title: Five-year results: the initial clinical trial of MammoSite balloon brachytherapy for partial breast irradiation in early-stage breast cancer.
abstract: OBJECTIVE
  Patients with early-stage invasive ductal breast cancer were prospectively evaluated using MammoSite RTS balloon brachytherapy (RTS Cytyc Corp, Marlborough, MA) as the sole modality for delivering accelerated partial breast irradiation to the lumpectomy bed with breast-conserving surgery. This report presents the 5-year results of the treated patients.
  
  
  METHODS
  From May 2000 to October 2001, 70 patients were enrolled in this prospective study. Forty-three patients completed accelerated partial breast irradiation with MammoSite brachytherapy following lumpectomy and axillary staging. Thirty-six patients have been followed for a median of 5.5 years (mean 65.2 months). Criteria for entry into the study were unifocal invasive ductal carcinoma, tumor size < or = 2 cm, age > or = 45 years, absence of extensive intraductal component, cavity size > or = 3 cm in 1 dimension, node-negative, and final margins negative per National Surgical Adjuvant Breast and Bowel Project definition. A minimum balloon-to-skin surface distance of 5 mm was required. A dose of 34 Gy was delivered in 10 fractions over 5 days prescribed to 1 cm from the applicator surface using iridium-192 high-dose-rate brachytherapy. Data on infection, seromas, cosmetic outcome, and toxicities were collected at 3 and 6 months and at yearly intervals. Local recurrences, both true recurrences in the lumpectomy bed and failures outside the initially treated target volume (elsewhere failures), were recorded. Contralateral breast failure rates were noted.
  
  
  RESULTS
  The catheter was not implanted in 16 of the 70 enrolled patients due to cavity size not amenable to balloon placement (n = 10), ineligible by criteria (n = 4), and skin spacing (n = 2). Fifty-four patients were implanted and 43 were successfully treated with MammoSite balloon brachytherapy. Reasons for catheter explantation in 11 patients were poor cavity conformance in 7, inadequate skin spacing in 2, positive node in 1 and age less than 45 years in 1. Of the 43 patients who completed treatment, the infection rate was 9.3%. Seroma formation occurred in 32.6% of patients, of which 12% were symptomatic requiring aspiration. Asymptomatic fat necrosis was identified in 4 of the 43 patients, noted from time of catheter removal at 11, 14, 42, and 63 months. Good-excellent cosmetic outcomes were achieved in 83.3% of the 36 patients with more than 5 years of follow-up. Cosmetic outcomes were improved, with increased skin spacing having statistical significance at skin spacing > or = 7 mm. The only serious adverse events were 2 infections: mastitis and abscess. Seven of the 43 treated patients have been discontinued from follow-up. None had a local recurrence recorded at last visit. Reasons for exit from the study were death from metastatic disease (n = 3), lost to follow-up (n = 2), and placed in hospice for other medical conditions (n = 2). No local recurrences (either at the tumor bed or elsewhere in the breast) or regional recurrences have occurred in the 36 patients who have been followed for a median of 5.5 years. No contralateral cancers have developed.
  
  
  CONCLUSIONS
  MammoSite balloon brachytherapy as a sole modality for delivering radiation to the tumor bed has been successful in achieving excellent local control in this initial clinical study of patients with early-stage invasive ductal breast cancer. This has been achieved with minimal toxicities and good-excellent cosmetic outcomes in 83.3%. Accelerated partial breast irradiation using the MammoSite balloon in a carefully selected group of patients has demonstrated 5-year local recurrence results comparable to those achieved with conventional whole breast radiation therapy and interstitial catheter brachytherapy as reported at 5-year data points in studies of these treatment modalities. Poor cavity conformance and inadequate skin distance were the main factors limiting use of the MammoSite device. Extended follow-up will be required to determine the long-term efficacy of this treatment modality.
authors.affiliation: Department of Surgery, William Beaumont Hospital, 3577 W. 13 Mile Rd, Suite 201, Beaumont Cancer Center, Royal Oak, MI 48073, USA. pbenitez@beaumont.edu
authors.forename: Pamela R
authors.initials: PR
authors.lastname: Benitez
authors.forename: Martin E
authors.initials: ME
authors.lastname: Keisch
authors.forename: Frank
authors.initials: F
authors.lastname: Vicini
authors.forename: Alan
authors.initials: A
authors.lastname: Stolier
authors.forename: Troy
authors.initials: T
authors.lastname: Scroggins
authors.forename: Alonzo
authors.initials: A
authors.lastname: Walker
authors.forename: Julia
authors.initials: J
authors.lastname: White
authors.forename: Peter
authors.initials: P
authors.lastname: Hedberg
authors.forename: Mary
authors.initials: M
authors.lastname: Hebert
authors.forename: Doug
authors.initials: D
authors.lastname: Arthur
authors.forename: Vic
authors.initials: V
authors.lastname: Zannis
authors.forename: Coral
authors.initials: C
authors.lastname: Quiet
authors.forename: Oscar
authors.initials: O
authors.lastname: Streeter
authors.forename: Mel
authors.initials: M
authors.lastname: Silverstein
mesh_terms: D000328:Adult; D001918:Brachytherapy / Q000295:instrumentation; D001943:Breast Neoplasms / Q000473:pathology* / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology* / Q000532:radiotherapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D013997:Time Factors