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Clinical Trial
. 2022 Aug:64:136-142.
doi: 10.1016/j.breast.2022.05.008. Epub 2022 Jun 2.

Hypofractionation with simultaneous integrated boost after breast-conserving surgery: Long term results of two phase-II trials

Charlotte Pfaffendorf  1 , Reinhard Vonthein  2 , Katja Krockenberger-Ziegler  3 , Kathrin Dellas  1 , Andreas Schreiber  4 , Dorit Uhlemann  5 , Stefan Dinges  6 , Florian Würschmidt  7 , Peter Andreas  8 , Evelyn Weinstrauch  9 , Kirsten Eilf  10 , Dirk Rades  11 , Ulrike Höller  12 , Stephanie E Combs  13 , Renata Kazmierczak  14 , Fabian Fehlauer  15 , Ulrike Schreck  16 , Jörg Zimmer  4 , Jürgen Dunst  1 , David Krug  17
Affiliations
Clinical Trial

Hypofractionation with simultaneous integrated boost after breast-conserving surgery: Long term results of two phase-II trials

Charlotte Pfaffendorf et al. Breast. 2022 Aug.

Abstract

Purpose: To analyze long-term results of two multicenter prospective single-arm trials (ARO-2010-01 and ARO-2013-04) investigating adjuvant hypofractionated radiotherapy (HF) with simultaneous integrated boost (SIB) after breast-conserving surgery (BCS).

Methods: Eligible patients had histopathologically confirmed unifocal breast cancer planned for whole breast irradiation plus boost radiotherapy to the tumor bed. In both studies, a total dose of 40 Gy was applied to the whole breast and of 48 Gy to the tumor bed in 16 fractions of 2.5 and 3.0 Gy. Radiotherapy could be given either as three-dimensional conformal radiotherapy (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The primary study objectives were feasibility and security within an observation period of six months. The current investigation focuses on long-term efficacy and toxicities.

Results: Between 2011 and 2014, both trials enrolled 300 patients in total. Data from 274 of these patients could be used for the current analysis. The median follow-up time was 60 months and the 5-year disease-free survival 92.1%. Three patients suffered a local recurrence (after 36-72 months) while a regional recurrence occurred in one patient (after 17 months). The 5-year local control rate in the breast was 99.6%. 63.5% of all patients did not report any late radiation-related toxicity, 28.5% reported grade 1 and 7.3% grade 2 toxicities. The highest late toxicity was grade 3 in 2 women (0.7%, telangiectasia and lymphedema of the breast).

Conclusion: Our analysis demonstrates favorable efficacy and low rates of long-term side effects of HF with SIB after BCS. Randomized controlled phase III trials are ongoing.

Keywords: Boost irradiation; Late toxicity; Local recurrence; Moderate hypofractionation; SIB.

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Conflict of interest statement

D. Krug received honoraria from MSD Sharp & Dome and research funding from Merck KGaA. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Kaplan Meier graph for disease-free survival.
Fig. 2
Fig. 2
Kaplan Meier graph for locoregional control.
See this image and copyright information in PMC

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