Accelerated partial breast irradiation for suitable elderly women using a single fraction of multicatheter interstitial high-dose-rate brachytherapy: Early results of the Single-Fraction Elderly Breast Irradiation (SiFEBI) Phase I/II trial |
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| Affiliation: | 1. Department of Radiation Oncology, Antoine Lacassagne Cancer Center, University of Cote d''Azur, Nice, France;2. Biostatistic Unit, Antoine Lacassagne Cancer Center, University of Cote d''Azur, Nice, France;3. Lycée Massena, University of Cote d''Azur, Nice, France;4. Geriatric Unit, CHU de NICE, FHU ONCOAGE, University of Cote d''Azur, Nice, France;5. Department of Pathology, Antoine Lacassagne Cancer Center, University of Cote d’Azur, Nice, France;6. Department of Breast Surgery, Antoine Lacassagne Cancer Center, University of Cote d''Azur, Nice, France;7. Department of Medical Oncology, Antoine Lacassagne Cancer Center, University of Cote d''Azur, Nice, France |
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| Abstract: | Purpose/ObjectiveTo evaluate feasibility and early clinical outcomes of a single fraction of multi-catheter interstitial high-dose rate brachytherapy for accelerated partial breast irradiation (APBI) in the elderly.Material/MethodsFrom November 2012 to September 2014, 26 patients (≥70) with early breast cancer were enrolled in a prospective phase II trial (NCT01727011). After lumpectomy, intra-operative catheter implant was performed for post-operative APBI (single fraction 16 Gy). Surveillance was achieved at 1, 3 and 6 months after APBI, then twice a year. Acute toxicity was investigated. Early cosmetic outcome was analyzed (patient, radiation oncologist, 2 observers). Local and regional relapse-free survival, cancer specific survival and overall survival were analyzed.ResultsMedian age was 77 years [69–89]. Median CTV was 41 cc [22-95]. Acute toxicity was observed in 18 pts (70%) with a total of 44 events: G1: 75.7%; G2: 22.8%; G3: 4.5%. Breast fibrosis (31.8%), puncture site inflammation (13.6%) and skin hyperpigmentation (11.4%) were the most frequent side effects. Cosmetic evaluation at 6 months was excellent/good in 88%, 92%, 85% and 88% for patient, radiation oncologist, observer #1 and #2 respectively. With a median follow-up of 37.2 months [35.6-42.3], side effects were G1: 4 pts (15%) and G2: 1 pt (4%). Three-year Local and regional relapse-free survival, cancer specific survival and overall survival rates were 100%, 100%, 100% and 95.2% respectively.ConclusionsFor elderly early breast cancer, a post-operative multi-catheter interstitial high-dose rate brachytherapy single dose (16 Gy) appears feasible. Acute toxicity is acceptable as well as early cosmetic outcome. Oncologic outcome seems encouraging and allows going forward with new clinical trials focusing on single fraction APBI. |
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| Keywords: | Breast cancer Elderly women Single fraction Accelerated partial breast irradiation Brachytherapy |
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