REZOLVE (ANZGOG-1101): A phase 2 trial of intraperitoneal bevacizumab to treat symptomatic ascites in patients with chemotherapy-resistant, epithelial ovarian cancer

BackgroundThe primary aim of this study was to evaluate the activity intraperitoneal bevacizumab (IP-bev) in delaying re-accumulation malignant ascites women with chemotherapy-resistant epithelial ovarian cancer (CR-EOC) who have ceased chemotherapy. Secondary outcomes were safety and quality life.MethodsWomen CR-EOC that reaccumulated within 28 days their last paracentesis (P-1) administered IP-bev 5 mg/kg following first therapeutic on (P0). Additional doses allowed at each subsequent (P1, P2, etc) provided interval from dose 42 or greater (median time second ascitic drainage).Results24 participants age 67 years [range 38–86]; median 4.5 lines prior systemic treatment 1–12]; ECOG performance status 0 1, 1 8, 2–3 15) recruited. The 13 participants, 2 5, 3 2, 4 1. proportion a TTP >42 using competing risk analysis 77% (95% CI 58–92). Median P0 P1 death 48 (range 8–248). paracentesis-free (P0–P1 death) 4.29-fold 2.4–5.8) higher compared between paracenteses entry (P-1–P0).ConclusionIP-bev safe, active, warrants further as palliative intervention for recurrent patients receiving best supportive care.