Tyrosine kinase inhibitors (TKIs; gefitinib and erlotinib) are widely indicated in NSCLC patients, especially those harboring an active mutation of EGFR, and have shown excellent efficacy. However, severe interstitial lung disease (ILD) can occur as an adverse event with TKIs, and is sometimes fatal. Fexofenadine has been used to prevent TKI-induced skin rash in all patients, who received EGFR-TKIs, since April 2009 in our hospital, and seems to reduce the incidence of ILD. Therefore, we retrospectively analyzed the efficacy of fexofenadine in preventing TKI-induced ILD.Methods
145 NSCLC patients, in whom TKIs were administered, were analyzed in the study, comprising 54 and 91 patients with and without concomitant administration of fexofenadine, respectively. Univariate and multivariate analyses with logistic regression model were used to investigate whether fexofenadine could prevent EGFR-TKIs-induced ILD or not.Results
ILD occurred in 21 patients (14.5%), and was fatal in 5 (3.4%). The number of ILD patients with/without fexofenadine was 4 out of 54 (8.5%)/17 out of 91 (18.7%), and the mortality was 1 out of 54 patients (1.9%)/4 out of 91 (4.4%), respectively. Fexofenadine appears to reduce the ILD event (P = 0.062). Interestingly, severe ILD events (grades 2, 3, 4, or 5) were significantly reduced in patients with fexofenadine compared with patients without fexofenadine (P = 0.031). Although the administration of fexofenadine was not independent predictive factor for EGFR-TKIs-induced ILD according to multivariate analysis, it seems to reduce the ILD events (P = 0.061).Conclusions
Our data suggest that fexofenadine seem to reduce the incidence of TKI-induced ILD. However, the prospective study needs to be carried out to confirm our result.