TY - JOUR
T1 - Compound Kushen Injection Reduces Severe Toxicity and Symptom Burden Associated With Curative Radiotherapy in Patients With Lung Cancer
AU - Liu, Jie
AU - Yu, Qingxi
AU - Wang, Xin Shelley
AU - Shi, Qiuling
AU - Wang, Jun
AU - Wang, Fan
AU - Ren, Simeng
AU - Jin, Jiayue
AU - Han, Baojin
AU - Zhang, Wenzheng
AU - Su, Xueyao
AU - Yuan, Shuanghu
AU - Lin, Hongsheng
N1 - Publisher Copyright:
© 2023 Harborside Press. All rights reserved.
PY - 2023/8
Y1 - 2023/8
N2 - Background: Radiotherapy (RT) causes adverse events for which there are no effective treatments. This study investigated the clinical benefits of compound Kushen injection (CKI) in managing radiation injury in patients with lung cancer. Methods: A multicenter, open-label, randomized clinical trial randomly assigned patients with lung cancer to receive either CKI (20 mL/d for at least 4 weeks) integrated with curative RT (RT 1 CKI group; n5130) or RT alone (control group; n5130). The primary outcome was the incidence of grade $2 radiation-induced lung injury (RILI) in the lungs, esophagus, or heart. Secondary outcomes included patient-reported symptoms, quality of life, objective response rate (ORR), and toxic effects. Results: During the 16-week trial, the RT 1 CKI group had a significantly lower incidence of grade $2 RT-related injury than the control group (12.3% [n516] vs 23.1% [n530]; P5.02). Compared with the control group, the RT 1 CKI group experienced a significant decrease in moderate-to-severe symptoms of fatigue, cough, and pain (P,.001 for the treatment and time interaction term); significantly less physical symptom interference (P5.01); and significantly better quality of life by the end of the trial (P,.05). No statistically significant difference in ORR was found. Adverse reactions associated with CKI were rare. Conclusions: This study demonstrated low toxicity of CKI and its effectiveness in patients with lung cancer in reducing the incidence of grade $2 RILI and symptom burden, improving patients’ quality of life.
AB - Background: Radiotherapy (RT) causes adverse events for which there are no effective treatments. This study investigated the clinical benefits of compound Kushen injection (CKI) in managing radiation injury in patients with lung cancer. Methods: A multicenter, open-label, randomized clinical trial randomly assigned patients with lung cancer to receive either CKI (20 mL/d for at least 4 weeks) integrated with curative RT (RT 1 CKI group; n5130) or RT alone (control group; n5130). The primary outcome was the incidence of grade $2 radiation-induced lung injury (RILI) in the lungs, esophagus, or heart. Secondary outcomes included patient-reported symptoms, quality of life, objective response rate (ORR), and toxic effects. Results: During the 16-week trial, the RT 1 CKI group had a significantly lower incidence of grade $2 RT-related injury than the control group (12.3% [n516] vs 23.1% [n530]; P5.02). Compared with the control group, the RT 1 CKI group experienced a significant decrease in moderate-to-severe symptoms of fatigue, cough, and pain (P,.001 for the treatment and time interaction term); significantly less physical symptom interference (P5.01); and significantly better quality of life by the end of the trial (P,.05). No statistically significant difference in ORR was found. Adverse reactions associated with CKI were rare. Conclusions: This study demonstrated low toxicity of CKI and its effectiveness in patients with lung cancer in reducing the incidence of grade $2 RILI and symptom burden, improving patients’ quality of life.
KW - Compound Kushen Injection
KW - lung cancer
KW - radiation injury
KW - symptom burden
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U2 - 10.6004/jnccn.2023.7036
DO - 10.6004/jnccn.2023.7036
M3 - Article
C2 - 37549911
AN - SCOPUS:85166783191
SN - 1540-1405
VL - 21
SP - 821
EP - 830
JO - JNCCN Journal of the National Comprehensive Cancer Network
JF - JNCCN Journal of the National Comprehensive Cancer Network
IS - 8
ER -