David Krug1, René Baumann2,3, Katja Krockenberger4,5, Reinhard Vonthein6, Andreas Schreiber7, Alexander Boicev8, Florian Würschmidt9, Evelyn Weinstrauch10, Kirsten Eilf11, Peter Andreas12, Ulrike Höller13, Stefan Dinges14, Karen Piefel15,16, Jörg Zimmer7, Kathrin Dellas2, Jürgen Dunst2. 1. Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany. david.krug@uksh.de. 2. Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany. 3. Klinik für Radio-Onkologie, St. Marien-Krankenhaus Siegen, Siegen, Germany. 4. ZKS Lübeck, Universität zu Lübeck, Lübeck, Germany. 5. AMEDOM GmbH, Lübeck, Germany. 6. Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Lübeck, Germany. 7. Praxis für Strahlentherapie Dr. med. Andreas Schreiber, Dresden, Germany. 8. Klinik für Strahlentherapie und Radioonkologie, Heinrich-Braun-Klinikum Zwickau, Zwickau, Germany. 9. Radiologische Allianz, Hamburg, Germany. 10. Praxis für Radioonkologie, Johanniter-Zentren für Medizinische Versorgung Stendal, Stendal, Germany. 11. Praxis für Strahlentherapie, Kiel, Germany. 12. Abteilung für Strahlentherapie, Krankenhaus Buchholz, Buchholz in der Nordheide, Germany. 13. MVZ Charité Vivantes, Berlin, Germany. 14. Klinik für Strahlentherapie & Radioonkologie, Lüneburg, Germany. 15. Strahlenzentrum Hamburg MVZ, Hamburg, Germany. 16. Fachbereich Strahlentherapie, Ambulanzzentrum des UKE, Hamburg, Germany.
Abstract
PURPOSE: We report results of a multicenter prospective single-arm phase II trial (ARO-2013-04, NCT01948726) of moderately accelerated hypofractionated radiotherapy with a simultaneous integrated boost (SIB) in patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery. METHODS: The eligibility criteria included unifocal breast cancer with an indication for adjuvant radiotherapy to the whole breast and boost radiotherapy to the tumor bed. The whole breast received a dose of 40 Gy and the tumor bed a total dose of 48 Gy in 16 fractions of 2.5 and 3 Gy, respectively. Radiotherapy could be given either as 3D conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The study was designed as a prospective single-arm trial to evaluate the acute toxicity of the treatment regimen. The study hypothesis was that the frequency of acute skin reaction grade ≥2 would be 20% or less. RESULTS: From November 2013 through July 2014, 149 patients were recruited from 12 participating centers. Six patients were excluded, leaving 143 patients for analysis. Eighty-four patients (58.7%) were treated with 3D-CRT and 59 (41.3%) with IMRT. Adherence to the treatment protocol was high. The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%). The most frequent grade 3 toxicity (11%) was hot flashes. CONCLUSION: This study demonstrated low toxicity of and high treatment adherence to hypofractionated adjuvant radiotherapy with SIB in a multicenter prospective trial, although the primary hypothesis was not met.
PURPOSE: We report results of a multicenter prospective single-arm phase II trial (ARO-2013-04, NCT01948726) of moderately accelerated hypofractionated radiotherapy with a simultaneous integrated boost (SIB) in patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery. METHODS: The eligibility criteria included unifocal breast cancer with an indication for adjuvant radiotherapy to the whole breast and boost radiotherapy to the tumor bed. The whole breast received a dose of 40 Gy and the tumor bed a total dose of 48 Gy in 16 fractions of 2.5 and 3 Gy, respectively. Radiotherapy could be given either as 3D conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The study was designed as a prospective single-arm trial to evaluate the acute toxicity of the treatment regimen. The study hypothesis was that the frequency of acute skin reaction grade ≥2 would be 20% or less. RESULTS: From November 2013 through July 2014, 149 patients were recruited from 12 participating centers. Six patients were excluded, leaving 143 patients for analysis. Eighty-four patients (58.7%) were treated with 3D-CRT and 59 (41.3%) with IMRT. Adherence to the treatment protocol was high. The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%). The most frequent grade 3 toxicity (11%) was hot flashes. CONCLUSION: This study demonstrated low toxicity of and high treatment adherence to hypofractionated adjuvant radiotherapy with SIB in a multicenter prospective trial, although the primary hypothesis was not met.
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