Burgos-Burgos J, Vega V, Macias-Verde D, Vicente E, Murias C, Santana C, Lara P C
Centro Oncologico Integral Canario, Hospital Universitario San Roque, Universidad Fernando Pessoa Canarias, Insituto Canario de Investigación del Cáncer, Las Palmas, Spain.
Clin Transl Oncol. 2025 May;27(5):2054-2059. doi: 10.1007/s12094-024-03759-z. Epub 2024 Oct 28.
To assess for the first time the safety and feasibility of combining photon-intraoperative radiotherapy (ph-IORT) with hypofractionated whole breast irradiation (h-WBI) in patients referred to primary systemic therapy (PST).
From March 2019 to December 2020, patients referred for breast conservative surgery (BCS) after PST in our institution were prospectively included in the present trial. PST was prescribed to all patients according the ESMO-SEOM guidelines. Once the PST was completed, BCS was discussed in the multidisciplinary tumor board (MTB). 20 Gy were prescribed to the surface of the applicator of an Intrabeam®photon-IORT during BCS. h-WBI (40.5 Gy/2.67 Gy/15frx) was planned to be administered 3-5w after BCS. All patients were treated with hWBI VMAT-Rapid-Arc&Daily Exac-Trac-IGRT. The primary end points of the study were feasibility and safety (grade 3 toxicity rate CTCAE.5.0-scale) of the proposed treatment protocol. The secondary end points included cosmetic results (Harvard Scale), local relapse rate and overall survival.
Thirty-five patients were included in the trial. The median age was 54 years. Tumor size was > 2 cm in all cases. Eighteen patients were N + (51.4%). There was no disease progression during PST. All patients received the planned 20 Gy-ph-IORT boost at the time of BCS and the proposed h-WBI. 31/35 (88,6%) patients started h-WBI within the predefined time period (3-5w after BCS). No patient showed ≥ G3 acute toxicity 3 months after the end of h-WBI. No ≥ G3 late toxicity was observed at 12 months of follow-up and thereafter. Cosmetic results were scored excellent/good in 26 patients (74.2%). After a median follow-up of 52 months, a TNBC patient locally relapsed at 13 months of follow-up.
We demonstrated for the first time that ph-IORT + hWBI is feasible and safe in patients referred to BCS after PST.
首次评估在接受原发性全身治疗（PST）的患者中，将光子术中放疗（ph-IORT）与大分割全乳照射（h-WBI）相结合的安全性和可行性。
2019年3月至2020年12月，前瞻性纳入我院在PST后接受保乳手术（BCS）的患者。所有患者均根据ESMO-SEOM指南接受PST。PST完成后，在多学科肿瘤委员会（MTB）中讨论BCS。BCS期间，对Intrabeam®光子术中放疗的施源器表面给予20 Gy剂量。计划在BCS后3-5周给予h-WBI（40.5 Gy/2.67 Gy/15次分割）。所有患者均接受h-WBI容积调强弧形放疗（VMAT-Rapid-Arc）和每日精确放疗影像引导放疗（Daily Exac-Trac-IGRT）。本研究的主要终点是所提议治疗方案的可行性和安全性（采用CTCAE 5.0版3级毒性率）。次要终点包括美容效果（哈佛量表）、局部复发率和总生存率。
35例患者纳入试验。中位年龄为54岁。所有病例肿瘤大小均>2 cm。18例患者为N+（51.4%）。PST期间无疾病进展。所有患者在BCS时均接受了计划的20 Gy光子术中放疗加量及提议的h-WBI。31/35（88.6%）例患者在预定时间内（BCS后3-5周）开始接受h-WBI。h-WBI结束后3个月，无患者出现≥3级急性毒性。随访12个月及之后，未观察到≥3级晚期毒性。26例患者（74.2%）的美容效果评分为优/良。中位随访52个月后，1例三阴性乳腺癌患者在随访13个月时局部复发。
我们首次证明，在PST后接受BCS的患者中，ph-IORT+h-WBI是可行且安全的。
