Safety and efficacy study of the recombinant granulocyte colony-stimulating factor for prevention of neutropenia and neutropenia-related complications in women with metastatic breast cancer receiving docetaxel/doxorubicin

Background. We evaluated efficacy and safety of recombinant granulocyte-colony stimulating factor (rGCSF) used as primary prophylaxis to prevent neutropenia and neutropenia-related complications induced by docetaxel and doxorubicin chemotherapy in patients with metastatic breast cancer. Patients and methods. Three centers in Lithuania enrolled 36 patients who received rGCSF (5 μg/kg/d) on day 2 of each 21-day chemotherapy with docetaxel 75 mg/m2 and doxorubicin 50 mg/m2 (AT) starting in the first cycle. Treatment regimen was repeated for up to six cycles. Results. Leukocytosis, bone pain, and headache were the most frequent adverse events, with incidence rates of 22%, 19%, and 8%, respectively. Adverse events were typical for rGCSF in this patient population. Overall incidence rate of febrile neutropenia was 14%. The mean duration of febrile neutropenia episodes across cycles was 2.14 days. Incidence of chemotherapy delay was 2%. There was no reduction in chemotherapy dose due to expected toxicity or side effects. Intravenous antibiotics for the treatment of febrile neutropenia were needed in 19% of cases. Quality-of-life assessment shows a significant improvement in emotional functioning and a significant decrease in pain score. The efficacy profile of rGCSF observed in the present study was comparable with that of other rGCSF products previously described in the published scientific literature. Conclusions. The primary prophylaxis of neutropenia and its complications by rGCSF was safe and effective for women with metastatic breast cancer who received chemotherapy with docetaxel and doxorubicin