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

BACKGROUND

NCCN 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.

METHODS

Patients 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.

RESULTS

Compared 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).

CONCLUSIONS

ALRTI could well be prevented after prophylactic application of PEG-rhG-CSF (3 mg), and was related to the reduced neutropenia.