Division of Surgical Oncology, University of Minnesota, Minneapolis, Minnesota.
Int J Radiat Oncol Biol Phys. 2013 Nov 1;87(3):494-8. doi: 10.1016/j.ijrobp.2013.06.2056.
To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery.
We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR).
A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years.
Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.
评估保乳手术后应用 MammoSite 行加速部分乳腺照射（APBI）治疗导管原位癌（DCIS）的效果。
我们于 2003 年至 2009 年进行了一项前瞻性、多中心试验。纳入标准包括年龄＞18 岁、经空心针活检诊断为 DCIS 且无既往乳腺癌病史。所有患者均接受保乳手术联合 MammoSite 植入。放疗采用 2 次/d，共 5 天，总剂量 34Gy。评估患者的毒性反应、美容效果及同侧乳腺肿瘤复发（IBTR）情况。
共有 41 例（42 侧乳房）患者完成了研究中的治疗，中位随访时间为 5.3 年。总体上，28 例（68.3%）患者发生了不良事件。皮肤改变和疼痛是最常见的不良事件。6 个月时，100%的医生和 96.8%的患者认为美容效果为优秀/良好；12 个月时，86.7%的医生和 92.3%的患者认为美容效果为优秀/良好。总体上，4 例（9.8%）患者发生了 IBTR（均为 DCIS），5 年累积发生率为 11.3%。所有的 IBTR 均位于治疗野外。在发生 IBTR 的患者中，复发的平均时间为 3.2 年。
应用 MammoSite 行 APBI 似乎可提供安全且美容效果可接受的结果；然而，在中位随访时间为 5.3 年的情况下，IBTR 发生率为 9.8%仍令人担忧。在推荐常规应用 APBI 治疗 DCIS 之前，有必要开展前瞻性随机试验。
