Department of Radiation Oncology, Val d'Aurelle Cancer Institute, Montpellier, France.
Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.
We recently presented the intraoperative radiotherapy (IORT) technique given as a reliable alternative to conventional boost radiation after breast-conserving surgery. The low crude numbers of recurrence in elderly patients led us to investigate the feasibility and the efficacy of this procedure as a sole treatment.
We included 94 patients older than 65 years in this phase II trial. Among them, 42 patients presented with all the inclusion criteria, i.e., stages pT0 to pT1 and pN0, ductal invasive unifocal carcinoma, and tumor-free margin of >2 mm. IORT was delivered using a dedicated linear accelerator. One 21-Gy fraction was prescribed and specified at the 90% isodose, using electrons. In vivo dosimetry was performed for all patients. The primary endpoint was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, and specific and overall rates of survival.
The median follow-up was 30 months (range, 12-49 months), and median age was 72 years (range, 66-80 years). The median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Endpoints for all but one patient corresponded to acceptable quality index criteria. Pretreatment quality-of-life scores were maximal, and no significant decrease was observed during follow-up. Cosmesis was good to excellent at 6 months. Two patients experienced recurrence but underwent salvage mastectomy.
Our results confirm that exclusive partial-breast IORT is feasible for treating early-stage breast cancer in the elderly. IORT may be considered an alternative treatment for a selected population and offers a safe one-step treatment.
我们最近提出了术中放疗（IORT）技术，作为保乳手术后常规加量放疗的可靠替代方法。老年患者的复发粗率较低，促使我们研究该方法作为单一治疗的可行性和疗效。
我们在这项 II 期试验中纳入了 94 名年龄大于 65 岁的患者。其中，42 名患者符合所有纳入标准，即 pT0 至 pT1 期和 pN0 期、导管内浸润性单灶癌、切缘无肿瘤>2mm。IORT 使用专用直线加速器进行。处方和指定的剂量为 21Gy，采用电子方式，在 90%等剂量线处。对所有患者进行体内剂量测定。主要终点是质量指数。次要终点是生活质量、局部复发、美容效果以及特定和总体生存率。
中位随访时间为 30 个月（范围，12-49 个月），中位年龄为 72 岁（范围，66-80 岁）。肿瘤直径中位数为 10mm。所有患者均接受了全剂量照射。未观察到急性 3 级毒性。除 1 名患者外，所有患者的终点均符合可接受的质量指数标准。治疗前的生活质量评分最高，随访期间未观察到显著下降。6 个月时美容效果良好至优秀。2 名患者出现复发，但接受了挽救性乳房切除术。
我们的结果证实，对于老年早期乳腺癌，单独进行部分乳房 IORT 是可行的。IORT 可被视为一种可供选择的治疗方法，适用于特定人群，提供了一种安全的一步治疗方法。
