Vol 16, No 1 (2020)
Review paper
Published online: 2020-02-28

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Febrile neutropenia prophylaxis with short- and long-acting granulocyte colony-stimulating factors during treatment of solid tumours

Łukasz Kwinta1
Oncol Clin Pract 2020;16(1):9-13.

Abstract

Haematological toxicity of chemotherapy is a very important problem in oncology. The introduction of granulocyte colony-stimulating factor (G-CSF) into clinical practice is one of the most important breakthrough moments in supportive care. The use of G-CSF allows to reduce the risk of febrile neutropenia and maintain the intensity of oncological treatment, so increases not only the safety, but also the effectiveness of cancer therapy. The application of biosimilars, including biosimilar filgrastim and pegfilgrastim, was another important step that made it possible to increase access to modern biological medicines.

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References

  1. Morstyn G, Campbell L, Souza LM, et al. Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet. 1988; 1(8587): 667–672.
  2. http://onkologia.zalecenia.med.pl/pdf/zalecenia_PTOK_tom1_16_Leczenie_wspomagajace_20150226.pdf (dostęp 28.06.2019).
  3. Klastersky J, de Na, Rolston K, et al. Management of febrile neutropenia: ESMO Clinical Practice Guidelines. Ann Oncol. 2016; 27: v111–v118.
  4. Smith TJ, Bohlke K, Lyman GH, et al. American Society of Clinical Oncology. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015; 33(28): 3199–3212.
  5. https://www.nccn.org (dostęp 28.06.2019).
  6. 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): 3158–3167.
  7. Clark OAC, Lyman GH, Castro AA, et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomized controlled trials. J Clin Oncol. 2005; 23(18): 4198–4214.
  8. Yang BB, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet. 2011; 50(5): 295–306.
  9. 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): 727–731.
  10. Green MD, Koelbl H, Baselga J, et al. International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003; 14(1): 29–35.
  11. Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005; 23(6): 1178–1184.
  12. Bondarenko I, Gladkov OA, Elsaesser R, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer. 2013; 13: 386–397.
  13. Volovat C, Bondarenko IM, Gladkov OA, et al. Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non-small cell lung cancer receiving myelosuppressive therapy. SpringerPlus. 2015; 4: 316–326.
  14. Pinto L, Liu Z, Doan Q, et al. Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. Curr Med Res Opin. 2007; 23(9): 2283–2295.
  15. Cooper KL, Madan J, Whyte S, et al. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011; 11: 404–504.
  16. Cornes P, Gascon P, Chan S, et al. Systematic review and meta-analysis of short- versus long-acting granulocyte colony-stimulating factors for reduction of chemotherapy-induced febrile neutropenia. Adv Ther. 2018; 35(11): 1816–1829.
  17. 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): 3295–3304.
  18. Siena S, Piccart MJ, Holmes FA, et al. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II–IV breast cancer. Oncol Rep. 2003; 10(3): 715–724.
  19. Lyman GH, Yau L, Nakov R, et al. Overall survival and risk of second malignancies with cancer chemotherapy and G-CSF support. Ann Oncol. 2018; 29(9): 1903–1910.
  20. Waller C, Blakeley C, Pennella E, et al. Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-Neulasta ® in the prophylactic treatment of chemotherapy-induced neutropenia. Eur J Cancer. 2017; 72: S42.
  21. Kahan Z, Grecea D, Smakal M, et al. Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy. BMC Cancer. 2019; 19(1): 122–131.
  22. Harbeck N, Lipatov O, Frolova M, et al. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016; 12(11): 1359–1367.
  23. Blackwell K, Donskih R, Jones CM, et al. A comparison of proposed biosimilar LA-EP2006 and reference pegfilgrastim for the prevention of neutropenia in patients with early-stage breast cancer receiving myelosuppressive adjuvant or neoadjuvant chemotherapy: pegfilgrastim randomized oncology (supportive care) trial to evaluate comparative treatment (PROTECT-2), a phase III, randomized, double-blind trial. Oncologist. 2016; 21(7): 789–794.
  24. 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): 2272–2277.