Prospective Phase II Multicenter Registry of Ablation after Breast Lumpectomy Added to Extend (ABLATE) Intraoperative Margins in the Treatment of Breast Cancer

摘要

Breast cancer therapy has dramatically changed over the last few decades. Continued research has allowed women an evidence-based option to preserve their breast without sacrificing recurrence or survival. Recent years have seen crucial advances with improvement in local radiotherapy adjuncts to breast conservation surgery (BCS). Aspirations for improved local control while simultaneously decreasing treatment morbidity have been the main driving force for such innovation. However, lack of access to radiation therapy centers, treatment morbidity and duration, and transportation problems often influence patients' decision towards mastectomy. Some are unfortunately relegated to the cohort of patients with incomplete treatment and inferior outcomes.;Accelerated partial breast irradiation (APBI) treats the lumpectomy cavity locally over a much shorter duration, either intraoperatively or immediately after BCS for selected early stage breast cancer patients. The rationale is based on the fact that more than 75 percent of local recurrences (LR) after BCS occur at or near the lumpectomy site, and elsewhere ipsilateral recurrences occur in less than 6 percent of patients (equivalent rates as to the development of a contralateral breast recurrence). Studies confirm that APBI provides equivalent local control rates to whole breast irradiation and is a good alternative for favorable patients.;Radiofrequency ablation (eRFA) applies thermal energy to the lumpectomy cavity causing focal tissue destruction by alternating electric current, which results in intense frictional heat. It has been used intraoperatively with success after excision of lumpectomy specimens in a prospective single center trial, resulting in less than five percent margin re-excision rate and a three percent local recurrence rate at five years. Based on those results this multicenter, prospective Phase II registry of eRFA alone for local breast cancer therapy was undertaken. Some of the benefits of eRFA include single intraoperative administration, improved margin negativity, local control, cosmesis, and quality of life. The two Specific Aims of this dissertation and their key findings are listed below:;Specific Aim1: Establish a multi-site study involving breast cancer clinics in North America to accrue 250 patients to a prospective Phase II registry, who present with operable breast cancer, desire breast conservation surgery (BCS) and fit all inclusion and no exclusion criteria. • To date, 267 women have been screened for the study in seven different sites. 25 patients were either screening failures or lost to follow-up.;Specific Aim 2: Acquire, evaluate and report vital patient outcomes via an interim analysis with at least two years median follow-up for local recurrence, side effects and complications. • 242 evaluable patients were accrued to this ongoing study with a median follow-up of 36 months. • Re-excision for positive margins was < 5%. • 2.5% in local breast cancer recurrence which was highest in the DCIS group. • Breast pain at 6 months was 19% with RFA+XRT versus 1.7% with RFA alone. • Cosmesis was good or excellent in 88% of evaluable patients • QOL did not significantly change before and after eRFA.