Nintedanib plus a prednisone taper resulted in an improvement in pulmonary exacerbations in patients with grade 2 or higher radiation pneumonitis, according to a study published in International Journal of Radiation Oncology, Biology, Physics.

Researchers conducted a phase 2, randomized, double-blind, placebo-controlled trial to determine whether patients with newly diagnosed grade 2 or higher radiation pneumonitis would benefit from the addition of nintedanib to their standard 8-week prednisone taper ( Identifier: NCT02452463).

Between October 2015 and February 2020, 34 patients were enrolled, of whom 30 were deemed evaluable. Of those 30, 18 participants were randomly assigned to the experimental Arm A, which received nintedanib with the prednisone taper, and 12 participants to control Arm B, which received a placebo with the prednisone taper.

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Patients received oral doses of nintedanib 150 mg or placebo twice a day for 12 weeks, along with a concurrent taper of prednisone. The original dose of oral prednisone was 40 mg daily for 2 weeks, then the dose was tapered by 10 mg every 2 weeks for 4 weeks, then 10 mg for 1 week, and 5 mg for the final week.

The researchers determined that the primary endpoint for the study was freedom from pulmonary exacerbations at 1 year. Kaplan Meier analysis, used to estimate probability of freedom from exacerbations, results were 72% (95% CI, 54%-96%) for Arm A and 40% (95% CI, 20%-82%) in Arm B (P =.037). The improvement was deemed statistically significant.

Patients who experienced adverse events from nintedanib were most likely to experience diarrhea and dyspnea, which is consistent with data from other studies.

The increased use of immunotherapy may be a factor in the development of radiation pneumonitis in patients who undergo thoracic radiotherapy, the researchers suggested.

They hope this trial could serve as a benchmark for future trials on the treatment of radiation pneumonitis.

“Though a corticosteroid taper is the standard of care for treating radiation pneumonitis, the optimal dose and duration have not previously been prospectively evaluated, and this study showed that acute exacerbations are common despite corticosteroid treatment,” the researchers wrote. “Further investigation of nintedanib in the treatment of radiation pneumonitis is warranted given the observed benefit in reducing pulmonary exacerbations at one year and promising results of nintedanib in other subacute and chronic respiratory illnesses.”

Disclosure: This research was supported by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI), as well as the Fiona and Stanley Druckenmiller Center for Lung Cancer Research, and National Institutes of Health/National Cancer Institute Cancer Center support grant P30 CA008748. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Rimner A, Moore ZR, Lobaugh S, et al. Randomized phase 2 placebo-controlled trial of nintedanib for the treatment of radiation pneumonitisInt J Radiat Oncol Biol Phys. Published March 6, 2023. doi:10.1016/j.ijrobp.2023.02.030