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].Chinese Journal of Radiological Medicine and Protection,2024,44(11):931-935
Hypofractionated radiotherapy in 10 fractions following modified radical mastectomy for breast cancer: a phase Ⅱ study
Received:December 07, 2023  
DOI:10.3760/cma.j.cn112271-20231207-00203
KeyWords:Breast cancer  Modified radical mastectomy  Hypofractionated radiotherapy  Phase Ⅱ study
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Author NameAffiliationE-mail
Jiang Huayong Department of Radiation Oncology, Seventh Medical Center of Chinese PLA General Hospital, No. 5 Nanmencang, Beijing 100070, China
Department of Radiation Oncology, Senior Department of Oncology, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China 
 
Zhao Dawei Department of Radiology, Characteristic Medical Center of Chinese People's Armed Police Force, Tianjin 300162, China  
Luo Yanrong Department of Radiation Oncology, Hainan Hospital of Chinese PLA General Hospital, Sanya 572000, China  
Meng Lingling Department of Radiation Oncology, Senior Department of Oncology, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
Department of Radiation Oncology, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China 
 
Dai Xiangkun Department of Radiation Oncology, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China  
Yu Wei Department of Radiation Oncology, Senior Department of Oncology, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
Department of Radiation Oncology, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China 
 
Ma Lin Department of Radiation Oncology, Senior Department of Oncology, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
Department of Radiation Oncology, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China 
malinpharm@sina.com 
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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.
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