Clinical Efficacy and Safety of Secondary Prophylactic Pegylated G-CSF (Pegteograstim)

초록

Background/Aims: Febrile neutropenia (FN) is a common and potentially fatal complication of anticancer treatment, particularly in patients receiving myelosuppressive chemotherapy. It has been shown that prophylaxis with granulocyte colony-stimulating factor (G-CSF), especially its pegylated forms, significantly reduces the incidence of FN, the likelihood of chemotherapy dose intensity reduction and, also, the number of hospitalizations due to FN. This study evaluated the efficacy and safety of pegteograstim which is recombinant human G-CSF conjugated with methoxy-maleimide-polyethylene glycol in patients who experienced febrile neutropenia or grade (Gr.) 4 neutropenia on prior chemotherapy cycle. Methods: Among patients who receiving chemotherapy in Inha University Hospital, the patients who experienced grade 4 neutropenia or febrile neutropenia in prior chemotherapy cycle were enrolled. Patients had to satisfied baseline absolute neutrophil count (ANC) of 1500/㎕ and platelet count of 100,000/㎕ before chemotherapy. Pegteograstim was administered to enrolled patients 24 hours after termination of chemotherapy. Complete blood count test and adverse effect evaluation were performed within 1week after pegteograstim injection. Results: Thirty patients with a median age 59 were enrolled. There were 29 females (96.7%) and 1 male (3.3%). Patients had diagnoses of breast cancer (n=16), gynecologic cancer (n=9) colon cancer (n=3), stomach cancer (n=1) and esophageal cancer (n=1). The median ANC at occurrence of neutropenia was 225 /㎕. Cell blood count (CBC) and side effects were evaluated between 5 ~ 7 days after courses of chemotherapy. The median ANC was 12528/㎕ and Gr. 4 or febrile neutropenia occurred in 1 (3.3%) and 3 (10.0%) patients, respectively. Gr. 3/4 anemia was reported in 4 patients (13.3%), and musculoskeletal adverse effect of Gr. 3/4 were not developed.