Optimal use of recombinant granulocyte colony-stimulating factor with chemotherapy for solid tumors

Expert Review of Anticancer Therapy

Volumn 11, Issue 8, 2011, Pages 1303-1313

  Danova, Marco ^a   Barni, Sandro ^b   Del Mastro, Lucia ^c   Danesi, Romano ^d   Pappagallo, Giovanni L ^e  

^a Ospedale Civile   (Italy)

^b TREVIGLIO HOSPITAL   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

^d UNIVERSITY OF PISA   (Italy)

^e Ufficio di Epidemiologia and Sperimentazioni Cliniche   (Italy)

Author keywords

antineoplastic agents; bone marrow compartments; chemotherapy induced neutropenia; international guidelines; prophylaxis; recombinant granulocyte colony stimulating factor

Indexed keywords

ANTIBIOTIC AGENT; ANTINEOPLASTIC AGENT; CARBOPLATIN; DOCETAXEL; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR RECEPTOR; LEVOFLOXACIN; NAVELBINE; PLACEBO; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ANTIBIOTIC PROPHYLAXIS; BLOOD TOXICITY; BONE MARROW DEPRESSION; BONE MARROW TOXICITY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SURVIVAL; DISEASE FREE SURVIVAL; DRUG EFFICACY; FEBRILE NEUTROPENIA; HEAD AND NECK TUMOR; HEMATOLOGIC MALIGNANCY; HUMAN; INFECTION RATE; LUNG CANCER; LYMPHOMA; MORTALITY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PATIENT SELECTION; PHARMACODYNAMICS; REVIEW; RISK FACTOR; SIDE EFFECT; SOLID TUMOR;

ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; NEOPLASMS; NEUTROPENIA;

EID: 80052330744     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.11.72     Document Type: Review

References (85)

