Efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor in the primary and secondary prevention of chemotherapy-induced neutropenia in patients with lymphoma.

Abstract

e20061 Background: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF, brand name: Jinyouli) in the primary and secondary prevention of chemotherapy-induced neutropenia in patients with lymphoma. Methods: This single-center, one-arm and open-label clinical study enrolled 119 patients with lymphoma in Peking University Cancer Hospital & Institute from May 2016 to December 2018. Patients ≥45 kg received a single dose of PEG-rhG-CSF for 6mg, < 45kg for 3mg, subcutaneous injection once in 24-48 h after chemotherapy. Results: 119 lymphoma patients, including 60 primary and 59 secondary prevention patients, underwent a total of 427 cycles of chemotherapy. The overall incidence of febrile neutropenia (FN) was 6.32% (27/427), with rates of 5.39% and 7.17% in the primary and secondary prevention groups, respectively. There was no significant difference between two groups ( P> 0.05).The incidence of FN was significantly lower in the second cycle than in the first cycle in both the primary and secondary prevention groups ( In the primary group: cycle 1 vs. cycle 2: 15.00% vs. 2.22%, respectively, P= 0.027; In the secondary group: cycle 1 vs. cycle 2: 16.95% vs. 5.08%, respectively, P= 0.040). The overall incidence of grade Ⅳ neutropenia was 13.58% (58/427), with rates of 8.82% and 17.94% in the primary and secondary prevention groups, respectively. There was a significant difference between two groups ( P= 0.006). The incidence of grade Ⅳ neutropenia was significantly lower in the second cycle than in the first cycle (In the primary group: cycle 1 vs. cycle 2: 25.00% vs. 4.44%, respectively, P= 0.005; In the secondary group: cycle 1 vs. cycle 2: 47.46% vs. 11.86%, respectively, P< 0.001). The main treatment-related adverse event was bone pain, with an incidence of 2.52% (3/119). Conclusions: PEG-rhG-CSF can effectively reduce the incidence of FN and neutropenia with good safety in patients with lymphoma after chemotherapy. Primary prevention can significantly reduce the risk of grade IV neutropenia in all chemotherapy cycles compared with the secondary prevention. Clinical trial information: NCT02905916 .