A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites

Nicoletta Colombo, Giorgia Mangili, Serafina Mammoliti, Mårten Kalling, Bengt Tholander, Lars Sternas, Giliane Buzenet, Donald Chamberlain

Research output: Contribution to journalArticle

Abstract

Objective: The recombinant fusion protein, aflibercept binds and neutralizes vascular endothelial growth factor (VEGF) A, B and placental growth factor (PlGF). Aflibercept inhibits ascites formation and reduces tumor burden in an ovarian cancer model. This open-label, single-arm, multicenter phase II study assessed the efficacy and safety of aflibercept in patients with advanced chemo-resistant epithelial ovarian cancer and symptomatic malignant ascites. Methods: Patients who required ≥ 3 previous paracenteses at 1-4 paracenteses per month received intravenous aflibercept 4 mg/kg every 2 weeks. The primary endpoint was repeat paracentesis response rate (RPRR), with response defined as at least a two-fold increase in time to repeat paracentesis compared with the baseline interval. Results: Ten out of 16 enrolled patients achieved a response; the RPRR was 62.5% (95% CI 35.4%-84.8%). Aflibercept was considered effective based on a hypothesis that the RPRR was ≥ 60%. Median time to repeat paracentesis was 76.0 (95% CI 64.0-178.0) days, which was 4.5 times longer than the baseline interval (16.8 days). Median progression-free survival was 59.5 (95% CI 41.0-83.0) days. Twelve patients experienced adverse events considered related to aflibercept treatment including hypertension (7 patients), headache, anorexia, and dysphonia (3 patients each). Two patients experienced Grade 3/4 treatment-related adverse events (Grade 3 hypertension and weight loss in one patient, Grade 3 intestinal perforation in one patient). Conclusion: Aflibercept 4 mg/kg every 2 weeks was effective at controlling malignant ascites, reducing the interval between repeat paracenteses. The safety profile was consistent with that reported for anti-VEGF agents.

Original languageEnglish
Pages (from-to)42-47
Number of pages6
JournalGynecologic Oncology
Volume125
Issue number1
DOIs
Publication statusPublished - Apr 2012

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Keywords

  • Aflibercept
  • Malignant ascites
  • Ovarian cancer
  • Phase II study
  • VEGF trap

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology

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