Hypofractionation with simultaneous integrated boost for early breast cancer: results of the German multicenter phase II trial (ARO-2010-01)

Strahlenther Onkol. 2014 Jul;190(7):646-53. doi: 10.1007/s00066-014-0658-5. Epub 2014 Apr 16.

Abstract

Purpose: To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison.

Methods: Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22-29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL.

Results: 151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99%) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89% (95% CI 82% to 93%). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged.

Conclusion: Hypofractionation with a SIB is feasible and was well tolerated in this study.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Breast Neoplasms / diagnosis*
  • Breast Neoplasms / radiotherapy*
  • Dose Fractionation, Radiation*
  • Early Diagnosis
  • Feasibility Studies
  • Female
  • Germany
  • Humans
  • Middle Aged
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant / methods*
  • Treatment Outcome