Multi-center randomized trial of Compound Kushen injection for decreasing radiation- induced thoracic toxicity in lung cancer patients

Abstract

Background: Thoracic radiation therapy plays an important role in the treatment of inoperable lung cancer. However, radiotherapy-induced toxicity poses an important challenge for radiation oncologists. Research has shown that Compound Kushen Injection (CKI) has anti-inflammatory activity and can reduce toxicity when given with chemotherapy. So, we hypothesis CKI can decrease chemoradiotherapy-induced thoracic toxicity in lung cancer patients and conducted this randomized, multi-center study. Methods: A prospective, open, randomized, multi-center，phase IV trial was performed, in which a total of 296 lung cancer patients were enrolled and randomly divided 1:1 into experimental and control groups. The control group received standard chemoradiotherapy including precise thoracic radiotherapy (60 Gy/30 fractions/6 weeks) plus concurrent platinum-based chemotherapy. The experimental group received standard chemoradiotherapy plus CKI via mainline treatments of 250 ml CKI (20 ml diluted in 0.9% normal saline) daily for 20 continuous days. The incidence of adverse events and severity of thoracic toxicity after treatment were observed according to version 4.0 of the Common Terminology Criteria for Adverse Events. Adverse drug reactions (ADRs) and quality of life (QLQ-C30) also were compared between the two groups.Results: Two hundred ninety-one qualifying patients were included in the statistical analysis. Symptomatic radiation-induced thoracic toxicity was lower in the experimental group than in the control group (14.1% vs 25.6%, p=0.017). According to QLQ-C30 questionnaire findings, CKI provided superior outcomes related to pain relief, relieving fatigue, social functioning and emotional functioning (p<0.05). The rates of adverse events (26.4% vs 30.8%, p>0.05) and severe adverse events (5.4% vs 2.8%, p>0.05) did not differ significantly between the experimental and control groups.Conclusion: CKI significantly alleviated symptomatic radiation-induced thoracic toxicity, as well as pain, when given with chemoradiotherapy for lung cancer treatment.