September 23 1998  


 

The National Institutes of Health (NIH) is sponsoring a five-year clinical trial which tracks women with early stage breast cancer and their treatment with High Dose Rate (HDR) brachytherapy, an outpatient radiation therapy.


In the past, breast conservation treatment (BCT) has meant a lumpectomy with six weeks of radiation. Seven nationally recognized studies have demonstrated that BCT outcomes are equivalent to a mastectomy in terms of survival rates. While BCT has strong emotional appeal for women who want to save their breast, the six week cycle of radiation has been a deterrent in the past. The National Institutes of Health (NIH) is sponsoring a five-year clinical trial which tracks women with early stage breast cancer and their treatment with High Dose Rate (HDR) brachytherapy, an outpatient radiation therapy. In the past, breast conservation treatment (BCT) has meant a lumpectomy with six weeks of radiation. Seven nationally recognized studies have demonstrated that BCT outcomes are equivalent to a mastectomy in terms of survival rates. While BCT has strong emotional appeal for women who want to save their breast, the six week cycle of radiation has been a deterrent in the past.


An innovative radiation treatment known as HDR brachytherapy has reduced the radiation cycle from six weeks to five days, allowing breast cancer patients to be treated on an outpatient basis. This first multi-hospital study of HDR will focus on Stage I and II breast carcinoma at hospitals throughout the U.S. and Canada. Participating institutions include Notre Dame Hospital, Montreal, Canada; the Medical College of Virginia , Richmond, VA; Mt. Sinai Medical Center, Miami, FL; Ochsner Clinic, New Orleans, LA and six other medical centers.


"Although the percentage of women eligible for BCT is high, the number of women who select this option has been low," said Dr. Douglas Arthur, Medical College of Virginia, a participating institution in the study. "A mastectomy is perceived as a fast way to be done with the cancer. Now, with the HDR five day radiation cycle, women have a medically and emotionally appealing way to retain their breast while moving forward with their lives."


BCT with six weeks of radiation has been inconvenient for patients such as working women, elderly women and women who live far from a treatment center. "HDR has facilitated the delivery of BCT to new groups of women," said Dr. Leonard Toonkel, Mt. Sinai Medical Center, Miami, FL. "We've treated women with HDR who receive the radiation in the morning and then go to work after their treatment."


HDR brachytherapy has been called a "smart bomb" because a powerful radiation source is temporarily inserted into the cancer site using computerized technology, which allows oncologists to treat only the tumor and spare healthy surrounding tissues and organs.


For the NIH study, patient selection criteria exclude those women who may have an increased risk of microscopic disease in multiple areas of the breast. Data suggests that approximately 71,000 women per year would be eligible for this protocol.


Nucletron Corporation, an international medical device company, specializes in some of the most innovative products used for cancer treatment, including the equipment and technology for HDR brachytherapy. Nucletron is considered the world leader in brachytherapy, supplying 75 percent of all remote afterloading systems internationally. The company has 11 offices worldwide, including its corporate headquarters in The Netherlands. The American division, headquartered in Columbia, MD, serves the United States, Mexico and Canada.