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

PurposeThis prospective phase II study was undertaken to assess the feasibility of a larynx preservation protocol with simultaneous radiochemotherapy.Patients and methodsBetween 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 66 Gy in 5 weeks using a concomitant boost technique and 70 mg/m2 Carboplatin on days 1–5 in weeks 1 and 5.ResultsThe 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.ConclusionsDue to the late laryngeal toxicity observed the value of this regimen for larynx preservation is limited.