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01-08-2019 | Breast Cancer | Breast Oncology

Multicenter Phase II Study of Intraoperative Radiotherapy of Early Breast Cancer: Ipsilateral Tumor Recurrence

Authors: Masataka Sawaki, MD, PhD, Takeshi Miyamoto, MD, PhD, Tomomi Fujisawa, MD, PhD, Yoshiyuki Itoh, MD, PhD, Takeshi Ebara, MD, PhD, Hiroyuki Tachibana, MD, PhD, Takeshi Kodaira, MD, PhD, Toyone Kikumori, MD, PhD, Yasuhiro Yanagita, MD, PhD, Hiroji Iwata, MD, PhD

Published in: Annals of Surgical Oncology | Issue 8/2019

Abstract

Background

We performed a multicenter phase II study on the efficacy and safety of intraoperative radiotherapy (IORT) as partial breast irradiation using multiple devices.

Methods

The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Key inclusion criteria were T < 2.5 cm, age > 50 years, surgical margin > 1 cm, intraoperative pathologically free margins, and sentinel node negative. After resection of the tumor, radiation at 21 Gy was delivered directly to the mammary gland employing an electron linear accelerator in the operating room, otherwise the patient was transported from the surgical suite to the radiation room.

Results

Overall, 142 patients were enrolled in this study and 129 underwent IORT. Stage 0: n = 4 (3.1%); stage I: n = 98 (76.0%); and stage IIA: n = 27 (20.9%). Luminal type: n = 116 (89.9%); triple-negative: n = 9 (7.0%); and human epidermal growth factor receptor 2: n = 4 (3.1%). Median follow-up time was 59.5 months (range 27.5–99.0), and the rate of IBTR was 3.1% (95% confidence interval 0.9–7.8). The toxicities included fibrosis in deep-connective tissue: grade 1, 78.1%; wound infection: grade 3, 1.6% and grade 2, 1.6%; and soft tissue necrosis: grade 3, 0.8% and grade 2, 0.8%. Recurrence in the breast occurred in four cases; the site of recurrence was just under the skin near the primary tumor site, with similar histology and subtype.

Conclusions

In this multicenter phase II study, the rate of IBTR was low and IORT at 21 Gy was feasible in properly selected patients. It is important to use a careful surgical technique to reduce local recurrence because the skin is not included in the radiation field of IORT.

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Title: Multicenter Phase II Study of Intraoperative Radiotherapy of Early Breast Cancer: Ipsilateral Tumor Recurrence
Authors: Masataka Sawaki, MD, PhD
Takeshi Miyamoto, MD, PhD
Tomomi Fujisawa, MD, PhD
Yoshiyuki Itoh, MD, PhD
Takeshi Ebara, MD, PhD
Hiroyuki Tachibana, MD, PhD
Takeshi Kodaira, MD, PhD
Toyone Kikumori, MD, PhD
Yasuhiro Yanagita, MD, PhD
Hiroji Iwata, MD, PhD
Publication date: 01-08-2019
Publisher: Springer International Publishing
Keywords: Breast Cancer
Breast Cancer
Radiotherapy
Published in: Annals of Surgical Oncology / Issue 8/2019
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-019-07350-7

At a glance: The STEP trials

Springer Medicine

Multicenter Phase II Study of Intraoperative Radiotherapy of Early Breast Cancer: Ipsilateral Tumor Recurrence

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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