An open-label phase II trial to assess to efficacy of sunitinib as an antieffusion agent in patients with malignant peritoneal and/or pleural effusions

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e14647 Background: Pleural and peritoneal effusions are common in advanced malignant disease and relative resistant to traditional treatments. VEGF-A is considered to be a crucial factor in the biology of accumulation of malignant effusions (ME). Sunitinib is a multi-targeted TKI with a high potency of inhibiting VEGFR2. A treatment that could symptomatically reduce ME would be useful, regardless of its anti-tumoural or anti-angiogenic effect. Methods: Refractory patients with symptomatic ME were enrolled to receive 2x6 weeks of daily 37.5mg sunitinib regardless of their primary histology or site. Outcome was measured by time to re-puncture or by measurement of volume ME by CT-scan every 6 weeks or at the end of treatment. Puncture fluids and blood samples were collected for extensive biomarker analysis (VEGFA&C, VEGFR1–3, b-FGF, PDGFA-B, PDGFRα-β, PlGF1–2) on consecutive samples. Results: At present 6 patients have been enrolled. Patients had ovarian cancer (N=3), breast cancer (N=2) and squamous cervical cancer (N=1) as primary tumours. All patients had been extensively pre-treated with 4 to 8 lines of systemic therapy. Efficacy: Three (3/6) patients showed regression of effusion fluid by consecutive CT-scans. Two (2/6) patients had unchanged volume and one (1/6) patient had an increase of fluid volume. Follow-up: Two (2/6) patients stopped the trial early due to toxicity. Two patients (2/6) died during treatment due to disease progression elsewhere. Two patients (2/6) completed the 2 cycles of 6 weeks treatment. Of which, one had sustained reduction in volume fluid accumulation, while the other one had initial stabilisation after one cycle but eventually had increasing volume of ascites. Conclusions: These findings support the hypothesis that sunitinib could be useful in the management of ME. Although the numbers are low, in a majority of patients (5/6) there was reduction or stabilisation of fluid accumulation. Toxicity led to study withdrawal in a third of our patients. An update of patient numbers as well as results of translational/biomarker analysis will be presented at the meeting. No significant financial relationships to disclose.