Purpose: 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. Methods: 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). Results: 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. Conclusions: 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.
目的：本研究旨在首次分析一项针对早期乳腺癌患者采用光子术中放疗进行部分乳腺照射的大型前瞻性学术多中心试验结果，重点关注同侧乳腺肿瘤复发。次要终点包括：(a) 区域/远处复发率，(b) 生存率，以及(c) 毒性反应。方法：自2013年1月至2022年12月，符合TARGIT-A低风险标准的浸润性乳腺癌患者被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所大学医院（因苏拉尔大学医院、马特诺-因凡蒂尔大学医院和内格林博士大学医院）开展，患者在保乳手术期间接受光子术中放疗进行部分乳腺照射。结果：研究共纳入312例患者。诊断时平均年龄为62岁（范围46-88岁）。所有肿瘤均被归类为管腔型分子亚型。无患者接受补充性外照射放疗。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。17例患者死于并发疾病，仅2例患者分别在68个月和95个月时死于乳腺癌相关原因。中位随访时间为78个月（范围7-140个月），精算5年无局部复发生存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级毒性反应。结论：光子术中放疗进行部分乳腺照射是早期乳腺癌患者保乳术后可行、安全且有效的治疗方式。需要更长时间的随访以确认当前结果。
Long-Term Results of a Prospective Multicenter Trial of APBI with Photon IORT
肿瘤(癌症)患者之家