Recurrence-Free Survival Improved with Taxotere® Compared to Navelbine®

Recurrence-Free Survival Improved with Taxotere® Compared to Navelbine® in Early Breast Cancer

According to an article recently published in the New England Journal of Medicine, treatment with the chemotherapy agent Taxotere® (docetaxel) improves recurrence-free survival compared with the chemotherapy agent Navelbine® (vinorelbine) for the treatment of early breast cancer. Furthermore, the addition of Herceptin® (trastuzumab) to both chemotherapy agents improved recurrence-free survival in HER2-positive patients.

Each year over 200,000 women are diagnosed with breast cancer in the U.S. alone. Early breast cancer refers to cancer that has not spread outside the breast and axillary (under the arm) lymph nodes. Cure rates remain high following standard therapy for early breast cancer.

Adjuvant therapy is treatment administered following surgery. The goal of adjuvant therapy is to kill any cancer cells that may remain in the body following surgery. Chemotherapy is commonly used as adjuvant therapy in early breast cancer, particularly for patients whose cancer has spread to axillary nodes (node-positive breast cancer). To further improve outcomes, researchers continue to evaluate different chemotherapy agents and combinations for the treatment of early breast cancer.

Approximately 30% of cancers overexpress a protein referred to as the human epidermal growth factor receptor-2 (HER2) protein. The HER2 protein is involved in cellular growth and replication. Fortunately, the targeted agent Herceptin (trastuzumab) binds to HER2 receptors and prevents or reduces replication of cancer cells that overexpress HER2.

Herceptin is currently approved by the FDA as a single agent for the treatment of patients with HER2-overexpressing metastatic breast cancer, or for those who have received at least one prior chemotherapy regimen for metastatic disease. It is also approved for use in combination with paclitaxel for the treatment of metastatic breast cancer in patients who overexpress HER2 and have not received prior treatment for their metastatic disease. Results from previous trials have demonstrated the effectiveness of Herceptin used as adjuvant therapy in combination with chemotherapy for patients with early breast cancer.

Researchers from Finland recently conducted a clinical trial to compare Taxotere to Navelbine as adjuvant therapy in breast cancer. This trial included 1,010 women with node-positive early breast cancer (these women were considered to be at a high risk of developing a recurrence); they were treated with either Taxotere or Navelbine. Both groups were then treated with the chemotherapy agents 5-fluorouracil, epirubicin, and cyclophosphamide. Of these patients, 232 were HER2-positive. Approximately half was treated with Herceptin, while the other half was not, regardless of which chemotherapy regimen they received.

Patients treated with Taxotere had improved recurrence-free survival compared to those treated with Navelbine:

  • At 3 years, recurrence-free survival was 91% for patients treated with Taxotere, compared with 86% for those treated with Navelbine.
  • Overall survival did not differ between the two groups of patients at 3 years.
  • Among HER2-positive patients, those treated with Herceptin had an improved recurrence-free survival (89%) compared to those who did not receive Herceptin (78%).
  • Taxotere was associated with more side effects.
  • Herceptin did not increase complications to the heart.

The researchers concluded that Taxotere is superior to Navelbine in terms of recurrence-free survival in the treatment of adjuvant breast cancer. Furthermore, addition of Herceptin to either chemotherapy regimen improved recurrence-free survival in HER2-positive patients without significant side effects to the heart.

Patients with early breast cancer may wish to speak with their physician regarding their individual risks and benefits of Taxotere as part of their chemotherapy regimen.

Reference: Joensuu H, Kellokumpu-Lehtinen P-L, Bono P, et al. Adjuvant Docetaxel or Vinorelbine with or without Trastuzumab for Breast Cancer. New England

Journal of Medicine. 2006; 354:809-820.

Related News:

Taxotere® Vs. Taxol® in Adjuvant Treatment of Breast Cancer (12/14/05)

Non-Anthracycline Chemotherapy Regimen plus Herceptin®: Effective and Less Toxic Adjuvant Therapy for Early Breast Cancer (12/13/05)

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