Aristei Cynthia, Palumbo Isabella, Capezzali Giorgia, Farneti Alessia, Bini Vittorio, Falcinelli Lorenzo, Margaritelli Manuela, Lancellotta Valentina, Zucchetti Claudio, Perrucci Elisabetta
Radiation Oncology Section, University of Perugia and Santa Maria della Misericordia Hospital, Italy.
Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.
Partial breast irradiation (PBI) is an alternative to whole-breast irradiation after breast-conserving surgery in selected patients. Until the results of randomized phase III studies are available, phase II studies inform about PBI. We report the 5 year results of a phase II prospective study with PBI using interstitial multi-catheter high-dose-rate brachytherapy (ClinicalTrials.gov Identifier: NCT00499057).
Hundred patients received PBI (4 Gy, twice a day for 4 days, until 32 Gy). Inclusion criteria were: age ≥ 40years, infiltrating carcinoma without lobular histology, ductal in situ carcinoma, tumor size ≤ 2.5 cm, negative surgical margins and axillary lymph nodes.
At a median follow-up of 60 months late toxicity occurred in 25 patients; the 5-year probability of freedom from late toxicity was 72.6% (95% CI: 63.7-81.7). Tamoxifen was the only significant risk factor for late toxicity. Cosmetic results, judged by physicians and patients, were good/excellent in 98 patients. Three local relapses (1 true, 2 elsewhere) and 1 regional relapse occurred. The 5-year probability of local or regional relapse-free survival was 97.7% (95% CI: 91.1-99.4) and 99.0% (95% CI: 92.9-99.8), respectively.
PBI with interstitial multi-catheter brachytherapy is associated with low relapse and late toxicity rates.
对于部分经选择的患者，保乳手术后局部乳腺照射（PBI）是全乳照射的一种替代方案。在随机III期研究结果公布之前，II期研究可为PBI提供相关信息。我们报告一项使用组织间多导管高剂量率近距离放射疗法进行PBI的II期前瞻性研究的5年结果（ClinicalTrials.gov标识符：NCT00499057）。
100例患者接受了PBI（4 Gy，每天2次，共4天，直至32 Gy）。纳入标准为：年龄≥40岁，浸润性癌（无小叶组织学类型），导管原位癌，肿瘤大小≤2.5 cm，手术切缘阴性且腋窝淋巴结阴性。
中位随访60个月时，25例患者出现晚期毒性反应；5年无晚期毒性反应的概率为72.6%（95%可信区间：63.7 - 81.7）。他莫昔芬是晚期毒性反应的唯一显著危险因素。经医生和患者评估，98例患者的美容效果为良好/极佳。发生了3例局部复发（1例为真性复发，2例为其他部位复发）和1例区域复发。5年局部或区域无复发生存率分别为97.7%（95%可信区间：91.1 - 99.4）和99.0%（95%可信区间：92.9 - 99.8）。
组织间多导管近距离放射疗法进行PBI与低复发率和晚期毒性反应率相关。
