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| |  Adding Lapatinib, Continuing Trastuzumab Despite Progression Adds Months to Breast Cancer Survival: Presented at SABCS By Ed Susman SAN ANTONIO, Tex -- December 12, 2009 -- Researchers said that adding lapatinib to the treatment regimen of patients with breast cancer whose disease is progressing on trastuzumab can extend survival for an average of 4.5 months compared with stopping trastuzumab and adding lapatinib alone. After 1 year of treatment, 41% of women who were treated with lapatinib monotherapy were alive compared with 56% of women treated with lapatinib plus trastuzumab, said Kimberly Blackwell, MD, Duke University Medical Center, Durham, North Carolina, here December 11 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). “We observed a 26% reduction in the risk of death (P = .026) among women on the combination therapy,” Dr. Blackwell said. She noted that the median survival of the women taking lapatinib and trastuzumab was 14 months compared with 9.5 months for lapatinib alone. In the study, 145 women were assigned to the lapatinib monotherapy arm while 148 women were on lapatinib and trastuzumab. The women received oral lapatinib 1,500 mg each day or oral lapatinib 100 mg each day plus intravenous trastuzumab 2 to 4 mg/kg weekly. The women were about 51 years of age and were in good performance status; they had a median of 4 to 5 chemotherapy regimens prior to entering the trial. About 52% of the women crossed over to receive both drugs are progression continued. Dr. Blackwell said that adverse side effects were low in the trial, with the most frequent grade 3 or grade 4 adverse event being diarrhoea. Grade 3 and grade 4 cardiac events occurred in 3 women on the combination treatment and in 1 patient in the lapatinib monotherapy arm. One death occurred in the combination arm, cause by pulmonary thromboembolism. “As a clinician, I think it’s amazing there was no increase in side effects with the combination of drugs,” Dr. Blackwell said. All the women in the study had been treated with trastuzumab alone or in combination with other chemotherapy regimens, but despite that these women with human epidermal growth factor receptor 2-positive metastatic breast cancer patients continued to progress. “In the US, there’s a tendency of doctors to take women off trastuzumab once it fails to help, but this shows significant benefit to continuing with it and adding a second targeted agent,” said Edith Perez, MD, Mayo Clinic, Jacksonville, Florida. Funding for this study was provided by GlaxoSmithKline. [Presentation title: Updated Survival Analysis of a Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With HER2-Positive Metastatic Breast Cancer Progressing on Trastuzumab Therapy. Abstract 61]
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