Andreas Rimner, Zachary R Moore, Stephanie Lobaugh, Alexander Geyer, Daphna Y Gelblum, Raja-Elie E Abdulnour, Annemarie F Shepherd, Narek Shaverdian, Abraham J Wu, John Cuaron, Jamie E Chaft, Marjorie G Zauderer, Juliana Eng, Gregory J Riely, Charles M Rudin, Nicholas Vander Els, Mohit Chawla, Megan McCune, Henry Li, David R Jones, Dennis M Sopka, Charles B Simone, Raymond Mak, Gerald L Weinhouse, Zhongxing Liao, Daniel R Gomez, Zhigang Zhang, Paul K Paik
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...
March 6, 2023: International Journal of Radiation Oncology, Biology, Physics