Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)

Tuberculosis and Respiratory Diseases

article

Kwan-Ho Lee¹  Kye-Young Lee²  Young-June Jeon³  Maan-Hong Jung⁴  Choonhee Son⁵  Min-Ki Lee⁶  Jeong-Seon Ryu⁷  Sei-Hoon Yang⁸  Jae-Cheol Lee⁹  Young-Chul Kim^1,10  Sun-Young Kim^1,11 

[1] Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine;Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine;Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine;Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine;Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine;Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine;Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon;Department of Internal Medicine, Wonkwang University Hospital, Wonkwang University School of Medicine;Department of Internal Medicine, Universitivy of Ulsan College of Medicine;Department of Internal Medicine, Chonnam National University Medical School;Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine

关键词: Gefitinib;    Receptor;    Epidermal Growth Factor;    Mutation;    Carcinoma;    Non-Small-Cell Lung;    Disease-Free Survival;   

DOI  :  10.4046/trd.2012.73.6.303

学科分类：医学（综合）

来源: The Korean Academy of Tuberculosis and Respiratory Diseases

【 摘 要 】

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.

【 授权许可】

CC BY-NC