Efficacy and safety of 3 mg pegylated recombinant human granulocyte colony-stimulating factor as support to chemotherapy for lung cancer.

Abstract

BackgroundNCCN guidelines recommend a dose of 100 μg/kg or a fixed dose of 6 mg pegylated recombinant human granulocyte colony‐stimulating factor (PEG rhG‐CSF) for chemotherapy‐induced neutropenia. However, a single dose of 60 μg/kg or 100 μg/kg produced a similar neutrophil response among patients with chemotherapy‐induced neutropenia (CIN). Thus, this prospective randomized study was designed to investigate the efficacy of 3 mg PEG rhG‐CSF in preventing acute lower respiratory tract infection (ALRTI) after chemotherapy.MethodsPatients with stage IIIB/IVA lung cancer who underwent chemotherapy were randomly divided into a (i) control group, and (ii) treatment group subject to 3 mg PEG rhG‐CSF after chemotherapy. Patients in the control group were administered rhG‐CSF (5 μg/kg) when decreased absolute neutrophil count (ANC) reached grade 3 of adverse events. The primary outcome was incidence of ALRTI, and the secondary outcomes included ANC, febrile neutropenia (FN), incidence of delayed chemotherapy, infection‐related medical expenses and adverse reactions.ResultsCompared with the control group, there was a significant decrease in the incidence of ALRTI (9.6% vs. 24.6%, p < 0.01), FN (1.7% vs. 7.3%, p < 0.001) and neutropenia (8.3% vs. 23.3%, p < 0.01) in the PEG‐rhG‐CSF group. The incidence of ALRTI was significantly correlated with the grade of CTCAE on ANC. The main adverse reactions of PEG‐rhG‐CSF were pain and fatigue, among which three cases showed pain of ≥ grade 3. The cost of infection‐associated medical expenditure in the treatment group was greatly reduced compared with the control group (p < 0.001).ConclusionsALRTI could well be prevented after prophylactic application of PEG‐rhG‐CSF (3 mg), and was related to the reduced neutropenia.