According to the results of a Phase II clinical trial published in the Journal of Clinical Oncology, neoadjuvant (before surgery) treatment with Taxotere® (docetaxel), Navelbine® (vinorelbine), and Herceptin® (trastuzumab) resulted in a complete disappearance of detectable cancer in 39% of women with locally advanced HER2-positive breast cancer; the rate of side effects, however, suggested that studies to evaluate a lower dose of treatment may be warranted.
Patients with large breast cancers are often classified as having locally advanced breast cancer. These cancers are difficult to completely remove surgically and breast-conserving surgery is not routinely performed. Over the past decade, a standard treatment has been to administer neoadjuvant (before surgery) chemotherapy before attempting surgical removal in order to make surgery less extensive and easier to perform. Clinical studies comparing neoadjuvant chemotherapy to mastectomy followed by adjuvant (post-surgery) chemotherapy have demonstrated that the number of patients eligible for treatment with breast-conserving strategies can be increased with neoadjuvant chemotherapy. However, there is currently no evidence that survival is improved with neoadjuvant versus adjuvant chemotherapy in women with locally advanced breast cancer.
To evaluate patient outcomes after neoadjuvant treatment with Taxotere, Navelbine, and Herceptin, researchers conducted a Phase II clinical trial among 31 patients with Stage IIB or Stage III HER2-positive breast cancer. Ninety percent of patients had node-positive cancer. All patients received neoadjuvant therapy, followed by surgery and additional chemotherapy with doxorubicin and cyclophosphamide.
- 39% of patients experience a pathologic complete response (no evidence of cancer in the tissue removed during surgery).
- After more than two years of follow-up, overall survival was 97% and cancer-free survival was 84%.
- Serious side effects include low white blood cell levels (neutropenia), low red blood cell levels (anemia), mouth sores (mucositis), and skin rash. All but one patient experienced grade 3 or grade 4 neutropenia. Twenty-two percent of patients experienced neutropenia accompanied by fever (febrile neutropenia).
The results of this study suggest that neoadjuvant therapy with Taxotere, Navelbine, and Herceptin produces high rates of response in patients with locally advanced HER2-positive breast cancer. In order to decrease the frequency of febrile neutropenia, however, the researchers note that additional studies of reduced doses of Taxotere and/or Navelbine are needed.
Limentani SA, Brufsky AM, Erban JK, et al. Phase II study of neoadjuvant docetaxel, vinorelbine, and trastuzumab followed by surgery and adjuvant doxorubicin plus cyclophosphamide in women with human epidermal growth factor receptor 2-overexpressing locally advanced breast cancer. Journal of Clinical Oncology. 2007;25:1232-1238.
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