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01-12-2009

A Phase I Study of Intraoperative Radiotherapy for Early Breast Cancer in Japan

Authors: Masataka Sawaki, Shigenori Sato, Toyone Kikumori, Shunichi Ishihara, Yuichi Aoyama, Yoshiyuki Itoh, Akimasa Nakao, Tsuneo Imai

Published in: World Journal of Surgery | Issue 12/2009

Abstract

Background

The present study was designed to identify the optimal intraoperative radiotherapy (IORT) dose for early breast cancer in Japanese women.

Methods

A phase I study was designed using a scheme of dose-escalation from 19, 20, and 21 Gy at 90% isodose. The primary endpoint was early toxicity. Secondary endpoints were efficacy for a long period and late toxicity. Inclusion criteria were as follows: (1) tumor size <2.5 cm, (2) age >50 years, (3) surgical margin >1 cm, (4) intraoperative pathologically free margins, (5) written informed consent. Exclusion criteria were (1) contraindication to radiation therapy, (2) extensive intraductal component. Partial resection was performed with at least a 1-cm margin around the tumor. Radiation was delivered directly to the mammary gland employing a MOBETRON device. Toxicity was evaluated with the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

Results

From December 2007 to September 2008, 9 patients were enrolled in the study. The first three patients received a radiation dose of 19 Gy. Within 3 months toxicity in each case was deep connective tissue fibrosis (grade 1: 2/3, grade 2: 1/3). The next three patients received a dose of 20 Gy and had toxicities of deep connective tissue fibrosis (grade 1: 3/3), hematoma (grade 1: 2/3), infection in the musculoskeletal soft tissue (grade 1: 2/3), and soft tissue necrosis (grade 2: 1/3). The final three patients received a dose of 21 Gy and had toxicities of deep connective tissue fibrosis (grade 1: 2/3), hematoma (grade 1: 1/3), infection in the musculoskeletal soft tissue (grade 1: 1/3), and soft tissue necrosis (grade 2: 2/3).

Conclusions

The IORT treatment was tolerated very well in Japanese women, and we now recommend the dose of 21 Gy.

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Title: A Phase I Study of Intraoperative Radiotherapy for Early Breast Cancer in Japan
Authors: Masataka Sawaki
Shigenori Sato
Toyone Kikumori
Shunichi Ishihara
Yuichi Aoyama
Yoshiyuki Itoh
Akimasa Nakao
Tsuneo Imai
Publication date: 01-12-2009
Publisher: Springer-Verlag
Published in: World Journal of Surgery / Issue 12/2009
Print ISSN: 0364-2313
Electronic ISSN: 1432-2323
DOI: https://doi.org/10.1007/s00268-009-0227-8

At a glance: The STEP trials

Springer Medicine

A Phase I Study of Intraoperative Radiotherapy for Early Breast Cancer in Japan

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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