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| |  Adjuvant Trastuzumab With Chemotherapy for 1 Year Delays Breast Cancer Progression: Presented at SABCS By Ed Susman SAN ANTONIO, Tex -- December 13, 2009 -- Trastuzumab as adjuvant therapy improves survival over yearlong administration, according to results from a clinical trial presented here at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). After 1 year, 80.1% of women who were receiving trastuzumab following surgery and chemotherapy had achieved disease-free progression compared with 71.9% of patients who received chemotherapy alone after definitive surgery for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, noted Edith Perez, MD, Mayo Clinic, Jacksonville, Florida. “That difference reached statistical significance at the P = .0005 level,” Dr. Perez said here on December 12 at an oral presentation. The trial, which was initiated in 2000, and followed subjects for an average of 5.5 years, also tried to determine in what sequence trastuzumab should be delivered. A 25% reduction in the risk of breast cancer recurrence was seen when trastuzumab was administered concurrently, rather than following chemotherapy. In all, 84.2% of patients who received trastuzumab concurrently achieved disease-free survival compared with 79.8% among patients who received trastuzumab following chemotherapy. Dr. Perez described the difference as a strong trend (P = .0190). She added that, due to interim analyses and fewer than expected events, a significant P value for this aspect of the trial would have been P < .0001. “Often the research community conducts studies that conclude with ‘That was interesting, but let’s do more research,’” said Dr. Perez. “This is an important finding on how we can help prevent breast cancer recurrence and improve survival.” All patients enrolled in this phase 3 trial were receiving standard chemotherapy of doxorubicin and cyclophosphamide followed by paclitaxel. In the first comparison, Dr. Perez and colleagues randomly assigned 2,448 patients to either chemotherapy alone or chemotherapy followed by trastuzumab. The second comparison included 1,903 women, comparing those who received trastuzumab after chemotherapy with those who received it concurrently with paclitaxel. “This study has global implications,” Dr. Perez noted. “In the United States, trastuzumab is approved for use either following or concurrently with chemotherapy. However, currently, in some countries, trastuzumab is only approved for use following chemotherapy as adjuvant therapy for HER2-positive breast cancer. We hope our findings will change those policies. In the United States, this will clearly inform physician decision making.” Funding for this study was provided by Genentech as well as the US-funded cooperative cancer study groups. [Presentation title: Results of Chemotherapy Alone, With Sequential or Concurrent Addition of 52 Weeks of Trastuzumab in the NCCTG N9831 HER2-Positive Adjuvant Breast Cancer Trial. Abstract 80]
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