Kang Ai injection combined with chemotherapy in treatment of advanced non-small-cell lung cancer: a randomized, parallel controlled, multi-center study

Objective: To evaluate the efficacy and safety of Kang Ai injection combined with chemotherapy in the treatment of advanced non-small-cell lung cancer (NSCLC). Methods: Three hundred and ninety patients with advanced NSCLC were enrolled in a randomized, parallel controlled, multi-center study. The patients were randomized to orally receive either Kang Ai injection combined with chemotherapy (n=195) or chemotherapy (n=195) for 2 courses. Results: The response rate (RR) was 26.8% the experimental group, and 14.7% in the control group among patients with pathologic diagnosis of non-squamous-cell carcinomas (P<0.05). Among people with ECOG score of 0~1, the RR was 30.2% in the experimental group, and 19.2% in the control group (P<0.05). In terms of median progression-free time (PFS), it was 185 days in the experimental group and 115 days in the control group (P<0.05) among TNM stage IV sub-group. In terms of FACT-L quality of life scale, physical and emotional conditions of the experimental group improved better than that in the control group (P<0.05). In TNM stage IV sub-group, clinical symptoms in the experimental group improved better than that in the control group (P<0.05) after 2 courses of treatment. While in terms of KPS/PS score, body weight, immune function, tumor markers and adverse reactions, there was no obvious difference between the two groups. Conclusion: Kang Ai injection combined with first-line chemotherapy can improve RR of non-squamous-cell carcinomas or among people with ECOG score of 0 to 1 points. It can prolong PFS of advanced NSCLC patients in stage IV and improve the quality of life and clinical symptoms.