Department of Radiation Oncology, University of Louisville School of Medicine, Louisville, Kentucky.
Department of Bioinformatics and Biostatistics, University of Louisville School of Public Health and Information Sciences, Louisville, Kentucky.
Int J Radiat Oncol Biol Phys. 2020 Aug 1;107(5):934-942. doi: 10.1016/j.ijrobp.2020.04.041. Epub 2020 May 6.
To evaluate patient-reported outcomes (PROs) and cosmesis from a phase 2 trial of once-weekly hypofractionated breast irradiation (WH-WBI) after breast-conserving surgery (BCS).
Patients had stage 0-II breast cancer treated with BCS and negative margins. WH-WBI was 28.5 to 30 Gy in 5 weekly fractions of 5.7 to 6 Gy delivered with or without a boost. PROs were collected for 3 years after treatment using the Breast Cancer Treatment Outcome Scale (BCTOS) and European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). Physicians rated cosmetic outcome with the Global Cosmesis Score. Longitudinal growth models were used to assess changes in BCTOS across time, and baseline values and changes between time points were correlated with patient and treatment factors.
From 2011 to 2015, 158 women received WH-WBI, and 148 were eligible for analysis after a median follow-up of 39.3 months. Adverse changes (P < .001) in global BCTOS score and breast pain and arm function subscores were observed 6 months after radiation therapy, followed by improvement to near-baseline values at years 1 and 3. Adverse changes in BCTOS cosmetic subscore were also detected at 6 months (P < .001), with no significant improvement at 1 (P = .385) and 3 (P = .644) years. No effect was detected for longitudinal changes in BCTOS scoring for age, body mass index, diabetes, smoking, breast volume, tumor size, seroma volume, dosimetric factors, dose, boost, or systemic therapy. Physician-rated cosmesis at 3 years was excellent/good in 89% and fair/poor in 11%.
WH-WBI was associated with transient worsening in arm function and breast pain but persistent adverse changes in cosmetic PROs that were typically mild or moderate in severity. Physician-rated cosmetic outcomes were acceptable.
评估保乳手术后每周一次的Hypo-WBI （WH-WBI）的 2 期临床试验中的患者报告结局（PRO）和美容效果。
患者患有 0 期至 II 期乳腺癌，接受了保乳手术和阴性切缘。WH-WBI 为 28.5 至 30 Gy，分为 5 周 5.7 至 6 Gy 的 5 个分数，可与或不与加量照射一起使用。使用乳腺癌治疗结果量表（BCTOS）和欧洲癌症研究与治疗组织乳腺癌特异性生活质量问卷（QLQ-BR23）在治疗后 3 年内收集 PRO。医生使用全球美容评分来评估美容结果。使用纵向增长模型评估 BCTOS 随时间的变化，并且将基线值和各时间点之间的变化与患者和治疗因素相关联。
从 2011 年到 2015 年，158 名女性接受了 WH-WBI，148 名女性在中位随访 39.3 个月后符合分析条件。在放射治疗后 6 个月时观察到全球 BCTOS 评分和乳房疼痛及手臂功能子评分的不良变化（P<0.001），1 年和 3 年后接近基线值。在 6 个月时还发现 BCTOS 美容子评分的不良变化（P<0.001），在 1 年（P=0.385）和 3 年（P=0.644）时没有明显改善。年龄、体重指数、糖尿病、吸烟、乳房体积、肿瘤大小、血清肿体积、剂量学因素、剂量、加量或全身治疗对 BCTOS 评分的纵向变化没有影响。3 年后医生评定的美容效果为 89%为优秀/良好，11%为一般/较差。
WH-WBI 与手臂功能和乳房疼痛的短暂恶化有关，但与美容 PRO 的持续不良变化有关，这些变化通常为轻度或中度严重程度。医生评定的美容效果是可以接受的。
