External accelerated partial breast irradiation for ductal carcinoma in situ: long-term follow-up from a phase 3 randomized trial

Tumori. 2019 Jun;105(3):205-209. doi: 10.1177/0300891618811278. Epub 2018 Nov 26.

Abstract

Introduction: For a long time, accelerated partial breast irradiation (APBI) effectiveness for ductal carcinoma in situ (DCIS) has been debated, due to conflicting published results. Recent encouraging data from phase 3 trials reopened new perspectives for this radiation approach. The aim of the present study was to analyze the long-term efficacy and safety results of the series of patients with DCIS enrolled in the APBI arm of the APBI-IMRT-Florence phase 3 trial (NCT02104895).

Methods: Patients were treated in a phase 3 randomized trial comparing whole breast irradiation (50 Gy in 25 fractions to the whole breast, plus 10 Gy in 5 fractions to the tumor bed) to APBI (30 Gy in 5 nonconsecutive fractions) using the intensity-modulated radiotherapy technique.

Results: Overall, 22 patients were treated in the APBI arm. Median age was 62 years (mean 59; range 42-75 years). At a median follow-up of 9.2 years (mean 8.8; range 3.8-12.1 years), no contralateral invasive/DCIS occurrence, distant metastasis, or breast cancer-related death were recorded. The 5- and 10-year local recurrence, distant metastasis-free survival, and breast cancer-specific survival were 100%. The 10-year overall survival rate was 90.9%. No late toxicity at 5 and 10 years was recorded.

Conclusions: Waiting for pending studies and mature follow-up, we confirmed the efficacy and safety of APBI for low-risk DCIS.

Keywords: Breast cancer; ductal carcinoma in situ; guidelines; partial breast irradiation; radiotherapy.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Brachytherapy / adverse effects
  • Breast / pathology
  • Breast / radiation effects
  • Breast / surgery
  • Breast Neoplasms / pathology
  • Breast Neoplasms / radiotherapy*
  • Breast Neoplasms / surgery
  • Carcinoma, Ductal, Breast / epidemiology
  • Carcinoma, Ductal, Breast / pathology
  • Carcinoma, Ductal, Breast / radiotherapy*
  • Carcinoma, Ductal, Breast / surgery
  • Carcinoma, Intraductal, Noninfiltrating / epidemiology
  • Carcinoma, Intraductal, Noninfiltrating / pathology
  • Carcinoma, Intraductal, Noninfiltrating / radiotherapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Mastectomy, Segmental
  • Middle Aged
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / radiotherapy
  • Progression-Free Survival
  • Radiotherapy, Intensity-Modulated / adverse effects*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02104895