Роль пролонгированных гранулоцитарных колониестимулирующих факторов в профилактике фебрильной нейтропении у пациентов, получающих двухнедельные режимы химиотерапии

1. Wildiers H, Reiser M. Relative dose intensity of chemotherapy and its impact on outcomes in patients with early breast cancer or aggressive lymphoma. Crit Rev Oncol Hematol 2011; 77 (3): 221–40. DOI: 10.1016/j.critrevonc.2010.02.002
2. Aspinall SL, Good CB, Zhao X et al. Adjuvant chemotherapy for stage III colon cancer: relative dose intensity and survival among veterans. BMC Cancer 2015; 15: 62. DOI: 10.1186/s12885-015-1038-y
3. Nakayama G, Tanaka C, Uehara K et al. The impact of dose/time modification in irinotecan and oxaliplatin-based chemotherapies on outcomes in metastatic colorectal cancer. Cancer Chemother Pharmacol 2014; 73 (4): 847–55. DOI: 10.1007/s00280-014-2416-x
4. 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. DOI: 10.1016/j.ejca.2010.10.013.4
5. Pettengell R, Schwenkglenks M, Bosly A. Association of reduced relative dose intensity and survival in lymphoma patients receiving CHOP-21 chemotherapy. Ann Hematol 2008; 87 (5): 429–30. DOI: 10.1007/s00277-008-0447-2
6. Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 2003; 21 (24): 4524–31. DOI: 10.1200/JCO.2003.05.002
7. Wang L, Baser O, Kutikova L et al. The impact of primary prophylaxis with granulocyte colonystimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 2015; 23 (11): 3131–40. DOI: 10.1007/s00520-015-2686-9
8. Crawford J, Dale DC, Kuderer NM et al. Risk and timing of neutropenic events in adult cancer patients receiving chemotherapy: the results of a prospective nationwide study of oncology practice. J Natl Compr Canc Netw 2008; 6 (2): 109–18. DOI: 10.6004/jnccn.2008.0012
9. Chang J. Chemotherapy dose reduction and delay in clinical practice. Evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. Eur J Cancer 2000; 36 (1): 11–4. DOI: 10.1016/s0959-8049(99)00259-2
10. American Society of Clinical Oncology. Recommendations for the Use of Hematopoietic Colony-Stimulating Factors: evidence-based clinical practice guidelines. J Clin Oncol 1994; 12 (11): 2471–508. DOI: 10.1200/JCO.1994.12.11.2471
11. Klastersky J, de Naurois J, Rolston K et al. Management of febrile neutropaenia: ESMO Clinical Practice Guidelines. Ann Oncol 2016; 27 (5): 111–8. DOI: 10.1093/annonc/mdw325
12. Снеговой А.В., Кагония Л.М., Кононенко И.Б. и др. Практические рекомендации по назначению колониестимулирующих факторов с целью профилактики развития фебрильной нейтропении у онкологических больных. Злокачественные опухоли. 2015; 4: 342–9. DOI: 10.18027/2224-5057-2016-4s2-394-401
[Snegovoi A.V., Kagoniia L.M., Kononenko I.B. et al. Prakticheskie rekomendatsii po naznacheniiu koloniestimuliruiushchikh faktorov s tsel'iu profilaktiki razvitiia febril'noĭ neĭtropenii u onkologicheskikh bol'nykh. Zlokachestvennye opukholi. 2015; 4: 342–9. DOI: 10.18027/2224-5057-2016-4s2-394-401 (in Russian).]
