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Article Open Access

Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer

  • Authors:
    • Akihiro Hori
    • Taiju Shimbo
    • Jun Ikenaga
    • Takaaki Itami
    • Mari Mukai
    • Kazuma Kobata
    • Takashi Ogawa
    • Ayaka Kihara
    • Mio Nakata
    • Yuuki Yoshino
    • Satoshi Takeno
    • Kanabu Nawa
    • Hiroto Yoshioka
    • Keiji Nihei
    • Hironori Akiyama
    • Ken Yoshida
    • Kosei Kimura
    • Mitsuhiko Iwamoto
  • View Affiliations / Copyright

    Affiliations: 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, Department of Radiology, Kansai Medical University Medical Center, Moriguti, Osaka 573‑1121, Japan, Department of Breast and Endocrine Surgery, Osaka Medical and Pharmaceutical University, Takatuki, Osaka 569‑8686, Japan
    Copyright: © Hori et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 568
    |
    Published online on: October 2, 2025
       https://doi.org/10.3892/ol.2025.15314
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Abstract

Kochi Oxydol‑Radiation Therapy for Unresectable Carcinomas (KORTUC) is a novel radiosensitizing treatment developed in Japan that involves intratumoral injections of hydrogen peroxide (H2O2) 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 H2O2/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).
View Figures

Figure 1

Overall survival. The median follow-up
was 27 months, and the 3-year overall survival was 98%.

Figure 2

Local control late. (A) 3-year LCR was
89.3%. (B) LCR according to clinical stage. The 3-year LCRs were
100% for 0-I and IIA, 53.3% for IIB, 75% for IIIA,75% for IIIB, and
100% for IIIC. LCR, local control rate.

Figure 3

DFS rate. (A) 3-year DFS rate was
80.9%. (B) DFS rate according to clinical stage. The 3-year DFS
rates ware 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. DFS, disease free
survival.

Figure 4

Local control rates in patients with
metastatic lymph nodes. (A) Primary tumor control rate in patients
with metastatic lymph node. The 3-year local control rate for the
primary tumors was 72.9%. (B) Metastatic lymph node control rate.
The 3-year control rate of metastatic lymph nodes was 100%.

Figure 5

Comparison of treatment outcomes with
and without chemotherapy in patients with stage IIB-IIIC. (A)
Comparison of DFS rates with and without chemotherapy in patients
with stage IIB-IIIC. The 3-year DFS rate was 38.8% in patients in
the non-chemotherapy group, whereas it was 75% in the chemotherapy
group. There was no significant difference between the two groups
(P=0.347). (B) Comparison of LCR with and without chemotherapy in
patients with stage IIB-IIIC. The 3-year LCR was 64.2% in the
non-chemotherapy group, whereas it was 100% in the chemotherapy
group. There was no significant difference between the two groups
(P=0.238). DFS, disease free survival. LCR, local control rate.
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Copy and paste a formatted citation
Spandidos Publications style
Hori A, Shimbo T, Ikenaga J, Itami T, Mukai M, Kobata K, Ogawa T, Kihara A, Nakata M, Yoshino Y, Yoshino Y, et al: Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer. Oncol Lett 30: 568, 2025.
APA
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K. ... Iwamoto, M. (2025). Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer. Oncology Letters, 30, 568. https://doi.org/10.3892/ol.2025.15314
MLA
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K., Ogawa, T., Kihara, A., Nakata, M., Yoshino, Y., Takeno, S., Nawa, K., Yoshioka, H., Nihei, K., Akiyama, H., Yoshida, K., Kimura, K., Iwamoto, M."Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer". Oncology Letters 30.6 (2025): 568.
Chicago
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K., Ogawa, T., Kihara, A., Nakata, M., Yoshino, Y., Takeno, S., Nawa, K., Yoshioka, H., Nihei, K., Akiyama, H., Yoshida, K., Kimura, K., Iwamoto, M."Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer". Oncology Letters 30, no. 6 (2025): 568. https://doi.org/10.3892/ol.2025.15314
Copy and paste a formatted citation
x
Spandidos Publications style
Hori A, Shimbo T, Ikenaga J, Itami T, Mukai M, Kobata K, Ogawa T, Kihara A, Nakata M, Yoshino Y, Yoshino Y, et al: Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer. Oncol Lett 30: 568, 2025.
APA
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K. ... Iwamoto, M. (2025). Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer. Oncology Letters, 30, 568. https://doi.org/10.3892/ol.2025.15314
MLA
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K., Ogawa, T., Kihara, A., Nakata, M., Yoshino, Y., Takeno, S., Nawa, K., Yoshioka, H., Nihei, K., Akiyama, H., Yoshida, K., Kimura, K., Iwamoto, M."Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer". Oncology Letters 30.6 (2025): 568.
Chicago
Hori, A., Shimbo, T., Ikenaga, J., Itami, T., Mukai, M., Kobata, K., Ogawa, T., Kihara, A., Nakata, M., Yoshino, Y., Takeno, S., Nawa, K., Yoshioka, H., Nihei, K., Akiyama, H., Yoshida, K., Kimura, K., Iwamoto, M."Non‑surgical breast‑conserving treatment using Kochi oxydol‑radiation therapy for unresectable carcinomas II for patients with stage 0 to IIIC breast cancer". Oncology Letters 30, no. 6 (2025): 568. https://doi.org/10.3892/ol.2025.15314
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