Abstract
1145 Background: Therapies targeting HER2 are very effective in metastatic breast cancer (MBC) combined with chemotherapeutic agents (CAs). Lapatinib (L) demonstrated activity and improved time to disease progression in pts who had progressed on trastuzumab (T) (Cameronet al 2008). Since April 2007, L in combination with capecitabine (X) was available in Italy within an expanded access program and thereafter as commercial drug. Methods: From April 2007 to March 2009, 58 HER2-positive MBC pts who had developed progression after antracycline-, taxane-, and T-based regimens, were treated with L plus X in our Institution. Results: Fifty-seven pts were evaluable for response. The median number of previous treatment lines, including the adjuvant setting, was 3 (ranging from 1 to 7). The median duration of previous T treatment (given alone or with chemotherapy) was 19 months (range 2.5-57 months). The median time to progression (MTTP) after first line T plus a cytotoxic agent (CA) was 11 months. At progression, 40 pts (69%) had visceral disease and in particular 8 pts (14%) had brain metastasis. The median number of cycles of L-X was 7 (range 2-29+ cycles). MTTP after L-X was 5,3 months. Clinical benefit (CB) (defined as complete remission plus partial remission plus stable disease lasting for at least 6 months) was noted in 33 pts (57%) with 4 pts having long lasting CR in visceral sites. The most frequent nonhematological toxicity was diarrhea and hand-foot syndrome. No G4 toxicity was noted. Conclusions: The combination of L and X is confirmed to be an active regimen even in highly pretreated HER2-positive MBC pts and in pts with visceral and brain metastases. Unfortunately the toxicity of both agents appears to be partly overlapping, even if only few pts experienced severe toxicities. Comparative studies with other CAs appear to be warranted. No significant financial relationships to disclose.
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