SAVI Breast Brachytherapy Safe for Women with Breast Implants, Study Says

Peer-Reviewed Paper from M.D. Anderson Cancer Center
Says Multicatheter Radiation Treatment Limits Dose to Normal Structures

ALISO VIEJO, Calif. - The SAVI® applicator for breast brachytherapy was used to safely deliver post-lumpectomy radiation therapy to a woman with breast implants, according to a newly published paper in a peer-reviewed journal. The case study showed that SAVI produced an "optimal" clinical outcome and "excellent cosmetic results that pleased the patient," wrote the authors.

The study was conducted by researchers at the University of Texas M.D. Anderson Cancer Center (Houston, Tex.) and is published online in the journal Brachytherapy.

The study was significant, the authors said, because to their knowledge there had never before been a published, peer-reviewed case report about SAVI being used on a patient with augmented breasts. The fact that the patient was able to successfully complete breast brachytherapy treatment shows that SAVI "can be used to deliver APBI safely in a patient with breast implants," the authors wrote.

Accelerated partial breast irradiation, or APBI, is a shortened course of high-dose radiation for early-stage breast cancer patients following lumpectomy surgery. SAVI is one method of delivering APBI. By specifically targeting radiation where the cancer is most likely to recur, SAVI reduces treatment time from the traditional six weeks to just five days.

"The number of breast cancer patients with breast augmentation is growing," said Robert R. Kuske, Jr., M.D., of Arizona Breast Cancer Specialists, "and these women deserve a radiation treatment that will safely and effectively treat breast cancer while preserving their appearance."

Dr. Kuske, an internationally known expert on radiation oncology who was not affiliated with the paper published in Brachytherapy, added: "This study shows that SAVI can be considered for treating women with augmented breasts. Previous research has shown that SAVI also produces excellent results for patients in general, while also being an option for women who might be excluded from other single-entry breast brachytherapy approaches."

Dr. Kuske led the first study to examine image-guided brachytherapy in women with breast implants. The study found that brachytherapy provides better cosmetic outcomes than whole breast irradiation because it delivers more targeted and better controlled radiation dosage. The treatment also produces fewer side effects and avoids the risk of implant hardening, while increasing the availability of breast conservation therapy (BCT) to women who wish to avoid mastectomy and/or implant removal.

The new study, led by M.D. Anderson radiation oncologist Elizabeth S. Bloom, M.D., is consistent with these results. The patient in the case report tolerated the treatment well and the device was removed without complication.

An examination eight weeks after treatment revealed no palpable seroma (a potential complication of radiation therapy). At the six-month follow-up examination, the cosmetic outcome was rated excellent according to the Harvard scale. There was no evidence of cancer recurrence as determined by both physical examination and diagnostic mammogram.

Based on their experience with this patient plus previous studies of SAVI, the authors stated that patients should not be excluded from SAVI because of non-tumor-related issues such as breast size, the spacing of the surgical cavity in relation to the skin or ribs, or the presence of breast implants. They also noted that "The APBI brachytherapy method with the greatest versatility in dosimetric coverage and the best ability to limit the dose to normal structures is multicatheter brachytherapy."

SAVI is currently used with the majority of APBI cases at M.D. Anderson.

SAVI is a multicatheter brachytherapy device. It is also the only single-entry breast brachytherapy device that allows physicians to customize radiation based on patient-specific anatomy. Clinical studies show this unique ability can make the benefits of APBI available to twice as many women, as well as result in better outcomes including less skin toxicity, reduced risk of infection and improved cosmesis.

A video featuring a SAVI patient with breast implants can be viewed here. The patient in the video is not the patient who was the subject of the study published in Brachytherapy.

About Cianna Medical, Inc.

Cianna Medical, Inc. is a medical device company focused on women's health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.

For more information, call (toll-free) 866-920-9444 or visit www.ciannamedical.com/.