Gefitinib: an adverse effects profile

Author: Cersosimo, Robert J

Source: Expert Opinion on Drug Safety, Volume 5, Number 3, May 2006 , pp. 469-479(11)

Publisher: Informa Healthcare

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Abstract:

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 ∼ 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.

Keywords: adverse effect; gefitinib; toxicity

Document Type: Research article

DOI: http://dx.doi.org/10.1517/14740338.5.3.469

Publication date: 2006-05-01

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