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• W3205959172 abstract "Radiation pneumonitis (RP) is the most common limiting toxicity for definitive thoracic radiation therapy. Currently, the only standard management consists of an empiric prolonged steroid taper. Nevertheless, many patients with RP experience subsequent pulmonary exacerbations and worsening lung function leading to significant decline in quality of life. Nintedanib, a multiple tyrosine kinase inhibitor, has been shown to be effective in the treatment of idiopathic pulmonary fibrosis that shares many pathophysiological pathways with the chronic inflammation of the subacute phase of RP. This is the first prospective trial for the treatment of RP. The goal was to investigate the efficacy and safety of nintedanib in addition to a standard prednisone taper in reducing pulmonary exacerbations in patients with grade 2 or higher (G2+) RP. In this prospective, phase 2, randomized, double-blinded, placebo-controlled trial, patients with newly diagnosed G2+ RP were randomized 1:1 to nintedanib 150mg twice daily for 12 weeks or placebo in addition to a standard 8-week prednisone taper starting at 40mg. The primary endpoint was freedom from pulmonary exacerbations within 12 months defined as development or unexplained worsening of cough, dyspnea, hypoxia or pneumonitis lasting more than 4 days, new or worsening pulmonary infiltrates on chest CT without significant pneumothorax or pleural effusion, and exclusion of alternative causes. Secondary endpoints, including pulmonary function tests, radiographic fibrosis, quality of life, and hospitalizations will be reported in the future. Kaplan-Meier survival analysis was used to estimate probability of being free from exacerbation, with log rank test for p value and 95% confidence interval (CI). The study was closed early due to slow accrual (final enrollment 34 out of 68 planned patients). Of 34 patients enrolled, three patients withdrew consent and one was not treated. Of the evaluable 30 patients, 18 were randomized to Arm A (nintedanib + prednisone taper) and 12 to Arm B (placebo + prednisone taper). Five patients in Arm A failed to complete treatment (three noncompliant, one dose limiting grade 2 venous thrombosis, one death). Median follow-up was 368 days. There was no statistically significant difference in freedom from exacerbation between treatment arms at one year (p=0.074) or overall (p=0.136). In Arm A, an estimated 78% of patients were free from exacerbation at 100 days (CI 61%-100%) versus 50% of patients in Arm B (CI 28%-88%), p=0.111. Median freedom from exacerbation was not reached in Arm A versus 193 days in Arm B. After the initial onset of G2+ RP, treatment with nintedanib plus prednisone taper did not significantly increase the duration of freedom from pulmonary exacerbation compared to placebo plus prednisone taper. However, there was a trend toward a benefit from nintedanib, with a notably higher freedom from exacerbation in the nintedanib arm at 100 days. Although this study was limited by low accrual, the numerical differences observed warrant further evaluation of nintedanib as an agent to prevent pulmonary exacerbations following RP. This study can serve as a benchmark for further trials studying the treatment of RP." @default.
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• W3205959172 date "2021-10-01" @default.
• W3205959172 modified "2023-10-01" @default.
• W3205959172 title "FP09.03 Phase II Randomized Trial to Evaluate Prednisone Taper With or Without Nintedanib for the Treatment of Radiation Pneumonitis" @default.
• W3205959172 doi "https://doi.org/10.1016/j.jtho.2021.08.237" @default.
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