1500P - A randomized, multi-center, parallel-group, phase II(single blind)/III(double blind) study to evaluate the efficacy and safety of green cross pegte...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications/Toxicities of treatment
Supportive measures
Therapy
Presenter Moon Hee Lee
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors M.H. Lee1, K.H. Lee2, J. Kim3, K.U. Park4, I. Park5, E.K. Cho6, J.H. Lim1, S. Yoon7, J.H. Kim8, I.S. Choi9, J. Park10, Y.J. Choi11, H.J. Kim12, K.H. Jung13, S. Kim14, D. Oh15, S. Im15
  • 1Internal Medicine, Inha University Hospital, 400-711 - Incheon/KR
  • 2Department Of Internal Medicine, Chungbuk National University College of Medicine, Cheongju/KR
  • 3Internal Medicine, Seoul Nat'l University Hospital, 110-744 - SEOUL/KR
  • 4Internal Medicine, Dongsan Medical Center, Keimyung University, Daegu/KR
  • 5Internal Medicine, National Cancer Center, Goyang/KR
  • 6Internal Medicine, Hematology And Oncology, Gachon University Gil Medical Center, 405-760 - Incheon/KR
  • 7Internal Medicine, Konkuk University Medical Center7, Seoul/KR
  • 8Internal Medicine, Seoul National University Bundang Hospital, 463-707 - GYEONGGI-DO/KR
  • 9Internal Medicine, SMG-SNU Boramae Medical Center, Seoul/KR
  • 10Internal Medicine, Ulsan University Hospital, Ulsan/KR
  • 11Hemato- Oncolgy, Pusan National University Hospital, 602-739 - Busan/KR
  • 12Division Of Hematology/medical Oncology, Internal Medicine, Chung-Ang University Hospital, 156-755 - Seoul/KR
  • 13Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 14Internal Medicine, Kyung Hee University Hospital, 130-702 - Seoul/KR
  • 15Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR

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<500/mm3) in chemotherapy cycle 1. Secondary efficacy end points were the depth of ANC nadir, the time to ANC recovery (ANC≥2000/mm3) in chemotherapy cycle 1, and rate of febrile neutropenia in all cycles.

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 <0.0001). Other secondary endpoints (the depth of ANC nadir, rate of febrile neutropenia) showed no significant difference between 2 groups. The safety profile did not differ between two groups.

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.