Three-year analysis of treatment efficacy, cosmesis, and toxicity by the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial in patients treated with accelerated partial breast irradiation (APBI).

BACKGROUND: This report presents 3 years of data on treatment efficacy, cosmetic results, and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite (Cytyc, Bedford, Mass) Breast Brachytherapy Registry Trial. METHODS: A total of 1440 patients (1449 cases) with early stage breast cancer who were undergoing breast-conserving therapy were treated with the MammoSite device to deliver accelerated partial breast irradiation (APBI) (34 Gy in 3.4 Gy fractions). Of these, 1255 (87%) cases had invasive breast cancer (IBC; median size = 10 mm), and 194 (13%) cases had ductal carcinoma in situ (DCIS; median size = 8 mm). Median follow-up was 30.1 months. RESULTS: Twenty-three (1.6%) cases developed an ipsilateral breast tumor recurrence (IBTR) for a 2-year actuarial rate of 1.04% (1.11% for IBC and 0.59% for DCIS). No variables were associated with IBTR. Six (0.4%) patients developed an axillary failure. The percentages of breasts with good to excellent cosmetic results at 12 (n = 980), 24 (n = 752), 36 (n = 403), and 48 months (n = 67 cases) were 95%, 94%, 93%, and 93%, respectively. Breast seromas were reported in 23.9% of cases (30% in open-cavity implants and 19% in closed-cavity implants). Symptomatic seromas occurred in 10.6% of cases, and 1.5% of cases developed fat necrosis. A subset analysis of the first 400 consecutive cases enrolled was performed (352 with IBC, 48 DCIS). With a median follow-up of 37.5 months, the 3-year actuarial rate of IBTR was 1.79%. CONCLUSIONS: Treatment efficacy, cosmesis, and toxicity 3 years after treatment with APBI using the MammoSite device are good and similar to those reported with other forms of APBI with similar follow-up

The surgeon\u27s role in breast brachytherapy.

Although two-thirds of invasive breast cancers and half of non-invasive breast cancers are amenable to lumpectomy, only about 70% of such patients choose breast conservation. Of that group, up to one-third do not follow-up with radiation therapy despite it being clinically indicated. The reasons include the patient\u27s and surgeon\u27s attitude toward breast conservation as well as the inconvenience and distance of a suitable radiation facility. The advent of shorter courses of radiation therapy may encourage more patients to seek adjuvant therapy. An increasingly popular and more convenient alternative to traditional whole-breast radiation therapy in patients with early-stage breast cancer is accelerated partial breast irradiation (APBI), for which the American Society of Breast Surgeons and the American Brachytherapy Society have promulgated guidelines for candidate selection. Although several methods are emerging, the most widely used brachytherapy technique utilizes the MammoSite single-catheter balloon brachytherapy device. In a best practices symposium convened in 2006, breast surgeons from academic and community practices with extensive experience in balloon brachytherapy developed general guidelines for integrating APBI into a breast surgical practice. Important considerations include patient age, histology, tumor location and size, and breast size. Thoughtful lumpectomy planning is essential to optimize balloon placement. Real-time sonographic guidance is essential as the surgeon should attend closely to volume excised and cavity shape. A cavity evaluation device can act as a place holder while patient suitability for APBI is considered. Many breast surgeons expert in this procedure insert the balloon catheter in the office either through a de novo skin entrance site removed from the lumpectomy incision or through the original incision. Optimally, insertion occurs within 2-3 weeks after lumpectomy. Close and continual communication with the radiation oncologist is essential to assure optimal outcomes. In this review, several key aspects of a successful APBI program from a surgeon\u27s perspective as well as a consensus panel from a best practices symposium on the topic herein are highlighted

Four-year clinical update from the American Society of Breast Surgeons MammoSite brachytherapy trial.

BACKGROUND: We present a 4-year update on the efficacy, cosmetic results, and complications of MammoSite breast brachytherapy in patients enrolled in the American Society of Breast Surgeons registry trial. METHODS: A total of 1,449 breasts in 1,440 patients with early stage breast cancer undergoing breast-conserving therapy were treated with adjuvant, accelerated partial breast irradiation (APBI) (34 Gy in 3.4-Gy fractions) delivered with the MammoSite device. The median follow-up period for the entire group was 36.1 months. RESULTS: The 3-year actuarial rate of ipsilateral breast tumor recurrence was 2.15%. The 3-year actuarial rate of axillary recurrence was .36%. Complication rates were as follows: infection, 9.5%; seroma, 26.8% (symptomatic seroma, 12.7%); and fat necrosis, 2.0%. The percentages of breasts with good or excellent cosmetic results were as follows: 12 months, 95%; 24 months, 94%; 36 months, 94%; and 48 months, 91%. CONCLUSIONS: Locoregional control, complications, and cosmetic outcomes from MammoSite APBI at the 4-year update are acceptable and similar to results seen with other forms of APBI

Local control, toxicity, and cosmesis in women \u3e70 years enrolled in the American Society of Breast Surgeons accelerated partial breast irradiation registry trial

Purpose: The American Society of Breast Surgeons enrolled women in a registry trial to prospectively study patients treated with the MammoSite Radiation Therapy System breast brachytherapy device. The present report examined the outcomes in women aged \u3e70 years enrolled in the trial. Methods and Materials: A total of 1,449 primary early stage breast cancers were treated in 1,440 women. Of these, 537 occurred in women \u3e70 years old. Fisher\u27s exact test was performed to correlate age (≤70 vs. \u3e70 years) with toxicity and with cosmesis. The association of age with local recurrence (LR) failure times was investigated by fitting a parametric model. Results: Older women were less likely to develop telangiectasias than younger women (7.9% vs. 12.4%, p = 0.0083). The incidence of other toxicities was similar. Cosmesis was good or excellent in 92% of the women \u3e70 years old. No significant difference was found in LR as a function of age. The 5-year actuarial LR rate with invasive disease for the older vs. younger population was 2.79% and 2.92%, respectively (p = 0.5780). In women \u3e70 years with hormone-sensitive tumors ≤2 cm who received hormonal therapy (n = 195), the 5-year actuarial rate of LR, overall survival, disease-free survival, and cause-specific survival was 2.06%, 89.3%, 87%, and 97.5%, respectively. These outcomes were similar in women who did not receive hormonal therapy. Women with small, estrogen receptor-negative disease had worse LR, overall survival, and disease-free survival compared with receptor-positive patients. Conclusions: Accelerated partial breast irradiation with the MammoSite radiation therapy system resulted in low toxicity and produced similar cosmesis and local control at 5 years in women \u3e70 years compared with younger women. This treatment should be considered as an alternative to omitting adjuvant radiotherapy for older women with small-volume, early-stage breast cancer. © 2012 Elsevier Inc