1. Fortner BV, Tauer K, Zhu L et al. Medical visits for chemotherapy and chemotherapy-induced neutropenia: A survey of the impact on patient time and activities. BMC Cancer 4, 22 (2004).
2. Caggiano V, Weiss RV, Rickert TS, Linde-Zwirble WT. Incidence, cost and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 103, 1916-1924 (2005).
3. Courtney DM, Aldeen AZ, Gorman SM et al. Cancer-associated neutropenic fever: Clinical outcome and economic costs of emergency department care. Oncologist 12, 1019-1026 (2007).
4. Kuderer NM, Dale DC, Crawford J, Cosler LE, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 106(10), 2258-2266 (2006).
5. Elting LS, Lu C, Escalante CP et al. Outcomes and cost of outpatient or inpatient management of 712 patients with febrile neutropenia. J. Clin. Oncol. 26, 606-611 (2008).
6. Cameron D. Management of chemotherapy-associated febrile neutropenia. Br. J. Cancer 101(Suppl.), S18-S22 (2009).
7. Even C, Taillade L, Spano JP, Vignot S. Febrile neutropenia in adult patients with solid tumors: A review of literature toward a rationale and optimal management. Bull. Cancer 97, 547-557 (2010).
8. Herbst C, Naumann F, Kruse EB et al. Prophylactic antibiotics or G-CSF for the prevention of infections and improvement of survival in cancer patients undergoing chemotherapy. Cochrane Database Syst. Rev. 21, CD007107 (2009).
9. Walwyn M, Nicholson A, Lee MG, Wharfe G, Frankson MA. Febrile neutropenia in cancer patients. West. Indian Med. 59, 209-214 (2010).
10. Aapro MS, Cameron DA, Pettengell R et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur. J. Cancer 42(15), 2433-2453 (2006).
11. Citron ML, Berry DA, Cirrincione C et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J. Clin. Oncol. 21(8), 1431-1439 (2003).
12. Marangolo M, Bengala C, Conte PF et al. Dose and outcome: The hurdle of neutropenia (review). Oncol. Rep. 16(2), 233-248 (2006).
13. Crawford J, Armitage J, Balducci L et al. Myeloid growth factors. J. Natl. Compr. Canc. Netw. 7, 64-83 (2009).
14. Teuffel O, Ethier MC, Alibhai SM, Beyene J, Sung L. Outpatient management of cancer patients with febrile neutropenia: A systematic review and meta-analysis. Ann. Oncol. DOI: 10.1093/annonc/mdq745 (2011) (Epub ahead of print).
15. Clark OA, Lyman GH, Castro AA, Clark LG, Djulbegovic B. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: A meta-analysis of randomized controlled trials. J. Clin. Oncol. 23(18), 4198-4214 (2005).
16. Smith TJ, Khatcheressian J, Lyman GH et al. Update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline. J. Clin. Oncol. 24(19), 3187-3205 (2006).
17. Carrato A, Paz-Ares Rodriguez L, Rescure A et al. Spanish Society of Medical Oncology consensus for the use of haematopoietic colony stimulating factors in cancer patients. Clin. Transl. Oncol. 11, 446-454 (2009).
18. Crawford J, Caserta C, Roila F. Hematopoietic growth factors: ESMO clinical practice guidelines for the applications. Ann. Oncol. 21(Suppl. 5), v248-v251 (2010).
19. 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 tumors. Eur. J. Cancer 47, 8-32 (2011).
20. Danova M, Rosti G, De Placido S, Bencardino K, Venturini M. Use of granulocyte colony-stimulating factor: A survey among Italian medical oncologists. Oncol. Rep. 14(6), 1405-1412 (2005).
21. Weycker D, Hackett J, Edelsberg JS, Oster G, Glass AG. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann. Pharmacother. 40(3), 402-407 (2006).
22. Hendler D, Rizel S, Yerushalmi R et al. Differente schedules of granulocyte growth factor support for patient with breast cancer receiving adjuvant dose-dense chemotherapy: A prospective non randomized study. Am. J. Clin. Oncol. PMID: 21217400 (2011) (Epub ahead of print).
23. Falandry C, Campone H, Carton G, Guerin D, Freyer G. Trends in G-CSF use in 990 patients after EORTC and ASCO guidelines. Eur. J. Cancer 46, 2389-2398 (2010).
24. Lingaratnam S, Slavin MA, Mileshkin L et al. An Australian survey of clinical practices in management of neutropenic fever in adult cancer patients 2009. J. Intern. Med. 41, 110-120 (2011).
