New FDA approved mobile electron-beam system increases survival rates of women with advanced rectal cancer

Feb 27 2006

Colorectal cancer is widely considered a man's disease, but actually affects an equal number of women and men. Detected early, it is highly curable in both genders, with survival rates approaching 90 percent. But if the cancer is detected at a more advanced stage, the outlook is often dismal.

The good news is that an FDA-approved mobile electron-beam system known as the Mobetron, developed by Intraop Medical Corporation of Sunnyvale, Calif., has proven clinically successful in extending survival rates and reducing tumor recurrence rates in patients with advanced rectal cancer.

The Mobetron delivers radiation directly to the tumor bed as part of colorectal cancer surgery. This is the ideal time to radiologically cleanse the area of any errant cancer cells that might have escaped removal. This technique is known as intraoperative radiation therapy or IORT.

About 130,000 new cases of colorectal cancer are diagnosed annually in the U.S. with more than 56,000 deaths each year, according to American Cancer Society statistics. This makes colorectal cancer the third most-common cancer in the U.S.

In the recent European clinical study, 651 women and men with locally advanced rectal cancer received IORT as part of their treatment. These patients showed substantial improvement in survival rates and tumor recurrences over those who did not.

After standard treatment for advanced rectal cancer, which consists of surgery, chemotherapy and radiation, about 25% of patients are expected to survive five years, and 50% of these patients have tumor recurrences that require additional surgery, treatment and hospitalization. In the recent European study, however, patients treated with IORT in addition to the standard treatments showed five-year survival rates of 67%, 10-year survival rates of 46%, and five- and 10-year tumor-control rates of 88% and 86%, respectively.

Dr. Harm Rutten, Chief of Surgery at Catharina Zeikenhuis in Eindhoven, Holland, the principal investigator of the study, commented: "These results are truly exceptional. As a surgeon who treats many patients with this advanced disease, it is gratifying to have a tool that can help these patients and save their lives."

This extensive study of patients with locally advanced rectal cancer was conducted by four major European referral centers, all members of the International Society of IORT-Europe (ISIORT-Europe). It is the largest such study ever reported in medical literature, as well as the largest ever that involved intraoperative radiation therapy.

"With clear evidence of such dramatic tumor control with IORT, this is a most important study," agrees Dr. Donald A. Goer, President and CEO of Intraop. "These results," he adds, "represent a triple-win - a win for the patients, a win for their doctors, and a major win for cost-effective healthcare. This study strengthens the evidence that IORT and the Mobetron present a major advance in cancer treatments for both women and men."

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