[Predictive factors for response and survival of gefitinib-treated locally advanced or metastatic non-small cell lung cancer patients: a retrospective analysis of two phase II clinical trials].

Background And Objective: Clinical factors and molecular markers can be used to predict the prognosis of gefitinib-treated locally advanced or metastatic non-small cell lung cancer (NSCLC). This study was to identify predictive factors for the response and survival of gefitinib-treated locally advanced or metastatic NSCLC patients in China.

Methods: Clinical data of 256 gefitinib-treated Chinese NSCLC patients from two existing clinical trials were analyzed. Univariate and multivariate analyses were performed to determine predictive factors of response and survival.

Results: The objective response rate was 24.6%; the disease control rate was 54.7%. Median survival time was 11.43 months (95% CI, 8.64-14.22 months). The 1-year survival rate was 48.0% (95% CI, 41.0%-55.0%). Adenocarcinoma and skin rash were associated with better response. The patients with lower performance status (PS) score (0-1) and those with disease control (complete remission, partial remission, and stable disease) had longer survival when compared with their counterparts.

Conclusions: Adenocarcinoma and skin rash are predictors of better response to gefitinib. Low PS score and disease control are predictors of longer survival after treatment of gefitinib.