Lapatinib Superior to Hormonal Therapy in Patients with Renal Cell Carcinoma Failing Initial Therapy

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Lapatinib Superior to Hormonal Therapy in Patients with Renal Cell Carcinoma Failing Initial Therapy

Researchers have reported that lapatinib extends overall survival compared with hormonal therapy in patients with advanced renal-cell carcinoma that over-express epidermal growth factor receptor (EGFR). The details of this large randomized trial were presented at the June 2006 meeting of the American Society of Clinical Oncology in Atlanta, Georgia.

Recently two tyrosine kinase inhibitors, Sutent® (sunitib malate) and Nexavar® (sorafenib) have been found to be effective therapy for patients with renal cell carcinoma and have been approved by the FDA for treatment of patients with renal cell carcinoma who have failed primary therapy. Lapatinib is also a tyrosine kinase inhibitor in clinical development. It is a potent dual inhibitor of EGFR. Over-expression of ErbB1 and ErbB2 appears to be associated with poor prognosis and reduced overall survival. Preliminary studies have shown that lapatinib is active in some patients with breast cancer.

In this study, 417 patients with advanced renal-cell carcinoma were randomly allocated to receive oral lapatinib or hormonal treatment. Table 1 summarizes the main results of this trial.

Table 1: Oral Lapatinib Versus Hormonal Therapy Alone in Advanced Renal Cell Carcinoma

	Lapatinib	Hormonal Therapy
Time to Tumor Progression (all N = 417)	15.3 weeks	15.4 weeks
Median Overall Survival (all N = 417)	46.9 weeks	43.1 weeks
Time to Tumor Progression (EGRF Over-expression N = 241)	15.1 weeks	10.9 weeks
Median Overall Survival (EGRF Over-expression N = 241)	46.0 weeks	37.9 weeks

For the 241 patients with EGRF over-expression the hazard ratios were 0.76 for time to progression and 0.69 for overall survival for patients receiving lapatinib.

Comments: This adds to the list of biologic agents that are active in patients with renal cell carcinoma.

Reference: Ravaud A, Gardner J, Hawkins H, et al. Efficacy of lapatinib in patients with high tumor EGFR expression: Results of a phase III trial in advanced renal cell carcinoma (RCC). Journal of Clinical Oncology . 2006;24, Abstract # 4502.

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