Paclitaxel (Taxol) chemotherapy in combination with Bevacizumab (Avastin) has become a standard treatment regimen for her-2 negative patients with metastatic breast cancer, based on findings of improved outcomes with the combination in the ECOG 2100 study. That trial compared paclitaxel alone to paclitaxel and bevacizumab combination therapy. For the combination, response rate was improved (30% vs. 14%, p<0.0001) and progression-free survival was improved (11.4 mos. vs. 6.1 mos; HR=0.51, p<0.0001). Bevacizumab was approved for treatment of metastatic breast cancer based on these results.
Many patients may not be appropriate for the combination of paclitaxel and bevacizumab therapy. Patients who have received prior taxane therapy in the adjuvant setting (particularly with a short disease-free interval to the time of metastatic disease) may increased risk for resistance to taxane therapy. Patients who are diabetic may have exacerbation of diabetes because of corticosteroid premedication required before taxane therapy. Patients with neuropathy may have worsening of neuropathy with taxane therapy.
For these patients, therapy with another chemotherapy agent in combination with bevacizumab may be considered. However, clinical trial data supporting the combination of other chemotherapy agents with bevacizumab is limited, and insurer coverage may be restrictive. An example of an alternative regimen would be gemcitabine (Gemzar) and bevacizumab. No corticosteriod premedications are required for gemcitabine therapy, and there is no risk of neuropathy.
Other important clinical circumstances may make the use of bevacizumab unattractive, such as severe hypertension, angina or recent ischemic events from coronary or cerebrovascular disease, thrombosis risk, bleeding, or the presence of CNS metastatic disease. Bevacizumab may cause proteinuria, increased blood pressure, bleeding, thrombosis, infusion reactions, delayed wound healing, or other rare toxicities (bowel perforation).
For more information about breast cancer therapy and clinical trial information, contact a CORT Research Coordinator at 972-566-5588 (Dallas) or 972-981-4012 (Plano), or visit our website at www.CORTPA.com.
Tags: Avastin, bevacizumab, Breast Cancer, clinical trial, gemcitabine, Gemzar, metastatic breast cancer, V06-031 study
January 12, 2009 at 10:14 pm |
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