Cosmetic Outcome and Toxicity After Stereotactic Accelerated Partial Breast Irradiation in Early Breast Cancer: A Prospective Observational Cohort Study.

ABSTRACT

PURPOSE: The aim of this work was to prospectively evaluate the toxicity and cosmetic outcomes of 5-fraction, stereotactic, accelerated partial breast irradiation (APBI). METHODS AND MATERIALS This prospective observational cohort study enrolled women who underwent APBI for invasive carcinoma or carcinoma in situ of the breast. APBI was delivered using a CyberKnife M6 robotic radiosurgery system at 30 Gy in 5 nonconsecutive, once-daily fractions. Women undergoing whole breast irradiation (WBI) were also enrolled for comparison. Patient-reported and physician-assessed adverse events were recorded. Breast fibrosis was measured using a tissue compliance meter, and breast cosmesis was assessed using BCCT.core (an automatic, computer-based software). Outcomes were collected until 24 months posttreatment according to the study protocol. RESULTS: In total, 204 patients (APBI, n = 103; WBI, n = 101) were enrolled. Regarding patient-reported outcomes, the APBI group reported significantly less skin dryness (6.9% vs 18.3%; P = .015), radiation skin reaction (9.9% vs 23.5%; P = .010), and breast hardness (8.0% vs 20.4%; P = .011) at 6 months than the WBI group. On physician assessment, the APBI group had significantly less dermatitis at 12 months (1.0% vs 7.2%; P = .027) than the WBI group. Any severe toxicities after APBI were rare in patient-reported outcomes (score ≥3, 3.0%) and physician assessments (grade ≥3, 2.0%). In the uninvolved quadrants, measured fibrosis in the APBI group was significantly lower than that in the WBI group at 6 (P = .001) and 12 (P = .029) months but not at 24 months. In the involved quadrant, measured fibrosis in the APBI group was not significantly different from that in the WBI group at any time. Cosmetic outcomes in the APBI group were mostly excellent or good (77.6%) at 24 months, and there was no significant cosmetic detriment from the baseline. CONCLUSIONS: Stereotactic APBI was associated with less fibrosis in the uninvolved breast quadrants than WBI. Patients showed minimal toxicity and no detrimental effects on cosmesis after APBI.