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.
From June 1988 to January 1991 the efficacy of a low-dose (5 x 2 Gy) versus a high-dose (10 x 2 Gy, resp. 5 x 3,5 Gy) prophylactic postoperative radiotherapy was assessed in a prospective randomized trial. 60 patients at the highest risk for formation of heterotopic ossification (HO) were included in this study, i.e. patients that presented already HO in the ipsi- or contralateral hip at the time of surgery. After both irradiation regimen the incidence and severity of HO was significantly less than without prophylaxis; there was no significant difference (regarding the severity of HO, the hip score (16) and the hip mobility) between the two regimen.
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