Igaki Hiroshi, Murakami Naoya, Nakamura Satoshi, Yamazaki Naoya, Kashihara Tairo, Takahashi Akira, Namikawa Kenjiro, Takemori Mihiro, Okamoto Hiroyuki, Iijima Kotaro, Chiba Takahito, Nakayama Hiroki, Takahashi Ayaka, Kaneda Tomoya, Takahashi Kana, Inaba Koji, Okuma Kae, Nakayama Yuko, Shimada Kazuaki, Nakagama Hitoshi, Itami Jun
Department of Radiation Oncology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
Division of Research and Development for Boron Neutron Capture Therapy, National Cancer Center Exploratory Oncology Research & Clinical Trial Center, Tsukiji 5-1-1 Chuo-ku, Tokyo 104-0045, Japan.
Clin Transl Radiat Oncol. 2022 Feb 18;33:128-133. doi: 10.1016/j.ctro.2022.02.006. eCollection 2022 Mar.
This study reports the first-in-human use of a linear accelerator-based boron neutron capture therapy (BNCT) system and the first treatment of patients with scalp-angiosarcoma with accelerator-based BNCT.
A single-center open-label phase I clinical trial has been conducted using the system since November 2019. Patients with a localized node-negative scalp-angiosarcoma along with the largest diameter of the tumor ≤ 15 cm who refused primary surgery and chemotherapy were enrolled. After administration of boronophenylalanine (BPA), a single treatment of BNCT with the maximum dose delivered to the skin being 12 Gy-Eq was performed. The safety and effectiveness of accelerator-based BNCT therapy for localized scalp angiosarcoma were evaluated.
Scalp-angiosarcoma of the two patients did not develop the dose-limiting toxicity in the clinical trial. They reached CR within half a year and did not exhibit in-field failure 20 months after BNCT without any severe treatment-related adverse events. Although a grade 3 adverse event of an asymptomatic but increased serum amylase level was noted in both patients, it relieved without any treatment. Additionally, no severe acute dermatitis was observed for both patients, which is typically seen with conventional primary radiotherapy.
It was suggested that BNCT would be a promising treatment modality for scalp-angiosarcoma, which is difficult to treat.
本研究报告了基于直线加速器的硼中子俘获疗法(BNCT)系统的首次人体应用,以及基于加速器的BNCT对头皮血管肉瘤患者的首次治疗。
自2019年11月起使用该系统进行了一项单中心开放标签的I期临床试验。纳入了患有局限性淋巴结阴性头皮血管肉瘤且肿瘤最大直径≤15 cm、拒绝接受初次手术和化疗的患者。在给予硼苯丙氨酸(BPA)后,进行了单次BNCT治疗,皮肤接受的最大剂量为12 Gy-Eq。评估了基于加速器的BNCT疗法对局限性头皮血管肉瘤的安全性和有效性。
两名患者的头皮血管肉瘤在临床试验中均未出现剂量限制性毒性。他们在半年内达到完全缓解(CR),在BNCT后20个月未出现野内复发,且未发生任何严重的治疗相关不良事件。尽管两名患者均出现了无症状但血清淀粉酶水平升高的3级不良事件,但未经任何治疗即缓解。此外,两名患者均未观察到典型的常规初次放疗中出现的严重急性皮炎。
提示BNCT可能是一种治疗困难的头皮血管肉瘤的有前景的治疗方式。