Response: Re: Randomized Trial of Induction Chemotherapy With Cisplatin and 5-Fluorouracil With or Without Docetaxel for Larynx Preservation

Extract

We thank Dr Haddad for raising important issues. The Groupe d’Oncologie Radiotherapie Tete Et Cou (GORTEC) 2000-01 trial was especially designed for organ preservation, and the primary endpoint was 3-year larynx preservation rate. Laryngectomy-free survival, prolonged tracheotomy, and percutaneous endoscopic gastrostomy (permanent feeding tube) dependency were not initially planned in the analysis. Moreover, the panel consensus led by Jean Louis Lefebvre and Kian Ang ( 1 , 2 ) created laryngoesophageal dysfunction–free survival as the new primary endpoint for organ preservation trials. This endpoint would be measured as the time from random assignment, and events would include death, local relapse, total or partial laryngectomy, tracheotomy at 2 years or later, or feeding tube at 2 years or later. Their recommendations for secondary endpoints include overall survival, progression-free survival, locoregional control, time to tracheotomy, time to laryngectomy, time to discontinuation of feeding tube, and quality-of-life for patient-reported outcomes. Therefore, we have not analyzed the criteria proposed by Dr Haddad, and a prospective evaluation of laryngeal function is currently ongoing.