Stereotactic image-guided neoadjuvant ablative single-dose radiation, then lumpectomy, for early breast cancer: the SIGNAL prospective single-arm trial of single-dose radiation therapy.

Background and Purpose: Adjuvant whole-breast irradiation after breast-conserving surgery, typically delivered over several weeks, is the traditional standard of care for low-risk breast cancer. More recently, hypofractionated, partial-breast irradiation has increasingly become established. Neoadjuvant single-fraction radiotherapy (rt) is an uncommon approach wherein the unresected lesion is irradiated preoperatively in a single fraction. We developed the signal (Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy) trial, a prospective single-arm trial to test our hypothesis that, for low-risk carcinoma of the breast, the preoperative single-fraction approach would be feasible and safe. Methods: Patients presenting with early-stage (T < 3 cm), estrogen-positive, clinically node-negative invasive carcinoma of the breast with tumours at least 2 cm away from skin and chest wall were enrolled. All patients received prone breast magnetic resonance imaging (mri) and prone computed tomography simulation. Treatable patients received a single 21 Gy fraction of external-beam rt (as volumetric-modulated arc therapy) to the primary lesion in the breast, followed by definitive surgery 1 week later. The primary endpoints at 3 weeks, 6 months, and 1 year were toxicity and cosmesis (that is, safety) and feasibility (defined as the proportion of mri-appropriate patients receiving rt). Results: Of 52 patients accrued, 27 were successfully treated. The initial dosimetric constraints resulted in a feasibility failure, because only 57% of eligible patients were successfully treated. Revised dosimetric constraints were developed, after which 100% of patients meeting mri criteria were treated according to protocol. At 3 weeks, 6 months, and 1 year after the operation, toxicity, patient- and physician-rated cosmesis, and quality of life were not significantly different from baseline. Conclusions: The signal trial presents a feasible method of implementing single-dose preoperative rt in early-stage breast cancer. This pilot study did not identify any significant toxicity and demonstrated excellent cosmetic and quality-of-life outcomes. Future randomized multi-arm studies are required to corroborate these findings.

Stereotactic core biopsy of breast microcalcifications: comparison of film versus digital mammography, both using an add-on unit.

OBJECTIVE: The goal of this study was to assess the accuracy of an add-on stereotactic unit for core biopsy of indeterminate breast microcalcifications and to compare digital with conventional stereotactic guidance. MATERIALS AND METHODS: We conducted a retrospective review of 232 lesions with indeterminate microcalcifications in 218 women who underwent stereotactically guided breast biopsies. All biopsies were performed using a standard mammography machine with an add-on unit, 121 with conventional and 111 with digital stereotactic guidance. Successful sampling of the lesion was determined by the detection of microcalcifications on specimen radiography or at pathology. RESULTS: Using the add-on unit, 219 (94.4%) of the 232 targeted lesions were successfully sampled. The size, location, number of cores per lesion, and histology of the lesions were not different between the conventional and digital stereotactic biopsy groups (p > 0.1). Indeterminate microcalcifications were missed on biopsy in nine (7.4%) of 121 cases using conventional radiography and in only four (3.6%) of 111 cases using digital imaging. Digital stereotactic guidance allowed sampling of lesions with fewer calcifications per square centimeter (p < 0.001). CONCLUSION: Sampling of indeterminate microcalcifications using a standard mammography machine and an add-on unit has a high accuracy, similar to rates reported for dedicated prone biopsy tables. An add-on unit offers the advantage of considerable cost and space savings. Relative to conventional radiography, digital stereotactic guidance allows lesions with fewer calcifications to be sampled and achieves a greater biopsy success rate. Immediate digital images in the biopsy room also permit rapid adjustment of alignment and minimize patient movement.