title: Partial breast irradiation as sole therapy for low risk breast carcinoma: early toxicity, cosmesis and quality of life results of a MammoSite brachytherapy phase II study.
abstract: OBJECTIVE
  The MammoSite is a device that was developed with the goal of making breast-conserving surgery (BCT) more widely available. Our objective was to evaluate the MammoSite device performances after an open cavity placement procedure and quality of life in highly selected patients with early-stage breast cancer.
  
  
  METHODS
  From March 2003 to March 2005, 43 patients with T1 breast cancer were enrolled in a phase II study. The median age was 72 years. Twenty-five (58%) patients were treated with high-dose rate brachytherapy using the MammoSite applicator to deliver 34Gy in 10 fractions. The main disqualifying factor was pathologic sentinel node involvement (10/43; 23%). There were no device malfunctions, migration or rupture of the balloon.
  
  
  RESULTS
  After a median follow-up of 13 months, there were no local recurrences and one contralateral lobular carcinoma. Seventeen (68%), 13 (52%), 8 (32%), 5 (20%) and 2 (8%) patients had erythema, seroma, inflammation, hematoma and sever infection, respectively. Only 2 patients developed telangiectasia. At 1 year the rate of "good to excellent" cosmetic results was 84%. Significant changes in QoL were observed for emotional and social well-being between 3 and 12 months. At 24 months, only emotional well-being subscore changes were statistically significant (p=0.015).
  
  
  CONCLUSIONS
  Our data in patients older than 60 years support the previously published data. Histologic features were the main disqualifying criteria. With higher skin spacing levels we observed very low incidence of telangiectasia. QoL evaluation indicates that baseline scores were satisfactory. Changes concerned emotional and social well-being.
authors.affiliation: Department of Radiation Oncology, Oscar Lambret Anti-Cancer Center, Cedex, France. yazid.belkacemi@hmn.aphp.fr
authors.forename: Yazid
authors.initials: Y
authors.lastname: Belkacémi
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Chauvet
authors.forename: Sylvia
authors.initials: S
authors.lastname: Giard
authors.forename: Sylviane
authors.initials: S
authors.lastname: Villette
authors.forename: Thomas
authors.initials: T
authors.lastname: Lacornerie
authors.forename: François
authors.initials: F
authors.lastname: Bonodeau
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Baranzelli
authors.forename: Jacques
authors.initials: J
authors.lastname: Bonneterre
authors.forename: Eric
authors.initials: E
authors.lastname: Lartigau
mesh_terms: D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D002404:Catheterization; D019583:Dose Fractionation, Radiation; D004954:Esthetics; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011788:Quality of Life; D021701:Sentinel Lymph Node Biopsy; D018709:Statistics, Nonparametric; D016896:Treatment Outcome