National Cancer Center Hospital, Tokyo, Japan.
Int J Clin Oncol. 2019 Jun;24(6):603-607. doi: 10.1007/s10147-019-01423-z. Epub 2019 Mar 11.
Early-stage breast cancer is increasingly detected by screening mammography, and we aim to establish radiofrequency ablation therapy (RFA) as a minimally invasive, cost-efficient, and cosmetically acceptable local treatment. Although there were many studies on resection after RFA, none of them provided sufficient evidence to support RFA as a standard therapy for breast cancer.
In our Phase I study, localized tumors with a maximum diameter of 2 cm, preoperatively diagnosed by imaging and histopathology, were treated with RFA. A 90% complete ablation rate was confirmed histopathologically. Our phase II multicenter study of RFA without resection for early breast cancer will evaluate the long-term safety and efficacy of RFA as well as its cosmetic results, which are a perceived advantage of this technique. We started a phase III multicenter study to demonstrate the non-inferiority of RFA compared with standard treatment (breast-conserving surgery) in terms of ipsilateral breast tumor recurrence (IBTR) rate, which is the best index of local control.
To standardize RFA for breast cancer, the results of our multicenter study, Radiofrequency Ablation Therapy for Early Breast Cancer as Local Therapy (the RAFAELO study) that began in 2013, are eagerly awaited.
早期乳腺癌越来越多地通过筛查乳房 X 光摄影术检测到，我们旨在将射频消融治疗（RFA）确立为一种微创、具有成本效益且美容效果可接受的局部治疗方法。虽然有许多关于 RFA 后切除的研究，但没有一项研究提供足够的证据支持 RFA 作为乳腺癌的标准治疗方法。
在我们的 I 期研究中，对最大直径为 2cm 的局部肿瘤，通过影像学和组织病理学术前诊断，采用 RFA 进行治疗。组织病理学证实了 90%的完全消融率。我们的 RFA 治疗早期乳腺癌而无需切除的 II 期多中心研究将评估 RFA 的长期安全性和有效性及其美容效果，这被认为是该技术的一个优势。我们开始了一项 III 期多中心研究，旨在证明 RFA 在同侧乳房肿瘤复发（IBTR）率方面不劣于标准治疗（保乳手术），这是局部控制的最佳指标。
为了使 RFA 标准化用于乳腺癌治疗，我们从 2013 年开始的多中心研究——早期乳腺癌局部治疗的射频消融治疗（RAFAELO 研究）的结果正在急切等待中。
