García-Cabrera Laura, Pinar-Sedeño Beatriz, Cabezón-Pons María Auxiliadora, Rodriguez-Ibarria Nieves, Dominguez-Dominguez Alba, Aguiar-Santana Daniel, Martín-Barrientos Paula, Rey-López Irene, Lara Pedro C, Lloret-Saez-Bravo Marta
Radiation Oncology Department, Dr. Negrin University Hospital Las Palmas GC, 35010 Las Palmas de Gran Canaria, Spain.
Medical School, Las Palmas University, 35001 Las Palmas de Gran Canaria, Spain.
Cancers (Basel). 2025 May 23;17(11):1762. doi: 10.3390/cancers17111762.
The aim of the present study is to analyze, for the first time, the results of a large prospective academic multicenter trial of partial breast irradiation (PBI) with exclusive photon intraoperative radiation therapy (ph-IORT) in early breast cancer patients, focusing on ipsilateral breast tumor recurrence. The secondary endpoints were (a) incidence of regional/distant recurrence, (b) survival, and (c) toxicity.
From January 2013 to December 2022, patients with low-risk TARGIT-A criteria invasive breast cancer were included in a prospective academic multicenter study of exclusive PBI with ph-IORT during breast-conserving surgery, conducted in three university hospitals in Las Palmas (Hospital Universitario Insular, Hospital Universitario Materno-Infantil, and Hospital Universitario de Gran Canaria Dr. Negrín).
Three hundred and twelve patients were included in the study. The mean age at diagnosis was 62 years (46-88). All tumors were classified as luminal molecular profile. No patient received supplementary external beam radiotherapy. Four patients developed ipsilateral breast tumor recurrence (IBTR) at 19, 29, 43, and 62 months of follow-up. Seventeen patients died of intercurrent diseases, and there were only 2 breast cancer-related deaths at 68 and 95 months, respectively. With a median follow-up of 78 months (7-140), actuarial 5-year freedom from local relapse and cancer survival rates were 98.9% and 100%, respectively. No patient developed early or late grade-3 toxicity.
Partial breast irradiation with ph-IORT is a feasible, safe, and useful treatment in early breast cancer patients after BCS. A longer follow-up is needed to confirm the present results.
本研究旨在首次分析一项针对早期乳腺癌患者的大型前瞻性学术多中心试验结果，该试验采用单纯光子术中放射治疗（ph-IORT）进行部分乳腺照射（PBI），重点关注同侧乳腺肿瘤复发情况。次要终点为：（a）区域/远处复发发生率；（b）生存率；（c）毒性。
2013年1月至2022年12月，符合低风险TARGIT-A标准的浸润性乳腺癌患者纳入一项前瞻性学术多中心研究，该研究在拉斯帕尔马斯的三家大学医院（大加那利岛大学医院、妇幼大学医院、德拉内格林博士大加那利岛大学医院）进行，在保乳手术期间采用单纯ph-IORT进行PBI。
312例患者纳入研究。诊断时的平均年龄为62岁（46 - 88岁）。所有肿瘤均为管腔分子亚型。无患者接受辅助外照射放疗。4例患者在随访19、29、43和62个月时出现同侧乳腺肿瘤复发（IBTR）。17例患者死于并发疾病，仅分别在68和95个月时有2例乳腺癌相关死亡。中位随访78个月（7 - 140个月），5年无局部复发率和癌症生存率分别为98.9%和100%。无患者出现早期或晚期3级毒性。
ph-IORT进行部分乳腺照射对保乳术后的早期乳腺癌患者是一种可行、安全且有效的治疗方法。需要更长时间的随访来证实目前的结果。
