1242MO - The addition of belomethason propionate inhalation to radical radiotherapy for patients with locally advanced non-small cell lung cancer: A randomized controlled, open-label phase II study

Background

Thoracic radiotherapy (RT) plays important role in comprehensive treatment for non-small cell lung cancer (NSCLC). Radiation-induced lung injury (RILI) is a serious long-term complication of radiotherapy with limited treatment option. About 30% of patients with lung or breast cancer receiving thoracic radiotherapy may present with radiation-induced pneumonitis (RIP). The mechanisms underlying RIP, however, remain poorly understood. The aim of this study is to use belomethason propionate inhalation to reduce RIP in pts with NSCLC.

Methods

All eligible pts with NSCLC from Shanghai Pulmonary Hospital between 2019 to 2021 were randomly in a 1:1 ratio assigned to corticosteroid group and control group. All pts received curative radiotherapy for lung lesions. Patients in the prevention group inhaled beclomethasone propionate concurrently with radiotherapy once a day. The patients in the control group only received radiotherapy. Other background treatments were at treating physicians’ discretion following the local guidance. The primary endpoint of this study is the incidence of RIP, the secondary endpoints included ORR, DCR, PFS, OS and toxicity.

Results

A total of 292 pts were enrolled. 142 pts were assigned to corticosteroid prevention group, and 150 pts in control group. Baseline characteristics were well balanced in two groups. The results showed that the incidence of all grade radiation pneumonitis in prevention group and control group was 35.3% vs. 52.8% respectively (P=0.03). The incidence of grade ≥3 radiation pneumonitis in prevention group and control group were 12% vs. 28.2%, which was a statistical significant reduction(P=0.01). The ORR of the pts in prevention and control group was 40.9% vs.35.9%, there was no difference(P=0.65). With follow-up of 2 years, no OS difference was observed in two groups (P=0.425). The incidence of hyperglycemia was higher in prevention group comparing with control goroup (p=0.025).

Conclusions

The addition of inhaled corticosteroids to radiotherapy significantly reduced the incidence of radiation-induced pneumonitis in pts with NSCLC. This result warrant further confirmed by phase III clinical studies.

Clinical trial identification

The trial protocol number: NCT03886441, release date: March 2019.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai Pulmonary Hospital, Shanghai, China.

Funding

The Clinical Science and Technology Innovation Project of Shanghai Shenkang Hospital Development Center (No. HDC12019X29).

Disclosure

All authors have declared no conflicts of interest.