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OPERa Study


Authors: P. Tesařová
Authors‘ workplace: Onkologická klinika 1. LF UK a VFN v Praze
Published in: Klin Onkol 2013; 26(6): 425-433
Category: Original Articles

Overview

Background:
On the whole, most European and international guidelines recommend prophylactic use of granulocyte-colony stimulating factors (G-CSFs) when the risk of chemotherapy-induced febrile neutropenia (FN) in cancer patients exceeds 20%. In patients treated with intermediate-risk chemotherapy regimens the recent EORTC guidelines recommend to consider supplementary patient-related adverse risk factors such as elderly age (≥ 65 years) prior to administrating each cycle of chemotherapy. The primary objective of our study is to describe the most important FN risk factors that underlie the use of pegfilgrastim PP in daily practice in the Czech Republic; secon­dary endpoints include FN incidence, chemotherapy dose intensity, anti-infective agents admini­stration, hospitalization length and safety of chemotherapy regimens.

Patients and methods:
This prospective, multicenter, non-interventional study enrolled patients receiving a chemotherapy with high FN risk (≥ 20% according to EORTC guidelines) based on investigators` assessment. ­

Results:
Data were collected on a total of 333 patients treated for breast cancer (69%), lymphoma (20%), ovarian (5%), lung (4%) and testicular cancer (1%). The most frequent indications for G-CSF prophylaxis were myelotoxic chemotherapy regimen (96%), elderly age (36%), advanced stage disease (35%), female gender (30%), cancer type (15%) and previous FN episode (12%). The overall FN incidence was 3% in patients receiving primary pegfilgrastim prophylaxis (n = 210) and 12% in patients with no pegfilgrastim PP (n = 123).

Conclusion:
The myelotoxicity of a chemotherapeutic regimen was the most significant FN risk factor identified by the inquired physicians. The second most compelling FN risk factor was elderly age and advanced stage disease. FN incidence in patients who received pegfilgrastim PP was relatively low in comparison to the commonly expected FN incidence in a population of patients receiving a chemotherapy regimen with high risk of FN.

Key words:
granulocyte colony-stimulating factor – pegfilgrastim – febrile neutropenia – prophylaxis – chemotherapy

The author declare she has no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

Submitted:
5. 11. 2013

Accepted:
14. 11. 2013


Sources

1. Caggiano V, Weiss RV, Rickert TS et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 2005; 103(9): 1916–1924.

2. Lyman GH, Michels SL, Reynolds MW et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer 2010; 116(23): 5555–5565.

3. Freifeld AG, Bow EJ, Sepkowitz KA et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis 2011; 52(4): e56–e93.

4. Nccn.org [homepage on the Internet]. National Comprehensive Cancer Network (NCCN) guidelines. Available from: http://www.nccn.org.

5. Smith TJ, Khatcheressian J, Lyman GH 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): 3187–3205.

6. Uptodate.com [homepage on the Internet]. Available from: http:/www.uptodate.com.

7. 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.

8. 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.

9. Ozer H, Armitage JO, Bennett CL et al. 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. American Society of Clinical Oncology Growth Factors Expert Panel. J Clin Oncol 2000; 18(20): 3558–3585.

10. Timmer-Bonte JN, Adang EM, Smit HJ et al. Cost-effectiveness of adding granulocyte colony-stimulating factor to primary prophylaxis with antibiotics in small-cell lung cancer. J Clin Oncol 2006; 24(19): 2991–2997.

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. Lathia N, Mittmann N, DeAngelis C et al. Evaluation of direct medical costs of hospitalization for febrile neutropenia. Cancer 2010; 116(3): 742–748.

13. 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.

14. Sung L, Nathan PC, Alibhai SM et al. Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection. Ann Intern Med 2007; 147(6): 400–411.

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.

16. Bohlius J, Herbst C, Reiser M et al. Granulopoiesis-stimulating factors to prevent adverse effects in the treat­ment of malignant lymphoma. Cochrane Database Syst Rev 2008; (4): CD003189.

17. Bennett CL, Djulbegovic B, Norris LB et al. Colony-stimulating factors for febrile neutropenia during cancer therapy. N Engl J Med 2013; 368(12): 1131–1139.

18. Leonard RC, Mansi J, Benstead K et al. Secondary PROphylaxis with G-CSF has a major effect on delivered dose intensity: the results of the UK NCRI/Anglo Celtic SPROG trial for adjuvant chemotherapy of breast cancer. EJC Supplements 2009; 7(2): 271.

19. Bonadonna G, Valagussa P, Moliterni A et al. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancor: the results of 20 years of fol­low-up. N Engl J Med 1995; 332(14): 901–906.

20. Bonadonna G, Moliterni A, Zambetti M et al. 30 years’ follow up of randomised studies of adjuvant CMF in oper­able breast cancer: cohort study. BMJ 2005; 330(7485): 217.

