Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE) / 결핵및호흡기질환
Tuberculosis and Respiratory Diseases
;
: 303-311, 2012.
Article
in English
| WPRIM
| ID: wpr-183852
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Pruritus
/
Quinazolines
/
Adenocarcinoma
/
Carcinoma, Non-Small-Cell Lung
/
Disease-Free Survival
/
Cough
/
Diarrhea
/
Exanthema
/
ErbB Receptors
/
Lung
Type of study:
Controlled clinical trial
/
Observational study
Limits:
Female
/
Humans
Language:
English
Journal:
Tuberculosis and Respiratory Diseases
Year:
2012
Type:
Article
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