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.

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