Literature DB >> 25806200

Is overall survival still the primary endpoint in maintenance non-small cell lung cancer studies? An analysis of phase III randomised trials.

Fausto Petrelli1, Sandro Barni1.   

Abstract

BACKGROUND: In advanced non-small cell lung cancer (NSCLC), the increasing number of active compounds available in second line settings makes overall survival (OS) with maintenance treatment a not frequently observed endpoint. A literature review was conducted to examine whether post-progression survival (PPS) correlates with OS in maintenance trials.
MATERIALS AND METHODS: PPS was defined as median OS - median PFS. The authors used the coefficient of correlation (r) to assess the correlation between them. They also evaluated the surrogacy of PFS and OS.
RESULTS: Ten trials with 11 arms were identified. Overall, a stronger correlation was observed between OS and PPS [Spearman rank correlation coefficient (r) =0.75] than OS and PFS time (r=0.37). The correlation of differences in median PFS (ΔPFS) and median OSOS) is 0.64 (P=0.0326). The slope of the regression line is 0.76, indicating that a maintenance therapy producing a one-month gain in PFS will yield an estimated three weeks prolongation in OS.
CONCLUSIONS: PPS is strongly associated with OS because of intensive post-study further lines of treatment. However, improvements in PFS are moderately associated with improvements in OS. Hence, in this setting, PFS is a possible surrogate for OS.

Entities:  

Keywords:  Non small cell lung cancer; maintenance therapy; overall survival; post progression survival; progression free survival; surrogate endpoint

Year:  2013        PMID: 25806200      PMCID: PMC4367648          DOI: 10.3978/j.issn.2218-6751.2012.11.06

Source DB:  PubMed          Journal:  Transl Lung Cancer Res        ISSN: 2218-6751


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