Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy

Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.

Abstract

Background and purpose: 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.

Conclusion: PBI with interstitial multi-catheter brachytherapy is associated with low relapse and late toxicity rates.

Keywords: Breast cancer; Conservative surgery; High-dose-rate brachytherapy; Interstitial multi-catheter partial breast irradiation.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Brachytherapy / adverse effects*
  • Brachytherapy / instrumentation*
  • Brachytherapy / methods
  • Breast Neoplasms / mortality*
  • Breast Neoplasms / pathology
  • Breast Neoplasms / radiotherapy*
  • Breast Neoplasms / surgery
  • Catheterization / methods
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Mastectomy, Segmental / methods
  • Middle Aged
  • Neoplasm Invasiveness / pathology
  • Neoplasm Staging
  • Prospective Studies
  • Radiation Injuries
  • Radiodermatitis / diagnosis
  • Radiodermatitis / epidemiology
  • Radiodermatitis / pathology
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Radiotherapy, High-Energy / adverse effects
  • Radiotherapy, High-Energy / methods*
  • Risk Assessment
  • Survival Analysis
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00499057