13. Chang J. Chemotherapy dose reduction and delay in clinical practice. Evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. Eur J Cancer 2000; 36 (1): 11–4. DOI: 10.1016/S0959-8049(99)00259-2
14. Lyman GH, Morrison VA, Dale DC et al. Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin's lymphoma receiving CHOP chemotherapy. Leuk Lymphoma 2003; 44 (12): 2069–76. DOI: 10.1080/1042819031000119262
15. Caggiano V, Weiss RV, Rickert TS et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 2005; 103 (9): 1916–24. DOI: 10.1002/cncr.20983
16. Kuderer NM, Dale D, Crawford J, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 2006; 106 (10): 2258–66. DOI: 10.1002/cncr.21847
17. Shayne M, Crawford J, Dale D et al. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat 2006; 100 (3): 255–62. DOI: 10.1007/s10549-006-9254-4
18. Skipper HE. Kinetics of Mammary Tumor Cell Growth and Implications for Therapy. Cancer 1971; 28 (6): 1479–99. DOI: 10.1002/1097-0142(197112)28:6<1479::aid-cncr2820280622>3.0.co;2-m
19. Dale D. Colony-stimulating Factors for the Management of Neutropenia in Cancer Patients. Drugs 2002; 62 (1): 1–15. DOI: 10.2165/00003495-200262001-00001
20. Aapro MS, Cameron DA et al. EORTC guidelines for the use of granulocytecolony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 2006; 42 (15): 2433–53. DOI: 10.1016/j.ejca.2006.05.002
21. Smith TJ, Khatcheressian J et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based, clinical practice guideline. J Clin Oncol 2006; 24 (19): 3187–205. DOI: 10.1200/JCO.2006.06.4451
22. Leonard RC, Mansi JL, Keerie C et al. AngloCeltic Collaborative Oncology G (2015) A randomised trial of secondary prophylaxis using granulocyte colony-stimulating factor ('SPROG' trial) for maintaining dose intensity of standard adjuvant chemotherapy for breast cancer by the Anglo-Celtic Cooperative Group and NCRN. Ann Oncol 2015; 26 (12): 2437–41. DOI: 10.1093/annonc/mdv389
23. Pierce LJ, Lippman M, Ben-Baruch N et al. The effect of systemic therapy on localregional control in locally advanced breast cancer. Int J Radiat Oncol Biol Phys 1992; 23 (5): 949–60. DOI: 10.1016/0360-3016(92)90899-s
24. Low JA, Berman AW, Steinberg SM et al. Long-term follow-up for locally advanced and inflammatory breast cancer patients treated with multimodality therapy. J Clin Oncol 2004; 22 (20): 4067–74. DOI: 10.1200/JCO.2004.04.068
25. Green MD, Koelbl H, Baselga J et al. 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. DOI: 10.1093/annonc/mdg019
26. 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. DOI: 10.1200/JCO.2002.20.3.727
27. Smith TJ, Bohlke K, Lyman GH et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 2015; 33 (28): 3199–212. DOI: 10.1200/JCO.2015.62.3488
28. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors, version 2.2020. https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf
29. Molineux G. The design and development of pegfilgrastim (PEGrmetHuG-CSF, Neulasta). Curr Pharm Des 2004; 10 (11): 1235–44. DOI: 10.2174/1381612043452613
30. Molineux G. Pegfilgrastim: using pegylation technology to improve neutropenia support in cancer patients. Anticancer. Drugs 2003; 14 (4): 259–64. DOI: 10.1097/00001813-200304000-00002
31. Johnston E, Crawford J, Blackwell S et al. Randomized, dose escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000; 18 (13): 2522–8. DOI: 10.1200/JCO.2000.18.13.2522
32. Инструкция по применению лекарственного препарата Неуласта для медицинского применения. https://www.medicines.org.uk/emc/product/6770
[Instruktsiia po primeneniiu lekarstvennogo preparata Neulasta dlia meditsinskogo primeneniia. https://www.medicines.org.uk/emc/product/6770 (in Russian).]
33. Инструкция по применению лекарственного препарата Лонквекс для медицинского применения. https://www.medicines.org.uk/emc/medicine/28948
[Instruktsiia po primeneniiu lekarstvennogo preparata Lonkveks dlia meditsinskogo primeneniia. https://www.medicines.org.uk/emc/medicine/28948 (in Russian).]
34. Криворотько П.В., Бурдаева О.Н., Нечаева М.Н. и др. Эффективность и безопасность препарата Экстимия® (эмпэгфилграстим) у пациентов с диагнозом «рак молочной железы», получающих миелосупрессивную химиотерапию: результаты двойного слепого сравнительного клинического исследования III фазы. Современная онкология. 2015; 17 (2): 45–52. https://www.elibrary.ru/item.asp?id=24121465
[Krivorot'ko P.V., Burdaeva O.N., Nechaeva M.N. et al. Effektivnost' i bezopasnost' preparata Ekstimiia® (empegfilgrastim) u patsientov s diagnozom "rak molochnoi zhelezy', poluchaiushchikh mielosupressivnuiu khimioterapiiu: rezul'taty dvoinogo slepogo sravnitel'nogo klinicheskogo issledovaniia III fazy. Journal of Modern Oncology. 2015; 17 (2): 45–52. https://www.elibrary.ru/item.asp?id=24121465 (in Russian).]
