Abstract

Lapatinib is an oral dual inhibitor of EGFR and HER2, the coexpression of which is associated with metastatic disease in patients with renal cell carcinoma. A recent randomized phase III trial of lapatinib versus hormone therapy was conducted in patients with cytokine-refractory metastatic renal cell carcinoma and tumors overexpressing EGFR and/or HER2. The study included 416 such patients who received either lapatinib (n = 209) or hormone therapy (n = 207). No benefit in time to progression, which was the primary end point of the study, or other clinical outcome measures, could be demonstrated for lapatinib therapy. A nonsignificant numerical advantage in time to progression was observed in patients with EGFR overexpression in the primary tumor (immunohistochemistry score 3+), suggesting that lapatinib could be of benefit in this subset of patients. This commentary emphasizes the need for further prospective studies to demonstrate the benefit of lapatinib therapy in patients with metastatic renal cell carcinoma.

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