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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

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Abstract

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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Author information

Author notes

  1. Sung Gwe Ahn, Soong June Bae, and Hak Woo Lee contributed equally to this work.

Authors and Affiliations

  1. Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 135-720, Republic of Korea

    Sung Gwe Ahn, Soong June Bae, Hak Woo Lee, Chang Ik Yoon & Joon Jeong

  2. Department of Radiation Oncology, Gangnam Severance Hospital, College of Medicine, Yonsei University, Gangnam-gu, Seoul, Republic of Korea

    Jun Won Kim & Ik Jae Lee

Authors
  1. Sung Gwe Ahn
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Corresponding author

Correspondence to Joon Jeong.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The institutional review boards approved the trial according to their local laws and regulations (IRB No 3-2013-0299). All patients gave written informed consent, and the trial was conducted in compliance with the Helsinki Declaration.

Electronic supplementary material

Below is the link to the electronic supplementary material.

10549_2018_5038_MOESM1_ESM.tif

Volumetry by preoperative magnetic resonance imaging. a Manual measurement of breast and tumor portion on axial breast MRI images. b 3D volume of breast tissue portion. c 3D volume of tumor portion. Supplementary material 1 (TIF 2341 KB)

The applicator size and duration of TARGIT. Supplementary material 2 (TIF 313 KB)

10549_2018_5038_MOESM3_ESM.tif

Two cases with complications. a Wound dehiscence. A 52-year-old female did not have a medical history of diabetes mellitus and had a low body mass index (18.68) and low breast volume (401.703 cc). Wound dehiscence with discharge was first noted on POD #15. Wound revision under local anesthesia was performed on POD #27. b Wound infection. A 76-year-old female had a medical history of diabetes mellitus, a high body mass index (33.85), and a high breast volume (1441.18 cc). A wound infection was first noted after the 2nd cycle of docetaxel-cyclophosphamide chemotherapy. This patient was treated with antibiotics for 1 week. Supplementary material 3 (TIF 4989 KB)

10549_2018_5038_MOESM4_ESM.tif

Comparison of age and body mass index (BMI) according to the incidence of complications using the Student t-test. a Comparison of mean age between the non-complication and complication groups (p < 0.001). b Comparison of mean BMI between the non-complication and complication groups (p = 0.001). c Comparison of mean breast volume between the non-complication and complication groups (p = 0.017). d Comparison of mean tumor volume between the non-complication and complication groups (p = 0.094). e Comparison of the mean tumor-volume ratio between the non-complication and complication groups (p = 0.696). Supplementary material 4 (TIF 1054 KB)

Supplementary material 5 (DOCX 13 KB)

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Ahn, S.G., Bae, S.J., Lee, H.W. et al. 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. Breast Cancer Res Treat 174, 157–163 (2019). https://doi.org/10.1007/s10549-018-5038-x

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  • DOI: https://doi.org/10.1007/s10549-018-5038-x

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