25. Shinjo K, Takeshita A, Ohnishi K, Ohno R. Granulocyte colony-stimulating factor receptor at various differentiation stages of normal and leukemic hematopoietic cells. Leuk. Lymphoma 25(1-2), 37-46 (1997).
26. Richards MK, Liu F, Iwasaki H, Akashi K, Link DC. Pivotal role of granulocyte colony-stimulating factor in the development of progenitors in the common myeloid pathway. Blood 102(10), 3562-3568 (2003).
27. Engervall P, Lundahl J. Alterations in adhesion molecule (CD11b/CD18 and CD62L) expression on granulocytes after chemotherapy. Eur. J. Clin. Invest. 28(11), 924-929 (1998).
28. Terashi K, Oka M, Ohdo S et al. Close association between clearance of recombinant human granulocyte colony-stimulating factor (G-CSF) and G-CSF receptor on neutrophils in cancer patients. Antimicrob. Agents Chemother. 43(1), 21-24 (1999).
29. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: Characteristics and guidelines for use. Am. J. Public Health 74(9), 979-983 (1984).
30. Murphy MK, Black NA, Lamping DL et al. Consensus development methods, and their use in clinical guideline development. Health Technol. Assess. 2(3), i-iv 1-88 (1998).
31. US Department of Health and Human Sciences PHS. Agency for Health Health Care Policy and Research. 115-127 (1992).
32. Gafter-Gvili A, Fraser A, Paul M, Leibovici L. Meta-analysis: Antibiotic prophylaxis reduces mortality in neutropenic patients. Ann. Intern. Med. 142, 979-995 (2005).
33. Bokemeyer C, Honecker F, Wedding U, Spath-Schwalbe E, Lipp HP, Kolb G. Use of hematopoietic growth factors in elderly patients receiving cytotoxic chemotherapy. Onkologie 25(1), 32-39 (2002).
34. Lyman GH, Kuderer NM, Djulbegovic B. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: A meta-analysis. Am. J. Med. 112(5), 406-411 (2002).
35. Sung L, Nathan PC, Alibhai SM, Tomlinson GA, Beyene J. Meta-analysis: Effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection. Ann. Intern. Med. 147(6), 400-411 (2007).
36. Kuderer NM, Dale DC, Crawford J, Lyman GH. 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. 25(21), 3158-3167 (2007).
37. Kuderer NM. Meta-analysis of randomized controlled trials of granulocyte colony-stimulating factor prophylaxis in adult cancer patients receiveng chemotherapy. Cancer Treat. Res. 157, 127-143 (2011).
38. Lyman GH, Kuderer NM, Crawford J et al. Prospective validation of a risk model for first cycle neutropenic complications in patients receiving cancer chemotherapy. J. Clin. Oncol. 24(18S), 8561 (Abstract) (2006).
39. Ozer H, Armitage JO, Bennet CL et al. Update of recommendations for the use of haematopietic colony stimulating factors: Evidenced-based, clinical practice guidelines. American Society of Clinical Oncology (ASCO) growth factors expert panel. J. Clin. Oncol. 18, 3558-3585 (2000).
40. 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. 23(6), 1178-1184 (2005).
41. Timmer-Bonte JN, De Boo TM, Smit HJ et al. Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: A Dutch randomized Phase III study. J. Clin. Oncol. 23(31), 7974-7984 (2005).
42. Aapro M, Crawford J, Kamioner D. Prophylaxis of chemotherapy-induced febrile neutropenia with granulocyte colony-stimulating factors: Where are we now? Supp. Care Cancer 18, 529-541 (2010).
43. Chatta GS, Price TH, Allen RC, Dale DC. Effects of in vivo recombinant methionyl human granulocyte colony-stimulating factor on the neutrophil response and peripheral blood colony-forming cells in healthy young and elderly adult volunteers. Blood 84(9), 2923-2929 (1994).
44. Crawford J, Kreisman H, Garewal H et al. The impact of filgrastim schedule variation on hematopoietic recovery post-chemotherapy. Ann. Oncol. 8(11), 1117-1124 (1997).
45. Koumakis G, Vassilomanolakis M, Barbounis V et al. Optimal timing (preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology 56(1), 28-35 (1999).
46. 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. 20(3), 727-731 (2002).
