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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
DC Field | Value | Language |
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dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Kang, Jin Hyoung | - |
dc.contributor.author | Mok, Tony | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Srimuninnimit, Vichien | - |
dc.contributor.author | Lin, Chia-Chi | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Tsai, Chun-Ming | - |
dc.contributor.author | Barraclough, Helen | - |
dc.contributor.author | Altug, Sedat | - |
dc.contributor.author | Orlando, Mauro | - |
dc.contributor.author | Park, Keunchil | - |
dc.date.accessioned | 2020-04-27T11:23:55Z | - |
dc.date.available | 2020-04-27T11:23:55Z | - |
dc.date.created | 2020-02-19 | - |
dc.date.issued | 2014-09 | - |
dc.identifier.citation | European Journal of Cancer, Vol.50 No.13, pp.2219-2230 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | 91730 | - |
dc.identifier.uri | https://hdl.handle.net/10371/165402 | - |
dc.description.abstract | Background: 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.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1016/j.ejca.2014.05.011 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 000340849800005 | - |
dc.identifier.scopusid | 2-s2.0-84905105613 | - |
dc.citation.endpage | 2230 | - |
dc.citation.number | 13 | - |
dc.citation.startpage | 2219 | - |
dc.citation.volume | 50 | - |
dc.identifier.sci | 000340849800005 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | RECEPTOR GENE-MUTATIONS | - |
dc.subject.keywordPlus | SUPPORTIVE CARE | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | ERLOTINIB | - |
dc.subject.keywordPlus | GEMCITABINE | - |
dc.subject.keywordPlus | GUIDELINES | - |
dc.subject.keywordPlus | PARAMOUNT | - |
dc.subject.keywordPlus | TUMORS | - |
dc.subject.keywordAuthor | Non-squamous non-small cell lung cancer | - |
dc.subject.keywordAuthor | Pemetrexed | - |
dc.subject.keywordAuthor | Gefitinib | - |
dc.subject.keywordAuthor | Cisplatin | - |
dc.subject.keywordAuthor | East Asian patients | - |
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