NEW YORK (Reuters Health) – Progression-free survival (PFS) is significantly longer in women with recurrent ovarian cancer when bevacizumab is added to chemotherapy, a multicenter team reports in the Journal of Clinical Oncology online April 23.

“As ovarian cancer becomes a chronic illness, treatments that prolong PFS, and therefore time without cytotoxic chemotherapy, become increasingly relevant,” the authors comment.

Dr. Carol Aghajanian, at Memorial Sloan-Kettering Cancer Center New York, New York, and colleagues explain that women with epithelial ovarian cancer who relapse more than 6 months after platinum-based chemotherapy are considered to have platinum-sensitive disease, for which retreatment with gemcitabine and carboplatin is recommended.

Noting the activity of bevacizumab seen in three phase II studies of recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC), the team conducted a randomized phase III trial (OCEANS) in which 484 women with platinum-sensitive ROC received 6 to 10 cycles of gemcitabine-carboplatin chemo along with either bevacizumab or placebo. The add-on agents were then continued until disease progression.

Median progression-free survival was 12.4 months in the bevacizumab group compared to 8.4 months in the placebo arm (hazard ratio 0.484; p<0.0001), the investigators found.

While no new safety concerns were noted, bevacizumab compared to placebo was associated with more grade 3+ hypertension (17.4% vs <1%) and proteinuria (8.5% vs <1%), according to the report.

Dr. Aghajanian and colleagues note that overall survival data from the trial are not yet available. For now, they conclude, “The data from OCEANS demonstrate that the addition of BV (bevacizumab) to GC (gemcitabine and carboplatin) can improve outcomes, and ongoing studies will assess whether this ability to add benefit is universal to other platinum-based combinations.”

SOURCE:

OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

J Clin Oncol 2012:30.