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Initial Outcomes for Patients Treated on the American Society of Breast Surgeons MammoSite Clinical Trial for Ductal Carcinoma-In-Situ of the Breast

¹ Department of Surgical Oncology, Unit 444, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030
² Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan 48073
³ Department of Surgery, Dallas Breast Center, Dallas, Texas 75235
⁴ Department of Radiology Oncology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901
⁵ Foundation for Cancer Research and Education, Arizona Oncology Services, Scottsdale, Arizona 85260
⁶ Department of Surgery, Breast Care Center of the Southwest, Phoenix, Arizona 85023
⁷ Department of Surgery, Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224
⁸ Department of Radiation Oncology, St. Louis Cancer & Breast Center, St. Louis, Missouri 63141
⁹ Department of Surgery, Alabama Breast Center, Montgomery, Alabama 36106
¹⁰ Department of Surgery, Sacred Heart Hospital, Allentown, Pennsylvania 18103
¹¹ Department of Surgery, The Breast Center of Southern Arizona, Tucson, Arizona 85712
¹² Department of Surgery, Nashville Breast Center, Nashville, Tennessee 37203
¹³ Department of Surgery, The Breast Center, Marietta, Georgia 30060
¹⁴ Synergos, Inc., The Woodlands, Texas 77380

Correspondence: Address correspondence and reprint requests to: Henry M. Kuerer, MD, PhD, FACS; E-mail: hkuerer{at}mdanderson.org.

Background: The MammoSite device was designed as a breast brachytherapy applicator and is currently used to deliver accelerated partial breast irradiation (APBI). We hypothesized that APBI delivered with the MammoSite device would be well tolerated and be associated with a good cosmetic outcome in patients with ductal carcinoma-in-situ (DCIS).

Methods: From 2002 to 2004, 191 patients with DCIS were enrolled in a registry trial to assess the MammoSite applicator. Fifteen patients were excluded from analysis because of device- or patient-related factors; 7 patients were excluded after receiving a radiotherapy boost, thus leaving 169 patients available for study. Follow-up information was available for 158 patients. The average length of follow-up was 7.35 months. Forty-three patients had at least 1 year of follow-up.

Results: Skin spacing for the MammoSite applicator was as follows: < 5 mm, 3 patients (1.78%); 5 to 7 mm, 18 patients (10.65%); and 7 mm, 148 patients (87.57%). Patients with a device-to-skin distance of 7 mm had the best cosmetic result. Patients with a device-to-skin distance of 7 mm also had a lower incidence of radiation dermatitis. Data on 43 patients who were followed up for at least 1 year confirmed these findings. Additional adverse events were primarily related to skin changes, with breast infections occurring in five patients (3.16%). No patient in the study has experienced a recurrence.

Conclusions: APBI delivered via MammoSite is well tolerated in patients with DCIS, and the lowest toxicity was obtained in patients with the greatest device-to-skin distance. Long-term follow-up data regarding patient satisfaction, cosmesis, and efficacy are needed and will be determined from a recently opened large randomized study.

Key Words: MammoSite • Radiotherapy • Breast cancer • Cosmesis

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