PURPOSE Radiation dermatitis represents one of the most frequent side effects in breast cancer patients undergoing adjuvant whole-breast irradiation (WBI). Whether hypofractionated WBI induces comparable or less acute radiation-induced skin reactions than conventional WBI is still not fully clarified, as randomized evidence and objective assessments are limited. The aim of this study was to objectively determine frequency and severity of acute radiation-induced skin reactions during hypofractionated vs. conventionally fractionated adjuvant WBI. METHODS In this randomized multicenter study, a total of 140 breast cancer patients underwent either hypofractionated or conventional WBI following breast-preserving surgery. Maximum radiation dermatitis severity was assessed at completion and during follow-up by physician-assessed CTCAE v4.03 and the patient-reported RISRAS scale. Additionally, photospectrometric skin readings were performed to objectify skin color differences between both treatment arms. RESULTS Radiation dermatitis severity was significantly lower in patients receiving hypofractionation compared with conventional fractionation (mean 1.05 vs. 1.43, p = .024). Grade 0 radiation dermatitis occurred in 21.43% vs. 4.28%, grade ≥2 in 27.14% vs. 42.91% and grade ≥3 in 0% vs. 4.34% of patients following hypofractionated and conventional WBI, respectively. Objective photospectrometric measurements (n = 4200) showed both decreased erythema severity (p = .008) and hyperpigmentation (p = .002) in the hypofractionation arm. Patients allocated to hypofractionated WBI also reported less pain (p = .006), less hyperpigmentation (p = <0.001) and less limitations of day-to-day activities (p = <0.001). CONCLUSION Physician and patient-assessed toxicity scorings as well as objective photospectrometric skin measurements revealed that hypofractionated WBI yielded lower rates and severity of acute radiation-induced skin toxicity.

中文翻译：

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大分割与传统全乳照射中急性辐射引起的皮肤毒性：使用分光光度法进行的客观、随机多中心评估

目的 放射性皮炎是接受辅助全乳房照射 (WBI) 的乳腺癌患者最常见的副作用之一。与传统 WBI 相比，大分割 WBI 是否会引起与常规 WBI 相当或更少的急性辐射引起的皮肤反应，仍然没有完全阐明，因为随机证据和客观评估是有限的。本研究的目的是客观确定大分割与常规分割辅助 WBI 期间急性辐射引起的皮肤反应的频率和严重程度。方法 在这项随机多中心研究中，共有 140 名乳腺癌患者在保乳手术后接受了大分割或常规 WBI。最大放射性皮炎严重程度在完成时和随访期间由医生评估的 CTCAE v4 进行评估。03 和患者报告的 RISRAS 量表。此外，进行了光度计皮肤读数以客观化两个治疗臂之间的皮肤颜色差异。结果 与常规分割相比，接受大分割的患者放射性皮炎的严重程度显着降低（平均 1.05 对 1.43，p = .024）。0 级放射性皮炎发生率分别为 21.43% 和 4.28%，27.14% 和 42.91% 发生≥2 级，0% 和 4.34% 的大分割和常规 WBI 患者发生≥3 级。客观光谱测量 (n = 4200) 显示大分割组的红斑严重程度 (p = .008) 和色素沉着过度 (p = .002) 均有所降低。分配到大分割 WBI 的患者也报告疼痛较少（p = .006），色素沉着较少（p = <0. 001）和较少的日常活动限制（p = <0.001）。结论 医生和患者评估的毒性评分以及客观的光度计皮肤测量显示，大分割 WBI 产生的急性辐射引起的皮肤毒性的发生率和严重程度较低。