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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
DC Field | Value | Language |
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dc.contributor.author | Bang, Y. -J. | - |
dc.contributor.author | Kang, Y. -K. | - |
dc.contributor.author | Ng, M. | - |
dc.contributor.author | Chung, H. C. | - |
dc.contributor.author | Wainberg, Z. A. | - |
dc.contributor.author | Gendreau, S. | - |
dc.contributor.author | Chan, W. Y. | - |
dc.contributor.author | Xu, N. | - |
dc.contributor.author | Maslyar, D. | - |
dc.contributor.author | Meng, R. | - |
dc.contributor.author | Chau, I | - |
dc.contributor.author | Ajani, J. A. | - |
dc.date.accessioned | 2021-01-31T11:09:17Z | - |
dc.date.available | 2021-01-31T11:09:17Z | - |
dc.date.created | 2020-03-25 | - |
dc.date.issued | 2019-02 | - |
dc.identifier.citation | European Journal of Cancer, Vol.108, pp.17-24 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | 93602 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173063 | - |
dc.description.abstract | Background: 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.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1016/j.ejca.2018.11.017 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 000457738500002 | - |
dc.identifier.scopusid | 2-s2.0-85058933461 | - |
dc.citation.endpage | 24 | - |
dc.citation.startpage | 17 | - |
dc.citation.volume | 108 | - |
dc.identifier.sci | 000457738500002 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Y. -J. | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | 1ST-LINE THERAPY | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CAPECITABINE | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | EPIRUBICIN | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | CETUXIMAB | - |
dc.subject.keywordPlus | MK-2206 | - |
dc.subject.keywordAuthor | Ipatasertib | - |
dc.subject.keywordAuthor | Gastric cancer | - |
dc.subject.keywordAuthor | Gastroesophageal junction cancer | - |
dc.subject.keywordAuthor | mFOLFOX6 | - |
dc.subject.keywordAuthor | Akt inhibitor | - |
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