Efficacy and safety of Rh-endostatin in the treatment of radiation pneumonitis in non-small cell lung cancer

Background Radiation pneumonitis (RP) is the common adverse event related to thoracic radiotherapy in patients with non-small cell lung cancer (NSCLC). The treatment of RP needs to be improved. Methods NSCLC patients with grade 2 or higher RP were enrolled and randomly assigned into two groups: Rh-endostatin group (Rh-endostatin + glucocorticoid) and control group (glucocorticoid only). The primary endpoint was RP relapse rate. Results A total of 40 patients were included. The relapse rate of RP was significantly lower in Rh-endostatin group (15.0% vs. 45%, P = 0.038). Though the remission rate of RP was similar in the two groups, the combined therapy significantly reduced the interval from RP treatment to RP remission (0.92 vs. 1.47 months, P = 0.048). The RP mortality rate was 5.0% and 35.0% in the Rh-endostatin group and control group, respectivly (P = 0.044). The incidence of pulmonary fibrosis was numerically lower in Rh-endostatin group (25.0% vs.45.0%, P = 0.185). The circulating lymphocyte levels in Rh-endostatin group significantly increased after treatment, when compared to the control group. The median progression-free survival was 7.8 months and 6.0 months respectively (hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.40-2.23, P = 0.910). The median overall survival was 16.0 months and 7.7 months in two groups respectively (HR 0.56, 95%CI 0.27-1.16, P = 0.119). There was no significant difference between the two groups in adverse events. Conclusion This prospective randomized study provides evidence that the combination of Rh-endostatin and glucocorticoids can reduce RP relapse rates and promote remission without increasing adverse events in advanced NSCLC patients. Discussion This Discussion can take one of two forms: 350 words and two salient graphics, such as a table, schema, waterfall plot, image or graph; or 450 words with a single salient graphic. This discussion is part of the Abstract and as such needs to be distinct from the extended Discussion at the end of the paper. Citation of references should be done in the extended Discussion at the end of the CTR; references (up to 5) should be cited in the Author Summary only if absolutely necessary.