Vienna, Austria—Adding bevacizumab (Avastin) to chemotherapy improves outcomes in patients with platinum-resistant recurrent ovarian cancer, according to results of the phase 3 clinical trial AURELIA, which was presented at the 2012 European Society for Medical Oncology Congress. Bevacizumab improved progression-free survival (PFS) and overall response rate (ORR) with any of the 3 chemotherapy regimens in the study, but adding bevacizumab to weekly paclitaxel was the most active combination in an exploratory analysis of the trial.
AURELIA is one of the only trials to show a positive outcome in patients with platinum-resistant ovarian cancer, said Nicoletta Colombo, MD, University of Milan-Bicocca, European Institute of Oncology, Milan, Italy.
In the overall trial, the median PFS was 6.7 months for bevacizumab plus chemotherapy versus 3 months for chemotherapy alone.
Investigators could choose chemotherapy from among weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan. When chemotherapy regimens were analyzed separately, the bevacizumab plus weekly paclitaxel regimen achieved the best results. The median PFS durations for the different cohorts were:
“Bevacizumab combined with chemotherapy should be considered a new standard option for platinum-resistant recurrent ovarian cancer,” stated lead author Andres M. Poveda, MD, Fundacion Instituto Valenciano de Oncologia, Valencia, Spain.
AURELIA randomized 361 patients (median age, approximately 60 years) with platinum-resistant recurrent ovarian cancer whose disease progressed with up to 2 previous regimens to chemotherapy alone versus chemotherapy plus bevacizumab. Treatment was continued until unacceptable toxicity or progressive disease occurred.
Demographic and disease characteristics were well balanced at baseline between the treatment arms. Approximately 90% of the patients had stage III/IV disease.
Response rates were superior for all 3 chemotherapy regimens with the addition of bevacizumab, with the highest rate seen with weekly paclitaxel plus bevacizumab—51.7% versus 28.8% for chemotherapy alone; the ORRs for bevacizumab plus pegylated liposomal doxorubicin were 18.3% and 7.9%, respectively, and 5.8% and 2.1%, respectively, for the topotecan cohort.
No new toxicity concerns emerged in the trial. Toxicities were similar in the 2 treatment arms. A higher rate of peripheral neuropathy was reported in the weekly paclitaxel cohort and a higher rate of hand-foot syndrome in the patients treated with pegylated liposomal doxorubicin.
Dr Colombo was particularly impressed by the results in the weekly paclitaxel plus bevacizumab cohort. She stated that this combination should be explored earlier in the course of disease.
