title: Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy.
abstract: OBJECTIVE
  Partial breast irradiation (PBI) is an alternative to whole-breast irradiation after breast-conserving surgery in selected patients. Until the results of randomized phase III studies are available, phase II studies inform about PBI. We report the 5 year results of a phase II prospective study with PBI using interstitial multi-catheter high-dose-rate brachytherapy (ClinicalTrials.gov Identifier: NCT00499057).
  
  
  METHODS
  Hundred patients received PBI (4 Gy, twice a day for 4 days, until 32 Gy). Inclusion criteria were: age ≥ 40years, infiltrating carcinoma without lobular histology, ductal in situ carcinoma, tumor size ≤ 2.5 cm, negative surgical margins and axillary lymph nodes.
  
  
  RESULTS
  At a median follow-up of 60 months late toxicity occurred in 25 patients; the 5-year probability of freedom from late toxicity was 72.6% (95% CI: 63.7-81.7). Tamoxifen was the only significant risk factor for late toxicity. Cosmetic results, judged by physicians and patients, were good/excellent in 98 patients. Three local relapses (1 true, 2 elsewhere) and 1 regional relapse occurred. The 5-year probability of local or regional relapse-free survival was 97.7% (95% CI: 91.1-99.4) and 99.0% (95% CI: 92.9-99.8), respectively.
  
  
  CONCLUSIONS
  PBI with interstitial multi-catheter brachytherapy is associated with low relapse and late toxicity rates.
authors.affiliation: Radiation Oncology Section, University of Perugia and Santa Maria della Misericordia Hospital, Italy. Electronic address: cynthia.aristei@unipg.it.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Aristei
authors.forename: Isabella
authors.initials: I
authors.lastname: Palumbo
authors.forename: Giorgia
authors.initials: G
authors.lastname: Capezzali
authors.forename: Alessia
authors.initials: A
authors.lastname: Farneti
authors.forename: Vittorio
authors.initials: V
authors.lastname: Bini
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Falcinelli
authors.forename: Manuela
authors.initials: M
authors.lastname: Margaritelli
authors.forename: Valentina
authors.initials: V
authors.lastname: Lancellotta
authors.forename: Claudio
authors.initials: C
authors.lastname: Zucchetti
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Perrucci
mesh_terms: D000328:Adult; D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D001943:Breast Neoplasms / Q000401:mortality* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D002404:Catheterization / Q000379:methods; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D011446:Prospective Studies; D011832:Radiation Injuries; D011855:Radiodermatitis / Q000175:diagnosis / Q000453:epidemiology / Q000473:pathology; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D011882:Radiotherapy, High-Energy / Q000009:adverse effects / Q000379:methods*; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: Breast cancer; Conservative surgery; High-dose-rate brachytherapy; Interstitial multi-catheter partial breast irradiation