Compound Kushen Injection Reduces Severe Toxicity and Symptom Burden Associated With Curative Radiotherapy in Patients With Lung Cancer

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Jie Liu Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

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Qingxi Yu Department of Radiation Oncology, Shandong Cancer Hospital, Shandong, China

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Xin Shelley Wang Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas

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Qiuling Shi School of Public Health, Chongqing Medical University, Chongqing, China

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Jun Wang Department of Radiation Oncology, Hebei Tumor Hospital, Hebei, China

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Fan Wang Department of Radiation Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui, China

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Simeng Ren Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

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Jiayue Jin Beijing University of Chinese Medicine, Beijing, China

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Baojin Han Beijing University of Chinese Medicine, Beijing, China

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Wenzheng Zhang Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

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Xueyao Su School of Public Health, Chongqing Medical University, Chongqing, China

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Shuanghu Yuan Department of Radiation Oncology, Shandong Cancer Hospital, Shandong, China

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Hongsheng Lin Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

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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 + CKI group; n=130) or RT alone (control group; n=130). 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 + CKI group had a significantly lower incidence of grade ≥2 RT-related injury than the control group (12.3% [n=16] vs 23.1% [n=30]; P=.02). Compared with the control group, the RT + 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 (P=.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.

Submitted January 3, 2023; final revision received May 3, 2023; accepted for publication May 17, 2023.

Previous presentation: Portions of this study were presented as a poster (A Multi-Center Randomized Trial Using Compound Kushen Injection to Decrease Chemoradiotherapy-Induced Thoracic Toxicities in Patients with Locally Advanced Non-Small Cell Lung Cancer) at the 2019 Annual Meeting of the American Society for Therapeutic Radiology and Oncology; September 15–18, 2019; Chicago, Illinois; and presented as an abstract at the 16th International Conference of the Society for Integrative Oncology; October 19–21, 2019; New York, New York.

Author contributions: Study concept and design: Liu, X.S. Wang, Shi, Yuan, Lin. Provision of study materials or patients: Yu, J. Wang, F. Wang, Yuan. Collection and assembly of data: Yu, Ren, Jin, Han, Zhang. Data analysis and interpretation: Liu, X.S. Wang, Shi, Su. Manuscript preparation: All authors.

Disclosures: The authors have disclosed that they have not received any financial considerations from any person or organization to support the preparation, analysis, results, or discussion of this article.

Correspondence: Hongsheng Lin, MD, Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Bei Xian Ge Street, Xi Cheng District, Beijing 100053, China. Email: drlinhongsheng@163.com; and
Shuanghu Yuan, MD, Department of Radiation Oncology, Shandong Cancer Hospital, 440 Jiyan Road, Jinan, Shandong 250000, China. Email: yuanshuanghu@sina.com

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