Gefitinib treatment in patients with postoperative recurrent non-small-cell lung cancer harboring epidermal growth factor receptor gene mutations.

ABSTRACT

BACKGROUND: The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib is an effective treatment for recurrent or advanced lung cancer harboring EGFR gene mutations, and has improved progression-free survival in several clinical trials. However, the effect of gefitinib treatment for recurrent lung cancers with EGFR gene mutations after complete resection and the influence of the timing of such treatment have not been fully elucidated in a practical setting. METHODS: We investigated 64 patients (median age 68 years; men 22; women 42; adenocarcinoma 61; adenosquamous cell carcinoma 2; combined large cell neuroendocrine carcinoma 1) with recurrent lung cancer after complete resection who received gefitinib for the recurrent lesions and in whom the tumors had EGFR gene mutations. Progression-free survival, response rate, and safety were analyzed. RESULTS: Complete response and partial response were achieved in 2 patients and in 42 patients, respectively (objective response rate 69 %). Stable disease was obtained in 16 patients, the disease control rate was 94 %, and median progression-free survival was 16 months. The timing of gefitinib treatment (first line, second line, or later) and the type of EGFR gene mutation present did not influence progression-free survival. However, a smaller number of recurrent sites at the start of gefitinib treatment was linked to better progression-free survival. Hematologic and nonhematologic toxicities were generally mild, but 1 patient experienced interstitial lung disease. CONCLUSIONS: Our results suggest that gefitinib treatment for recurrent lung cancer with gene EGFR mutations is a useful option in a practical setting, irrespective of the timing of such treatment and the type of EGFR gene mutation present.