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Title: Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: evidence from a meta-analysis of 2334 patients from 5 randomised trials
Authors: Laporte, Silvy
Squifflet, Pierre
Baroux, Noemie
Fossella, Frank
Georgoulias, Vassilis
Pujol, Jean-Louis
Douillard, Jean-Yves
Kudoh, Shinzohy
Pignon, Jean-Pierre
Quinaux, Emmanuel
BUYSE, Marc 
Issue Date: 2013
Source: BMJ OPEN, 3 (3), (ART N° e001802)
Abstract: Objectives: To investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in advanced non-small-cell lung cancer (NSCLC). Design: Meta-analysis of individual patient data from randomised trials. Setting: Five randomised controlled trials comparing docetaxel-based chemotherapy with vinorelbine-based chemotherapy for the first-line treatment of NSCLC. Participants: 2331 patients with advanced NSCLC. Primary and secondary outcome measures: Surrogacy of PFS for OS was assessed through the association between these endpoints and between the treatment effects on these endpoints. The surrogate threshold effect was the minimum treatment effect on PFS required to predict a non-zero treatment effect on OS. Results: The median follow-up of patients still alive was 23.4 months. Median OS was 10 months and median PFS was 5.5 months. The treatment effects on PFS and OS were correlated, whether using centres (R²=0.62, 95% CI 0.52 to 0.72) or prognostic strata (R²=0.72, 95% CI 0.60 to 0.84) as units of analysis. The surrogate threshold effect was a PFS hazard ratio (HR) of 0.49 using centres or 0.53 using prognostic strata. Conclusions: These analyses provide only modest support for considering PFS as an acceptable surrogate for OS in patients with advanced NSCLC. Only treatments that have a major impact on PFS (risk reduction of at least 50%) would be expected to also have a significant effect on OS. Whether these results also apply to targeted therapies is an open question that requires independent evaluation.
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ISSN: 2044-6055
e-ISSN: 2044-6055
DOI: 10.1136/bmjopen-2012-001802
ISI #: 000330560500008
Rights: This final article is available for use under the terms of the Creative Commons Attribution Non-Commercial 2.0 Licence; see
Category: A1
Type: Journal Contribution
Validations: ecoom 2015
Appears in Collections:Research publications

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