• Michelle Wallace, Alvaro Martinez, Christina Mitchell, Peter Y Chen, Mihai Ghilezan, Pamela Benitez, Eric Brown, and Frank Vicini.
• Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI 48073, USA.
• Int. J. Radiat. Oncol. Biol. Phys. 2010 Jun 1; 77 (2): 531-6.

PurposeInitial Phase I/II results using balloon brachytherapy to deliver accelerated partial breast irradiation (APBI) in 2 days in patients with early-stage breast cancer are presented.Materials And MethodsBetween March 2004 and August 2007, 45 patients received adjuvant radiation therapy after lumpectomy with balloon brachytherapy in a Phase I/II trial delivering 2800 cGy in four fractions of 700 cGy. Toxicities were evaluated using the National Cancer Institute Common Toxicity Criteria for Adverse Events v3.0 scale and cosmesis was documented at >or=6 months.ResultsThe median age was 66 years (range, 48-83) and median skin spacing was 12 mm (range, 8-24). The median follow-up was 11.4 months (5.4-48 months) with 21 patients (47%) followed >or=1 year, 11 (24%) >or=2 years, and 7 (16%) >or=3 years. At <6 months (n = 45), Grade II toxicity rates were 9% radiation dermatitis, 13% breast pain, 2% edema, and 2% hyperpigmentation. Grade III breast pain was reported in 13% (n = 6). At >or=6 months (n = 43), Grade II toxicity rates were: 2% radiation dermatitis, 2% induration, and 2% hypopigmentation. Grade III breast pain was reported in 2%. Infection was 13% (n = 6) at <6 months and 5% (n = 2) at >or=6 months. Persistent seroma >or=6 months was 30% (n = 13). Fat necrosis developed in 4 cases (2 symptomatic). Rib fractures were seen in 4% (n = 2). Cosmesis was good/excellent in 96% of cases.ConclusionsTreatment with balloon brachytherapy using a 2-day dose schedule resulted acceptable rates of Grade II/III chronic toxicity rates and similar cosmetic results observed with a standard 5-day accelerated partial breast irradiation schedule.Copyright 2010 Elsevier Inc. All rights reserved.

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