Is treatment of docetaxel(Taxotere) with bevacizumab(Avastin) safe?

This paper evaluates whether adding bevacizumab (Avastin) to docetaxel (Taxotere)-containing chemotherapy treatment is safe in patients with breast cancer.

For early stage breast cancer, docetaxel (a drug that interferes with cell division)-containing chemotherapy improves survival. Bevacizumab (a drug that slows the growth of new blood vessels) improves survival in metastatic breast cancer (cancer that spreads to other parts of body). However, adding bevacizumab to docetaxel-containing chemotherapy may increase cardiotoxicity (damage to the heart).

Hence, the authors evaluated the safety and effectiveness of adding bevacizumab to three standard docetaxel-containing adjuvant breast cancer treatment regimens (treatment undertaken after primary treatment).

212 patients were treated who had undergone mastectomy (surgery to remove breast) or breast-conserving surgery (surgery to remove part of breast). They were lymph node positive (cancer present in lymph node) or high-risk node-negative (no cancer present in lymph node) . Patients did not have cardiac disease.

Patients received a treatment regimen based on their human epidermal growth factor 2 status (HER2; a protein found on the cell surface). Regimen A was treatment with doxorubicin (Doxil, Adriamycin) + cyclophosphamide (Cytoxan) followed by docetaxel. Regimen B was treatment with docetaxel + doxorubicin + cyclophosphamide. Regimen C was treatment with docetaxel + carboplatin (Paraplatin) + trastuzumab (Herceptin). All patients received bevacizumab for 52 weeks. Patients without human epidermal growth factor 2 randomly received either regimen A or B. Patients with human epidermal growth factor 2 received regimen C.

Patients underwent medical examinations and were evaluated for safety and toxicity. Evaluations were conducted after 52 weeks of treatment, 4 weeks after last dose and at 2 years follow up.

Cardiac heart failure of grade 3 and above (when physical activity causes fatigue) was experienced by 1.3% of patients in regimen A, 1.7% of patients in regimen C and 4% of patients in regimen B. Overall, 32.1% of patients in regimen A, 28% of patients in regimen B and 39% of patients in regimen C experienced at least 1 cardiac failure event.

The percentage of patients who experienced peripheral edema (swelling of feet and legs) was 20.5% (regimen A), 14.7% (regimen B) and 11.9% (regimen C). The percentage of patients who experienced edema (swelling of body tissues) was 7.7% (regimen A), 5.3% (regimen B) and 10.2% (regimen C). The percentage of patients who experienced decreased ejection fraction (decreased heart performance) was 6.4% (regimen A), 9.3% (regimen B) and 11.9% (regimen C).

The authors concluded that adding bevacizumab to docetaxel-based chemotherapy regimens was associated with a low rate of cardiac heart failure of grade 3 and above in patients with early stage breast cancer.