Bevacizumab delayed progression of epithelial ovarian cancer

Burger RA. N Engl J Med. 2011;365:2473-2483.

The use of bevacizumab during and after carboplatin and paclitaxel chemotherapy prolonged PFS in patients with epithelial ovarian cancer by approximately 4 months, according to trial data published in the Dec. 29 issue of The New England Journal of Medicine.

In a double blind, placebo-controlled, phase 3 trial, 1,873 patients were enrolled from 336 sites in the United States, Canada, South Korea and Japan. Researchers randomly assigned eligible patients — eligibility determined as previously untreated or incompletely resectable stage III or any stage IV ovarian cancer — to one of three treatment groups. During the 22 3-week cycles of the study, all three groups received IV infusions on day 1, with the first six cycles consisting of standard chemotherapy with carboplatin at an area under the curve of 6 and paclitaxel at a dose of 175 mg per square meter of body-surface area.

The control group treatment consisted of chemotherapy with placebo added in cycles two to 22. The secondary group received chemotherapy with bevacizumab (Avastin, Genentech) added in cycles two to six and placebo added in cycles seven to 22. The third group received chemotherapy with bevacizumab added in cycles two to 22. Treatment was discontinued in all groups at the onset of disease progression, unacceptable toxic effects, completion of all 22 cycles or withdrawal.

According to researchers, 19% of study patients (16% of the control group, 17% of bevacizumab/placebo group and 24% of the group receiving bevacizumab throughout) completed the planned treatment, with an additional 15% still receiving treatment at the time of the database lock. Sixty-six percent of the study population withdrew prematurely, citing disease progression as the most common reason, including 48% of patients in the control group, 42% in the bevacizumab/placebo group and 26% in the bevacizumab-throughout group.

At the conclusion of the study, patients who received bevacizumab with chemotherapy throughout demonstrated a longer median of PFS (14.1 months) compared with patients in the control group (10.3 months) and the bevacizumab/placebo group (11.2 months). Compared with control treatment, the HR for progression or death was 0.908 (95% CI, 0.795-1.040) with bevacizumab/placebo and 0.717 (95% CI, 0.625-0.824) with bevacizumab administered throughout.

“This approach can be looked upon as a third major component of treatment for ovarian cancer and related malignancies,” Robert A. Burger, MD, lead investigator on the Gynecologic Oncology Group (GOG) study and director of the Women’s Cancer Center at Fox Chase Cancer Center in Philadelphia, said in a press release. “We’ve had the combination of surgical management and cytotoxic chemotherapy for many years, but we haven’t really seen anything else in terms of a fundamental class of treatment. This represents a new way for us to control the disease.”

Disclosure: The researchers report no relevant financial disclosures.

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