Hori Akihiro, Shimbo Taiju, Ikenaga Jun, Itami Takaaki, Mukai Mari, Kobata Kazuma, Ogawa Takashi, Kihara Ayaka, Nakata Mio, Yoshino Yuuki, Takeno Satoshi, Nawa Kanabu, Yoshioka Hiroto, Nihei Keiji, Akiyama Hironori, Yoshida Ken, Kimura Kosei, Iwamoto Mitsuhiko
Department of Radiation Oncology, Osaka Medical and Pharmaceutical University, Takatuki, Osaka 569-8686, Japan.
Department of Dental Radiology, Osaka Dental University, Hirakata, Osaka 570-8507, Japan.
Oncol Lett. 2025 Oct 2;30(6):568. doi: 10.3892/ol.2025.15314. eCollection 2025 Dec.
Kochi Oxydol-Radiation Therapy for Unresectable Carcinomas (KORTUC) is a novel radiosensitizing treatment developed in Japan that involves intratumoral injections of hydrogen peroxide (HO) and sodium hyaluronate (HA). KORTUC II, an evolved form of the therapy, aims to enhance radiotherapy efficacy by locally increasing oxygen tension and inhibiting antioxidant enzymes in the tumor microenvironment. This study retrospectively evaluated the safety and efficacy of KORTUC-based breast-conserving therapy (KORTUC-BCT) in patients with stage 0-IIIC primary breast cancer who refused standard treatment protocols. A total of 50 patients who underwent KORTUC-BCT between February 2013 and April 2022 and had at least 1 year of follow-up were included. Radiotherapy consisted of short-course tangential irradiation at a dose of 44 Gy in 16 fractions. For patients with lymph node metastases, the supraclavicular region was included in the radiation field. A boost dose of 9-12 Gy was subsequently delivered to the tumor using electron-beam radiation therapy. The HO/HA sensitizer was intratumorally injected twice weekly under ultrasound guidance. All patients achieved a clinical complete response within a median evaluation time of 12 months. The 3-year local control rate for all cases was 89.3%; by stage, it was 100% for 0-I, 100% for IIA, 53.3% for IIB, 75% for IIIA, 75.0% for IIIB and 100% for stage IIIC. The 3-year disease-free survival rate was 75% overall; by stage, it was 100% for 0-I, 91.7% for IIA, 53.3% for IIB, 60.0% for IIIA, 75.0% for IIIB and 20.0% for IIIC. Lymph node metastasis sites had a 100% 3-year control rate. No grade ≥3 adverse events or cosmetic complications were observed. These findings suggest that KORTUC-BCT is a minimally invasive and well-tolerated therapy with promising outcomes, particularly for patients with early-stage breast cancer who decline surgery. This clinical study was registered in the UMIN clinical trials registry (UMIN000003734; June 10, 2010).
高知过氧水-不可切除癌的放射治疗（KORTUC）是日本研发的一种新型放射增敏治疗方法，包括瘤内注射过氧化氢（HO）和透明质酸钠（HA）。KORTUC II是该疗法的改进形式，旨在通过局部提高氧张力和抑制肿瘤微环境中的抗氧化酶来增强放射治疗效果。本研究回顾性评估了基于KORTUC的保乳治疗（KORTUC-BCT）对拒绝标准治疗方案的0-IIIC期原发性乳腺癌患者的安全性和有效性。共有50例在2013年2月至2022年4月期间接受KORTUC-BCT且至少随访1年的患者纳入研究。放射治疗包括短程切线照射，剂量为44 Gy，分16次进行。对于有淋巴结转移的患者，锁骨上区域纳入放射野。随后使用电子束放射治疗对肿瘤追加9-12 Gy的剂量。HO/HA增敏剂在超声引导下每周瘤内注射两次。所有患者在中位评估时间12个月内均达到临床完全缓解。所有病例的3年局部控制率为89.3%；按分期，0-I期为100%，IIA期为100%，IIB期为53.3%，IIIA期为75%，IIIB期为75.0%，IIIC期为100%。3年无病生存率总体为75%；按分期，0-I期为100%，IIA期为91.7%，IIB期为53.3%，IIIA期为60.0%，IIIB期为75.0%，IIIC期为20.0%。淋巴结转移部位的3年控制率为100%。未观察到≥3级不良事件或美容并发症。这些结果表明，KORTUC-BCT是一种微创且耐受性良好的治疗方法，效果良好，尤其适用于拒绝手术的早期乳腺癌患者。本临床研究已在UMIN临床试验注册中心注册（UMIN000003734；2010年6月10日）。
