Abstract

Aim: HER2 receptor is a molecular target for breast cancer therapy. Two drugs acts against this receptor: Trastuzumab, a monoclonal antibody efficacy both in metastatic and adiuvant setting and Lapatinib, an orally kinase inhibitor both HER1 and HER2 receptors, approved for HER2-positive metastatic breast-cancer. The study establish efficacy and safety of Lapatinib in early stage HER2 over-expressing breast cancer and examines prognostic and predictive role of HER2 and HER1 receptors. Methods: Women with early-stage HER2 positive breast cancer, not previously treated with trastuzumab, but pretreated with adjuvant chemotherapy, were randomly assigned to receive Lapatinib 1500 mg or placebo orally once daily, for 12 months or until disease recurrence. Primary endpoint was disease-free survival (DFS). Safety and overall survival (OS) were secondary endpoints.
Results: Twelve women were enrolled. Five patients discontinued treatment: two for withdrawal consence and three for toxicity (skin-rush G3 in one case and diarrhea G2 in other two). Seven women completed 1-yr therapy: 3 didn't show toxicity and four had skin toxicity G1-2; a patient had a dose reduction. After 24 months of follow-up, 6 patients are disease free and a patient died after 3 months from diagnosis of SNC metastases (May 2009).
Conclusions: Lapatinib showed a good safety profile. Diarrhea and skin-rush were the most common side-effects and were mostly moderate and treatable. Follow-up is too short for disease free survival datas.

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