Efficacy and safety of the combination of lapatinib plus capecitabine for HER2-positive advanced breast cancer.

Abstract

e11520 Background: Effective treatment options for patients with metastatic breast cancer resistant to anthracyclines, taxanes and trastuzumab are limited. Lapatinib, an oral receptor tyrosine kinase inhibitor, targeting both the human epidermal growth factor receptor type 2 (HER2) and epidermal growth factor receptor (EGFR), is active in combination with capecitabine in women with HER2-positive advanced breast cancer. The retrospective study purpose is to assess the safety and efficacy of the 21-day schedule of lapatinib plus capecitabine in a nonselected population, as applied in the every-day practice of our department. Methods: We retrospectively reviewed data from 27 patients treated with lapatinib at a dose of 1,250 mg per day continuously plus capecitabine at a dose of 2,000 mg per square meter of body surface area on days 1 through 14 of a 21-day cycle from June 2007 to January 2010. It is of interest that this group of patients was heavily pretreated with taxanes (100%), anthacyclines (74%), trastuzumab (81%), and other chemotherapeutic drugs. They had received median 4 prior lines of chemotherapy for metastatic breast cancer. Results: Complete response (CR) was achieved in 2 patients (8%), partial response (PR) in 9 (33%), and stable disease (SD) in 3 (11%). The median time to progression was 23 weeks and the overall survival 73 weeks. The most common adverse events were diarrhea, vomiting, hand and foot syndrome, fatigue, and rash. Most adverse events were grade I and II. Grade III toxicities included diarrhea (11%), fatigue (4%), hand and foot syndrome (8%), vomiting (4%), and instability (4%). No toxic death occurred. Conclusions: The 21-day schedule was well tolerated and effective in heavily-pretreated women with HER2-positive advanced breast cancer. No significant financial relationships to disclose.