早期乳腺癌的适形分割同步整合推量：德国多中心 II 期试验（ARO-2010-01）的结果。
Hypofractionation with simultaneous integrated boost for early breast cancer: results of the German multicenter phase II trial (ARO-2010-01).
机构信息
Department of Radiooncology, University of Kiel, A.-Heller-Str. 3, 24105, Kiel, Germany,
出版信息
Strahlenther Onkol. 2014 Jul;190(7):646-53. doi: 10.1007/s00066-014-0658-5. Epub 2014 Apr 16.
PURPOSE
To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison.
METHODS
Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22-29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL.
RESULTS
151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99%) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89% (95% CI 82% to 93%). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged.
CONCLUSION
Hypofractionation with a SIB is feasible and was well tolerated in this study.
目的
评估德国所有情况下采用 SIB 进行分割放疗的可行性，为多中心治疗比较做准备。
方法
符合条件的患者为接受保乳术（BCS）治疗的组织学确诊乳腺癌患者。患者接受 WBI 40.0 Gy，16 次分割，每次 2.5 Gy。瘤床给予 SIB，每次 0.5 Gy，16 次分割，共 48.0 Gy，可保护心脏、LAD、肺、对侧乳房的 boost-PTV。主要研究目标是可行性，即能否在 22-29 天内，16 次分割，遵守特定剂量限制（心脏；LAD；对侧乳房），指定剂量；次要终点是毒性、QoL。
结果
2011 年 7 月至 2012 年 10 月，7 家机构共招募 151 例患者。10 例患者在放疗前符合排除标准。除 2 例患者外，所有患者（99%）均在 PTV 内接受了规定剂量。89%（95%CI 82%至 93%）的患者达到了剂量限制和时间限制。10 例患者中报告了 11 例不良反应（AE），其中 5 例与同期内分泌治疗有关。有 2 例 AE 与放疗相关：2 例患者出现 3 级热潮红。QoL 保持不变。
结论
本研究中，SIB 分割放疗是可行的，且耐受性良好。
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