35. 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 2015; 23 (6): 1178–84. DOI: 10.1200/jco.2005.09.102
36. Mey UJ, Maier A, Schmidt-Wolf IG et al. Pegfilgrastim as hematopoietic support for dose-dense chemoimmunotherapy with R-CHOP-14 as first-line therapy in elderly patients with diffuse large B cell lymphoma. Support Care Cancer 2007; 15 (7): 877–84. DOI: 10.1007/s00520-006-0201-z
37. Montella L, Addeo R, Guarrasi R et al. Once-per-cycle pegfilgrastim in breast cancer patients treated with docetaxel/epidoxorubicin/cyclophosphamide. Eur J Cancer Care (Engl) 2010; 19 (2): 200–4. DOI: 10.1111/j.1365-2354.2008.01004.x
38. Ozer H, Mirtsching B, Rader M et al. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist 2007; 12 (4): 484–94. DOI: 10.1634/theoncologist.12-4-484
39. Pro B, Fayad L, McLaughlin P et al. Pegfilgrastim administered in a single fixed dose is effective in inducing neutrophil count recovery after paclitaxel and topotecan chemotherapy in patients with relapsed aggressive non-Hodgkin's lymphoma. Leuk Lymphoma 2006; 47 (3): 481–5. DOI: 10.1080/10428190500305802
40. Kelly S, Wheatley D. Prevention of febrile neutropenia: use of granulocyte colony-stimulating factors. Br J Cancer 2009; 101 (1): 6–10. DOI: 10.1038/sj.bjc.6605269
41. Barnes G, Pathak A, Schwartzberg L. G-CSF utilization rate and prescribing patterns in United States: associations between physician and patient factors and GCSF use. Cancer Med 2014; 3 (6): 1477–84. DOI: 10.1002/cam4.344
42. Krzemieniecki K, Sevelda P, Erdkamp F et al. Neutropenia management and granulocyte colony-stimulating factor use in patients with solid tumours receiving myelotoxic chemotherapy – findings from clinical practice. Support Care Cancer 2014; 22 (3): 667–77. DOI: 10.1007/s00520-013-2021-2
43. Weycker D, Hackett J, Edelsberg JS et al. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother 2006; 40 (3): 402–7. DOI: 10.1345/aph.1G516
44. Link H, Nietsch J, Kerkmann M, Ortner P, Supportive Care Group of the German Cancer S. Adherence to granulocyte-colony stimulating factor (G-CSF) guidelines to reduce the incidence of febrile neutropenia after chemotherapy – a representative sample survey in Germany. Support Care Cancer 2016; 24 (1): 367–76. DOI: 10.1007/ s00520-015-2779-5
45. 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: 3295–304. DOI: 10.1007/s00520-017-3842-1
46. Del Mastro L, De Placido S, Bruzzi P et al. Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2×2 factorial, randomised phase 3 trial. Lancet 2015; 385 (9980): 1863–72. DOI: 10.1016/S0140-6736(14)62048-1
47. Lambertini M, Bruzzi P, Poggio F et al. Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial. Support Care Cancer 2016; 24 (3): 1285–94. DOI: 10.1007/s00520-015- 2907-2
48. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer, version 3.2020. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
49. Falcone A, Ricci S, Brunetti I et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 2007; 25 (13): 1670–6. DOI: 10.1200/JCO.2006.09.0928
50. Hecht JR, Pillai M, Gollard R et al. A randomized, placebo-controlled phase II study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer 2010; 9 (2): 95–101. DOI: 10.3816/CCC.2010.n.013
51. Falcone A, Masi G, Allegrini G et al. Biweekly chemotherapy with oxaliplatin, irinotecan, infusional fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol 2002; 20 (19): 4006–14. DOI: 10.1200/JCO.2002.12.075
52. Инструкция по применению лекарственного препарата Авастин для медицинского применения. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf 
[Instruktsiia po primeneniiu lekarstvennogo preparata Avastin dlia meditsinskogo primeneniia. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf (in Russian).]
53. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350 (23): 2335–42. DOI: 10.1056/NEJMoa032691
54. Yang B-B, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 2011; 50 (5): 295–306. DOI: 10.2165/11586040-000000000-00000
55. Invernizzi R, Grasso D, Travaglino E et al. Biological effects of pegfilgrastim on circulating neutrophils in breast cancer patients undergoing dose-dense chemotherapy. Oncology 2008; 75 (3–4): 237–44. DOI: 10.1159/000164588
56. Pirker R, Ulsperger E, Messner J et al. Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer. Lung 2006; 184 (5): 279–85. DOI: 10.1007/s00408-005-2594-8
57. J. Randolph Hecht, Madhavan Pillai, Russell Gollard et al. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer 2010; 9 (2): 95–101. DOI: 10.3816/CCC.2010.n.013
58. Pinter T, Klippel Z, Cesas A et al. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the ­PAVES Study. Clin Colorectal Cancer 2017; 16 (2): 103–14. DOI: 10.1016/j.clcc.2016.08.008
59. Douillard JY, Cunningham D, Roth AD et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000; 355 (9209): 1041–7. DOI: 10.1016/S0140-6736(00)02034-1
60. Presta LG et al. Humanization of an anti-VEGF monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res 1997; 57: 4593–9.
61. Hurwitz H et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350: 23352342.
62. Sandler A et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell-lung cancer. N Engl J Med 2006; 355: 2542–50.
63. Miller K et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357: 26662676.
64. Shojaei F et al. Tumor refractoriness to anti-VEGF treatment is mediated by CD11b+Gr1+ myeloid cells. Nat Biotechnol 2007; 25: 911920.
65. Ferrara N. Role of myeloid cells in tumor angiogenesis. In: Molineux G, Foote MA, Arvedson T. (eds). Twenty Years of G-CSF: Clinical and Nonclinical Discoveries, 1st ed. Basel: Springer, 2012; p. 423–33.
66. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008; 26 (12): 2013–9. DOI: 10.1200/JCO.2007.14.9930
67. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25 (12): 1539–44. DOI: 10.1200/JCO.2006.09.6305
68. Heinemann V, von Weikersthal LF, Decker T et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 2014; 15 (10): 1065–75. DOI: 10.1016/S1470-2045(14)70330-4
69. Schwartzberg LS, Rivera F, Karthaus M et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 2014; 32 (21): 2240–7. DOI: 10.1200/JCO.2013.53.2473
70. Crawford J, Ozer H, Stoller R et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991; 325 (3): 164–70. DOI: 10.1093/clinids/18.Supplement_2.S189

________________________________________________

1. Wildiers H, Reiser M. Relative dose intensity of chemotherapy and its impact on outcomes in patients with early breast cancer or aggressive lymphoma. Crit Rev Oncol Hematol 2011; 77 (3): 221–40. DOI: 10.1016/j.critrevonc.2010.02.002
2. Aspinall SL, Good CB, Zhao X et al. Adjuvant chemotherapy for stage III colon cancer: relative dose intensity and survival among veterans. BMC Cancer 2015; 15: 62. DOI: 10.1186/s12885-015-1038-y
3. Nakayama G, Tanaka C, Uehara K et al. The impact of dose/time modification in irinotecan and oxaliplatin-based chemotherapies on outcomes in metastatic colorectal cancer. Cancer Chemother Pharmacol 2014; 73 (4): 847–55. DOI: 10.1007/s00280-014-2416-x
4. 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. DOI: 10.1016/j.ejca.2010.10.013.4
5. Pettengell R, Schwenkglenks M, Bosly A. Association of reduced relative dose intensity and survival in lymphoma patients receiving CHOP-21 chemotherapy. Ann Hematol 2008; 87 (5): 429–30. DOI: 10.1007/s00277-008-0447-2
6. Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 2003; 21 (24): 4524–31. DOI: 10.1200/JCO.2003.05.002
7. Wang L, Baser O, Kutikova L et al. The impact of primary prophylaxis with granulocyte colonystimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 2015; 23 (11): 3131–40. DOI: 10.1007/s00520-015-2686-9
8. Crawford J, Dale DC, Kuderer NM et al. Risk and timing of neutropenic events in adult cancer patients receiving chemotherapy: the results of a prospective nationwide study of oncology practice. J Natl Compr Canc Netw 2008; 6 (2): 109–18. DOI: 10.6004/jnccn.2008.0012
9. Chang J. Chemotherapy dose reduction and delay in clinical practice. Evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. Eur J Cancer 2000; 36 (1): 11–4. DOI: 10.1016/s0959-8049(99)00259-2
10. American Society of Clinical Oncology. Recommendations for the Use of Hematopoietic Colony-Stimulating Factors: evidence-based clinical practice guidelines. J Clin Oncol 1994; 12 (11): 2471–508. DOI: 10.1200/JCO.1994.12.11.2471
11. Klastersky J, de Naurois J, Rolston K et al. Management of febrile neutropaenia: ESMO Clinical Practice Guidelines. Ann Oncol 2016; 27 (5): 111–8. DOI: 10.1093/annonc/mdw325
12. Snegovoi A.V., Kagoniia L.M., Kononenko I.B. et al. Prakticheskie rekomendatsii po naznacheniiu koloniestimuliruiushchikh faktorov s tsel'iu profilaktiki razvitiia febril'noĭ neĭtropenii u onkologicheskikh bol'nykh. Zlokachestvennye opukholi. 2015; 4: 342–9. DOI: 10.18027/2224-5057-2016-4s2-394-401 (in Russian).
