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Published on: July 31, 2016
A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites
Nicoletta Colombo1, Giorgia Mangili, Serafina Mammoliti
1Istituto Europeo di Oncologia, Divisione di Ginecologia, Via Ripamonti, Milano, Italy. nicoletta.colombo@ieo.it
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 4mg/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 4mg/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.
Insights
Aflibercept effectively controlled malignant ascites in ovarian cancer patients by significantly extending the time between paracentesis procedures. This anti-VEGF therapy demonstrated a favorable safety profile, offering a new treatment option.
Area of Science:
- Oncology
- Pharmacology
Background:
- Malignant ascites in advanced ovarian cancer significantly impacts patient quality of life.
- Vascular Endothelial Growth Factor (VEGF) plays a crucial role in angiogenesis and fluid accumulation in tumors.
Purpose of the Study:
- To evaluate the efficacy and safety of aflibercept in patients with advanced, chemo-resistant epithelial ovarian cancer and symptomatic malignant ascites.
- To assess aflibercept's impact on the need for repeat paracentesis.
Main Methods:
- An open-label, single-arm, multicenter phase II study was conducted.
- Patients received intravenous aflibercept (4mg/kg) every two weeks.
- The primary endpoint was the repeat paracentesis response rate (RPRR), defined as at least a two-fold increase in time to repeat paracentesis.
Main Results:
- The RPRR was 62.5% (10 out of 16 patients), meeting the study's efficacy hypothesis (≥60%).
- Median time to repeat paracentesis increased 4.5-fold to 76.0 days from a baseline of 16.8 days.
- Common adverse events included hypertension, headache, anorexia, and dysphonia; Grade 3/4 events were infrequent.
Conclusions:
- Aflibercept at 4mg/kg every two weeks is effective in managing malignant ascites in ovarian cancer patients.
- The treatment significantly reduces the frequency of paracentesis procedures.
- The safety profile of aflibercept is consistent with other anti-VEGF agents.
