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Clinical Trial
. 2012 May;19(5):1477-83.
doi: 10.1245/s10434-011-2133-1. Epub 2011 Nov 23.

Six-year Analysis of Treatment-Related Toxicities in Patients Treated With Accelerated Partial Breast Irradiation on the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial

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Clinical Trial

Six-year Analysis of Treatment-Related Toxicities in Patients Treated With Accelerated Partial Breast Irradiation on the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial

A J Khan et al. Ann Surg Oncol. .

Abstract

Background: The American Society of Breast Surgeons (ASBrS) enrolled women in a registry trial to prospectively study patients treated with the MammoSite RTS device. This report presents 6-year data on treatment-related toxicities from the trial.

Methods: A total of 1449 primary early-stage breast cancers were treated with accelerated partial breast irradiation (APBI) using the MammoSite device (34 Gy in 10 fractions) in 1440 women. Of these, 1255 case (87%) had invasive breast cancer (IBC) (median size = 10 mm) and 194 cases (13%) had ductal carcinoma in situ (DCIS) (median size = 8 mm). Median follow-up was 59 months. Fisher exact test was performed to correlate categorical covariates with toxicity.

Results: Breast seromas were reported in 28% of cases (35.5% with open cavity and 21.7% with closed cavity placement). Also, 13% of all treated breasts developed symptomatic seromas, and 77% of these seromas developed during the 1st year after treatment. There were 172 cases (11.9%) that required drainage to correct. Use of chemotherapy and balloon fill >50 cc were associated with the development of symptomatic seromas. Also, 2.3% of patients developed fat necrosis (FN). The incidence of FN during years 1 and 2 were 0.9% and 0.8%, respectively. Seroma formation, use of hormonal therapy, breast infection, and A/B cup size were associated with fat necrosis. There were 138 infections (9.5%) recorded; 98% occurred during the 1st year after treatment. Chemotherapy and seroma formation were associated with the development of infections.

Conclusions: Treatment-related toxicities 6 years after treatment with APBI using the MammoSite device are similar to those reported with other forms of APBI with similar follow-up.

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