47. 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. 14(1), 29-35 (2003).
48. Von Minckwitz G, Kummel S, Du Bois A et al. Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/ cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann. Oncol. 19(2), 292-298 (2008).
49. Morrison VA, Wong M, Hershman D, Campos LT, Ding B, Malin J. Observational study of the prevalence of febrile neutropenia in patients who received filgrastim or pegfilgrastim associated with 3-4 week chemotherapy regimens in community oncology practices. J. Manag. Care Pharm. 13(4), 337-348 (2007).
50. Burstein HJ, Parker LM, Keshaviah A et al. Efficacy of pegfilgrastim and darbepoetin a as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J. Clin. Oncol. 23(33), 8340-8347 (2005).
51. Hartmann LC, Tschetter LK, Habermann TM et al. Granulocyte colony-stimulating factor in severe chemotherapy-induced afebrile neutropenia. N. Engl. J. Med. 336(25), 1776-1780 (1997).
52. Link BK, Budd GT, Scott S et al. Delivering adjuvant chemotherapy to women with early-stage breast carcinoma: Current patterns of care. Cancer 92(6), 1354-1367 (2001).
53. Lyman GH, Delgado DJ. Risk and timing of hospitalization for febrile neutropenia in patients receiving CHOP, CHOP-R, or CNOP chemotherapy for intermediate-grade non-Hodgkin lymphoma. Cancer 98(11), 2402-2409 (2003).
54. Bonadonna G, Valagussa P, Moliterni A, Zambetti M, Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: The results of 20 years of follow-up. N. Engl. J. Med. 332(14), 901-906 (1995).
55. Papaldo P, Lopez M, Marolla P et al. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J. Clin. Oncol. 23(28), 6908-6918 (2005).
56. Leibovici L, Paul M, Cullen M et al. Antibiotic prophylaxis in neutropenic patients: New evidence, practical decisions. Cancer 107(8), 1743-1751 (2006).
57. Imran H, Tleyjeh IM, Arndt CA et al. Fluoroquinolone prophylaxis in patients with neutropenia: A meta-analysis of randomized placebo-controlled trials. Eur. J. Clin. Microbiol. Infect. Dis. 27(1), 53-63 (2008).
58. Gafter-Gvili A, Paul M, Fraser A, Leibovici L. Effect of quinolone prophylaxis in afebrile neutropenic patients on microbial resistance: Systematic review and meta-analysis. J. Antimicrob. Chemother. 59(1), 5-22 (2007).
59. Innes H, Lim SL, Hall A, Chan SY, Bhalla N, Marshall E. Management of febrile neutropenia in solid tumours and lymphomas using the Multinational Association for Supportive Care in Cancer (MASCC) risk index: Feasibility and safety in routine clinical practice. Support. Care Cancer 16(5), 485-491 (2008).
60. Klastersky J, Paesmans M, Georgala A et al. Outpatient oral antibiotics for febrile neutropenic cancer patients using a score predictive for complications. J. Clin. Oncol. 24(25), 4129-4134 (2006).
61. Georgoulias V, Kouroussis C, Androulakis N et al. Front-line treatment of advanced non-small-cell lung cancer with docetaxel and gemcitabine: A multicenter Phase II trial. J. Clin. Oncol. 17(3), 914-920 (1999).
62. Georgoulias V, Ardavanis A, Tsiafaki X et al. Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: A Phase III randomized trial. J. Clin. Oncol. 23(13), 2937-2945 (2005).
63. Riedel RF, Andrews C, Garst J et al. A Phase II trial of carboplatin/vinorelbine with pegfilgrastim support for the treatment of patients with advanced non-small cell lung cancer. J. Thorac. Oncol. 2(6), 520-525 (2007).
64. De Wit R, Verweij J, Bontenbal M et al. Adverse effect on bone marrow protection of prechemotherapy granulocyte colony-stimulating factor support. J. Natl Cancer Inst. 88(19), 1393-1398 (1996).
65. Tjan-Heijnen VC, Biesma B, Festen J et al. Enhanced myelotoxicity due to granulocyte colony-stimulating factor administration until 48 hours before the next chemotherapy course in patients with small-cell lung carcinoma. J. Clin. Oncol. 16(8), 2708-2714 (1998).
66. Frasci G, D'Aiuto G, Thomas R et al. Biweekly docetaxel-irinotecan treatment with filgrastim support is highly active in antracycline-paclitaxel- refractory breast cancer patients. Oncology 68(4-6), 391-397 (2005).
