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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/10767

Title: Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data
Authors: Michiels, Stefan
Le Maitre, Aurelie
BUYSE, Marc
BURZYKOWSKI, Tomasz
Maillard, Emilie
Bogaerts, Jan
Vermorken, Jan B.
Budach, Wilfried
Pajak, Thomas F.
Ang, Kian K.
Bourhis, Jean
Pignon, Jean-Pierre
Issue Date: 2009
Publisher: ELSEVIER SCIENCE INC
Citation: LANCET ONCOLOGY, 10(4). p. 341-350
Abstract: Background The gold standard endpoint in randomised trials of locally advanced head and neck squamous-cell carcinoma (HNSCC) is overall survival. Our objective was to study whether duration of locoregional control or event-free survival (EFS) could be considered as surrogate endpoints to estimate the effect of radiotherapy and chemotherapy on overall survival. This would allow a reduction in the duration and cost of the development of new treatments. Methods Individual patient data from 104 trials (22 744 patients), with 116 treatment-control comparisons, from four meta-analyses on hyperfiractionated or accelerated radiotherapy and concomitant, induction, or adjuvant chemotherapy were analysed. Duration of locoregional control was defined as the time from randomisation to the first locoregional event and EFS as the time to any first event (ie, locoregional relapse, distant recurrence, or death). At the individual level, a rank correlation coefficient between the surrogate endpoint and overall survival was used to assess surrogacy; at the trial level, a correlation coefficient R between treatment effects was used. Findings At the individual level, overall survival was more strongly correlated with EFS (range of correlations 0.82-0.90) than with locoregional control (0.65-0.76). For radiotherapy, treatment effects on both locoregional control and EFS were strongly correlated with those on overall survival (R=0.94 and 0.98, respectively). For chemotherapy, the correlations between treatment effects on EFS and overall survival were stronger than those between locoregional control and overall survival (range of R 0.79-0.93 vs 0.53-0.84, respectively). Interpretation EFS is a better correlate with overall survival than locoregional control and could be used as a surrogate for overall survival to assess the treatment effect of radiotherapy and chemotherapy in randomised trials of locally advanced HNSCC. Funding Programme Hospitalier de Recherche Clinique, the Association pour la Recherche sur le Cancer, the Ligue Nationale Contre le Cancer, and Sanofi-Aventis.
Notes: [Michiels, Stefan; Le Maitre, Aurelie; Maillard, Emilie; Pignon, Jean-Pierre] Inst Gustave Roussy, Dept Biostat & Epidemiol, F-94805 Villejuif, France. [Bourhis, Jean] Inst Gustave Roussy, Dept Radiotherapy, F-94805 Villejuif, France. [Buyse, Marc] Int Inst Drug Dev, Louvain, Belgium. [Buyse, Marc; Burzykowski, Tomasz] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, Diepenbeek, Belgium. [Bogaerts, Jan; Vermorken, Jan B.; Budach, Wilfried] European Org Res Treatment Canc, Brussels, Belgium. [Pajak, Thomas F.; Ang, Kian K.] Radiat Therapy Oncol Grp, Philadelphia, PA USA.
URI: http://hdl.handle.net/1942/10767
DOI: 10.1016/S1470-2045(09)70023-3
ISI #: 000264812300019
ISSN: 1470-2045
Category: A1
Type: Journal Contribution
Validation: ecoom, 2010
Appears in Collections: Research publications

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