Clinical study on modified Tonifying Spleen and Nourishing qi Recipe combined with anlotinib as second-line chemotherapy in treatment of advanced esophageal cancer

Objective To observe the clinical efficacy of modified Tonifying Spleen and Nourishing qi Recipe combined with anlotinib as second-line chemotherapy in treatment of advanced esophageal cancer.

Methods A total of 60 patients with advanced esophageal cancer diagnosed by histopathological examination who were progressed after first-line chemotherapy were randomly divided into control group (30 cases) and experimental group (30 cases). The control group was treated with anlotinib for 12 mg once a day, and the drug was continuously administrated for 2 weeks and discontinued for 1 week. The efficacy was evaluated after 2 cycles of treatment. The experimental group administrated modified Tonifying Spleen and Nourishing qi Recipe guided by theory of invigorating the spleen and nourishing healthy qi method based on the treatment of anlotinib. The curative effect, adverse reactions and clinical symptoms of the two groups were observed.

Results The improvement rate of quality of life assessed by Kanofsky performance score(KPS) in the experimental group was 46.67%(14/30), which was higher than 20.00%(6/30) in the control group, and the difference was statistically significant (P < 0.05). The incidence of fatigue, hypertension and diarrhea in the experimental group were 46.67%, 30.00% and 23.33%, respectively, which were lower than 56.67%, 40.00% and 40.00%, respectively in the control group, and the differences were statistically significant (P < 0.05). The objective response rate(ORR) of the experimental group was 26.67%, which was higher than that of the control group (20.00%); the disease control rate (DCR) of the experimental group was 70.00%, which was higher than 63.33% of the control group, but the differences were not statistically significant (P > 0.05). The improvement of nausea, drowsiness and appetite in the experimental group was better than that in the control group, and the difference was statistically significant (P < 0.05).

Conclusion Invigorating the spleen and nourishing healthy qi therapy combined with anrotinib can significantly improve the quality of life of patients with advanced esophageal cancer and can be tolerated adverse reactions, therefore, it can be used as an effective palliative treatment for advanced esophageal cancer.