Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):400-7. doi: 10.1016/j.ijrobp.2009.10.032. Epub 2010 Apr 13.
Determine cosmetic outcome and toxicity profile of intraoperative radiation delivered before tumor excision for patients with early-stage breast cancer.
Patients age 48 or older with ultrasound-visible invasive ductal cancers <3 cm and clinically negative lymph nodes were eligible for treatment on this institutional review board-approved Phase II clinical trial. Treatment planning ultrasound was used to select an electron energy and cone size sufficient to cover the tumor plus a 1.5- to 2.0-cm circumferential margin laterally and a 1-cm-deep margin with the 90% isodose line. The dose was prescribed to a nominal 15 Gy and delivered using a Mobetron electron irradiator before tumor excision by segmental mastectomy. Physician- and patient-assessed cosmetic outcome and patient satisfaction were determined by questionnaire.
From March 2003 to July 2007, 71 patients were treated with intraoperative radiation therapy. Of those, 56 patients were evaluable, with a median follow-up of 3.1 years (minimum 1 year). Physician and patient assessment of cosmesis was "good or excellent" (Radiation Therapy Oncology Group cosmesis scale) in 45/56 (80%) and 32/42 (76%) of all patients, respectively. Eleven patients who received additional whole breast radiation had similar rates of good or excellent cosmesis: 40/48 (83%) and 29/36 (81%), respectively). Grade 1 or 2 acute toxicities were seen in 4/71 (6%) patients. No Grade 3 or 4 toxicities or serious adverse events have been seen.
Intraoperative radiotherapy delivered to an in situ tumor is feasible with acceptable acute tolerance. Patient and physician assessment of the cosmetic outcome is good to excellent.
确定早期乳腺癌患者在肿瘤切除术前接受术中放射治疗的美容效果和毒性概况。
本机构审查委员会批准的 II 期临床试验纳入了年龄在 48 岁或以上、超声可见的浸润性导管癌<3cm 且临床淋巴结阴性的患者。治疗计划超声用于选择电子能量和足够的锥形尺寸,以覆盖肿瘤加上 1.5-2.0cm 侧向圆周边缘和 90%等剂量线 1cm 深的边缘。剂量规定为名义 15Gy,并在通过节段性乳房切除术切除肿瘤之前使用 Mobetron 电子辐照器进行治疗。通过问卷调查确定医生和患者评估的美容效果和患者满意度。
从 2003 年 3 月至 2007 年 7 月,71 例患者接受了术中放射治疗。其中,56 例患者可评估,中位随访时间为 3.1 年(最短 1 年)。所有患者中,分别有 45/56(80%)和 32/42(76%)的医生和患者评估的美容效果为“好或优秀”(放射治疗肿瘤学组美容量表)。接受额外全乳放疗的 11 例患者的美容效果相似:分别有 40/48(83%)和 29/36(81%)的患者评估为“好或优秀”。71 例患者中有 4 例(6%)出现 1 级或 2 级急性毒性。未出现 3 级或 4 级毒性或严重不良事件。
向原位肿瘤递送术中放射治疗是可行的,具有可接受的急性耐受度。患者和医生对美容效果的评估为良好至优秀。