Herceptin® Improves Survival in Early Breast Cancer
Published: May 17, 2005
According researchers at the 2005 annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Herceptin® (trastuzumab) to chemotherapy improves progression-free and overall survival as adjuvant therapy in women with early breast cancer. It was suggested that Herceptin become standard of care in the treatment of human epidermal growth factor (HER-2) positive early breast cancer.
Herceptin is a monoclonal antibody targeted against the HER-2 receptor. It is currently approved as a single agent in the treatment of HER2-positive metastatic breast cancer in patients who have received prior therapy, and as initial therapy to be used in combination with Taxol® (paclitaxel) in HER2-positive metastatic breast cancer. It is estimated that approximately 30% of breast cancers over express HER2.
Results presented at this year’s ASCO meeting included a joint analysis of the two large phase III randomized clinical trials NSABP B13 and NCCTG N9831, both of which were evaluating Herceptin in the adjuvant setting of over 3,000 women with HER2 positive early breast cancer.[1],[2] The two trials were comparing the chemotherapy combination doxorubicin and cyclophosphamide (AC) followed by Taxol (T) with or without Herceptin. One arm of the joint analysis included patients treated with AC +T sequentially followed with Herceptin, while another arm consisted of patients treated with AC+T treated with concurrent Herceptin. Herceptin therapy was continued for a total of one year. Patients in these trials were node-positive or high-risk node-negative patients, and received no prior anthracycline or taxane therapy.
Overall, at 3 years, the addition of Herceptin reduced the risk of a breast cancer event by 53%. At 2 years, Herceptin plus chemotherapy resulted in a 33% relative risk reduction of death, compared to chemotherapy alone (HR =0.67, p=0.015). There was an update of the analysis presented regarding outcomes of sequential versus concurrent Herceptin. Although not enough events have occurred to date to provide confirmatory results, at a median follow-up of 1.5 years, concurrent Herceptin to chemotherapy has significantly improved disease-free survival compared to sequential administration of Herceptin to chemotherapy. Overall, chemotherapy plus concurrent Herceptin increases disease-free survival by 36% when compared plus the sequential administration of Herceptin (p=0.0114). Differences in congestive heart failure or cardiac deaths were less than 4% in the Herceptin versus chemotherapy-only arms.
The researchers concluded that the addition of Herceptin should become the standard of care in the adjuvant setting of HER2-positive breast cancer, as survival is improved with acceptable toxicity. Further analysis of optimal scheduling of Herceptin, overall survival and optimal cardiac monitoring schedules is planned.
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