Comparison of Long-Acting G-CSF (PD-Lasta) with Short-Acting G-CSF (PD-Grastim) in Neutrophil Recovery Following Consolidation Chemotherapy with High-Dose Cytarabine in Acute Myeloid Leukemia: A Randomized Clinical Trial
Abstract
Background: Acute myeloid leukemia (AML) patients are often neutropenic as a result of their disease alone or following their chemotherapy. In this randomized clinical trial the efficacy of Iranian short-acting (PD-Grastim) and long-acting G-CSF (PD-Lasta) were compared in term of time to recovery from neutropenia in de novo AML patients following the consolidation chemotherapy.
Materials and Methods: Patients (n = 51) received one or two courses of Cytarabine and Daunorubicin as an induction. If complete remission was achieved, the treatment was followed by high-dose Cytarabine as consolidation chemotherapy. Twenty four hours after the consolidation chemotherapy, patient were randomized to receive either daily short-acting G-CSF (PD-Grastim) (300 µg/kg) or single-dose long-acting G-CSF (PD-Lasta) (6 mg).
Results: The median time to recovery of neutrophils was 11.00 and 13.00 days for short-acting G-CSF (PD-Grastim) (n=22) and long-acting G-CSF (PD-Lasta) (n=29) groups, respectively (U=186.5, P>0.05 two-tailed). Incidence of adverse effects was similar in both short-acting G-CSF (PD-Grastim) and long-acting G-CSF (PD-Lasta) groups.
Conclusion: Overall, data show that Iranian long-acting G-CSF (PD-Lasta) was not significantly different with Iranian short-acting G-CSF (PD-Grastim).
1. Bennett CL, Djulbegovic B, Norris LB, et al. Colony-stimulating factors for febrile neutropenia during cancer therapy. N Engl J Med. 2013; 368(12):1131–9.
2. Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006; 106(10):2258–66.
3. Harousseau JL, Witz B, Lioure B, et al. Granulocyte colony-stimulating factor after intensive consolidation chemotherapy in acute myeloid leukemia: Results of a randomized trial of the Groupe Ouest-Est Leucémies Aigues Myeloblastiques. J Clin Oncol. 2000; 18(4):780–7.
4. MA Ehsani, M Ordouee, P Salamati, et al. Evaluation of efficacy and side effects of FILGRASTIM versus PD-Grastim in prevention of neutropenia in patients with neuroblastoma under treatment with OPEC chemotherapy protocol – A Comparative Study. IRAN J Pediatr.2006; 16(3):319–24.
5. Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des. 2004; 10(11):1235–44.
6. Green MD. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Annals of Oncology. 2003; 14(1):29–35.
7. Holmes FA, O'Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002; 20(3):727–31.
8. Jagasia MH, Greer JP, Morgan DS, et al. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: Phase II study. Bone Marrow Transplant. 2005; 35(12):1165–9.
9. Ballestrero A, Boy D, Gonella R, et al. Pegfilgrastim compared with filgrastim after autologous peripheral blood stem cell transplantation in patients with solid tumours and lymphomas. Ann Hematol. 2008; 87(1):49–55.
10. Aapro M, Boccia R, Leonard R, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: Consensus guidance recommendations. Support Care Cancer. 2017; 25(11):3295–304.
11. Jaramillo S, Benner A, Krauter J, et al. Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia. Blood Cancer J. 2017; 7(5):e564.
12. Heil G, Hoelzer D, Sanz MA, et al. Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia. Leukemia. 2006;20(3):404–9.
13. Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia. The International Acute Myeloid Leukemia Study Group. Blood. 1997;90(12):4710–8.
14. Sierra J, Szer J, Kassis J, et al. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: Results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008;8:195.
15. Field E, Caimi PF, Cooper B, et al. Comparison of Pegfilgrastim and Filgrastim to Prevent Neutropenic Fever during Consolidation with High Dose Cytarabine for Acute Myeloid Leukemia. Blood. 2018;132(Supplement 1):1404.
16. Lustberg MB. Management of neutropenia in cancer patients. Clin Adv Hematol Oncol. 2012;10(12):825–6.
17. Lyman GH, Michels SL, Reynolds MW, et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer. 2010;116(23):5555–63.
18. Mhaskar R, Clark OAC, Lyman G, et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia. Cochrane Database Syst Rev. 2014(10):CD003039.
19. Kuderer NM, Dale DC, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review. J Clin Oncol. 2007;25(21):3158–67.
20. Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8–32.
