Adjuvant hypofractionated radiotherapy with simultaneous integrated boost after breast-conserving surgery: results of a prospective trial

• DOI: 10.1007/s00066-020-01689-7
• Publication Date: 2020-10-01T15:04:17Z
• Authors: David Krug; René Baumann; Katja Krockenberger; Reinhard Vonthein; Andreas Schreiber; Alexander Boicev; Florian Würschmidt; Evelyn Weinstrauch; Kirsten Eilf; Peter Andreas; Ulrike Höller; Stefan Dinges; Karen Piefel; Jörg Zimmer; Kathrin Dellas; Jürgen Dunst
• Keywords: Antineoplastic Agents, Hormonal; Esthetics; Radiotherapy, Adjuvant/methods [MeSH] ; Hot Flashes/chemically induced [MeSH] ; Radiotherapy, Conformal/methods [MeSH] ; Radiotherapy, Adjuvant/adverse effects [MeSH] ; Esthetics [MeSH] ; Breast Neoplasms/radiotherapy [MeSH] ; Original Article ; Adverse events ; Intensity modulated radiotherapy ; Pain/etiology [MeSH] ; Radiation Dose Hypofractionation [MeSH] ; Radiotherapy, Conformal/adverse effects [MeSH] ; Breast Neoplasms/surgery [MeSH] ; Combined Modality Therapy [MeSH] ; Radiotherapy, Intensity-Modulated/methods [MeSH] ; Acute toxicity ; Female [MeSH] ; Mastectomy, Segmental [MeSH] ; Humans [MeSH] ; Prospective Studies [MeSH] ; Breast Neoplasms/drug therapy [MeSH] ; Radiotherapy, Intensity-Modulated/adverse effects [MeSH] ; Chemotherapy, Adjuvant [MeSH] ; Antineoplastic Agents, Hormonal/adverse effects [MeSH] ; Radiation dermatitis ; Pilot Projects [MeSH] ; Antineoplastic Agents, Hormonal/therapeutic use [MeSH] ; Treatment compliance ; Radiodermatitis/etiology [MeSH]; Pain; Breast Neoplasms; Pilot Projects; Mastectomy, Segmental; Combined Modality Therapy; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Chemotherapy, Adjuvant; Hot Flashes; Humans; Original Article; Female; Radiation Dose Hypofractionation; Radiotherapy, Adjuvant; Prospective Studies; Radiotherapy, Intensity-Modulated; Radiodermatitis; Radiotherapy, Conformal

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.