Abstract
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.
Disclosures
No relevant conflicts of interest to declare.
Earlier corticosteroid use for adverse event management in patients receiving axicabtagene ciloleucel for large B‐cell lymphoma
