Post-surgical treatment of early-stage breast cancer with electronic brachytherapy: an intersociety, multicenter brachytherapy trial

Abstract

Introduction

Electronic brachytherapy (EBT) was developed to allow accelerated partial breast irradiation to be performed in a patient procedure room with minimal shielding. This observational, nonrandomized, multicenter study evaluated EBT as a post-surgical adjuvant radiation therapy for early stage breast cancer.

Methods

This study included women aged 50 years or more with invasive carcinoma or ductal carcinoma in situ, tumor size ≤3 cm, negative lymph node status, and negative surgical margins. The endpoints were skin and subcutaneous toxicities, efficacy outcomes, cosmetic outcomes, and device performance. In this interim report, 1-month, 6-month, and 1-year follow-up data are available on 68, 59, and 37 patients, respectively.

Results

The EBT device performed consistently, delivering the prescribed 34 Gy to all 69 patients (10 fractions/patient). Most adverse events were Grade 1 and included firmness, erythema, breast tenderness, hyperpigmentation, pruritis, field contracture, seroma, rash/desquamation, palpable mass, breast edema, hypopigmentation, telangiectasia, and blistering, which were anticipated. Breast infection occurred in two (2.9%) patients. No tumor recurrences were reported. Cosmetic outcomes were excellent or good in 83.9%–100% of evaluable patients at 1 month, 6 months, and 1 year.

Conclusion

This observational, nonrandomized, multicenter study demonstrates that this EBT device was reliable and well tolerated as an adjuvant radiation therapy for early stage breast cancer.

Keywords:

• radiation therapy
• electronic brachytherapy
• breast cancer

Acknowledgments

The authors thank the patients who participated in this study and their families. The authors wish to thank the research staff for their help with this study. The authors acknowledge the contributions of the Oversight Committee members: Douglas Arthur, MD, of ABS; Peter Beitsch, MD, of ASBS; Jeffrey Demanes, MD, of ACRO; Arve Gillette, MD, of ACRO, Michael Kinney, MD, of ASBS; Henry Kuerer, MD, of ASBS; Helen Pass, MD, of ASBS; Rakesh Patel, MD, of ABS; Frank Vicini, MD, of ABS; David Wazer, MD, of ABS and ACRO; James Welsh, MD, of ACRO; and Pat Whitworth, MD, of ASBS. The authors acknowledge the contributions of the Data Safety Monitoring Board: Sushil Beriwal, MD, of ABS; Tricia Kelly, MD, of ASBS; and William Rate, MD, of ACRO. The authors acknowledge the numerous investigators who contributed to this study: George W Nunn, Dwelvin L Simmons, Michael S Gilligan, Tappan Roy, Jonathon K Foley, John P Thropay, Timothy D Nichols, Bruce A Bornstein, Elizabeth P Tito, Steven C Lane, Julie G White, Manjeet Chadha, and Susan K Boolbol.

Disclosure

The authors report no conflicts of interest in this work.