A new Avastin study in recurrent, platinum-sensitive ovarian cancer showed women lived significantly longer without their disease getting worse. Bevacizumab (trade name Avastin) is a humanized monoclonal antibody that recognizes and blocks vascular endothelial growth factor A. VEGF-A is a chemical signal that stimulates the growth of new blood vessels (angiogenesis), especially in cancer, retinal proliferation of diabetes in the eye, and other diseases. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.

Pharmaceutical manufacturer, Roche, announced today that OCEANS, a phase III study evaluating Avastin in combination with chemotherapy followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary treatment objectives.

Bevacizumab is currently approved by the U.S. Food and Drug Administration (FDA) for cancers that are metastatic (have spread to other parts of the body). It received its first approval in 2004 for combination use with standard chemotherapy for metastatic colon cancer and non-small cell lung cancer. In 2008, it was approved by the FDA for use in metastatic breast cancer, a decision that generated some controversy as it went against the recommendation of its advisory panel, who objected because it only slowed tumor growth but failed to extend survival. In the US, Members of a Food and Drug Administration panel said in July 2010 that they do not see enough of a benefit from Avastin in advanced breast cancer to justify its serious risks.

Hal Barron M.D., Chief Medical Officer and Head Global Product Development said in a statement:

“We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options. Avastin has now demonstrated a significant improvement in PFS in ovarian cancer in three large phase III studies and we are looking forward to sharing the data at an upcoming medical meeting.”

Bevacizumab is increasingly used in cancer patients, it is particularly important for all health care practitioners and patients to understand and recognize the risk of treatment-related mortality and to monitor closely to identify and treat serious adverse effects.

The study showed that women, who received a combination of Avastin and chemotherapy followed by the continued use of Avastin alone, lived longer without their disease worsening.

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 regiment 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, 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.

The time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-sensitive’ disease if disease recurrence occurred more than six months after completing their initial platinum-based chemotherapy, and ‘platinum-resistant’ disease if recurrence occurred within six months.

Source: Roche

Written by Sy Kraft, B.A.