13. Chang J. Chemotherapy dose reduction and delay in clinical practice. Evaluating the risk to patient outcome in adjuvant chemotherapy for breast cancer. Eur J Cancer 2000; 36 (1): 11–4. DOI: 10.1016/S0959-8049(99)00259-2
14. Lyman GH, Morrison VA, Dale DC et al. Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin's lymphoma receiving CHOP chemotherapy. Leuk Lymphoma 2003; 44 (12): 2069–76. DOI: 10.1080/1042819031000119262
15. Caggiano V, Weiss RV, Rickert TS et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 2005; 103 (9): 1916–24. DOI: 10.1002/cncr.20983
16. Kuderer NM, Dale D, Crawford J, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 2006; 106 (10): 2258–66. DOI: 10.1002/cncr.21847
17. Shayne M, Crawford J, Dale D et al. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat 2006; 100 (3): 255–62. DOI: 10.1007/s10549-006-9254-4
18. Skipper HE. Kinetics of Mammary Tumor Cell Growth and Implications for Therapy. Cancer 1971; 28 (6): 1479–99. DOI: 10.1002/1097-0142(197112)28:6<1479::aid-cncr2820280622>3.0.co;2-m
19. Dale D. Colony-stimulating Factors for the Management of Neutropenia in Cancer Patients. Drugs 2002; 62 (1): 1–15. DOI: 10.2165/00003495-200262001-00001
20. Aapro MS, Cameron DA et al. EORTC guidelines for the use of granulocytecolony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 2006; 42 (15): 2433–53. DOI: 10.1016/j.ejca.2006.05.002
21. Smith TJ, Khatcheressian J et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based, clinical practice guideline. J Clin Oncol 2006; 24 (19): 3187–205. DOI: 10.1200/JCO.2006.06.4451
22. Leonard RC, Mansi JL, Keerie C et al. AngloCeltic Collaborative Oncology G (2015) A randomised trial of secondary prophylaxis using granulocyte colony-stimulating factor ('SPROG' trial) for maintaining dose intensity of standard adjuvant chemotherapy for breast cancer by the Anglo-Celtic Cooperative Group and NCRN. Ann Oncol 2015; 26 (12): 2437–41. DOI: 10.1093/annonc/mdv389
23. Pierce LJ, Lippman M, Ben-Baruch N et al. The effect of systemic therapy on localregional control in locally advanced breast cancer. Int J Radiat Oncol Biol Phys 1992; 23 (5): 949–60. DOI: 10.1016/0360-3016(92)90899-s
24. Low JA, Berman AW, Steinberg SM et al. Long-term follow-up for locally advanced and inflammatory breast cancer patients treated with multimodality therapy. J Clin Oncol 2004; 22 (20): 4067–74. DOI: 10.1200/JCO.2004.04.068
25. Green MD, Koelbl H, Baselga J et al. 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. DOI: 10.1093/annonc/mdg019
26. 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. DOI: 10.1200/JCO.2002.20.3.727
27. Smith TJ, Bohlke K, Lyman GH et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 2015; 33 (28): 3199–212. DOI: 10.1200/JCO.2015.62.3488
28. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors, version 2.2020. https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf
29. Molineux G. The design and development of pegfilgrastim (PEGrmetHuG-CSF, Neulasta). Curr Pharm Des 2004; 10 (11): 1235–44. DOI: 10.2174/1381612043452613
30. Molineux G. Pegfilgrastim: using pegylation technology to improve neutropenia support in cancer patients. Anticancer. Drugs 2003; 14 (4): 259–64. DOI: 10.1097/00001813-200304000-00002
31. Johnston E, Crawford J, Blackwell S et al. Randomized, dose escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000; 18 (13): 2522–8. DOI: 10.1200/JCO.2000.18.13.2522
32. Instruktsiia po primeneniiu lekarstvennogo preparata Neulasta dlia meditsinskogo primeneniia. https://www.medicines.org.uk/emc/product/6770 (in Russian).
