"Outstanding" Early Experience with SAVI, Study Reports.

PHOENIX -- A study co-authored by Arizona Oncology Services (AOS) reports "outstanding" early experiences with the SAVI[TM] applicator -- particularly for minimal side effects and the device's potential to increase the number of women eligible for shorter breast cancer radiation treatment.

The retrospective study evaluated the first 102 patients to undergo therapy with the SAVI device, making it the largest clinical evaluation of the SAVI applicator to date. Researchers examined several parameters to assess the device's performance, including dosimetry, seroma formation and infection rates. Almost half of the evaluated patients were not eligible for other single-entry breast brachytherapy devices because of skin spacing or breast size.

"I think the most important finding is that we have a device that significantly increases the number of women who are candidates for breast brachytherapy," said Coral Quiet, M.D., a radiation oncologist at AOS and co-author of the study. "The multiple catheters allow tremendous flexibility in radiation delivery, which results in more individualized treatment. SAVI gives more women an opportunity to have a choice regarding radiation therapy."

Robert Kuske, M.D. and Salih Gurdalli, Ph.D., also of AOS, co-authored the study with Dr. Quiet, along with the Department of Radiation Oncology at the University of California, San Diego. Surgeon Victor Zannis, M.D. of the Phoenix-based Breast Care Center of the Southwest was also a co-author. The study was presented as a scientific poster at the recent 2008 Breast Cancer Symposium, Sept. 5-7, 2008 in Washington, D.C.

AOS was the first medical facility in the nation to offer SAVI as an option for breast conservation therapy.

SAVI is a single-entry, multi-catheter device that delivers radiation as part of breast conservation therapy. It is the only single-entry breast brachytherapy device that can customize the dose based on patient-specific anatomy. By more precisely targeting radiation therapy, the device targets tissue where cancer is most likely to recur, while minimizing the exposure of healthy tissue like the skin, heart, lungs and ribs.

Researchers observed that this newer device combines the ease of placement of single-entry brachytherapy devices with the increased dose modulation of interstitial brachytherapy. The result is improved dosimetry compared to first-generation single-entry devices, such as balloon brachytherapy.

"Unfortunately, interstitial brachytherapy is so complex that very few physicians offer it. That's why we've been motivated to develop single-entry devices that are easy for physicians to place, but still allow superior dose control," said Dr. Quiet. "SAVI is nearly as good as interstitial, and it's also significantly easier to utilize."

The study also reported favorable outcomes regarding seroma formation and infection rates with SAVI. Only 8% of patients had a palpable seroma, all of which were asymptomatic. In contrast, seroma rates with balloon brachytherapy are reported to vary from 15%-60%. The infection rate with SAVI was 3%, which is comparable to the average rate of infections for breast procedures.

"Having more than 100 patients in the study provides considerable support that SAVI is a safe, effective device for the delivery of radiation therapy," said Dr. Zannis, the Phoenix breast surgeon. "SAVI continues to prove itself clinically and gives a lot more women a choice in their radiation treatment options."

Added Dr. Quiet, "We're proud we were able to help expand breast cancer treatment options for women by being the first to introduce this new technology, both in the state of Arizona and across the country."

About Arizona Oncology Services

Arizona Oncology Services is a radiation oncology practice with over 20 physicians and 13 locations in the greater Phoenix area and Yuma. Formed in 1981, AOS is a nationally recognized leader in numerous radiation techniques, including accelerated partial breast therapy, brachytherapy, prostate seed implants, stereotactic radiosurgery and monoclonal antibody radiation therapy. AOS physicians and staff partner with patients, families and referring physicians to provide superior radiation oncology care with a focus on leading edge treatment, empathy and compassion. For more information, call 602-274-4484 or access www.azoncology.com.