Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)
- Kwan-Ho Lee; Kye-Young Lee; Young-June Jeon; Maan-Hong Jung; Choonhee Son; Min-Ki Lee; Jeong-Seon Ryu; Sei-Hoon Yang; Jae-Cheol Lee; Young-Chul Kim; Sun-Young Kim
- Dept. of Internal Medicine (내과학)
- Issue Date
- 결핵 및 호흡기 질환, Vol.73(6) : 303-311, 2012
- Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to
the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC).
Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who
had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor
(EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker.
These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the
objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics
of modified intent-to-treat population.
Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects
achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher
in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004).
In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence
interval, 3.9∼8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most
common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%).
Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy
in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association
with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.
Key Words: Gefitinib; Receptor, Epidermal Growth Factor; Mutation; Carcinoma, Non-Small-Cell Lung; Disease-Free
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- 1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
- Keimyung Author(s)
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