title: Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy.
abstract: OBJECTIVE
  We present the results of the initial clinical testing of the MammoSite balloon breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy.
  
  
  METHODS
  Seventy patients were enrolled in a multicenter prospective trial testing the applicator for safety and performance. Fifty-four patients were implanted, and 43 patients were ultimately eligible for and received brachytherapy as the sole radiation modality after lumpectomy. Patients were staged T1N0M0 with negative pathologic margins and age >45 years. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using 192Ir high-dose-rate brachytherapy. A minimum skin-to-balloon surface distance of 5 mm was required for treatment. Device performance, complications, and cosmesis were assessed.
  
  
  RESULTS
  Computed tomography imaging post-balloon inflation showed 8, 14, and 21 patients with 5-6 mm, 7-9 mm, and >10 mm of skin spacing, respectively. Two patients were explanted because of inadequate skin spacing and 7 because of suboptimal conformance of the surgical cavity to the applicator balloon. One patient was explanted because of positive nodal status and another because of age. The most common side effects related to device placement included mild erythema, drainage, pain, and echymosis. No severe side effects related to implantation, brachytherapy, or explantation occurred. Side effects related to radiation therapy were generally mild with erythema, pain, and dry desquamation being the most common. At 1 month, 88% of patients were evaluated as having good-to-excellent cosmetic results.
  
  
  CONCLUSIONS
  The MammoSite balloon breast brachytherapy applicator performed well clinically. All eligible patients completed treatment. Side effects were mild to moderate and self-limiting. Skin-balloon surface distance and balloon-cavity conformance were the main factors limiting the initial use of the device.
authors.affiliation: Department of Radiation Oncology, Mount Sinai Medical Center, Miami Beach, FL 33140, USA. mkeisch@salick.com
authors.forename: Martin
authors.initials: M
authors.lastname: Keisch
authors.forename: Frank
authors.initials: F
authors.lastname: Vicini
authors.forename: Robert R
authors.initials: RR
authors.lastname: Kuske
authors.forename: Mary
authors.initials: M
authors.lastname: Hebert
authors.forename: Julia
authors.initials: J
authors.lastname: White
authors.forename: Coral
authors.initials: C
authors.lastname: Quiet
authors.forename: Doug
authors.initials: D
authors.lastname: Arthur
authors.forename: Troy
authors.initials: T
authors.lastname: Scroggins
authors.forename: Oscar
authors.initials: O
authors.lastname: Streeter
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation*; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002404:Catheterization; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies