Randomized, phase II, placebo-controlled trial of nintedanib for the treatment of radiation pneumonitis
Abstract
Background Radiation pneumonitis (RP) is the most common dose-limiting toxicity for thoracic radiation therapy. Nintedanib is used for the treatment of idiopathic pulmonary fibrosis, which shares pathophysiological pathways with the subacute phase of RP. Our goal was to investigate the efficacy and safety of nintedanib added to a prednisone taper compared to a prednisone taper alone in reducing pulmonary exacerbations in patients with grade 2 or higher (G2+) RP. Methods In this phase II, randomized, double-blinded, placebo-controlled trial, patients with newly diagnosed G2+ RP were randomized 1:1 to nintedanib or placebo in addition to a standard 8-week prednisone taper. The primary endpoint was freedom from pulmonary exacerbations at one year. Secondary endpoints included patient reported outcomes and pulmonary function tests. Kaplan-Meier analysis was used to estimate the probability of freedom from pulmonary exacerbations. The study was closed early due to slow accrual. Results 34 patients were enrolled between October 2015 and February 2020. Of 30 evaluable patients, 18 were randomized to the experimental Arm A (nintedanib + prednisone taper) and 12 to control Arm B (placebo + prednisone taper). Freedom from exacerbation at one year was 72% (CI 54%–96%) in Arm A and 40% (CI 20%–82%) in Arm B (one-sided p=0.037). In Arm A there were 16 G2+ adverse events possibly or probably related to treatment compared to five in the placebo arm. There were three deaths during the study…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 34 participants or records.
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