Adding bevacizumab to initial chemotherapy and then giving bevacizumab as maintenance therapy significantly slows disease progression in women with advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer, according to the results of a Phase III Gynecologic Oncology Group (GOG) study reported at the ASCO Annual Meeting.
And one month later, the drug’s manufacturer, Genentech, announced that a second large Phase III international study—ICON7, sponsored by the UK’s Medical Research Council and conducted through an international network of researchers in the Gynecologic Cancer InterGroup—showed similar results and would be submitted for presentation at an “upcoming medical meeting” (as of the end of July, which one had not yet been determined).
The lead investigator for the GOG study—reported at the ASCO meeting as Late-Breaking Abstract #1–Robert A. Burger, MD, Director of the Women’s Cancer Center at Fox Chase Cancer Center, said, “This is the first time a Phase III trial has demonstrated that an anti-angiogenic agent improved progression-free survival in women with this very hard-to-treat disease. Based on the results of this GOG trial, bevacizumab is an acceptable initial treatment option for patients with advanced ovarian, primary peritoneal, and fallopian tube cancers.”
Patients in that study were randomly assigned to one of three groups: standard chemotherapy (paclitaxel plus carboplatin) and placebo plus placebo maintenance; standard chemotherapy with bevacizumab plus placebo maintenance; or standard chemotherapy with bevacizumab, followed by bevacizumab maintenance.
ROBERT A. BURGER, MD...Image Tools
Patients receiving up to 10 months of bevacizumab maintenance had a statistically significant longer progression-free survival time (median of 14.1 months) compared with those who received standard chemotherapy alone (median of 10.3 months).
Those who received chemotherapy and bevacizumab followed by placebo maintenance had a median progression-free survival of 11.2 months, a difference that was not statistically significant compared with those who received standard chemotherapy alone, Dr. Burger said.
Although patients experienced bevacizumab-associated side effects (primarily hypertension and low white blood cell counts), the types and frequency appeared to be similar to what has been reported previously, he added.
© 2010 Lippincott Williams & Wilkins, Inc.