21. Chirivella I, Bermejo B, Insa A et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant set­ting improves outcome of breast cancer patient. Breast Cancer Res Threat 2009; 114(3): 479–484.

22. Pettengel R, Schwenkglenks M, Bosly. Association of reduced relative dose intensity and survival in lymphoma patients receiving CHOP-21 chemotherapy. Ann Hematol 2008; 87(5): 429–430.

23. Epelbaum R, Faraggi D, Ben-Arie Y et al. Survival of dif­fuse large cell lymphoma. A multivariate analysis including dose intensity variables. Cancer 1990; 66(6): 1124–1129.

24. Terada Y, Nakamae H, Moriguchi R et al. The impact of relative dose intensity of rituximab-CHOP on survival in Diffuse Large B-Cell Lymphoma patients. Blood (ASH Annual Meeting Abstracts) 2008; 112: abstr. 4931.

25. Hirakawa T, Yamaguchi H, Gomi S et al. Importance of relative dose intensity for survival in Diffuse Large B-Cell Lymphoma Patients treated with CHOP-Like regimen. Blood (ASH Annual Meeting Abstracts) 2008; 112: abstr. 3605.

26. Pettengell R, Gurney H, Radford JA et al. Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin‘s lymphoma: a randomized controlled trial. Blood 1992; 80(6): 1430–1436.

27. Rivera E, Erder MH, Moore TD et al. Targeted filgrastim support in patients with early-stage breast carcinoma: toward the implementation of a risk model. Cancer 2003; 98(2): 222–228.

28. Fosså SD, Kaye SB, Mead GM et al. Filgrastim during combination chemotherapy of patients with poor-prognosis metastatic germ cell malignancy. European Organization for Research and Treatment of Cancer, Genito-Urinary Group, and the Medical Research Council Testicular Cancer Working Party, Cambridge, United King­dom. J Clin Oncol 1998; 16(2): 716–724.

29. Aapro M, Schwenkglenks M, Lyman GH et al. Pegfilgrastim primary prophylaxis vs. current practice neutropenia management in elderly breast cancer patients receiv­ing chemotherapy. Crit Rev Oncol Hematol 2010; 74(3): 203–210.

30. Tjan-Heijnen VC, Postmus PE, Ardizzoni A et al. Reduc­tion of chemotherapy-induced febrile leucopenia by prophylactic use of ciprofloxacin and roxithromycin in small-cell lung cancer patients: an EORTC double-blind placebo-controlled phase III study. Ann Oncol 2001; 12(10): 1359–1368.

31. Dranitsaris G, Rayson D, Vincent M et al. Identifying patients at high risk for neutropenic complications during chemotherapy for metastatic breast cancer with doxorubicin or pegylated liposomal doxorubicin: the development of a prediction model. Am J Clin Oncol 2008; 31(4): 369–374.

32. Lyman GH, Kuderer NM, Crawford J et al. Predicting individual risk of neutropenic complications in patients receiving cancer chemotherapy. Cancer 2011; 117(9): 1917–1927.

33. Moreau M, Klastersky J, Schwarzbold A et al. A general chemotherapy myelotoxicity score to predict febrile neutropenia in hematological malignancies. Ann Oncol 2009; 20(3): 513–519.

34. Sharma S, Rezai K, Driscoll D et al. Characterization of neutropenic fever in patients receiving first-line adjuvant chemotherapy for epithelial ovarian cancer. Gynecol Oncol 2006; 103(1): 181–185.

35. Herskovic A, Martz K, al-Sarraf M et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 1992; 326(24): 1593–1598.

36. Pignon JP, Arriagada R, Ihde DC et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med 1992; 327(23): 1618–1624.

37. Marina J, Carabantes FJ, Escrivá de Romani S et al. ­Current practice of prophylaxis with granulocyte colony-stimulating factors for preventing chemotherapy-induced neutropenia in breast cancer patients in Spain. Eur ­­J Cancer Supplements 2009: 7(2): 181.

38. 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 2005; 23(31): 7974–7984.

39. Haim N, Shulman K, Goldberg H et al. The safety of full-dose chemotherapy with secondary prophylactic granulocyte colony stimulating factor (G-CSF) following a prior cycle with febrile neutropenia. Med Oncol 2005; 22(3): 229–232.

40. Chouaid C, Bassinet L, Fuhrman C et al. Routine use of granulocyte colony-stimulating factor is not cost-effective and does not increase patient comfort in the treatment of small-cell lung cancer: an analysis using a Markov model. J Clin Oncol 1998; 16(8): 2700–2707.

41. 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): 164–170.

42. Debled M, Houédé N, Madranges N et al. Does chemotherapy-induced neutropaenia result in a postponement of adjuvant or neoadjuvant regimens in breast cancer patients? Results of a retrospective analysis. Br J Cancer 2007; 97(12): 1642–1647.

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