| 蒋华勇,赵大伟,罗燕容,等.乳腺癌改良根治术后十次大分割放疗的Ⅱ期研究[J].中华放射医学与防护杂志,2024,44(11):931-935.Jiang Huayong,Zhao Dawei,Luo Yanrong,et al.Hypofractionated radiotherapy in 10 fractions following modified radical mastectomy for breast cancer: a phase Ⅱ study[J].Chin J Radiol Med Prot,2024,44(11):931-935 |
| 乳腺癌改良根治术后十次大分割放疗的Ⅱ期研究 |
| Hypofractionated radiotherapy in 10 fractions following modified radical mastectomy for breast cancer: a phase Ⅱ study |
| 投稿时间：2023-12-07 |
| DOI：10.3760/cma.j.cn112271-20231207-00203 |
| 中文关键词: 乳腺癌 改良根治术后 大分割放疗 Ⅱ期研究 |
| 英文关键词:Breast cancer Modified radical mastectomy Hypofractionated radiotherapy Phase Ⅱ study |
| 基金项目: |
| 作者 | 单位 | E-mail | | 蒋华勇 | 解放军总医院第七医学中心放疗科, 北京 100070
解放军总医院第五医学中心肿瘤医学部放疗科, 北京 100039 | | | 赵大伟 | 中国人民武装警察部队特色医学中心放射科, 天津 300162 | | | 罗燕容 | 解放军总医院海南医院放疗科, 三亚 572000 | | | 孟玲玲 | 解放军总医院第五医学中心肿瘤医学部放疗科, 北京 100039
解放军总医院第一医学中心放疗科, 北京 100853 | | | 戴相昆 | 解放军总医院第一医学中心放疗科, 北京 100853 | | | 俞伟 | 解放军总医院第五医学中心肿瘤医学部放疗科, 北京 100039
解放军总医院第一医学中心放疗科, 北京 100853 | | | 马林 | 解放军总医院第五医学中心肿瘤医学部放疗科, 北京 100039
解放军总医院第一医学中心放疗科, 北京 100853 | malinpharm@sina.com |
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| 中文摘要: |
| 目的 探索乳腺癌改良根治术后胸壁±区域淋巴结36.5 Gy/10次大分割放疗的安全性和临床疗效。方法 本研究为前瞻性、单臂Ⅱ期临床研究,自2014年3月至2015年12月,纳入85例局部区域进展期乳腺癌改良根治术后患者,胸壁±锁骨上区接受36.5 Gy/10次的大分割放疗。研究主要终点为放疗相关不良反应,次要终点为无局部区域复发生存率,无病生存率和总生存率。结果 患者中位随访98(94.0~109.0) 个月。放疗相关不良反应轻微,患者皮肤、肺1级急性不良反应发生率分别为52.9%、40%;皮肤、肺、上肢水肿和心脏1级晚期不良反应发生率分别为10.6%、29.4%、21.2%和2.4%。仅1例患者(1.2%)发生了2级放射性臂丛神经损伤。85例患者中1例出现区域复发(锁上淋巴结),6例远处转移,6例死于乳腺癌。患者9年无局部区域复发生存率、无病生存率和总生存率分别为97.7%、91.8%和92.8%。结论 乳腺癌改良根治术后36.5 Gy/10次大分割放疗不良反应轻微,有必要开展Ⅲ期研究以验证其临床疗效。 |
| 英文摘要: |
| Objective To evaluate the safety and clinical efficacy of hypofractionated radiotherapy (HFRT) at 36.5 Gy in 10 fractions for the chest wall and reginal lymph nodes following modified radical mastectomy for breast cancer. Methods This was a prospective, single-arm, phase Ⅱ clinical study. A total of 85 patients who received HFRT at 36.5 Gy in 10 fractions to the chest wall ±supraclavicular region following modified radical mastectomy for locally advanced breast cancer from March 2014 to December 2015 were included. The primary endpoint was radiotherapy toxicities. The secondary endpoints were locoregional failure-free survival (LRFFS), disease-free survival (DFS), and overall survival (OS). Results The median follow-up period was 98 (94.0-109.0) months. Radiotherapy toxicities were mild. The incidence rates of grade 1 acute cutaneous and pulmonary toxicities were 52.9% and 40%, and those of grade 1 late cutaneous, pulmonary, and cardiac toxicities and upper extremity edema were 10.6%, 29.4%, 2.4%, and 21.2%, respectively. Only 1 (1.2%) patient suffered from grade 2 radiation-induced brachial plexus injury. Of the 85 patients, one patient had regional recurrence (supraclavicular lymph nodes), six patients had distant metastasis, and six patients died of breast cancer. The 9-year LRFFS, DFS, and OS were 97.7%, 91.8%, and 92.8%, respectively. Conclusions HFRT at 36.5 Gy in 10 fractions following modified radical mastectomy for breast cancer is associated with mild toxicities. A phase Ⅲ study is necessary for validating HFRT's clinical efficacy. |
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