Hypofractionated radiotherapy in 10 fractions following modified radical mastectomy for breast cancer: a phase Ⅱ study
10.3760/cma.j.cn112271-20231207-00203
- VernacularTitle:乳腺癌改良根治术后十次大分割放疗的Ⅱ期研究
- Author:
Huayong JIANG
1
;
Dawei ZHAO
;
Yanrong LUO
;
Lingling MENG
;
Xiangkun DAI
;
Wei YU
;
Lin MA
Author Information
1. 解放军总医院第七医学中心放疗科，北京 100070
- Keywords:
Breast cancer;
Modified radical mastectomy;
Hypofractionated radiotherapy;
Phase Ⅱ study
- From:
Chinese Journal of Radiological Medicine and Protection
2024;44(11):931-935
- CountryChina
- Language:Chinese
-
Abstract:
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.
