A randomized controlled clinical study of pegylated recombinant human granulocyte colony-stimulating factor in chemotherapy-induced neutropenia

Objective: To compare the efficacy and safety of a single subcutaneous injection of PEG-rhG-CSF and daily rhG-CSF in chemotherapy-induced neutropenia. Methods: In the present randomized, open-label, match, and cross-over study, 78 patients with previously untreated non-small cell lung cancer, breast cancer, and non-Hodgkin's lymphoma with normal bone marrow function were enrolled. The patients were randomized into AB and BA groups. Each patient received two cycles of chemotherapy with identical regimens. In the study cycle, they received a single subcutaneous injection of 100 μg/kg PEG-rhG-CSF on day 3; and in the control cycle, daily subcutaneous infections of 5 μg/kg/d rhG-CSF began on day 3 and continued cither for 14 days or until the absolute neutrophil count (ANC) > 5.0 x 109/L twice post nadir, whichever occurred first. The efficacy and safety parameters were monitored. Results: The incidence of ANC < 1.5 x 109/L in 76 evaluable study cycles and 74 evaluable control cycles were 30.00% and 21.00%, with durations of 2.34 days and 2.31 days, respectively. Additionally, those with grade 4 neutropenia were 3.80% and 3.00%, respectively, in the trial and control cycles. The differences above were not statistically significant. None of the patients experienced febrile neutropenia after receiving PEG-rhG-CSF and rhG-CSF. Compared with that of rhG-CSF, the ANC profile of PEG-rhG-CSF exhibited limited "overshoot" of neutrophils after the nadir. Subgroup analysis according to disease type yielded similar results. The safety profiles of PEG-rhG-CSF and rhG-CSF were similar. Musculoskeletal pain or arthralgias occurred in 16.5% of the cases during the study cycles and 26.00% in the control cycles (P= 0.963), which were mostly mild or moderate. Other adverse effects, such as fever, fatigue, dizziness, gastrointestinal effects and injection-site pain, were transient and easily manageable. Conclusion: A single subcutaneous injection of 100 μg/kg PEG-rhG-CSF provides neutrophil support and a safety profile comparable to daily subcutaneous injections of 5 μg/kg/d rhG-CSF in Chinese patients receiving a variety of myelosuppressive chemotherapy regimens.