Department of Radiation Oncology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
Department of Mastology, Hospital Sirio-Libanes, Sao Paulo, Brazil.
Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1015-1023. doi: 10.1016/j.ijrobp.2014.04.038. Epub 2014 Jul 8.
To present local control, complications, and cosmetic outcomes of intraoperative radiation therapy (IORT) for early breast cancer, as well as technical aspects related to the use of a nondedicated linear accelerator.
This prospective trial began in May of 2004. Eligibility criteria were biopsy-proven breast-infiltrating ductal carcinoma, age >40 years, tumor <3 cm, and cN0. Exclusion criteria were in situ or lobular types, multicentricity, skin invasion, any contraindication for surgery and/or radiation therapy, sentinel lymph node involvement, metastasis, or another malignancy. Patients underwent classic quadrantectomy with intraoperative sentinel lymph node and margins evaluation. If both free, the patient was transferred from operative suite to linear accelerator room, and IORT was delivered (21 Gy). Primary endpoint: local recurrence (LR); secondary endpoints: toxicities and aesthetics. Quality assurance involved using a customized shield for chest wall protection, applying procedures to minimize infection caused by patient transportation, and using portal films to check collimator-shield alignment.
A total of 152 patients were included, with at least 1 year follow-up. Median age (range) was 58.3 (40-85.4) years, and median follow-up time was 50.7 (12-110.5) months. The likelihood of 5-year local recurrence was 3.7%. There were 3 deaths, 2 of which were cancer related. The Kaplan-Meier 5-year actuarial estimates of overall, disease-free, and local recurrence-free survivals were 97.8%, 92.5%, and 96.3%, respectively. The overall incidences of acute and late toxicities were 12.5% and 29.6%, respectively. Excellent, good, fair, and bad cosmetic results were observed in 76.9%, 15.8%, 4.3%, and 2.8% of patients, respectively. Most treatments were performed with a 5-cm collimator, and in 39.8% of the patients the electron-beam energy used was ≥12 MeV. All patients underwent portal film evaluation, and the shielding was repositioned in 39.9% of cases. No infection or anesthesia complications were observed.
Local control with IORT was adequate, with low complication rates and good cosmetic outcomes. More than one-third of patients benefited from the "image-guidance" approach, and almost 40% benefited from the option of higher electron beam energies.
介绍早期乳腺癌术中放疗（IORT）的局部控制、并发症和美容效果，以及与使用专用直线加速器相关的技术方面。
本前瞻性试验于 2004 年 5 月开始。入选标准为经活检证实的乳腺浸润性导管癌、年龄>40 岁、肿瘤<3cm 和 cN0。排除标准为原位或小叶型、多中心性、皮肤侵犯、手术和/或放疗的任何禁忌证、前哨淋巴结受累、转移或其他恶性肿瘤。患者行经典象限切除术，术中行前哨淋巴结和切缘评估。如果两者均为阴性，患者将从手术间转移至直线加速器室，并接受 IORT（21Gy）。主要终点：局部复发（LR）；次要终点：毒性和美容效果。质量保证涉及使用定制的胸壁保护屏蔽、应用程序以最大程度减少因患者运输引起的感染以及使用射野影像系统检查准直器-屏蔽对准。
共纳入 152 例患者，随访时间至少 1 年。中位年龄（范围）为 58.3（40-85.4）岁，中位随访时间为 50.7（12-110.5）个月。5 年局部复发的可能性为 3.7%。有 3 例死亡，其中 2 例与癌症有关。Kaplan-Meier 5 年总生存率、无病生存率和无局部复发生存率的估计值分别为 97.8%、92.5%和 96.3%。急性和迟发性毒性的总发生率分别为 12.5%和 29.6%。患者的美容效果分别为优 76.9%、良 15.8%、可 4.3%和差 2.8%。大多数治疗采用 5cm 准直器，39.8%的患者使用的电子束能量≥12MeV。所有患者均行射野影像系统评估，39.9%的病例重新定位屏蔽。未观察到感染或麻醉并发症。
IORT 的局部控制效果令人满意，并发症发生率低，美容效果好。超过三分之一的患者受益于“图像引导”方法，近 40%的患者受益于更高电子束能量的选择。
