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A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients

 Sung Gwe Ahn  ;  Soong June Bae  ;  Hak Woo Lee  ;  Chang Ik Yoon  ;  Jun Won Kim  ;  Ik Jae Lee  ;  Joon Jeong 
 BREAST CANCER RESEARCH AND TREATMENT, Vol.174(1) : 157-163, 2019 
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Breast cancer ; Intra-operative radiotherapy ; TARGIT ; Toxicity ; Tumor-bed boost ; Whole breast irradiation
BACKGROUND: There are concerns regarding local toxicity when IORT is applied in Asian women with a smaller breast volume than that of Western women. Trials are required to develop safety profiles for this technique. The aim of this trial was to evaluate acute toxicity after intra-operative radiotherapy (IORT) with low-energy X-ray plus whole breast irradiation (WBI) in Asian patients with breast cancer. METHODS: This single-arm, single-institute, phase II trial investigated acute toxicity after completion of radiotherapy (targeted IORT followed by WBI) in Korean patients treated with breast-conserving surgery (BCS). In the conventional WBI arm from the TARGIT-A trial, the incidence of acute toxicity within 6 months was 15%. To prove the non-inferiority of the acute toxicity rate, 215 patients were required. This trial is registered with ClinicalTrials.gov (NCT02213991). RESULTS: Two-hundred and fifteen women were enrolled, and 198 underwent IORT. In 33 patients, clinically significant complications during the acute period were noted. The incidence of acute toxicity was 16.7% (95% CI 11.5-21.9%). There were 29 patients with seroma needing more than 3 aspirations, 4 with wound infection, and 2 with skin breakdown. There was no difference in the rate of complications according to the tumor volume or the tumor-breast volume ratio. Advanced age and high BMI were risk factors for acute complications. CONCLUSIONS: Targeted intra-operative radiotherapy using Intrabeam® is a safe procedure for Korean patients with breast cancer with an acceptable toxicity profile in the acute period.
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1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jun Won(김준원) ORCID logo https://orcid.org/0000-0003-1358-364X
Bae, Soong June(배숭준) ORCID logo https://orcid.org/0000-0002-0012-9694
Ahn, Sung Gwe(안성귀) ORCID logo https://orcid.org/0000-0002-8778-9686
Yoon, Changik(윤창익)
Lee, Ik Jae(이익재) ORCID logo https://orcid.org/0000-0001-7165-3373
Lee, Hak Woo(이학우)
Jeong, Joon(정준) ORCID logo https://orcid.org/0000-0003-0397-0005
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