Patients with platinum-resistant recurrent ovarian cancer have a poor prognosis. For these patients, single-agent chemotherapy is the standard of care, as chemotherapy drug combinations lead to increased toxicity with no additional benefit. However, the recently reported results of the AURELIA phase III open-label randomized trial indicate that combination of single-agent chemotherapy with bevacizumab should be considered a standard option for patients with platinum-resistant ovarian cancer.

The investigators enrolled 361 women with histologically confirmed ovarian cancer who had disease progression within 6 months of completing platinum-based therapy, and randomly assigned them to receive either standard chemotherapy alone or in combination with bevacizumab. Single-agent chemotherapy—which included either pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel—was selected on an individual patient basis. The primary end point of the study was progression-free survival (PFS), and the secondary end points were objective response rate (ORR) and overall survival.

The study showed that, at a median follow-up of 13 months for the chemotherapy alone arm and 13.9 months for the combination arm, the addition of bevacizumab to standard chemotherapy nearly doubled the median PFS from 3.4 months to 6.7 months. The addition of bevacizumab resulted in more grade 2 or higher adverse events, such as hypertension and proteinuria, but the two arms were equivalent for grade ≥3 events. Furthermore, there was a significant improvement in quality of life and a consistent benefit in ORR regardless of the assessment method. Specifically, the ORR, as determined by RECIST, was 27.3% in the bevacizumab arm compared with 11.8% in the chemotherapy alone arm. Although no substantial difference was reported in overall survival, the trial was not designed to detect such difference as crossover to the combination regimen was allowed (and occurred for 40% of patients originally assigned to standard chemotherapy). This is the first randomized study to investigate bevacizumab in platinum-resistant ovarian cancer and the encouraging results in terms of improved quality of life, PFS and ORR will likely be practice changing.