Breast Cancer Research and Treatment

, Volume 135, Issue 1, pp 253–260

Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A

  • Elena Sperk
  • Grit Welzel
  • Anke Keller
  • Uta Kraus-Tiefenbacher
  • Axel Gerhardt
  • Marc Sütterlin
  • Frederik Wenz
Clinical Trial

DOI: 10.1007/s10549-012-2168-4

Cite this article as:
Sperk, E., Welzel, G., Keller, A. et al. Breast Cancer Res Treat (2012) 135: 253. doi:10.1007/s10549-012-2168-4

Abstract

The randomized phase III trial TARGIT A showed non-inferiority regarding local control after intraoperative radiotherapy (IORT 20 Gy which was followed by whole breast radiotherapy (WBRT) in patients with risk factors only) in comparison to standard WBRT (50–56 Gy) after breast-conserving surgery in selected patients. This is the first analysis of long-term toxicities in the setting of TARGIT. Between 02/2002 and 12/2008, 305 patients were treated within TARGIT A (Arm A: n = 34 IORT, n = 20 IORT + WBRT for risk factors; Arm B WBRT: n = 55) or received IORT as a planned boost (control group: n = 196) at a single center. Toxicity was assessed according to the LENT SOMA scales. No significant differences were seen between Arm A and Arm B regarding fibrosis, breast edema, retraction, ulceration, lymphedema, hyperpigmentation, and pain. Arm A had significantly less telangiectases compared to Arm B (p = 0.049). In the subanalysis (Arm A IORT vs. Arm A IORT + WBRT vs. Arm B), fibrosis had a cumulative rate of 5.9 versus 37.5 versus 18.4 %, respectively (38.2 % IORT boost control group), at 3 years. No telangiectases were seen after IORT alone (0 % Arm A IORT vs. 17.5 % Arm A IORT + WBRT vs. 17.7 % Arm B). The hazard ratio of higher grade toxicity as first event was 0.46 (95 % CI, 0.26–0.83) for Arm A IORT as compared to Arm B (p = 0.010). No recurrences were seen after a median follow-up of 40 months (Arm A) and 42 months (Arm B). With its very low chronic skin toxicity rates and outstanding long-term results regarding toxicity and local control, IORT with 50 kV X-rays is a safe and effective method for treatment of selected breast cancer patients.

Keywords

Breast cancer Intraoperative radiotherapy (IORT) Toxicity LENT SOMA TARGIT Fibrosis 

Copyright information

© Springer Science+Business Media, LLC. 2012

Authors and Affiliations

  • Elena Sperk
    • 1
  • Grit Welzel
    • 1
  • Anke Keller
    • 1
  • Uta Kraus-Tiefenbacher
    • 1
  • Axel Gerhardt
    • 2
  • Marc Sütterlin
    • 2
  • Frederik Wenz
    • 1
  1. 1.Department of Radiation OncologyUniversity Medical Center Mannheim, University of HeidelbergMannheimGermany
  2. 2.Department of Gynecology and ObstetricsUniversity Medical Center Mannheim, University of HeidelbergMannheimGermany

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