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Copenhagen, Denmark
Onsite/Online

ESTRO 2022

Session Item

Monday
May 09
11:40 - 12:40
Room D1
Highlights of Proffered Papers - Latest Clinical Trials
Anna Kirby, United Kingdom;
Ben Slotman, The Netherlands
Proffered Papers
Interdisciplinary
11:40 - 11:50
Acute toxicity after loco regional breast radiation therapy in the randomized DBCG SKAGEN trial 1
Marie Louise Milo, Denmark
OC-0829

Abstract

Acute toxicity after loco regional breast radiation therapy in the randomized DBCG SKAGEN trial 1
Authors:

Marie Louise Milo1, Tamás Lörincz1, Mette Holck Nielsen2, Claus Kamby3, Troels Bechmann4, Sami Al-Rawi5, Louise Wichmann Matthiessen6, Mechthild Krause7, Andreas Schreiber8, Ingvil Mjaaland9, Unn-Mariam Kasti10, Eigil Støre Brix11, piotr kedzierawski12, Tanja Marinko13, Carine kirkove14, Jens Overgaard15, Birgitte Vrou Offersen15

1Aalborg University Hospital, Department of Oncology, Aalborg, Denmark; 2Odense University Hospital, Department of Oncology, Odense, Denmark; 3Rigshospitalet, Department of Oncology, Copenhagen, Denmark; 4Vejle Hospital, Department of Oncology, Vejle, Denmark; 5Naestved Hospital, Department of Oncology, Naestved, Denmark; 6Herlev Universiyt Hospital, Department of Oncology, Herlev, Denmark; 7University Hospital and Faculty of Medicine Carl Gustav Carus, Department of Radiation Oncology and OncoRay, Heidelberg, Germany; 8Dresen Hospital, Department of Radiotherapy, Dresen, Germany; 9Stavanger University Hospital, Department of Oncology, Stavanger, Norway; 10Sørlandet Hospital, Department of Oncology, Kristiansand, Norway; 11University of North Norway, Department of Oncology, Tromsø, Norway; 12Holycross Cancer Center, Department of Radiotherapy, Kielce, Poland; 13Institute of Oncology Ljubljana, Department of Radiotherapy, Ljubljana, Slovenia; 14Cliniques Universitaires St-Luc, Department of Oncology, Brussel, Belgium; 15Aarhus University Hospital, Department of Experimental Clinical Oncology, Aarhus, Denmark

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Purpose or Objective

Background: In the past, poor outcome after hypofractionated radiation therapy (RT) in breast cancer patients (pts) was observed. Thus, in Denmark, normofractionation with 50Gy/25fr was standard for early breast cancer (BC) RT since 1982. In 2014, moderately hypofractionated RT became standard for pts treated with whole breast RT based on early results from the Danish Breast Cancer Group (DBCG) Hypo trial. The DBCG Skagen trial 1 was then initiated to evaluate the risks and gains following 50Gy/25fr versus moderately hypofractionated 40Gy/15fr loco-regional RT of BC pts with indication for loco-regional RT (LR-RT). The primary endpoint was 3-year arm lymph edema. In this study, we report evaluation of acute toxicity, a secondary outcome of the trial.

Material and Methods

Method: In this international, multi-center, randomized trial, pts operated for early BC, pT1-3, pN0-N3, M0 with an indication for LR-RT were randomly assigned 50Gy/25fr (standard) versus 40Gy/15fr (experimental). Acute toxicities were graded using the CTCAE 4.0 and the RTOG/EORTC criteria at baseline, three and five weeks after start of RT. Hereafter, evaluations were made every 2 weeks as long as there were acute morbidities above baseline level. The maximum grading is reported here. Each center was requested to report acute morbidities in 40 consecutive pts. 

Results

Results: From 2015 to 2021, 511 pts from six countries were evaluated for acute toxicity. In total, 259 pts were randomized to 50Gy/25fr and 252 pts to 40Gy/15fr No acute grade 4-5 toxicities were observed. For both randomization arms, grade 3 toxicity was observed in only 10% of the pts. The most common grade 2 toxicities were dermatitis 52% (50Gy/25fr) versus 27% (40Gy15fr) and fatigue 18% (50Gy/25fr) versus 19% (40Gy15fr), respectively. The most common grade 1 toxicities were dermatitis, pruritus and fatigue.   

Conclusion

Conclusion: In general, the frequency and severity of acute toxicities were low for pts treated with LR-RT regardless the randomization arm. Thus, moderately hypofractionated RT did not raise any safety concerns. A more detailed analysis of the acute morbidities will be provided at the ESTRO conference. Radiation-associated late morbidities are currently investigated as part of 10-year follow-up.