Medical School of Chinese PLA, 28 Fuxing Road, Beijing, 100853, China.
Department of Radiation Oncology, Senior Department of Oncology, the Fifth Medical Center of PLA General Hospital, 100 West Fourth Ring Middle Road, Beijing, 100859, China.
BMC Cancer. 2021 Dec 1;21(1):1284. doi: 10.1186/s12885-021-09032-8.
The purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5 Gy in 10 fractions in postmastectomy patients.
From March 2014 to December 2015, 85 patients with locally advanced breast cancer were eligible to participate in this study with a schedule of 36.5 Gy in 10 fractions. Intensity-modulated radiation therapy (IMRT) was delivered to the chest wall with or without the supraclavicular region. The primary endpoint was radiation-related toxicities. The secondary endpoints were locoregional failure-free survival (LRFFS), disease-free survival (DFS) and overall survival (OS). And the outcomes were compared with our retrospective study of 72 patients with 42.5 Gy in 16 fractions.
The median follow-up was 69.0 (range 66.5-71.5) months in the 36.5 Gy group and 93.0 (range 91.9-94.1) months in the 42.5 Gy group, respectively. Radiation-related toxicities were mainly grade 1, although a few patients had grade 2 plexopathy (1.2%) and acute skin toxicity (1.2%) in the 36.5 Gy group, and grade 2 acute skin toxicity (5.6%) and lymphedema (4.2%) in the 42.5 Gy group. There were no significant differences between the groups in acute and late toxicities. For all the patients, the 5-year LRFFS, DFS and OS were 97.7 and 100.0%, 93.1 and 90.3%, 98.8 and 97.2%, respectively, without significant differences between the groups.
Postmastectomy HFRT with a schedule of 36.5 Gy in 10 fractions was feasible, with mild toxicities and excellent 5-year clinical outcome.
Trial registration number: ChiCTR-ONRC-14004391 . Date of registration: 9/3/2014.
本 II 期研究的目的是评估 36.5Gy/10 次分割的Hypofractionated 放疗（HFRT）在乳腺癌根治术后患者中的可行性。
2014 年 3 月至 2015 年 12 月，85 例局部晚期乳腺癌患者符合条件，采用 36.5Gy/10 次分割的方案进行治疗。胸壁采用调强放疗（IMRT），包括或不包括锁骨上区域。主要终点是放疗相关毒性。次要终点是局部区域无失败生存（LRFFS）、无病生存（DFS）和总生存（OS）。并与我们回顾性的 72 例 42.5Gy/16 次分割的研究进行比较。
36.5Gy 组的中位随访时间为 69.0（范围 66.5-71.5）个月，42.5Gy 组为 93.0（范围 91.9-94.1）个月。放疗相关毒性主要为 1 级，尽管 36.5Gy 组有少数患者出现 2 级多发性神经病（1.2%）和急性皮肤毒性（1.2%），42.5Gy 组有 2 级急性皮肤毒性（5.6%）和淋巴水肿（4.2%）。两组间的急性和迟发性毒性无显著差异。所有患者的 5 年 LRFFS、DFS 和 OS 分别为 97.7%和 100.0%、93.1%和 90.3%、98.8%和 97.2%，两组间无显著差异。
乳腺癌根治术后 HFRT 采用 36.5Gy/10 次分割的方案是可行的，毒性轻微，5 年临床疗效良好。
试验注册号：ChiCTR-ONRC-14004391。注册日期：2014 年 9 月 3 日。
