Long-term results of a prospective multicenter phase II study to preserve the larynx function using concomitant boost radiochemotherapy with Carboplatin

Abstract Purpose This prospective phase II study was undertaken to assess the feasibility of a larynx preservation protocol with simultaneous radiochemotherapy. Patients and methods Between 3/1998 and 10/2000, 42 patients with moderately advanced cancer of the larynx ( n =25) and hypopharynx ( n =17) eligible for total laryngectomy (LE) were treated in a prospective larynx preservation study. The study protocol scheduled 66Gy in 5 weeks using a concomitant boost technique and 70mg/m 2 Carboplatin on days 1–5 in weeks 1 and 5. Results The median follow-up time of the censored study patients was 41 months (9–95 months). The 5-year overall survival was 0.66 (95% CI 0.48–0.84), the 5-year laryngectomy-free survival 0.60 (95% CI 0.42–0.78), and the laryngeal preservation rate at 5 years 0.67 (95% CI 0.49–0.85). Cox multivariate regression analysis showed the total tumor volume to be the only statistically significant factor on locoregional failure-free survival. Six of 23 tumor-free long-term survivors received a tracheotomy because of late laryngeal toxicity associated with dysphagia 30–79 months after radiochemotherapy. Conclusions Due to the late laryngeal toxicity observed the value of this regimen for larynx preservation is limited.