Progression-free survival of patients with advanced ovarian cancerextended by targeted therapy

Burger, MD, lead investigator on the GOG study and director ofthe Women's Cancer Center at Fox Chase Cancer Center. "We've hadthe combination of surgical management and cytotoxic chemotherapyfor many years, but we haven't really seen anything else in termsof a fundamental class of treatment. This represents a new way forus to control the disease." The placebo-controlled study, which was sponsored by the NationalCancer Institute, enrolled 1,873 patients with previously untreatedadvanced disease from 336 sites, primarily in the United States,but also in Canada, South Korea, and Japan. The patients either hadstage III ovarian cancer that could not be entirely removed withsurgery, or stage IV disease, and were randomly assigned to one ofthree groups.

For patients who received bevacizumab withchemotherapy followed by bevacizumab for up to an additional 10months, the median time until their cancer progressed was 14.1months, compared to 10.3 months for patients in the control group,who received chemotherapy with a placebo and then continued with aplacebo. The net effect was a 28% reduction in the risk of diseaseof ovarian cancer progression over time. Patients who receivedbevacizumab only with chemotherapy, but not afterward, had a medianprogression-free survival of 11.2 months. The National Cancer Institute estimates that nearly 22,000 womenwere diagnosed with ovarian cancer in 2011, and more than 15,000died of the disease.

For patients diagnosed before the cancer hasspread, the five-year relative survival rate is about 93 percent(relative survival measures survival of cancer only, independent ofother causes of death). But ovarian cancer is insidious - earlysymptoms, like bloating, abdominal pain, and trouble eating, aretypical of many illnesses and easily dismissed as non-threatening.Women often do not learn they have the disease until it's alreadyspread. In 62 percent of new cases, the patient's cancer hasmetastasized to distant sites, and the five-year survival rate isjust under 27 percent. Bevacizumab is already FDA-approved for use against some types ofcolon, lung, kidney and brain cancers; its accelerated approval formetastatic breast cancer was recently revoked by the FDA.

The drug acts by binding withvascular endothelial growth factor (VEGF), a protein produced bycertain cancers that helps initiate the growth of new blood vesselsthat feed the tumor. The process of growing new blood vessels iscalled angiogenesis, and bevacizumab is an angiogenesis inhibitor. "Bevacizumab blocks the growth factor VEGF, which is important inthe process of ovarian cancer progression," says Burger, "and we'veseen that this drug is also active in patients with recurrentdisease." Angiogenesis happens at the interface between the host and thedisease, which makes it an appealing target for treatment, saysBurger, who also led the Phase II GOG study on using bevacizumab inwomen with recurrent ovarian cancer. He says different ovariancancers may appear identical under the microscope but differbiologically, which means they'll respond differently to treatment.

In the NEJM paper, Burger and his co-authors point out that another ovariancancer trial conducted primarily in Europe called ICON7demonstrated positive results in using becavizumab in combinationwith chemotherapy and then continued for up to 7 months.

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