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 2weeks. 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 (16.8days). 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 2weeks was effective at controlling malignant ascites, reducing the interval between repeat paracenteses. The safety profile was consistent with that reported for anti-VEGF agents.
Colombo, N., Mangili, G., Mammoliti, S., Kalling, M., Tholander, B., Sternas, L., et al. (2011). A phase II study of aflibercept in patients with advainced epithelial ovarian cancer and symptomatic malignant ascites. GYNECOLOGIC ONCOLOGY [10.1016/j.ygyno.2011.11.021].
|Citazione:||Colombo, N., Mangili, G., Mammoliti, S., Kalling, M., Tholander, B., Sternas, L., et al. (2011). A phase II study of aflibercept in patients with advainced epithelial ovarian cancer and symptomatic malignant ascites. GYNECOLOGIC ONCOLOGY [10.1016/j.ygyno.2011.11.021].|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||No|
|Titolo:||A phase II study of aflibercept in patients with advainced epithelial ovarian cancer and symptomatic malignant ascites|
|Autori:||Colombo, N; Mangili, G; Mammoliti, S; Kalling, M; Tholander, B; Sternas, L; Buzenet, G; Chamberlain, D|
|Data di pubblicazione:||20-nov-2011|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.ygyno.2011.11.021|
|Appare nelle tipologie:||01 - Articolo su rivista|