Purpose: In platinum-resistant ovarian cancer (OC), single-agent chemotherapy is standard. Bevacizumab is active alone and in combination. AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab with chemotherapy in platinum-resistant OC VSports手机版. .

Patients and methods: Eligible patients had measurable/assessable OC that had progressed < 6 months after completing platinum-based therapy V体育安卓版. Patients with refractory disease, history of bowel obstruction, or > two prior anticancer regimens were ineligible. After investigators selected chemotherapy (pegylated liposomal doxorubicin, weekly paclitaxel, or topotecan), patients were randomly assigned to single-agent chemotherapy alone or with bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until progression, unacceptable toxicity, or consent withdrawal. Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone. The primary end point was progression-free survival (PFS) by RECIST. Secondary end points included objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes. .

Results: The PFS hazard ratio (HR) after PFS events in 301 of 361 patients was 0. 48 (95% CI, 0. 38 to 0. 60; unstratified log-rank P < . 001). Median PFS was 3. 4 months with chemotherapy alone versus 6. 7 months with bevacizumab-containing therapy. RECIST ORR was 11. 8% versus 27. 3%, respectively (P = . 001). The OS HR was 0. 85 (95% CI, 0. 66 to 1. 08; P < . 174; median OS, 13. 3 v 16. 6 months, respectively) V体育ios版. Grade ≥ 2 hypertension and proteinuria were more common with bevacizumab. GI perforation occurred in 2. 2% of bevacizumab-treated patients. .

Conclusion: Adding bevacizumab to chemotherapy statistically significantly improved PFS and ORR; the OS trend was not significant. No new safety signals were observed VSports最新版本. .