First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung
DC Field | Value | Language |
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dc.contributor.author | Han, Ji-Youn | - |
dc.contributor.author | Park, Keunchil | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Lee, Dae Ho | - |
dc.contributor.author | Kim, Hyae Young | - |
dc.contributor.author | Kim, Heung Tae | - |
dc.contributor.author | Ahn, Myung Ju | - |
dc.contributor.author | Yun, Tak | - |
dc.contributor.author | Ahn, Jin Seok | - |
dc.contributor.author | Suh, Cheolwon | - |
dc.contributor.author | Lee, Jung-Shin | - |
dc.contributor.author | Yoon, Sung Jin | - |
dc.contributor.author | Han, Jong Hee | - |
dc.contributor.author | Lee, Jae Won | - |
dc.contributor.author | Jo, Sook Jung | - |
dc.contributor.author | Lee, Jin Soo | - |
dc.date.accessioned | 2021-09-06T21:31:03Z | - |
dc.date.available | 2021-09-06T21:31:03Z | - |
dc.date.created | 2021-06-18 | - |
dc.date.issued | 2012-04-01 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/108751 | - |
dc.description.abstract | Purpose Gefitinib has shown high response rate and improved progression-free survival (PFS) in never-smokers with lung adenocarcinoma (NSLAs). We compared efficacy of gefitinib with gemcitabine and cisplatin (GP) chemotherapy in this group of patients as first-line therapy. Patients and Methods In this randomized phase III trial, a total of 313 Korean never-smokers with stage IIIB or IV lung adenocarcinoma, Eastern Cooperative Oncology Group performance status 0 to 2, and adequate organ function were randomly assigned to receive either gefitinib (250 mg daily) or GP chemotherapy (gemcitabine 1,250 mg/m(2) on days 1 and 8; cisplatin 80 mg/m2 on day 1 every 3 weeks, for up to nine courses). The primary objective was to demonstrate better overall survival (OS) for gefitinib compared with GP in chemotherapy-naive NSLAs. Results Three hundred nine patients were analyzed per protocol (gefitinib arm, n = 159; GP arm, n = 150). Gefitinib did not show better OS compared with GP (hazard ratio [HR], 0.932; 95% CI, 0.716 to 1.213; P = .604; median OS, 22.3 v 22.9 months, respectively). The 1-year PFS rates were 16.7% with gefitinib and 2.8% with GP (HR, 1.198; 95% CI, 0.944 to 1.520). Response rates were 55% with gefitinib and 46% with GP (P = .101). Myelosuppression, renal insufficiency, and fatigue were more common in the GP arm, but skin toxicities and liver dysfunction were more common in the gefitinib arm. Two patients (1.3%) in the gefitinib arm developed interstitial lung disease and died. Conclusion Gefitinib failed to demonstrate superior OS compared with GP as first-line therapy for NSLAs. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | AMER SOC CLINICAL ONCOLOGY | - |
dc.subject | GROWTH-FACTOR RECEPTOR | - |
dc.subject | METASTATIC ADENOCARCINOMA | - |
dc.subject | CLINICAL-TRIALS | - |
dc.subject | CANCER PATIENTS | - |
dc.subject | EGFR MUTATIONS | - |
dc.subject | GEFITINIB | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | SENSITIVITY | - |
dc.subject | FEATURES | - |
dc.subject | THERAPY | - |
dc.title | First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Jae Won | - |
dc.identifier.doi | 10.1200/JCO.2011.36.8456 | - |
dc.identifier.scopusid | 2-s2.0-84861976809 | - |
dc.identifier.wosid | 000302631300021 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, v.30, no.10, pp.1122 - 1128 | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.citation.title | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.citation.volume | 30 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 1122 | - |
dc.citation.endPage | 1128 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | GROWTH-FACTOR RECEPTOR | - |
dc.subject.keywordPlus | METASTATIC ADENOCARCINOMA | - |
dc.subject.keywordPlus | CLINICAL-TRIALS | - |
dc.subject.keywordPlus | CANCER PATIENTS | - |
dc.subject.keywordPlus | EGFR MUTATIONS | - |
dc.subject.keywordPlus | GEFITINIB | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | SENSITIVITY | - |
dc.subject.keywordPlus | FEATURES | - |
dc.subject.keywordPlus | THERAPY | - |
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