First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung
- Authors
- Han, Ji-Youn; Park, Keunchil; Kim, Sang-We; Lee, Dae Ho; Kim, Hyae Young; Kim, Heung Tae; Ahn, Myung Ju; Yun, Tak; Ahn, Jin Seok; Suh, Cheolwon; Lee, Jung-Shin; Yoon, Sung Jin; Han, Jong Hee; Lee, Jae Won; Jo, Sook Jung; Lee, Jin Soo
- Issue Date
- 1-4월-2012
- Publisher
- AMER SOC CLINICAL ONCOLOGY
- Citation
- JOURNAL OF CLINICAL ONCOLOGY, v.30, no.10, pp.1122 - 1128
- Indexed
- SCIE
SCOPUS
- Journal Title
- JOURNAL OF CLINICAL ONCOLOGY
- Volume
- 30
- Number
- 10
- Start Page
- 1122
- End Page
- 1128
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/108751
- DOI
- 10.1200/JCO.2011.36.8456
- ISSN
- 0732-183X
- 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.
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