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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

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dc.contributor.authorBang, Yung-Jue-
dc.contributor.authorKang, Y. -K.-
dc.contributor.authorNg, M.-
dc.contributor.authorChung, H. C.-
dc.contributor.authorWainberg, Z. A.-
dc.contributor.authorGendreau, S.-
dc.contributor.authorChan, W. Y.-
dc.contributor.authorXu, N.-
dc.contributor.authorMaslyar, D.-
dc.contributor.authorMeng, R.-
dc.contributor.authorChau, I-
dc.contributor.authorAjani, J. A.-
dc.date.accessioned2021-01-31T11:09:17Z-
dc.date.available2021-01-31T11:09:17Z-
dc.date.issued2019-02-
dc.identifier.citationEuropean Journal of Cancer, Vol.108, pp.17-24-
dc.identifier.issn0959-8049-
dc.identifier.other93602-
dc.identifier.urihttps://hdl.handle.net/10371/173063-
dc.description.abstractBackground: Akt activation is common in gastric/gastroesophageal junction cancer (GC/GEJC) and is associated with chemotherapy resistance. Treatment with ipatasertib, a pan-Akt inhibitor, may potentiate the efficacy of chemotherapy in GC/GEJC. Patients and methods: In this randomised, double-blind, placebo-controlled, multicentre, phase II trial, patients with locally advanced or metastatic GC/GEJC not amenable to curative therapy were randomised 1:1 to receive ipatasertib or placebo, plus mFOLFOX6 (modified regimen of leucovorin, bolus and infusional 5-fluorouracil [5-FU], and oxaliplatin). The co-primary end-point was progression-free survival (PFS) in the intent-to-treat (ITT) population and in phosphatase and tensin homolog (PTEN)-low patients. Secondary end-points included PFS in patients with PI3K/Akt pathway-activated tumours; overall survival, investigator-assessed objective response rate and duration of response in the ITT population; and safety assessments. Results: In 153 enrolled patients, the median PFS (ITT) was 6.6 months (90% confidence interval [CI], 5.7-7.5) with ipatasertib/mFOLFOX6 versus 7.5 months (90% CI, 6.2-8.1) with placebo/mFOLFOX6 (hazard ratio, 1.12; 90% CI, 0.81-1.55; P = 0.56). No statistically significant PFS benefit was observed in biomarker-selected patient subgroups (PTEN-low and PI3K/Akt pathway-activated tumours) with ipatasertib/mFOLFOX6 versus placebo/mFOLFOX6. Other secondary end-points did not favour the ipatasertib/mFOLFOX6 treatment arm. The percentages of patients with >= 1 adverse event (AE, 100% versus 98%) and grade >= 3 AEs (79% versus 74%) were similar between arms. Higher rates of AEs leading to treatment withdrawal (16% versus 6%) and serious AEs were reported in the ipatasertib arm (54% versus 43%). Thirty-nine and 29 deaths occurred in the ipatasertib and placebo arms, respectively. Conclusions: Ipatasertib/mFOLFOX6 compared with placebo/mFOLFOX6 did not improve PFS in unselected or biomarker-selected patients. No unexpected safety concerns were observed. Trial registration: ClinicalTrials.gov (NCT01896531). (C) 2018 Elsevier Ltd. All rights reserved.-
dc.subjectIpatasertib-
dc.subjectGastric cancer-
dc.subjectGastroesophageal junction cancer-
dc.subjectmFOLFOX6-
dc.subjectAkt inhibitor-
dc.titleA 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-
dc.typeArticle-
dc.contributor.AlternativeAuthor방영주-
dc.identifier.doi10.1016/j.ejca.2018.11.017-
dc.citation.journaltitleEuropean Journal of Cancer-
dc.identifier.scopusid2-s2.0-85058933461-
dc.citation.endpage24-
dc.citation.startpage17-
dc.citation.volume108-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0959804918315156?via%3Dihub-
dc.identifier.rimsid93602-
dc.identifier.sci000457738500002-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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