Intraop: Study shows Mobetron increases survival rates, reduces tumor recurrence in rectal cancer patients

By E. Janene Geiss

Philadelphia, Feb. 27 - Intraop Medical Corp. said Monday that a recent European study showed that the Food and Drug Administration-approved mobile electron-beam system Mobetron has successfully extended survival rates and reduced tumor recurrence 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, according to a company news release.

In the 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, officials said.

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, officials said.

In the 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, officials said.

"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," Harm Rutten, chief of surgery at Catharina Zeikenhuis in Eindhoven, Holland, and the principal investigator of the study, said in the release.

The study included patients with locally advanced rectal cancer. It was conducted by four major European referral centers, all members of the International Society of IORT-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. These results represent a triple-win - a win for the patients, a win for their doctors and a major win for cost-effective health care. This study strengthens the evidence that IORT and the Mobetron present a major advance in cancer treatments for both women and men," said Donald A. Goer, president and chief executive officer of Intraop, in the release.

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%. But if the cancer is detected at a more advanced stage, the outlook is often dismal.

About 130,000 new cases of colorectal cancer are diagnosed annually in the United States 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 United States.

Intraop, based in Santa Clara, Calif., was formed in April 1993 to develop, manufacture, market and service the Mobetron, a mobile electron beam system designed for intraoperative radiotherapy treatment of cancer, coronary/vascular restenosis and other medical applications.

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