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

결핵및호흡기질환
2012년 73권 6호 p.303 ~ p.311
이관호 ( Lee Kwan-Ho ) - Yeungnam University Medical Center Department of Internal Medicine

이계영 ( Lee Kye-Young ) - Konkuk University Medical Center Department of Internal Medicine
전영준 ( Jeon Young-June ) - Keimyung University Dongsan Medical Center Department of Internal Medicine
정만홍 ( Jung Maan-Hong ) - Kosin University College of Medicine Department of Internal Medicine
손춘희 ( Son Choon-Hee ) - Dong-A University Medical Center Department of Internal Medicine
이민기 ( Lee Min-Ki ) - Pusan National University Hospital Department of Internal Medicine
류정선 ( Ryu Jeong-Seon ) - Inha University Hospital Department of Internal Medicine
양세훈 ( Yang Sei-Hoon ) - Wonkwang University Hospital Department of Internal Medicine
이재철 ( Lee Jae-Cheol ) - University of Ulsan College of Medicine Department of Internal Medicine
김영철 ( Kim Young-Chul ) - Chonnam National University Medical School Department of Internal Medicine
김선영 ( Kim Sun-Young ) - Chungnam National University Hospital Department of Internal Medicine

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.

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