Gefitinib: an adverse effects profile.

Gefitinib, an epidermal growth factor receptor inhibitor, is currently approved for use in patients with advanced non-small cell lung cancer who have failed previous chemotherapy or who are not suitable for chemotherapy in > 30 countries. The approved dose in patients with non-small cell lung cancer is 250 mg/day. The most common adverse effects are rash, diarrhoea, acne, dry skin, nausea and vomiting. Most of the effects are mild-to-moderate in nature and do not require discontinuation of therapy. The severity of many of these effects is dose-related with grade 3-4 effects more likely at a dose > 250 mg/day. The most severe adverse effect is interstitial lung disease (ILD), which occurs in approximately 1% of patients worldwide except for Japan where the incidence of ILD is 2%. ILD is fatal in approximately one out of three of the cases. The most common adverse effects associated with chemotherapy, myelosuppression and alopecia, are not commonly seen with gefitinib monotherapy.