Long-term results of a prospective multicenter phase II study to preserve the larynx function using concomitant boost radiochemotherapy with Carboplatin.
OBJECTIVE
This prospective phase II study was undertaken to assess the feasibility of a larynx preservation protocol with simultaneous radiochemotherapy.


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.
Rudat
Volker
V
Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany. volker.rudat@gmail.com
Eckel
Hans
H
Volling
Peter
P
Schröder
Michael
M
Staar
Susanne
S
Wallner
Frank
F
Wannenmacher
Michael
M
Dietz
Andreas
A
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D016190:Carboplatin