Publication
Title
Larynx preservation clinical trial design: key issues and recommendations: a consensus panel summary
Author
Institution/Organisation
Larynx Preservation Consensus Panel
Abstract
Background To develop guidelines for the conduct of phase III clinical trials of larynx preservation in patients with locally advanced laryngeal and hypopharyngeal cancer. Methods A multidisciplinary international consensus panel developed recommendations after reviewing results from completed phase III randomized trials, meta-analyses, and published clinical reports with updates available through November 2007. The guidelines were reviewed and approved by the panel. Results The trial population should include patients with T2 or T3 laryngeal or hypopharyngeal squamous cell carcinoma not considered for partial laryngectomy and exclude those with laryngeal dysfunction or age more than 70 years. Functional assessments should include speech and swallowing. Voice should be routinely assessed with a simple, validated instrument. The primary endpoint should capture survival and function. The panel created a new endpoint: laryngo-esophageal dysfunction-free survival. Events are death, local relapse, total or partial laryngectomy, tracheotomy at 2 years or later, or feeding tube at 2 years or later. Recommended secondary endpoints are overall survival, progression-free survival, locoregional control, time to tracheotomy, time to laryngectomy, time to discontinuation of feeding tube, and quality of life/patient reported outcomes. Correlative biomarker studies for near-term trials should include EGFR, ERCC-1, E-cadherin and -catenin, epiregulin and amphiregulin, and TP53 mutation. Conclusions Revised trial designs in several key areas are needed to advance the study of larynx preservation. With consistent methodologies, clinical trials can more effectively evaluate and quantify the therapeutic benefit of novel treatment options for patients with locally-advanced laryngeal and hypopharyngeal cancer
Language
English
Source (journal)
Head and neck: journal for the sciences and specialties of the head and neck. - New York, N.Y.
Publication
New York, N.Y. : 2009
ISSN
1043-3074
Volume/pages
31:4(2009), p. 429-441
ISI
000264650200001
Full text (Publisher's DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identification
Creation 24.08.2009
Last edited 17.11.2017
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