A Randomized, Multi-Center, Parallel-Group, Phase Ii(Single Blind)/Iii(Double Blind) Study to Evaluate the Efficacy and Safety of Green Cross Pegteograstim (Gcpgc) on Chemotherapy-Induced Neutropenia Compared to Pegfilgrastim

Abstract

ABSTRACT Aim: GCPGC is a new formulation of pegylated recombinant human granulocyte colony-stimulating factor reducing the severity and duration of neutropenia. Previous phase I study reported that GCPGC at 30-100µg/kg is well tolerated in healthy subject. This study, consists of phase II and III trial, was conducted to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia and to evaluate the efficacy and safety of GCPGC compared to pegfilgrastim. Methods: In phase II part, 60 breast cancer patients receiving DA (docetaxel and doxorubicin) or TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy were randomly assigned to receive single subcutaneous GCPGC 3.6mg or 6.0mg on day2 of each cycle of chemotherapy. After choice of the dose from phase II, the phase III part was seamlessly started enrolling 117 patients to compare GCPGC with pegfilgrastim. The primary end point was the duration of grade 4 neutropenia (ANC Results: In phase II part, the mean duration of grade 4 neutropenia for GCPGC 3.6mg (n = 33) was similar to that of GCPGC 6.0mg (n = 26) (1.97 ± 1.79 days vs. 1.54 ± 0.95 days, p = 0.33). Therefore, GCPGC 6.0mg was selected to be compared with pegfilgrastim 6.0 mg in phase III part. Primary analysis revealed that the efficacy of GCPGC was non-inferior to pegfilgrastim (the duration of Gr 4 neutropenia (days), 1.64 ± 1.18 vs. 1.80 ± 1.05; difference, -0.15 ± 1.11 [97.5% C.I. -, 0.26]). Furthermore, the time to ANC recovery (ANC ≥2000/mm3) of GCPGC was significantly shorter than that of pegfilgrastim (the recovery days, 8.85 ± 1.45 vs. 9.83 ± 1.20; p Conclusions: GCPGC was shown to be as effective as pegfilgrastim for the reduction of chemotherapy-induced neutropenia. Disclosure: All authors have declared no conflicts of interest.