In breast cancer patients treated with docetaxel or vinorelbine followed by FEC (5-fluorouracil, epirubicin, cyclophosphamide), a nine-week course of Herceptin (trastuzumab) showed promising effectiveness without increasing the risk of heart problems. These results were recently presented at the 28th annual San Antonio Breast Cancer Symposium.
Herceptin is a monoclonal antibody that targets the HER-2 protein-a protein that is involved in cellular growth and replication and overexpressed in roughly 30% of breast cancers. The binding of Herceptin to HER-2 prevents or reduces replication of cancer cells.
The combination of Herceptin with an anthracycline-based chemotherapy regimen improves breast cancer outcomes compared to chemotherapy alone, but can result in severe heart complications. Researchers therefore continue to evaluate ways to maintain the effectiveness of Herceptin and chemotherapy while minimizing the risk of heart problems.
To assess the safety and effectiveness of a shorter than usual course of Herceptin, researchers in Finlandconducted a clinical trial among 1,010 women with either node-positive breast cancer or node-negative breast cancer that was greater than 20 mm.
Patients were initially randomized to receive either docetaxel or vinorelbine. Treatment with docetaxel or vinorelbine was followed by FEC (5-fluorouracil, epirubicin, cyclophosphamide) as well as five years of tamoxifen if hormone receptor-positive. Patients with amplification of the gene that produces HER-2 underwent a second randomization to receive either 9 weeks of Herceptin (concomitantly with docetaxel or vinorelbine) or no Herceptin.
This first interim analysis includes a median of 3 years of follow-up:
- 91% of patients treated with docetaxel were alive and free of cancer recurrence at the end of follow-up, compared to 86% of patients treated with vinorelbine.
- Among patients who were candidates for Herceptin, 89% of those who received Herceptin were alive and free of cancer recurrence, compared to 78% of those who did not receive Herceptin.
- At this point, overall survival is not significantly different between those who did and did not receive Herceptin, but there is a suggestion of longer survival in those who received Herceptin.
- There was no evidence of an increase in heart problems in patients treated with Herceptin.
The researchers concluded that a 9-week course of Herceptin given concomitantly with either docetaxel or vinorelbine significantly reduces cancer recurrence without increasing the risk of heart problems among patients also treated with FEC. The researchers state that additional studies are necessary to directly compare the standard one-year regimen of Herceptin to this shorter 9-week regimen to determine efficacy. Furthermore, it appears that docetaxel may provide superior results to vinorelbine when used prior to FEC in the adjuvant treatment of breast cancer.
Reference: Joensuu H, Kellokumpu-Lehtinen P-L, Bono P, et al. Trastuzumab in Combination with Docetaxel or Vinorelbine as Adjuvant Treatment of Breast Cancer: the FinHer Trial. Proceedings from the 28th annual San Antonio Breast Cancer Symposium. December 2005. Abstract #2.
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