cancer
  • Article
  • cancer mortality
  • cancer survival
  • consciousness disorder
  • controlled study
  • double blind procedure
  • drug fatality
  • drug withdrawal
  • East Asian
  • exploratory research
  • female
  • human
  • maintenance chemotherapy
  • major clinical study
  • multicenter study
  • ovary cancer
  • overall survival
  • peripheral neuropathy
  • phase 3 clinical trial
  • priority journal
  • progression free survival
  • race difference
  • randomized controlled trial
  • sensorimotor neuropathy
  • treatment outcome
  • adult
  • aged
  • clinical trial
  • disease free survival
  • drug administration
  • middle aged
  • mortality
  • ovary tumor
  • quality of life
  • young adult
  • Adult
  • Aged
  • Angiogenesis Inhibitors
  • Carcinoma, Ovarian Epithelial
  • Disease-Free Survival
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Ovarian Neoplasms
  • Pyrimidines
  • Quality of Life
  • Sulfonamides
  • Treatment Outcome
  • Young Adult

Cite this

Vergote, I., du Bois, A., Floquet, A., Rau, J., Kim, J-W., del Campo, J. M., Friedlander, M., Pignata, S., Fujiwara, K., Colombo, N., Mirza, M. R., Monk, B. J., Tsibulak, I., Calvert, P. M., Herzog, T. J., Hanker, L. C., Meunier, J., Lee, J-Y., Bologna, A., ... Harter, P. (2019). 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: Gynecologic Oncology. Gynecol. Oncol., 155(2), 186-191. https://doi.org/10.1016/j.ygyno.2019.08.024