Personalized arms using a “genomic (DNA) biomarker” had higher median RR than those using a “protein biomarker” (42.0% vs 22.4% P =. 63 respectively median PFS, 3.3 months vs 2.5 months P =. Nonpersonalized targeted arms had outcomes comparable with those that tested a cytotoxic agent (median RR, 5.1% vs 4.7% P =. Targeted therapy arms that used a biomarker-based selection strategy (n = 57 trials) were associated with statistically improved RR compared with targeted therapy arms (n = 177 arms) that did not (31.1% vs 5.1% P <. 001) and a longer median PFS (5.7 vs 2.95 months P <. Multivariable analysis (meta-regression and weighted multiple regression models) demonstrated that the personalized approach independently correlated with a significantly higher median RR (30.6% vs 4.9% P <. Overall survival was not analyzed owing to insufficient data.Ī total of 346 studies published in the designated 3-year time period were included in the analysis. Response rate and progression-free survival (PFS) were compared for arms that used a personalized strategy (biomarker selection) vs those that did not. Studies included trials that evaluated single agents, and reported efficacy end points (at least response rate ).ĭata were extracted independently by 2 investigators. PubMed search of phase 1 cancer drug trials (January 1, 2011, through December 31, 2013). To compare patient outcomes in phase 1 studies that used a biomarker selection strategy with those that did not. The impact of a biomarker-based (personalized) cancer treatment strategy in the setting of phase 1 clinical trials was analyzed.
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