Analysis of adverse events in cancer radiotherapy with the first carbon ion therapy system in China
10.3760/cma.j.cn113030-20230112-00007
- VernacularTitle:中国首台碳离子治疗系统放疗肿瘤不良事件分析
- Author:
Xiaoting QIANG
1
;
Li ZHANG
;
Xue WANG
;
Ying QI
;
Xiaoyue DU
;
Rong LIU
;
Xiaoyun MA
;
Yuqin LIU
;
Yajuan YANG
;
Shuanghui LIU
;
Shan ZHENG
Author Information
1. 甘肃省药物警戒中心，兰州 730070
- Keywords:
Radiotherapy;
Carbon ion;
Neoplasms;
Adverse events
- From:
Chinese Journal of Radiation Oncology
2023;32(10):907-913
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the clinical adverse events of the first carbon ion therapy system in radiotherapy for cancer patients in China.Methods:A retrospective analysis was conducted on the clinical trial monitoring data of the carbon ion therapy system obtained by the Pharmacovigilance Center of Gansu Province. A descriptive study was conducted on the demographic characteristics, radiotherapy techniques, irradiation site and dose parameters, postoperative follow-up, and adverse event information of 46 tumor patients who received carbon ion therapy and participated in the clinical trial in Wuwei Cancer Hospital, Gansu Province from November 2018 to February 2019. Frequency and percentage were used to describe and analyze the occurrence of adverse events after carbon ion therapy for cancer patients in different groups. All subjects who received radiotherapy were grouped according to the treatment dose and fractionation method.Results:The median age of the 46 patients was 47 years old, and the male to female ratio was 30∶16. There were 15, 5, 8, 9, and 9 patients with head and neck, chest, abdomen, pelvic cavity, and limb spinal tumors, respectively. The total duration of radiotherapy was 2-4 weeks for 10-16 times. There were 246 adverse events in 45 cases, with an incidence of 98%. No severe adverse events occurred. The adverse events definitely related to carbon ion devices accounted for 19.1%, and no severe adverse events related to carbon ion devices occurred. According to the evaluation criteria of common terminology criteria for adverse events (CTCAE), the main adverse events were CTCAE grade 2 and below, with only 1 (2%) head and neck tumor patient (nasopharyngeal malignant tumor) experienced CTCAE grade 3 adverse events after treatment. In addition, 43 patients developed acute adverse reactions, with an incidence of 93%, mainly involving the skin, mucosa, eyes, ears, pharynx and esophagus, upper gastrointestinal tract, lower gastrointestinal tract (including pelvic cavity), lung, genitourinary tract, heart, central nervous system and hematology (white blood cells, platelets and neutrophils), etc. Conclusion:The adverse reactions of patients treated with the first carbon ion therapy system are mainly CTCAE grade 2 and below, and the clinical adverse events are mild and controllable.
