Denis Soulières, MD, MSc

The identification of predictive or surrogate markers of response toHER1/epidermal growth factor receptor (EGFR) inhibitor treatmentwould permit selection of patients most likely to respond to such treatment.Markers could consist of tumor characteristics (eg, characteristicsof the receptor or downstream signaling molecules and determinantsof resistance) or host characteristics (eg, pharmacokinetic parametersand toxicities). The occurrence of rash may constitute a surrogatemarker of response to erlotinib (Tarceva) treatment in patientswith non–small-cell lung cancer and other cancers. The erlotinib markeridentification program has been designed to identify and investigateother candidate markers by analysis of a large number of clinicalsamples from patients enrolled in erlotinib trials in non–small-cell lungcancer, including the phase III TALENT and TRIBUTE trials oferlotinib combined with chemotherapy and the phase III BR.21 trial oferlotinib monotherapy in advanced non–small-cell lung cancer. Thisprogram should both contribute to understanding of the molecular biologyof HER1/EGFR inhibition and result in identification of potentialmarkers that can be evaluated in the clinical setting.