Abstract
OBJECTIVE: This study aimed to evaluate the safety, efficacy, and optimal dosing of intraoperative radiotherapy (IORT) as a tumor bed boost in combination with whole-breast irradiation (WBI) in individuals with breast cancer in China undergoing breast-conserving surgery (BCS). METHODS: A retrospective analysis was conducted on 217 female patients without metastatic disease who underwent BCS between May 2020 and December 2023 and received INTRABEAM IORT followed by postoperative WBI. Adjuvant therapies were administered as indicated. Evaluated outcomes included recurrence, disease-free survival (DFS), overall survival (OS), wound healing, and the incidence of radiodermatitis. RESULTS: The cohort ranged in age from 20 to 67 years, with a median age of 48 years. Among them, 18 patients underwent neoadjuvant chemotherapy prior to BCS. Molecular subtypes included Luminal A (25.8%), Luminal B (33.6%), hormone receptor-negative/human epidermal growth factor receptor 2 (HER2)-positive (6.9%), hormone receptor-positive/HER2-positive (12.9%), and triple-negative (20.7%). IORT doses were 10 Gy (n = 189), > 10 to < 20 Gy (n = 9), and 20 Gy (n = 19). At a median follow-up of 20 months (range: 12-55 months), all patients were alive. Disease recurrence was observed in 2.3% (n = 5). Age younger than 45 years (p = 0.044) and tumor size exceeding 2 cm (p = 0.040) identified as independent risk factors of recurrence. The 1-year and 2-year DFS rates were 99.1% and 98.2%, respectively. Most patients (95.4%) achieved complete wound healing within four weeks. Delayed wound healing exceeding two months occurred more frequently among those who received 20 Gy (15.8%) compared to those who received 10 Gy (2.6%) or > 10 to < 20 Gy (0%) (p < 0.001). CONCLUSIONS: The combination of IORT and WBI demonstrated favorable safety and efficacy profiles in individuals with breast cancer in China undergoing BCS. Younger age and tumor size > 2 cm were associated with increased recurrence risk. An IORT dose between 10 and 20 Gy (including 10 Gy), was determined to be optimal, as a 20 Gy dose was associated with increased wound complications without providing survival benefits. Further research is warranted to explore risk-stratified dosing strategies.