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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

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Abstract

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.

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Acknowledgments

The authors thank Drs. D. Craig Allred, David Page, and Stacey C. Tobin for their helpful assistance in preparing this manuscript. Supported by the Susan G. Komen Breast Cancer Foundation, Proxima Therapeutics, Inc., and the American Society of Breast Surgeons.

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Authors and Affiliations

  1. Department of Surgical Oncology, Unit 444, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030

    Jacqueline S. Jeruss MD, PhD & Henry M. Kuerer MD, PhD, FACS

  2. Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, Michigan, 48073

    Frank A. Vicini MD, FACR

  3. Department of Surgery, Dallas Breast Center, Dallas, Texas, 75235

    Peter D. Beitsch MD, FACS

  4. Department of Radiology Oncology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901

    Bruce G. Haffty MD

  5. Foundation for Cancer Research and Education, Arizona Oncology Services, Scottsdale, Arizona, 85260

    Coral A. Quiet MD

  6. Department of Surgery, Breast Care Center of the Southwest, Phoenix, Arizona, 85023

    Victor J. Zannis MD

  7. Department of Surgery, Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224

    Angela J. Keleher MD, FACS

  8. Department of Radiation Oncology, St. Louis Cancer & Breast Center, St. Louis, Missouri, 63141

    Delia M. Garcia MD, FACR

  9. Department of Surgery, Alabama Breast Center, Montgomery, Alabama, 36106

    Howard C. Snider MD

  10. Department of Surgery, Sacred Heart Hospital, Allentown, Pennsylvania, 18103

    Mark A. Gittleman MD

  11. Department of Surgery, The Breast Center of Southern Arizona, Tucson, Arizona, 85712

    Eric Whitacre MD

  12. Department of Surgery, Nashville Breast Center, Nashville, Tennessee, 37203

    Pat W. Whitworth MD

  13. Department of Surgery, The Breast Center, Marietta, Georgia, 30060

    Richard E. Fine MD

  14. Synergos, Inc., The Woodlands, Texas, 77380

    Stacey Arrambide MS

Authors
  1. Jacqueline S. Jeruss MD, PhD
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  2. Frank A. Vicini MD, FACR
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  3. Peter D. Beitsch MD, FACS
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  4. Bruce G. Haffty MD
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  5. Coral A. Quiet MD
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  6. Victor J. Zannis MD
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  7. Angela J. Keleher MD, FACS
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  8. Delia M. Garcia MD, FACR
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  9. Howard C. Snider MD
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  10. Mark A. Gittleman MD
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  11. Eric Whitacre MD
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  12. Pat W. Whitworth MD
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  13. Richard E. Fine MD
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  14. Stacey Arrambide MS
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  15. Henry M. Kuerer MD, PhD, FACS
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Corresponding author

Correspondence to Henry M. Kuerer MD, PhD, FACS.

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Jeruss, J.S., Vicini, F.A., Beitsch, P.D. et al. Initial Outcomes for Patients Treated on the American Society of Breast Surgeons MammoSite Clinical Trial for Ductal Carcinoma-In-Situ of the Breast. Ann Surg Oncol 13, 967–976 (2006). https://doi.org/10.1245/ASO.2006.08.031

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  • DOI: https://doi.org/10.1245/ASO.2006.08.031

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