Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein und Christian-Albrechts-Universität zu Kiel, Germany.
Institut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Germany.
Breast. 2022 Aug;64:136-142. doi: 10.1016/j.breast.2022.05.008. Epub 2022 Jun 2.
To analyze long-term results of two multicenter prospective single-arm trials (ARO-2010-01 and ARO-2013-04) investigating adjuvant hypofractionated radiotherapy (HF) with simultaneous integrated boost (SIB) after breast-conserving surgery (BCS).
Eligible patients had histopathologically confirmed unifocal breast cancer planned for whole breast irradiation plus boost radiotherapy to the tumor bed. In both studies, a total dose of 40 Gy was applied to the whole breast and of 48 Gy to the tumor bed in 16 fractions of 2.5 and 3.0 Gy. Radiotherapy could be given either as three-dimensional conformal radiotherapy (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The primary study objectives were feasibility and security within an observation period of six months. The current investigation focuses on long-term efficacy and toxicities.
Between 2011 and 2014, both trials enrolled 300 patients in total. Data from 274 of these patients could be used for the current analysis. The median follow-up time was 60 months and the 5-year disease-free survival 92.1%. Three patients suffered a local recurrence (after 36-72 months) while a regional recurrence occurred in one patient (after 17 months). The 5-year local control rate in the breast was 99.6%. 63.5% of all patients did not report any late radiation-related toxicity, 28.5% reported grade 1 and 7.3% grade 2 toxicities. The highest late toxicity was grade 3 in 2 women (0.7%, telangiectasia and lymphedema of the breast).
Our analysis demonstrates favorable efficacy and low rates of long-term side effects of HF with SIB after BCS. Randomized controlled phase III trials are ongoing.
分析两项多中心前瞻性单臂试验（ARO-2010-01 和 ARO-2013-04）的长期结果，这些试验调查了保乳手术后辅助短程大分割放疗（HF）联合同步整合 boost 放疗（SIB）。
符合条件的患者为组织病理学确诊的单灶乳腺癌，计划行全乳照射加肿瘤床 boost 放疗。在两项研究中，全乳总剂量为 40Gy，16 次分割，每次 2.5 或 3.0Gy；肿瘤床总剂量为 48Gy。放疗可采用三维适形放疗（3D-CRT）或调强放疗（IMRT）。主要研究目的是在 6 个月的观察期内评估可行性和安全性。本研究重点关注长期疗效和毒性。
2011 年至 2014 年，两项试验共入组 300 例患者。本分析共纳入 274 例患者的数据。中位随访时间为 60 个月，5 年无病生存率为 92.1%。3 例患者发生局部复发（36-72 个月后），1 例患者发生区域复发（17 个月后）。5 年乳房局部控制率为 99.6%。所有患者中 63.5%未报告任何晚期放射性毒性，28.5%报告 1 级毒性，7.3%报告 2 级毒性。最高的晚期毒性为 2 例女性（0.7%，乳房毛细血管扩张和淋巴水肿）的 3 级。
我们的分析表明，保乳手术后 HF 联合 SIB 的疗效良好，长期副作用发生率低。正在进行随机对照 III 期试验。
