Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2008
Long-term results of a prospective multicenter phase II study to preserve the larynx function using concomitant boost radiochemotherapy with Carboplatin.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Rudat Volker, Eckel Hans, Volling Peter, Schröder Michael, Staar Susanne, Wallner Frank, Wannenmacher Michael, Dietz Andreas
Аннотация
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.
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.