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First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian patients with locally advanced or metastatic non-squamous non-small cell lung cancer: A randomised, phase 3 trial

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dc.contributor.authorYang, James Chih-Hsin-
dc.contributor.authorKang, Jin Hyoung-
dc.contributor.authorMok, Tony-
dc.contributor.authorAhn, Myung-Ju-
dc.contributor.authorSrimuninnimit, Vichien-
dc.contributor.authorLin, Chia-Chi-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorTsai, Chun-Ming-
dc.contributor.authorBarraclough, Helen-
dc.contributor.authorAltug, Sedat-
dc.contributor.authorOrlando, Mauro-
dc.contributor.authorPark, Keunchil-
dc.date.accessioned2020-04-27T11:23:55Z-
dc.date.available2020-04-27T11:23:55Z-
dc.date.created2020-02-19-
dc.date.issued2014-09-
dc.identifier.citationEuropean Journal of Cancer, Vol.50 No.13, pp.2219-2230-
dc.identifier.issn0959-8049-
dc.identifier.other91730-
dc.identifier.urihttps://hdl.handle.net/10371/165402-
dc.description.abstractBackground: In the Iressa Pan-ASia Study (IPASS), gefitinib claimed improved progression-free survival (PFS) versus carboplatin-paclitaxel in clinically selected lung cancer patients. The primary objective of this study was to assess the PFS of pemetrexed-cisplatin (PC) followed by gefitinib maintenance versus gefitinib monotherapy in an IPASS-like population. Methods: In this open-label, randomised, phase 3 trial, eligible patients were >= 18 years, chemonaTive, East Asian, light ex-smokers/never-smokers with advanced non-squamous non-small cell lung cancer, an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and unknown epidermal growth factor receptor (EGFR) mutation status who enrolled at 12 sites in Asia. Patients randomly received (1:1) pemetrexed (500 mg/m(2)) plus cisplatin (75 mg/m(2)) for six 21-day cycles, followed by gefitinib maintenance or gefitinib monotherapy (250 mg/day). Patient tissue was retrospectively analysed for EGFR mutations. This study is registered with ClinicalTrials.gov, NCT01017874. Findings: Between 23rd November 2009 and 27th April 2012, 253 patients entered, and 236 patients were randomly assigned to and treated with PC therapy (N = 114) and gefitinib monotherapy (N = 118). Between-arm baseline characteristics were balanced. PFS was not significantly different between treatment arms (p = 0.217). The unadjusted hazard ratio (HR) was 0.85 (95% confidence interval (CI) 0.63-1.13). The HR should be cautiously interpreted as it was not constant. EGFR mutation status was determined for 74 tissue samples; 50 (67.6%) had mutations. In a pre-specified subgroup analysis, only the treatment-by-EGFR mutation interaction was significant (p = 0.008) for PFS. For the entire treatment period, a higher proportion of patients in the PC/gefitinib arm versus gefitinib experienced possibly drug-related grade 3-4 treatment-emergent adverse events (39 of 114 [34%] versus 19 of 118 [16%]; p = 0.002). Interpretation: In the intention-to-treat (ITT) population, PFS was not significantly different. In the biomarker-assessable population, front-line EGFR tyrosine kinase inhibitor monotherapy was not efficacious in patients with wild-type EGFR. Identification of EGFR mutation status is key in the management of advanced non-squamous non-small cell lung cancer. (C) 2014 Elsevier Ltd. All rights reserved.-
dc.language영어-
dc.publisherPergamon Press Ltd.-
dc.titleFirst-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian patients with locally advanced or metastatic non-squamous non-small cell lung cancer: A randomised, phase 3 trial-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1016/j.ejca.2014.05.011-
dc.citation.journaltitleEuropean Journal of Cancer-
dc.identifier.wosid000340849800005-
dc.identifier.scopusid2-s2.0-84905105613-
dc.citation.endpage2230-
dc.citation.number13-
dc.citation.startpage2219-
dc.citation.volume50-
dc.identifier.sci000340849800005-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusRECEPTOR GENE-MUTATIONS-
dc.subject.keywordPlusSUPPORTIVE CARE-
dc.subject.keywordPlusCHEMOTHERAPY-
dc.subject.keywordPlusERLOTINIB-
dc.subject.keywordPlusGEMCITABINE-
dc.subject.keywordPlusGUIDELINES-
dc.subject.keywordPlusPARAMOUNT-
dc.subject.keywordPlusTUMORS-
dc.subject.keywordAuthorNon-squamous non-small cell lung cancer-
dc.subject.keywordAuthorPemetrexed-
dc.subject.keywordAuthorGefitinib-
dc.subject.keywordAuthorCisplatin-
dc.subject.keywordAuthorEast Asian patients-
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