Larynx preservation clinical trial design: key issues and recommendations--a consensus panel summary: in regard to Lefebvre et al., for the larynx preservation consensus panel (Int J Radiat Oncol Biol Phys 2009;73:1293-1303).

摘要

To the Editor: We read with interest the report by Lefebvre and Ang (1), in which they developed guidelines for the conduct of Phase HI clinical trials of larynx preservation in patients with locally advanced laryngeal and hypo-pharyngeal cancer. They concluded that revised trial designs are needed to advance the study of larynx preservation. We agree that functional assessments are crucial, and the new endpoint "laryngoesophageal dysfunction-free survival" will help to improve the conclusions of future studies, in which the benefit of novel treatment options can be analyzed.