33. Instruktsiia po primeneniiu lekarstvennogo preparata Lonkveks dlia meditsinskogo primeneniia. https://www.medicines.org.uk/emc/medicine/28948 (in Russian).
34. Krivorot'ko P.V., Burdaeva O.N., Nechaeva M.N. et al. Effektivnost' i bezopasnost' preparata Ekstimiia® (empegfilgrastim) u patsientov s diagnozom "rak molochnoi zhelezy', poluchaiushchikh mielosupressivnuiu khimioterapiiu: rezul'taty dvoinogo slepogo sravnitel'nogo klinicheskogo issledovaniia III fazy. Journal of Modern Oncology. 2015; 17 (2): 45–52. https://www.elibrary.ru/item.asp?id=24121465 (in Russian).
35. 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 2015; 23 (6): 1178–84. DOI: 10.1200/jco.2005.09.102
36. Mey UJ, Maier A, Schmidt-Wolf IG et al. Pegfilgrastim as hematopoietic support for dose-dense chemoimmunotherapy with R-CHOP-14 as first-line therapy in elderly patients with diffuse large B cell lymphoma. Support Care Cancer 2007; 15 (7): 877–84. DOI: 10.1007/s00520-006-0201-z
37. Montella L, Addeo R, Guarrasi R et al. Once-per-cycle pegfilgrastim in breast cancer patients treated with docetaxel/epidoxorubicin/cyclophosphamide. Eur J Cancer Care (Engl) 2010; 19 (2): 200–4. DOI: 10.1111/j.1365-2354.2008.01004.x
38. Ozer H, Mirtsching B, Rader M et al. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist 2007; 12 (4): 484–94. DOI: 10.1634/theoncologist.12-4-484
39. Pro B, Fayad L, McLaughlin P et al. Pegfilgrastim administered in a single fixed dose is effective in inducing neutrophil count recovery after paclitaxel and topotecan chemotherapy in patients with relapsed aggressive non-Hodgkin's lymphoma. Leuk Lymphoma 2006; 47 (3): 481–5. DOI: 10.1080/10428190500305802
40. Kelly S, Wheatley D. Prevention of febrile neutropenia: use of granulocyte colony-stimulating factors. Br J Cancer 2009; 101 (1): 6–10. DOI: 10.1038/sj.bjc.6605269
41. Barnes G, Pathak A, Schwartzberg L. G-CSF utilization rate and prescribing patterns in United States: associations between physician and patient factors and GCSF use. Cancer Med 2014; 3 (6): 1477–84. DOI: 10.1002/cam4.344
42. Krzemieniecki K, Sevelda P, Erdkamp F et al. Neutropenia management and granulocyte colony-stimulating factor use in patients with solid tumours receiving myelotoxic chemotherapy – findings from clinical practice. Support Care Cancer 2014; 22 (3): 667–77. DOI: 10.1007/s00520-013-2021-2
43. Weycker D, Hackett J, Edelsberg JS et al. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother 2006; 40 (3): 402–7. DOI: 10.1345/aph.1G516
44. Link H, Nietsch J, Kerkmann M, Ortner P, Supportive Care Group of the German Cancer S. Adherence to granulocyte-colony stimulating factor (G-CSF) guidelines to reduce the incidence of febrile neutropenia after chemotherapy – a representative sample survey in Germany. Support Care Cancer 2016; 24 (1): 367–76. DOI: 10.1007/ s00520-015-2779-5
45. 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: 3295–304. DOI: 10.1007/s00520-017-3842-1
46. Del Mastro L, De Placido S, Bruzzi P et al. Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2×2 factorial, randomised phase 3 trial. Lancet 2015; 385 (9980): 1863–72. DOI: 10.1016/S0140-6736(14)62048-1
47. Lambertini M, Bruzzi P, Poggio F et al. Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial. Support Care Cancer 2016; 24 (3): 1285–94. DOI: 10.1007/s00520-015- 2907-2
48. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer, version 3.2020. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
49. Falcone A, Ricci S, Brunetti I et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 2007; 25 (13): 1670–6. DOI: 10.1200/JCO.2006.09.0928
50. Hecht JR, Pillai M, Gollard R et al. A randomized, placebo-controlled phase II study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer 2010; 9 (2): 95–101. DOI: 10.3816/CCC.2010.n.013
51. Falcone A, Masi G, Allegrini G et al. Biweekly chemotherapy with oxaliplatin, irinotecan, infusional fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol 2002; 20 (19): 4006–14. DOI: 10.1200/JCO.2002.12.075
52. Instruktsiia po primeneniiu lekarstvennogo preparata Avastin dlia meditsinskogo primeneniia. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf (in Russian).
53. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350 (23): 2335–42. DOI: 10.1056/NEJMoa032691
54. Yang B-B, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 2011; 50 (5): 295–306. DOI: 10.2165/11586040-000000000-00000
55. Invernizzi R, Grasso D, Travaglino E et al. Biological effects of pegfilgrastim on circulating neutrophils in breast cancer patients undergoing dose-dense chemotherapy. Oncology 2008; 75 (3–4): 237–44. DOI: 10.1159/000164588
56. Pirker R, Ulsperger E, Messner J et al. Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer. Lung 2006; 184 (5): 279–85. DOI: 10.1007/s00408-005-2594-8
57. J. Randolph Hecht, Madhavan Pillai, Russell Gollard et al. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer 2010; 9 (2): 95–101. DOI: 10.3816/CCC.2010.n.013
58. Pinter T, Klippel Z, Cesas A et al. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Pegfilgrastim in Patients Receiving First-Line FOLFOX/Bevacizumab or FOLFIRI/Bevacizumab for Locally Advanced or Metastatic Colorectal Cancer: Final Results of the ­PAVES Study. Clin Colorectal Cancer 2017; 16 (2): 103–14. DOI: 10.1016/j.clcc.2016.08.008
59. Douillard JY, Cunningham D, Roth AD et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000; 355 (9209): 1041–7. DOI: 10.1016/S0140-6736(00)02034-1
60. Presta LG et al. Humanization of an anti-VEGF monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res 1997; 57: 4593–9.
61. Hurwitz H et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350: 23352342.
62. Sandler A et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell-lung cancer. N Engl J Med 2006; 355: 2542–50.
63. Miller K et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357: 26662676.
64. Shojaei F et al. Tumor refractoriness to anti-VEGF treatment is mediated by CD11b+Gr1+ myeloid cells. Nat Biotechnol 2007; 25: 911920.
65. Ferrara N. Role of myeloid cells in tumor angiogenesis. In: Molineux G, Foote MA, Arvedson T. (eds). Twenty Years of G-CSF: Clinical and Nonclinical Discoveries, 1st ed. Basel: Springer, 2012; p. 423–33.
66. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008; 26 (12): 2013–9. DOI: 10.1200/JCO.2007.14.9930
67. Giantonio BJ, Catalano PJ, Meropol NJ et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 2007; 25 (12): 1539–44. DOI: 10.1200/JCO.2006.09.6305
68. Heinemann V, von Weikersthal LF, Decker T et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 2014; 15 (10): 1065–75. DOI: 10.1016/S1470-2045(14)70330-4
69. Schwartzberg LS, Rivera F, Karthaus M et al. PEAK: a randomized, multicenter phase II study of panitumumab plus modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or bevacizumab plus mFOLFOX6 in patients with previously untreated, unresectable, wild-type KRAS exon 2 metastatic colorectal cancer. J Clin Oncol 2014; 32 (21): 2240–7. DOI: 10.1200/JCO.2013.53.2473
70. Crawford J, Ozer H, Stoller R et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991; 325 (3): 164–70. DOI: 10.1093/clinids/18.Supplement_2.S189

И.Б. Кононенко*1, А.В. Снеговой1, О.П. Гребенникова1,2, В.Ю. Сельчук2, О.В. Пальчинская1

1 ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия;
2 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия
*Inessa.Kononenko@mail.ru

________________________________________________

Inessa B. Kononenko*1, Anton V. Snegovoy1, Olga P. Grebennikova1,2, Vladimir Yu. Sel’chuk2, Olga V. Palchinskaia1

1 Blokhin National Medical Research Center of Oncology, Moscow, Russia;
2 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia
*Inessa.Kononenko@mail.ru