Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE).
10.4046/trd.2012.73.6.303
- Author:
Kwan Ho LEE
1
;
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
Author Information
1. Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea. ghlee@med.yu.ac.kr
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Gefitinib;
Receptor, Epidermal Growth Factor;
Mutation;
Carcinoma, Non-Small-Cell Lung;
Disease-Free Survival
- MeSH:
Adenocarcinoma;
Carcinoma, Non-Small-Cell Lung;
Cough;
Diarrhea;
Disease-Free Survival;
Exanthema;
Female;
Humans;
Lung;
Lung Neoplasms;
Pruritus;
Quinazolines;
Receptor, Epidermal Growth Factor
- From:Tuberculosis and Respiratory Diseases
2012;73(6):303-311
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
