Date: 2011-06-04
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Avastin® (bevacizumab) in combination with chemotherapy (gemcitabine and carboplatin) followed by the continued use of Avastin® alone
Action mechanism: Avastin® specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). Its precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments.
Disease: recurrent platinum-sensitive ovarian cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details: OCEANS is a multicentre, randomized, double-blind, placebo-controlled phase III study in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer. Women in OCEANS had received no more than one treatment regimen prior to enrolment in the trial. The trial was designed to evaluate Avastin® (15mg/kg every three weeks) in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin® as a single agent until disease progression, or unacceptable toxicity, compared to placebo in combination with carboplatin and gemcitabine chemotherapy, followed by placebo alone. The primary endpoint of the study was progression-free survival. The secondary endpoints of the study included overall survival, objective response, duration of response and safety profile.
Latest
news: Roche announced results from OCEANS, a phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (gemcitabine and carboplatin) followed by the continued use of Avastin® alone in women with previously treated (recurrent) platinum-sensitive ovarian cancer. Women who received Avastin® experienced a 52 percent reduction in the risk of their disease progressing (HR = 0.48, p<0.0001) compared to women who received chemotherapy alone. Adverse events in OCEANS were consistent with those seen in previous pivotal trials of Avastin across tumor types.
In OCEANS, women with recurrent, platinum-sensitive ovarian cancer, who received Avastin® in combination with chemotherapy followed by continued use of Avastin® alone until disease progression, experienced the following results:
A median progression-free survival (PFS; the time without the disease progressing) of 12.4 months compared to 8.4 months in women who received chemotherapy alone
Tumor shrinkage (Overall Response Rate) in 79 percent of women receiving the Avastin®-based regimen compared to 57 percent of women who received chemotherapy alone.
Select adverse events (Grade 3-5) that occurred more often in the Avastin® arm compared to the chemotherapy alone arm were hypertension (high blood pressure; 17 percent vs. <1 percent), proteinuria (an excess of protein in the urine; 9 percent vs. 1 percent) and bleeding that does not occur in the central nervous system (6 percent vs. 1 percent). Notably, there were no gastrointestinal perforations (a hole in the stomach or intestine) seen during the safety reporting period of this study.
