background • Lapatinib is a dual tyrosine kinase inhibitor blocking human epidermal growth factor receptors (hER1, hER2). Lapatinib in combination with Capecitabine has showed efficacy in hER2+ metastatic breast cancer (MBC) previously treated with Anthracycline, taxane and trastuzumab. this study is the first to evaluate the clinical benefit and safety of the combination of Lapatinib and Capecitabine in hER2+ MBC previously treated with Anthracycline, taxane and trastuzumab, treated at Albairouni Cancer Center. Patients and Methods • Patients with hER2+, hormonal receptors negative, locally advanced or metastatic breast cancer that had failed Anthracycline, a taxane, and trastuzumab were enrolled. Patients received (Lapatinib 1250 mg per day continuously plus Capecitabine 2000 mg/m2 on days 1 through 14 of a 21-day cycle). treatment was given until progression. the primary endpoint was the clinical benefit (complete response, partial response or stability) for at least 3 months.

Results • In the 60 evaluable patients, clinical benefit rate was documented in 76% and 58.32% of the study population for 3 and 6 months, respectively. Progression beyond one year was seen in 15 patients (25%). Interestingly, one patient achieved time to progression (ttP) > 24 months. Median ttP was 8.1 months [95% CI: 6.5-11.2]. the most clinical side effects were mild: nausea (40%), vomiting (20%), diarrhea (35%), hand-foot syndrome (41.7%), rash (15%) and fatigue (11.66%).

Conclusion • the combination of Lapatinib and Capecitabine demonstrated a broad clinical benefit with acceptable safety profile in pretreated hER2+ metastatic breast cancer with either visceral or brain metastases.

Keywords: metastatic breast cancer; HER2; Lapatinib; Capecitabine

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