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First- or Second-line Therapy with Gefitinib Produces Equal Survival in Non–Small Cell Lung Cancer

¹ Department of Internal Medicine and ² Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; ³ Division of Biostatistics, Graduate Institute of Epidemiology and Center of Biostatistics Consultation, College of Public Health, National Taiwan University, Taipei, Taiwan; ⁴ Division of Critical Care Medicine, Department of Emergency and Critical Care Medicine, Lo-Tung Poh-Ai Hospital, Yi-Lan, Taiwan; and ⁵ Department of Radiology and ⁶ Department of Laboratory Medicine, National Taiwan University Hospital, Taipei, Taiwan

Correspondence and requests for reprints should be addressed to Jin-Yuan Shih, M.D., Ph.D., Department of Internal Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei 10002, Taiwan. E-mail: jyshih{at}ntu.edu.tw

Rationale: Gefitinib is effective in treating patients with non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Deletions in exon 19 and L858R in exon 21 are the best-documented EGFR mutations that are associated with effective gefitinib responsiveness.

Objectives: To clarify the influence of gefitinib timing, we conducted a study to compare the outcomes of different lines of gefitinib treatment in patients with exon 19 deletions or L858R.

Methods: We surveyed the clinical data and mutational studies of patients with NSCLC with EGFR mutations in the National Taiwan University Hospital (Taipei, Taiwan).

Measurements and Main Results: Three hundred and twenty-eight patients, who received gefitinib for stage IIIb or IV NSCLC, were adequately sequenced for EGFR mutations; 192 patients had mutant EGFR, including 77 patients with exon 19 deletions and 75 patients with L858R. The 152 patients with exon 19 deletions or L858R and who were receiving gefitinib were classified into a chemonaive group (91 patients) or a chemotherapy-treated group (61 patients). Chemonaive status before gefitinib and female sex were associated with clinical response to gefitinib (P = 0.006 and 0.053, respectively). Neither overall survival after the start of antitumor therapy nor progression-free survival after gefitinib therapy was significantly different between these two groups (P = 0.207 and 0.804, respectively). Clinical response to gefitinib was the only factor associated with better overall survival (P = 0.001).

Conclusions: This study suggests that gefitinib is effective in patients with EGFR mutations. The gefitinib response rate in chemonaive patients is higher than in chemotherapy-treated patients; however, there is no difference in overall survival.

Key Words: epidermal growth factor receptor • gefitinib • lung cancer • mutations

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Gefitinib is effective in treating non–small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations, especially the mutations of exon 19 deletions and L858R in exon 21. However, the influence of gefitinib timing is unclear. What This Study Adds to the Field This study suggests that gefitinib is effective in patients with EGFR mutations. In using gefitinib, the overall survival was not different whether gefitinib was used in chemo-naive patients or chemotherapy-treated patients.

 

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