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

Abstract

To evaluate whether Kushen injection could decrease chemoradiotherapy induced thoracic toxicities in patients with locally advanced non-small cell lung cancer. A prospective, open, randomized, multi-center study was performed, in which a total of 200 patients were enrolled and randomly 1:1 divided into the experimental group and the control group. The patients in the control group were treated with standard chemoradiotherapy including precise thoracic radiotherapy (60Gy/30fraction/6weeks) plus concurrent platinum-based chemotherapy. The patients in the experimental group were treated with Compound Kushen Injection combined with standard chemoradiotherapy. The incidence of adverse events and their severity after treatment were observed per CTCAE5.0. The adverse event rate, clinical symptoms, quality of life, and side effects were observed and assessed. One hundred and seventy-seven qualified patients were included in statistical analysis. Symptomatic radiation-induced pneumonitis was lower in the experimental group than in the group (3.8% vs 13.1%, P＝0.015). Symptomatic radiation-induced esophagitis showed no significant difference in two groups(1.9% vs 2.1%, P＝1.0). No symptomatic radiation-induced heart damage was observed in two groups. Compound Kushen Injection plays a significant role in alleviating symptomatic radiation-induced pneumonitis when combined with radiotherapy for locally advanced non-small cell lung cancer.