title: Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial.
abstract: OBJECTIVE
  To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer.
  
  
  METHODS
  Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed.
  
  
  RESULTS
  The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%.
  
  
  CONCLUSIONS
  Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated with decreased late toxicity.
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia. Electronic address: lcuttino@mcvh-vcu.edu.
authors.forename: Laurie W
authors.initials: LW
authors.lastname: Cuttino
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Douglas W
authors.initials: DW
authors.lastname: Arthur
authors.affiliation: Michigan Healthcare Professionals/21st Century Onoclogy, Farmington Hills, Michigan.
authors.forename: Frank
authors.initials: F
authors.lastname: Vicini
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Dorin
authors.initials: D
authors.lastname: Todor
authors.affiliation: Allegheny Hospital, Temple School of Medicine, Pittsburgh, Pennsylvania.
authors.forename: Thomas
authors.initials: T
authors.lastname: Julian
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Nitai
authors.initials: N
authors.lastname: Mukhopadhyay
mesh_terms: D001918:Brachytherapy / Q000295:instrumentation / Q000379:methods*; D001943:Breast Neoplasms / Q000453:epidemiology / Q000532:radiotherapy*; D002173:Cancer Care Facilities; D018270:Carcinoma, Ductal, Breast / Q000453:epidemiology / Q000532:radiotherapy*; D018275:Carcinoma, Lobular / Q000453:epidemiology / Q000532:radiotherapy*; D057785:Catheters; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D061847:Hospitals, High-Volume; D006801:Humans; D015994:Incidence; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D049291:Seroma / Q000453:epidemiology; D016896:Treatment Outcome