Prophylaxis of Neutropenia with Mecapegfilgrastim in Patients with Hematologic Malignancies

Background: Neutropenia is a frequently reported adverse event in patients with hematologic malignancies. Prophylactic administration of long-acting granulocyte colony stimulating factor(G-CSF) had been widely applied in different solid tumors. However, the effect of long-acting G-CSF in patients with hematologic malignancies was not well studied.

Methods: A multi-center, non-interventional study was conducted to explore the efficacy and safety of mecapegfilgrastim, a long-acting G-CSF, in patients with hematologic malignancies. Patients administered at least twice mecapegfilgrastim were included for statistical analysis. The baseline characteristics, effectiveness and safety results were presented.

Results: Mecapegfilgrastim were administrated prophylactically in 74 patients (pts) with hematologic malignancies (Diffuse large B-cell lymphoma 34 pts, follicular lymphoma 9 pts, peripheral T-cell lymphoma 3 pts, primary mediastinal large B-cell lymphoma 3 pts, angioimmunoblastic T-cell lymphoma 3 pts, Anaplastic Large Cell Lymphoma 3 pts, classic Hodgkin's lymphoma 3 pts, other lymphomas 12 pts, other hematologic malignancies 4 pts). The median age of pts was 58 years. The ECOG performance score were 0 -2. Common chemotherapy regimens were CHOP, CHOEP, DHAP and GemOx. Rituximab, anti-PD-1 antibody, BTK inhibitors, chidamide and lenalidomide were the most administrated targeted or immunotherapeutic agents. In all 250 treatment cycles (61 chemotherapy cycles and 189 immunochemotherapy), twenty-seven pts had grade ≥3 neutropenia in 41 (16.4 %) cycles, fifteen pts had grade 4 neutropenia in 22(8.8 %) cycles, four pts experienced febrile neutropenia in 4 (1.6 %) cycles. In 61 chemo-alone treatment cycles, grade 3/4 neutropenia was reported in 10(16.4%) and, 4 (4.9 %) cycles, febrile neutropenia was recorded in 2(3.3 %) cycles. During 189 cycles of immunochemotherapy treatment, grade 3/4 neutropenia and febrile neutropenia was observed in 31(16.4%), 18(9.5 %) and 2(1.1 %) cycles, respectively. There were 5 cycles of grade 4 neutropenia occurred in 9 lenalidomide contained treatment cycles, and febrile neutropenia was reported in 1 cycle.

Grade ≥ 3 neutropenia induced treatment delay (≥ 7 days) was reported in 12 cycles while dose of cytotoxic drugs were not decreased. Eleven pts developed infection including 6 pneumonia events, they were treated with antibiotics in 23 cycles. Adverse event (AE) was reported in 64(86.6 %) pts. Fourteen (18.9 %) pts were hospitalized due to AEs. Most common grade 1/2 AEs related to mecapegfilgrastim were leucocytosis (18.9%) and neutrocytosis (6.8 %).

Conclusion: Mecapegfilgrastim showed promising effectiveness and reliable safety profile in pts with hematologic malignancies. Further investigation is warranted.