Tuberc Respir Dis.  2012 Dec;73(6):303-311. 10.4046/trd.2012.73.6.303.

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

• Lee KH
• Lee KY
• Jeon YJ
• Jung MH
• Son C
• Lee MK
• Ryu JS
• Yang SH
• Lee JC
• Kim YC
• Kim SY

• KMID: 1842923
• DOI: http://doi.org/10.4046/trd.2012.73.6.303

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.

Keyword

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

MeSH Terms

Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Cough
Diarrhea
Disease-Free Survival
Exanthema
Female
Humans
Lung
Lung Neoplasms
Pruritus
Quinazolines
Receptor, Epidermal Growth Factor
Quinazolines
Receptor, Epidermal Growth Factor

Figure

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  Figure 1 Waterfall plot of individual patient tumor response. EGFR: epidermal growth factor receptor; SLD: sum of the longest dimensions; NA: not available.

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  Figure 2 Kaplan-Meier curve for progression-free survival.

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  Figure 3 Kaplan-Meier curve for overall survival.

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  Figure 4 Kaplan-Meier curve for progression-free survival by epidermal growth factor receptor (EGFR) mutation status. NA: not available.

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  Figure 5 Kaplan-Meier curve for overall survival by epidermal growth factor receptor (EGFR) mutation status. NA: not available.

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