A phase II, randomised study of mFOLFOX6 with or without the Akt inhibitor ipatasertib in patients with locally advanced or metastatic gastric or gastroesophageal junction cancer
European Journal of Cancer Feb 09, 2019
Bang YJ, et al. - In patients with locally advanced or metastatic gastric/gastroesophageal junction cancer (GC/GEJC) not amenable to curative therapy, researchers assessed outcomes after random administration 1:1 of ipatasertib or placebo, plus mFOLFOX6 (modified regimen of leucovorin, bolus and infusional 5-fluorouracil [5-FU], and oxaliplatin) in this randomised, double-blind, placebo-controlled, multicentre, phase II trial. They reported a median progression-free survival (PFS) (intent-to-treat) of 6.6 months vs 7.5 months with ipatasertib/mFOLFOX6 vs with placebo/mFOLFOX6, respectively, among 153 enrolled patients. They noted that in biomarker-selected patient subgroups [PTEN (phosphatase and tensin homolog)-low and PI3K/Akt pathway–activated tumours), there was no statistically significant PFS benefit with ipatasertib/mFOLFOX6 vs placebo/mFOLFOX6. In the ipatasertib arm, they observed higher rates of AEs leading to treatment withdrawal and serious AEs. Overall, in unselected or biomarker-selected patients, no improved PFS was offered by ipatasertib/mFOLFOX6 vs placebo/mFOLFOX6. No unexpected safety concerns were observed.
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