1. Six-Year Results From a Phase I/II Trial for Hypofractionated Accelerated Partial Breast Irradiation Using a 2-Day Dose Schedule
- Author
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Pamela Benitez, Alvaro Martinez, Chirag Shah, Frank A. Vicini, M. Wallace, J.B. Wilkinson, and Peter Y. Chen
- Subjects
Cancer Research ,Time Factors ,medicine.medical_treatment ,Brachytherapy ,Breast Neoplasms ,Balloon ,030218 nuclear medicine & medical imaging ,Dose schedule ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,medicine ,Humans ,Survival rate ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Partial Breast Irradiation ,Middle Aged ,medicine.disease ,Prognosis ,Clinical trial ,Survival Rate ,Phase i ii ,Oncology ,030220 oncology & carcinogenesis ,Female ,Radiation Dose Hypofractionation ,Nuclear medicine ,business ,Follow-Up Studies - Abstract
To report 6-year outcomes from a phase I/II trial using balloon-based brachytherapy to deliver APBI in 2 days.A total of 45 patients with early-stage breast cancer received adjuvant APBI in 2 days with high-dose rate (HDR) brachytherapy totaling 2800 cGy in 4 fractions (700 cGy BID) using a balloon-based applicator as part of a prospective phase I/II clinical trial. All patients had negative margins and skin spacing ≥8 mm. We evaluated toxicities (CTCAE v3) as well as ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), distant metastasis, disease-free survival, cause-specific survival, and overall survival.Median age and tumor size were 66 years old (48 to 83) and 0.8 cm (0.2 to 2.3 cm), respectively. Four percent of patients were N1 (n=2) and 73% were estrogen receptor (ER) positive (n=32). Median follow-up was 6.2 years (2.4 to 8.0 y). Nearly all toxicities at 6 years were grade 1 to 2 except 1 instance of grade 3 telangiectasia (2%). Eleven percent (n=5) of patients had chronic asymptomatic fat necrosis whereas asymptomatic seromas were noted on mammogram in 13% of cases (n=6). Cosmesis at last follow-up was good or excellent in 91% of cases (n=40) and fair in 9% (n=4). Two of the previously reported rib fractures healed with conservative measures. There were no IBTR or RNF (6 y IBTR/RNF rate 0%); however, 2 patients experienced distant metastasis (4% at 6 y). The 6-year actuarial disease-free survival, cause-specific survival, and overall survival were 96%, 100%, and 93%, respectively.Hypofractionated 2-day APBI using brachytherapy resulted in excellent clinical outcomes with acceptable chronic toxicities.
- Published
- 2017