Abstract: AIM: To evaluate the safety and tolerance of PEG-rhG-CSF in tumor patients, and to explore its efficacy of enhancing absolute neutrphil count(ANC).METHODS: This study was open-labeled, dose-escalation trial. All patients received 1 day chemotherapy. Patients received a single injection of PEG-rhG-CSF(30,60,100,150, or 200 μg/kg) 48 h after administration of chemotherapy drug. Each dose group had 3 patients.RESULTS: All the 15 patients enrolled were evaluable for safety and efficacy of PEG-rhG-CSF. Main adverse events related to PEG-rhG-CSF were fatigue(4/15), musculoskeletal pain(1/15). All adverse events were mild, and they were reversible without treatment. PEG-rhG-CSF enhanced ANC in a dose-dependent manner to some extent.CONCLUSION: PEG-rhG-CSF is well tolerated, with no serious adverse event in this trial.

Key words: Pegylation, Granulocyte colony-stimulating factor, Phase Ⅰ, Clinical trail, Drug tolerance