Abstract:
Objective To evaluate the efficacy and safety of PEG-rhG-CSF therapy in the primary and secondary prevention of chemotherapy-induced neutropenia.
Methods This single-center, one-arm, and open-label clinical study involved 217 patients with non-myeloid 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 secondary 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 administration 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 revealed 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 grade Ⅳ neutropenia 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 grade Ⅳ neutropenia was significantly lower in the second cycle 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 significantly reduce the risk of grade Ⅳ neutropenia in all chemotherapy cycles relative to the secondary prevention.