CHICAGO — The addition of bevacizumab to standard chemotherapy doubled PFS among women with platinum-resistant ovarian cancer, according to results of the randomized phase 3 AURELIA trial.
The trial is the first to show a combination therapy can significantly improve PFS in patients with the disease, said researcher Eric Pujade-Lauraine, MD, PhD, a professor at Universite de Paris Descartes in France and head of Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, a clinical trials cooperative group based in France.
“I think this will change practice, but of course we need to wait for the approval of the drug in this setting,” Pujade-Lauraine said during a press conference.
Pujade-Lauraine and colleagues enrolled 361 patients with epithelial ovarian, fallopian tube or primary peritoneal cancer in the multicenter, international study. All patients had disease progression within 6 months of their last dose of platinum therapy.
The study was designed to evaluate chemotherapy plus bevacizumab (Avastin, Genentech) vs. chemotherapy alone. The primary endpoint was PFS.
All patients received one of three standard chemotherapy regimens — weekly paclitaxel, topotecan or liposomal — based on their previous experiences with those drugs.
Researchers randomized 179 patients to receive bevacizumab in addition to chemotherapy, while 182 patients received chemotherapy alone.
Median follow-up was 13.5 months.
The patients assigned to the combination therapy had a median PFS of 6.7 months (range, 5.7-7.9), compared with 3.4 months for those assigned to chemotherapy alone (range, 2.2-3.7; P=.001).
Seventy-five percent of patients who received bevacizumab had disease recurrence, compared with 91% of those who received chemotherapy alone, the researchers said.
OS data is not yet available.
Patients assigned to bevacizumab experienced higher rates of grade-2 or higher adverse events, researchers said. These included hypertension (20% vs. 7%); proteinuria (11% vs. 1%); fistula or abscesses (2% vs. 0); and gastrointestinal perforations (2% vs. 0). Rates of grade-3 or higher adverse events were equivalent in both study arms, researchers said.
The results are “very significant” for the 20% of women who have primary platinum-resistant disease, as well as those whose disease later becomes platinum resistant, Pujade-Lauraine said.
“These patients have not had many treatment options open to them. They knew the end of their life was approaching,” Pujade-Lauraine said. “This shows that adding bevacizumab to chemotherapy halves the risk of disease getting worse in these very-difficult-to-treat patients and gives them new hope. This should be considered as a new standard option in patients with platinum-resistant disease.”
For more information:
Pujade-Lauraine E. Abstract #LBA5002. Presented at: the 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago.
Disclosure: Dr. Pujade-Lauraine reported having multiple relationships as a consultant, an advisor and having received honoraria and research funding from Roche Diagnostics. Other researchers who were part of the study have received honoraria from and held leadership positions with AstraZeneca, Boehringer Ingelheim, Merck, Roche, and Sanofi, among other pharmaceutical companies.