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Erlotinib: Recent Clinical Results and Ongoing Studies in Non–Small Cell Lung Cancer

Author's Affiliation: Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York

Requests for reprints: Roman Perez-Soler, Department of Oncology, Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467-2490. Phone: 212-920-4001; Fax: 718-798-7474; E-mail: rperezso{at}montefiore.org.

The epidermal growth factor receptor tyrosine kinase inhibitor erlotinib has shown to provide clinical benefit to patients with non–small cell lung cancer (NSCLC) after failure of front-line chemotherapy in a double-blind placebo-controlled clinical trial. More importantly, because of its unique mechanism of action, erlotinib seems to provide higher clinical benefit to specific subgroups of patients. The continued development of erlotinib in NSCLC is focused on the following areas: (a) validating clinical and molecular markers of clinical benefit in front-line therapy, (b) developing therapies for acquired and naturally resistant tumors, (c) revisiting combinations with chemotherapy, (d) developing combinations with antiangiogenesis agents, and (e) understanding the biological significance of the skin toxicity and developing rational approaches for its treatment. Clinical studies addressing these five areas are ongoing and are briefly described in this review.