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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. Cancer 2008. © 2008 American Cancer Society.

PURPOSE We were interested in examining the long-term outcome of patients with node-negative breast cancer to address the following questions: (1) Is node-negative breast cancer a disease that is curable by local modalities? (2) Are there predictors of disseminated disease in node-negative breast cancer? (3) Are there subgroups of tumors that have different times to recurrence? METHODS From 1927 to 1984, 826 women with node-negative breast cancer were treated at the University of Chicago. Patients underwent either a radical or extended radical mastectomy (83%) or a modified radical mastectomy (13%). RESULTS Follow-up evaluation ranged from 9 to 523 months (43.6 years); the mean follow-up period of survivors is 162 months (13.5 years). On multivariate analysis, the strongest predictor of outcome and time to relapse was pathologic tumor size. Patients with tumors less than 2 cm had a 20-year disease-free survival (DFS) rate of 79% and a median time to recurrence of 48 months as compared with patients with tumors greater than 2 cm, who had a survival rate of 64% (P < .001) and a median time to recurrence of 37 months (P = .01). CONCLUSION With extended follow-up evaluation, node-negative breast cancer is a curable disease. Size is the strongest predictor of dissemination and rate of relapse. These data suggest that given the natural history of node-negative breast cancer, analysis of clinical trials with short follow-up periods can be misleading, since it may identify those patients whose tumors have a greater virulence but not necessarily a greater likelihood to metastasize.

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