Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 135-720, Republic of Korea.
Department of Radiation Oncology, Gangnam Severance Hospital, College of Medicine, Yonsei University, Gangnam-gu, Seoul, Republic of Korea.
Breast Cancer Res Treat. 2019 Feb;174(1):157-163. doi: 10.1007/s10549-018-5038-x. Epub 2018 Nov 22.
There are concerns regarding local toxicity when IORT is applied in Asian women with a smaller breast volume than that of Western women. Trials are required to develop safety profiles for this technique. The aim of this trial was to evaluate acute toxicity after intra-operative radiotherapy (IORT) with low-energy X-ray plus whole breast irradiation (WBI) in Asian patients with breast cancer.
This single-arm, single-institute, phase II trial investigated acute toxicity after completion of radiotherapy (targeted IORT followed by WBI) in Korean patients treated with breast-conserving surgery (BCS). In the conventional WBI arm from the TARGIT-A trial, the incidence of acute toxicity within 6 months was 15%. To prove the non-inferiority of the acute toxicity rate, 215 patients were required. This trial is registered with ClinicalTrials.gov (NCT02213991).
Two-hundred and fifteen women were enrolled, and 198 underwent IORT. In 33 patients, clinically significant complications during the acute period were noted. The incidence of acute toxicity was 16.7% (95% CI 11.5-21.9%). There were 29 patients with seroma needing more than 3 aspirations, 4 with wound infection, and 2 with skin breakdown. There was no difference in the rate of complications according to the tumor volume or the tumor-breast volume ratio. Advanced age and high BMI were risk factors for acute complications.
Targeted intra-operative radiotherapy using Intrabeam® is a safe procedure for Korean patients with breast cancer with an acceptable toxicity profile in the acute period.
当 IORT 应用于亚洲女性时，由于乳房体积小于西方女性，因此存在局部毒性的担忧。需要进行试验以确定该技术的安全性。本试验旨在评估乳腺癌亚洲患者接受术中放疗（IORT）联合全乳照射（WBI）后的急性毒性。
这是一项单臂、单中心、II 期临床试验，研究了接受保乳手术（BCS）治疗的韩国患者完成放疗（靶向 IORT 后进行 WBI）后的急性毒性。在 TARGIT-A 试验的常规 WBI 组中，6 个月内急性毒性的发生率为 15%。为了证明急性毒性发生率的非劣效性，需要 215 例患者。本试验已在 ClinicalTrials.gov 注册（NCT02213991）。
共纳入 215 例女性，其中 198 例接受了 IORT。在 33 例患者中，在急性期间观察到有临床意义的并发症。急性毒性的发生率为 16.7%（95%CI 11.5-21.9%）。29 例患者需要超过 3 次抽吸才能解决血清肿，4 例患者发生伤口感染，2 例患者发生皮肤破裂。并发症的发生率与肿瘤体积或肿瘤-乳房体积比无关。高龄和高 BMI 是急性并发症的危险因素。
使用 Intrabeam®的靶向术中放疗是一种安全的方法，适用于韩国乳腺癌患者，其急性毒性谱可接受。