21. Gerds A, Fox-Geiman M, Dawravoo K, et al. Randomized phase III trial of pegfilgrastim versus filgrastim after autologus peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2010;16(5):678–85.
22. Arvedson T, O'Kelly J, Yang B-B. Design Rationale and Development Approach for Pegfilgrastim as a Long-Acting Granulocyte Colony-Stimulating Factor. BioDrugs. 2015;29(3):185–98.
23. Blackwell K, Gascon P, Jones CM, et al. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017;28(9):2272–7.
2. Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006; 106(10):2258–66.
3. Harousseau JL, Witz B, Lioure B, et al. Granulocyte colony-stimulating factor after intensive consolidation chemotherapy in acute myeloid leukemia: Results of a randomized trial of the Groupe Ouest-Est Leucémies Aigues Myeloblastiques. J Clin Oncol. 2000; 18(4):780–7.
4. MA Ehsani, M Ordouee, P Salamati, et al. Evaluation of efficacy and side effects of FILGRASTIM versus PD-Grastim in prevention of neutropenia in patients with neuroblastoma under treatment with OPEC chemotherapy protocol – A Comparative Study. IRAN J Pediatr.2006; 16(3):319–24.
5. Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr Pharm Des. 2004; 10(11):1235–44.
6. Green MD. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Annals of Oncology. 2003; 14(1):29–35.
7. Holmes FA, O'Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002; 20(3):727–31.
8. Jagasia MH, Greer JP, Morgan DS, et al. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: Phase II study. Bone Marrow Transplant. 2005; 35(12):1165–9.
9. Ballestrero A, Boy D, Gonella R, et al. Pegfilgrastim compared with filgrastim after autologous peripheral blood stem cell transplantation in patients with solid tumours and lymphomas. Ann Hematol. 2008; 87(1):49–55.
10. Aapro M, Boccia R, Leonard R, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: Consensus guidance recommendations. Support Care Cancer. 2017; 25(11):3295–304.
11. Jaramillo S, Benner A, Krauter J, et al. Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia. Blood Cancer J. 2017; 7(5):e564.
12. Heil G, Hoelzer D, Sanz MA, et al. Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia. Leukemia. 2006;20(3):404–9.
13. Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia. The International Acute Myeloid Leukemia Study Group. Blood. 1997;90(12):4710–8.
14. Sierra J, Szer J, Kassis J, et al. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: Results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008;8:195.
15. Field E, Caimi PF, Cooper B, et al. Comparison of Pegfilgrastim and Filgrastim to Prevent Neutropenic Fever during Consolidation with High Dose Cytarabine for Acute Myeloid Leukemia. Blood. 2018;132(Supplement 1):1404.
16. Lustberg MB. Management of neutropenia in cancer patients. Clin Adv Hematol Oncol. 2012;10(12):825–6.
17. Lyman GH, Michels SL, Reynolds MW, et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer. 2010;116(23):5555–63.
18. Mhaskar R, Clark OAC, Lyman G, et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia. Cochrane Database Syst Rev. 2014(10):CD003039.
19. Kuderer NM, Dale DC, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review. J Clin Oncol. 2007;25(21):3158–67.
20. Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8–32.
21. Gerds A, Fox-Geiman M, Dawravoo K, et al. Randomized phase III trial of pegfilgrastim versus filgrastim after autologus peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2010;16(5):678–85.
22. Arvedson T, O'Kelly J, Yang B-B. Design Rationale and Development Approach for Pegfilgrastim as a Long-Acting Granulocyte Colony-Stimulating Factor. BioDrugs. 2015;29(3):185–98.
23. Blackwell K, Gascon P, Jones CM, et al. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017;28(9):2272–7.
| Files | ||
| Issue | Vol 15, No 2 (2021) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijhoscr.v15i2.6040 | |
| Keywords | ||
| Neutropenia; Acute Myeloid Leukemia; Granulocyte colony-stimulating factor (G-CSF) | ||
| Rights and permissions | |
|
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Esfandbod M, Agha barazadeh F, Faraz M, Zarrabi F, Toogeh G. Comparison of Long-Acting G-CSF (PD-Lasta) with Short-Acting G-CSF (PD-Grastim) in Neutrophil Recovery Following Consolidation Chemotherapy with High-Dose Cytarabine in Acute Myeloid Leukemia: A Randomized Clinical Trial. Int J Hematol Oncol Stem Cell Res. 2021;15(2):96-102.
