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| |  Lapatinib Plus Nab-Paclitaxel Shows Promise for HER2-Positive Breast Cancer: Presented at SABCS By Jill Stein SAN ANTONIO, Tex -- December 11, 2009 -- The combination of lapatinib and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is very active as first-line treatment for HER2-positive breast cancer, researchers announced here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Virginia Kaklamani, MD, Northwestern University, Chicago, Illinois, presented response data in 25 women with newly diagnosed stage I to III breast cancer, here on December 10. While nab-paclitaxel has been shown to be one of the most active agents in metastatic breast cancer, it has not been studied as part of combination therapy in the neoadjuvant setting, according to Dr. Kaklamani. The rationale behind targeting breast cancer with this combination is to block 2 tumourigenic pathways, thereby offering an increased response rate with no compromise in toxicity. Patients received intravenous nab-paclitaxel 260 mg/m2 over 30 minutes every 21 days for a total of 4 treatment cycles. The first 10 patients received concurrent lapatinib 1000 mg/day for the duration of nab-paclitaxel treatment. After a safety evaluation, the next 20 patients received concurrent lapatinib 1000 mg/day for the duration of nab-paclitaxel treatment. The accrual goal of 30 patients has been met. The primary endpoint was the clinical response rate (CRR), as determined by clinical examination and imaging studies. Response data in 29 patients showed a CRR of 82%, with 4 (13.8%) patients demonstrating a complete response and 20 (69%) showing a partial response. Five (17.2%) patients had stable disease. Five (18.5%) patients achieved pathologic complete response (pCR). Major side effects included fatigue, diarrhoea, and rash, which were similar in intensity and frequency with what typically occurs with each individual medication. There were no cases of cardiac toxicity. Dr. Kaklamani said that the study showed that the combination of lapatinib and nab-paclitaxel is active in HER2-positive breast cancer. She emphasised that while the pCR was lower than in other neoadjuvant studies using anti-HER2 therapy, the current study used only 4 cycles of chemotherapy. Funding for this study was provided by GlaxoSmithKline and Abraxis Oncology. [Presentation title: Pilot Neoadjuvant Trial With Combination of Lapatinib and Nab-Paclitaxel in HER2+ Breast Cancer. Abstract 1091]
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