BackgroundAs it is difficult to obtain enough histopathological data for epidermal growth factor receptor (EGFR) gene detection, it is necessary for us to explore how to perform EGFR-tyrosine kinase inhibitor (TKI) therapy in patients with unknown EGFR gene mutations. MethodsWe analyzed the efficacy of Gefitinib treatment and the clinical characteristics of 214 patients with stage IV lung adenocarcinoma. ResultsObjective response rates (ORR) and overall survival (OS) of women were higher than men; ORR of patients with rash, diarrhea, or rash associated with diarrhea, was higher than patients without those side effects. Progression-free survival (PFS) of patients with performance status (PS) scores of 1, 2, and 3 points was 8.0 1.699, 7.3 +/- 0.419, and 6.0 +/- 2.010, respectively; OS was 26.0 +/- 1.536, 16.3 +/- 1.262, and 14.3 +/- 2.389, respectively. PFS and OS of patients with rash and diarrhea were better than for those without these side effects. In males, the PFS of patients >65 years old versus 65 years old was 13.0 +/- 2.7 months versus 5.5 +/- 0.197 months, respectively. Multivariate analysis showed that PS score, diarrhea, and rash affected the patients' PFS, while gender, PS score, and rash affected the patients' OS. ConclusionsIn patients with stage IV lung adenocarcinoma and unknown EGFR gene mutations treated with Gefitinib, our findings suggest a better prognosis for female patients and those with low PS scores.