67. Nistico C, Bria E, Agostara B et al. Weekly paclitaxel, 5-fluorouracil and folinic acid with granulocyte colony-stimulating factor support in metastatic breast cancer patients: A Phase II study. Anticancer Drugs 17(3), 345-351 (2006).
68. Nistico C, De Matteis A, Rossi E et al. Primary chemotherapy with epirubicin and vinorelbine in women with locally advanced breast cancer. Anticancer Res. 25(2B), 1343-1348 (2005).
69. Makatsoris T, Papakostas P, Kalofonos HP et al. Intensive weekly chemotherapy with docetaxel, epirubicin and carboplatin with G-CSF support in patients with advanced gastric cancer: A Hellenic Cooperative Oncology Group (HeCOG) Phase II study. Med. Oncol. 24(3), 301-307 (2007).
70. Benasso M, Lionetto R, Corvo R, Ponzanelli A, Vitale V, Rosso R. Impact of the treating institution on the survival of patients with head and neck cancer treated with concomitant alternating chemotherapy and radiation. Eur. J. Cancer 39(13), 1895-1898 (2003).
71. Sheikh H, Colaco R, Lorigan P et al. Use of G-CSF during concurrent chemotherapy and thoracic radiotherapy in patients with limited-stage small cell lung cancer: Safety data from a Phase II trial. Lung Cancer DOI: 10.1016/j.lungcan.2011.01.020 (2011) (Epub ahead of print).
72. Kelly S, Wheatley D. Prevention of febrile neutropenia: Use of granulocyte colony-stimulating factors. Br. J. Cancer 101, 6-10 (2009).
73. Advani SH, Achreckar S, Thomas D, Krishnankutty B. Granulocyte colony-stimulating factor (filgrastim) in chemotherapy-induced febrile neutropenia. Indian J. Med. Paed. Oncol. 31, 79-82 (2010).
74. Saloustros E, Tryfonidis K, Georgoulias V. Prophylactic and therapeutic strategies in chemotherapy-induced neutropenia. Exp. Opin. Pharmacother. 12(6), 851-863 (2011).
75. Gunzer K, Clarisse B, Lheureux S, Delcambre C, Joly F. Contibution of glycosylated recombinant human granulocyte colony-stimulating factor (lenograstim) use in current cancer treatment: Review of clinical data. Exp. Opin. Biol. Ther. 10, 615-630 (2010).
76. Orciuolo E, Buda G, Marturano E et al. Lenograstim reduces the incidence of febrile episodes, when compared with filgrastim, in multiple myeloma patients undergoing stem cell mobilization. Leuk. Res. 35(7), 899-903 (2011).
77. Weycker D, Malin J, Barron R, Edelsberg J, Kartashov A, Oster G. Comparative effectiveness of filgrastim, pegfilgrastim and sargramostim as prophylaxis against hospitalization for neutropenic complications in patients with cancer receiving chemotherapy. Am. J. Clin. Oncol. PMID: 21378538 (2011) (Epub ahead of print).
78. Tan H, Tomic K, Hurley D, Daniel G, Barron R, Malin J. Comparative effectiveness of colony stimulating factors for febrile neutropenia: A retrospective study. Curr. Med. Res. Opin. 27, 79-86 (2011).
79. Danova M, Rosti G, Doan QV. Cost-effectiveness of pegfilgrastim versus six days of filgrastim for preventing febrile neutropenia in breast cancer patients. Tumori 95(2), 219-226 (2009).
80. Liu Z, Doan QV, Malin J, Leonard R. The economic value of primary prophylaxis using pegfilgrastim compared with filgrastim in patients with breast cancer in the UK. Appl. Health Econ. Health Policy 7, 193-205 (2009).
81. Weycker D, Barron RL. Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-induced neutropenia. Cancer 116, 3073-3074 (2010).
82. Sullivan SD, Ramsey SD, Blough DK, McDermott CL, Clarke L, McCune JS. Health care use and primary prophylaxis with colony stimulating factors. Value Health 14, 247-252 (2011).
83. Mellstedt H, Niederwiser D, Ludwig H. The challenge of biosimilars. Ann. Oncol. 19, 411-419 (2008).
84. Gascon P, Fuhr U, Sorgel F et al. Development of a new G-CSF product based on biosimilarity assessment. Ann. Oncol. 21, 1419-1429 (2010).
85. Skrlin A, Radic I, Vuletic M et al. Comparison of the physico-chemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 38, 557-566 (2010). Websites