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大乳房女性俯卧位与仰卧位全乳腺照射随机临床试验 5 年结果

5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women.

机构信息

Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium.

Department of Human Structure and Repair, Ghent University, Ghent, Belgium.

出版信息

Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.

Abstract

PURPOSE

Prone position for whole breast irradiation (WBI) results in lower rates of toxicity and reduced ipsilateral mean lung and heart doses. No randomized trials comparing toxicity and cosmesis at 5 years with prone and supine positioning are available.

METHODS AND MATERIALS

In this phase 2 open-label trial, 100 patients with large breast size requiring WBI were randomized between prone and supine positioning. Physician-assessed toxicity (retraction, fibrosis, edema, telangiectasia, pigmentation changes) was scored yearly for a total of 5 years, and photographs were taken at 5 years to assess cosmesis. The data were analyzed longitudinally and cross-sectionally.

RESULTS

Longitudinal analysis shows lower grade 2 late toxicity with prone positioning. The results for at least grade 1 physician-assessed toxicity at 5 years are similar between supine and prone position, respectively, for retraction (56% vs 54%), fibrosis outside the tumor bed (33% vs 24%), tumor bed fibrosis (49% vs 46%), edema (11% vs 8%), telangiectasia (8% vs 3%), and breast pain (6% vs 8%) using cross-sectional analysis. However, the risk of pigmentation changes in prone position (0% vs 19%) 5 years after radiation therapy was significantly lower. Cosmesis was good or excellent in 92% and 75% of patients who used prone and supine positioning, respectively. The 5-year overall survival is 96% in both groups.

CONCLUSION

Prone positioning results in reduced rates of late toxicity.

摘要

目的

俯卧位全乳放疗(WBI)可降低毒性反应发生率,并减少同侧平均肺和心脏剂量。目前尚无比较俯卧位和仰卧位的 5 年毒性反应和美容效果的随机试验。

方法和材料

在这项 2 期开放标签试验中,100 例乳房较大需行 WBI 的患者被随机分配至俯卧位和仰卧位。医生评估的毒性反应(回缩、纤维化、水肿、毛细血管扩张、色素改变)每年评分一次,共 5 年,并在第 5 年拍摄照片以评估美容效果。数据进行了纵向和横向分析。

结果

纵向分析显示,俯卧位的晚期 2 级毒性反应发生率较低。仰卧位和俯卧位至少为 1 级医生评估的毒性反应在第 5 年的结果相似,分别为回缩(56%比 54%)、瘤床外纤维化(33%比 24%)、瘤床纤维化(49%比 46%)、水肿(11%比 8%)、毛细血管扩张(8%比 3%)和乳房疼痛(6%比 8%)。然而,5 年后放射性治疗后俯卧位色素改变的风险显著降低(0%比 19%)。分别采用俯卧位和仰卧位的患者中,美容效果良好或优秀的比例分别为 92%和 75%。两组的 5 年总生存率均为 96%。

结论

俯卧位可降低晚期毒性反应发生率。

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