Breast Cancer

, Volume 21, Issue 4, pp 415–422 | Cite as

Feasibility of intraoperative radiation therapy for early breast cancer in Japan: a single-center pilot study and literature review

  • Masataka SawakiEmail author
  • Naoto Kondo
  • Akiyo Horio
  • Aya Ushio
  • Naomi Gondo
  • Eri Adachi
  • Masaya Hattori
  • Takashi Fujita
  • Hiroyuki Tachibana
  • Takeshi Kodaira
  • Hiroji Iwata
Original Article



Intraoperative radiation therapy (IORT) is under evaluation in breast-conserving surgery because the feasibility of the IORT procedure including transportation of the patient under general anesthesia is not well established. Thus, this prospective single-center study aimed to test the feasibility of IORT at a single dose of 21 Gy in Japanese breast cancer patients.


The primary endpoint was early toxicity; the secondary endpoint was late toxicity. Patients with histologically or cytologically proven primary early breast cancer were eligible. Inclusion criteria were as follows: (1) T < 2.5 cm; (2) desire for breast-conserving surgery; (3) age >50 years; (4) surgical margin >1 cm; (5) intraoperative pathologically free margins; and (6) sentinel node negative. Exclusion criteria were (1) contraindications to radiation therapy; (2) past radiation therapy for the same breast or chest; (3) extensive intraductal component; and (4) a tumor located in the axillary tail of the breast. All patients gave written informed consent. Partial resection was performed with at least a margin of 1 cm around the tumor. The patient was transported from the surgical suite to the radiation room. Radiation (Clinac® 21EX, Varian Medical Systems, Inc.) at 21 Gy was delivered directly to the mammary gland. Toxicity was evaluated with the Common Terminology Criteria for Adverse Events V4.0.


Five patients were enrolled in this pilot study and received 21 Gy. Follow-up ranged from 7.8 to 11.0 months (median 10.2). Intraoperative transportation to the radiation room during the surgical procedure under general anesthesia was performed safely in all patients. Treatment-related toxicities within 3 months were deep connective tissue fibrosis (grade 1, n = 3) and pain (grade 1, n = 3). There was no case of wound infection, wound dehiscence, or soft tissue necrosis. Overall, there was no severe adverse event.


The procedure was tolerated very well in this first group of Japanese female patients treated with IORT, as was the case with European women. A longer follow-up is needed for the evaluation of any potential late side effects or recurrences. A phase II study is now being conducted for the next group of patients (UMIN000003578).


Breast cancer Intraoperative radiotherapy Early breast cancer 



Axillary lymph node dissection


Accelerated partial breast irradiation


American Society for Therapeutic Radiation Oncology


Breast-conserving therapy


Ductal carcinoma in situ


External beam radiation


Extensive intraductal component


Electron intraoperative therapy


Estrogen receptor


Intraoperative radiotherapy


Lobular carcinoma in situ


Lymph-vascular space invasion


Partial breast irradiation


Polymethyl methacrylate




Sentinel lymph node biopsy


Targeted intraoperative radiotherapy


Whole breast external irradiation therapy



This research was funded in part by the Japanese Foundation for Multidisciplinary Treatment of Cancer.

Conflict of interest

The authors state that they have no conflict of interest.


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Copyright information

© The Japanese Breast Cancer Society 2012

Authors and Affiliations

  • Masataka Sawaki
    • 1
    Email author
  • Naoto Kondo
    • 1
  • Akiyo Horio
    • 1
  • Aya Ushio
    • 1
  • Naomi Gondo
    • 1
  • Eri Adachi
    • 1
  • Masaya Hattori
    • 1
  • Takashi Fujita
    • 1
  • Hiroyuki Tachibana
    • 2
  • Takeshi Kodaira
    • 2
  • Hiroji Iwata
    • 1
  1. 1.Department of Breast OncologyAichi Cancer Center HospitalNagoyaJapan
  2. 2.Department of Radiation OncologyAichi Cancer Center HospitalNagoyaJapan

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