ABSTRACT
@#During chemotherapy of malignant tumors,neutropenia is the most important adverse event caused by myelosuppressive chemotherapeutics,of which the degree and duration are closely related to the risk of infection and even death.Granulocyte-colony stimulating factor(G-CSF) is an endogenous hematopoietic growth factor that can stimulate the proliferation and differentiation of neutrophil precursors,and increase the survival rate and activity of mature neutrophils.Recombinant human granulocyte-colony stimulating factor(rhG-CSF) is an artificially synthesized cytokine with G-CSF biological activity.It is used clinically for the prevention and treatment of neutropenia after treatment with cytotoxic chemotherapeutics,requiring multiple medications and repeated injections during application for its short half-life.Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is its long-acting dosage form,and patients only need to be administered once per cycle of chemotherapy,which has been widely used in clinical practice because of its stability and convenience.This paper systematically described the clinical application value of PEG-rhG-CSF in neutropenia after chemotherapy,aiming to provide a reference for its further clinical application.
ABSTRACT
Objective: To evaluate the efficacy and safety of PEG-rhG-CSF therapy in the primary and secondary prevention of chemo-therapy-induced neutropenia . Methods: This single-center, one-arm, and open-label clinical study involved 217 patients with non-my-eloid malignant tumors. These patients included 18 gynecologic oncology (3 endometrial and 15 ovarian cancer), 50 breast cancer, 30 bone tumor, and 119 lymphoma patients who underwent a total of 774 cycles of chemotherapy, comprising 146 primary and 71 sec-ondary prevention patients. The patients ≥45 kg and those <45 kg received a single subcutaneous injection of 6 mg and 3 mg PEG-rhG-CSF, respectively, 24-48 h after the chemotherapy was completed. All patients received only one dose of PEG-rhG-CSF admin-istration per chemotherapy cycle. Results: The overall incidence of febrile neutropenia (FN) was found to be 5.7%, with rates of 4.9% and 7.2% in the primary and secondary prevention groups, respectively. Univariate and multivariate Logistic regression analyses re-vealed that the longer PEG-rhG-CSF was sustained in the treatment cycle, the lower the incidence of FN was. The incidence of FN was significantly lower in the second cycle of the treatment than in the first in both the primary and secondary prevention groups (cycle 1 vs. cycle 2: 11.6% vs. 4.4%, respectively, P=0.039, in the primary group; 16.9% vs. 5.6%, respectively, P=0.034, in the secondary group). The overall incidence of gradeⅣneutropenia was 10.3% (80/774), with rates of 6.7% (34/510) and 17.4% (46/264) in the primary and secondary prevention groups, respectively (P<0.001). The incidence of gradeⅣneutropenia was significantly lower in the second cy-cle of the treatment than in the first (cycle 1 vs. cycle 2: 17.1% vs. 5.3%, respectively, P=0.004, in the primary group; 46.5% vs. 11.3%, respectively, P<0.001, in the secondary group). The treatment-induced toxicity mainly involved bone pain, with 3.7% (8/217) and 1.8% (4/217) incidence rates for grade 1-2 and 3-4 bone pain, respectively. Conclusions: PEG-rhG-CSF administration can effectively reduce the incidence of FN (5.7%) when prophylactically applied to patients with non-myeloid malignant tumors. Primary prevention can sig- nificantly reduce the risk of grade IV neutropenia in all chemotherapy cycles relative to the secondary prevention.
ABSTRACT
Objective:To compare the efficacy and costs of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) and granulocyte colony stimulating factor (G-CSF) for hematopoietic stem cell mobilization and hematopoietic recovery after transplantation in patients with relapsed or refractory malignant lymphoma. Methods:From July 2014 to October 2016, 15 patients with malignant lymphoma using peripheral blood stem cell mobilization (PBSCM) for autologous peripheral stem cell transplantation (APBSCT) were treated in our institution and enrolled in the PEG-rhG-CSF group (experimental group). We analyzed data from other 15 patients with malignant lymphoma mobilized with G-CSF who were treated in our institution from January 2013 to August 2015 (control group). Results:Patients in both groups were successfully mobilized. The median amounts of CD34+cells collected in the experimental and control groups were 16.2×106/kg and 8.9×106/kg, respectively (P=0.414), and the median amount of mononuclear cell (MNC) was 12.4×108/kg and 9.9× 108/kg, respectively (P=0.519). In the experimental and control groups, the mean durations of mobilization were 10.66±1.45 and 9.33±1.83 days (P=0.234), the mean durations of neutropenia during mobilization were 4.20±2.17 and 3.80±2.04 days (P=0.608), the mean durations of absolute neutrophil count recovery after APBSCT were 10.14±1.29 and 10.93±2.69 days (P=0.327), and the mean durations of platelet recovery were 10.36±2.27 and 12.27±3.38 days (P=0.121). Mobilization and hematopoietic recovery after APBSCT were not significantly different between the two groups. The cost was lower in the experimental group than that in the control group (RMB 3,960 yuan versus RMB 11,479.3±2,401.3 yuan). Conclusion:High-dose chemotherapy combined with PEG-rhG-CSF is a promising, effective, and low-cost mobilization regimen for patients with relapsed or refractory malignant lymphoma.
ABSTRACT
Objective: To compare the efficacy of pegylated recombinant human granulocyte colonystimulating factor (PEG-rhG-CSF) versus recombinant human granulocyte colony-stimulating factor (rhG-CSF) as prophylaxis of adjuvant chemotherapy (EC regimen: Epirubicin combined with cyclophosphamide)-induced neutropenia in patients with breast cancer, and examine the safety. Methods: A total of 135 breast cancer patients receiving adjuvant chemotherapy with EC regimen between October 2013 and March 2015 were divided into prophylactic group (n = 54) and non-prophylactic group (n = 81). The prophylactic group was further divided into PEG-rhG-CSF group (n = 19) and rhG-CSF group (n = 35). The PEG-rhG-CSF group was defined as being given PEG-rhG-CSF of single dose (3 mg) subcutaneously 48 hours after the end of the chemotherapy; the rhG-CSF group was defined as being given rhG-CSF 5 μg·kg-1·d- 1 subcutaneously 48 hours after the end of the chemotherapy and for 3-5 days. Results: There were significant differences in the incidence rates of grade 3/4 neutropenia and febrile neutropenia (FN) between the prophylactic group and non-prophylactic group (both P 0.05). Conclusion: Breast cancer patients receiving adjuvant chemotherapy with EC regimen should be prophylactically treated with G-CSF. PEG-rhG-CSF, which can prevent neutropenia effectively, is worth to be widely applied in clinical practice.