Cost-effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the united states

Clinical Therapeutics

Volumn 31, Issue 5, 2009, Pages 1092-1104

  Lyman, Gary H ^a   Lalla, Anjana ^b   Barron, Richard L ^c   Dubois, Robert W ^b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b CERNER CORPORATION   (United States)

^c AMGEN INC   (United States)

Author keywords

breast cancer; cost effectiveness; filgrastim; pegfilgrastim; primary prophylaxis

Indexed keywords

ANTINEOPLASTIC AGENT; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ARTICLE; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CONTROLLED STUDY; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG DOSAGE FORM COMPARISON; FEBRILE NEUTROPENIA; FEMALE; HEALTH CARE COST; HEALTH INSURANCE; HUMAN; MEDICAL DECISION MAKING; MORTALITY; MULTIPLE CYCLE TREATMENT; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PROBABILITY; QUALITY ADJUSTED LIFE YEAR; RISK ASSESSMENT; TREATMENT DURATION; UNITED STATES;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; COST-BENEFIT ANALYSIS; DECISION SUPPORT TECHNIQUES; FEMALE; FILGRASTIM; HUMANS; MIDDLE AGED; NEUTROPENIA; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX; SURVIVAL ANALYSIS; UNITED STATES;

EID: 66949127931     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.05.003     Document Type: Article

References (69)

1. Smith T., Khatcheressian J., Lyman G.H., et al. 2006 Update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline. J Clin Oncol. 24 (2006) 3187-3205
2. 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. 325 (1991) 164-170
3. Trillet-Lenoir V., Green J., Manegold C., et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 29A (1993) 319-324
4. Holmes F.A., O'Shaughnessy J.A., 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 (2002) 727-731
5. Green M.D., Koelbl H., Baselga J., et al., the International Pegfilgrastim 749 Study Group. A randomized doubleblind multicenter phase III study of fixed-dose singleadministration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 14 (2003) 29-35
6. Vogel C.L., Wojtukiewicz M.Z., Carroll R.R., 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 (2005) 1178-1184
7. Aapro M.S., Cameron D.A., Pettengell R., et al., the European Organisation for Research and Treatment of Cancer (EORTC) Granulocyte Colony-Stimulating Factor Guidelines Working Party. 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 42 (2006) 2433-2453
8. Lyman G.H. Guidelines of the National Comprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: A review of the evidence. J Natl Compr Canc Netw. 3 (2005) 557-571
9. Kuwabara T., Kobayashi S., and Sugiyama Y. Pharmacokinetics and pharmacodynamics of a recombinant human granulocyte colony-stimulating factor. Drug Metab Rev. 28 (1996) 625-658
10. Welte K., Gabrilove J., Bronchud M.H., et al. Filgrastim (r-metHuG-CSF): The first 10 years. Blood 88 (1996) 1907-1929
11. Bhana N. Granulocyte colony-stimulating factors in the management of chemotherapy-induced neutropenia: Evidence based review. Curr Opin Oncol. 19 (2007) 328-335
12. Molineux G., Kinstler O., Briddell B., et al. A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp Hematol 27 (1999) 1724-1734
13. The electronic Medicines Compendium (eMC). Neulasta. Summary of product characteristics. Accessed March 30, 2009. http://emc.medicines. org.uk/document.aspx?documentId=11783
14. Gabrilove J.L. An analysis of current neutropenia therapies, including pegfilgrastim. Clin Cornerstone. 8 Suppl 5 (2006) S19-S28
15. Kuderer N.M., Dale D.C., Crawford J., and Lyman G.H. Impact of primary prophylaxis with granulocyte colonystimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review. J Clin Oncol. 25 (2007) 3158-3167
16. 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. 23 (2007) 2283-2295
17. Siena S., Piccart M.J., Holmes F.A., et al. A combined analysis of two pivotal randomized trials of a single dose of pegfil-grastim per chemotherapy cycle and daily filgrastim in patients with stage II-IV breast cancer. Oncol Rep. 10 (2003) 715-724
18. Morrison V.A., Wong M., Hershman D., et al. 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 (2007) 337-348
19. Weycker D., Hackett J., Edelsberg J.S., et al. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization?. Ann Pharmacother. 40 (2006) 402-407
20. Scott S.D., Chrischilles E.A., Link B.K., et al. Days of prophylactic filgrastim use to reduce febrile neutropenia in patients with non-Hodgkin's lymphoma treated with chemotherapy. J Manag Care Pharm. 9 Suppl (2003) 15-21
21. von Minckwitz G., Kümmel S., du Bois A., et al., the German Breast Group. Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/ cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol. 19 (2008) 292-298
22. Martin M., Lluch A., Seguí M.A., et al. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): Impact of adding primary prophylactic granulocytecolony stimulating factor to the TAC regimen. Ann Oncol. 17 (2006) 1205-1212
23. Martin M., Pienkowski T., Mackey J., et al., the Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 352 (2005) 2302-2313
24. Fortner B.V., and Houts A.C. Greater physical and psychological symptom burden in patients with grade 3/4 chemotherapy-induced neutropenia. Support Cancer Ther. 3 (2006) 173-177
25. Caggiano V., Weiss R.V., Rickert T.S., and Linde-Zwirble W.T. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 103 (2005) 1916-1924
26. Kuderer N.M., Dale D.C., Crawford J., et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 106 (2006) 2258-2266
27. Lyman G.H., Dale D.C., Friedberg J., et al. Incidence and predictors of low chemotherapy dose-intensity in aggressive non-Hodgkin's lymphoma: A nationwide study. J Clin Oncol. 22 (2004) 4302-4311
28. Talcott J.A., Siegel R.D., Finberg R., and Goldman L. Risk assessment in cancer patients with fever and neutro-penia: A prospective, two-center validation of a prediction rule. J Clin Oncol. 10 (1992) 316-322
29. Klastersky J., Paesmans M., Rubenstein E.B., et al. The Multinational Association for Supportive Care in Cancer risk index: A multinational scoring system for identifying low-risk febrile neutropenic cancer patients. J Clin Oncol. 18 (2000) 3038-3051
30. Cosler L.E., Sivasubramaniam V., Agboola O., et al. Effect of outpatient treatment of febrile neutropenia on the risk threshold for the use of CSF in patients with cancer treated with chemotherapy. Value Health 8 (2005) 47-52
31. 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. 330 (2005) 217
32. Bonadonna G., Valagussa P., Moliterni A., et al. Adjuvant cyclophos-phamide, methotrexate, and fluo-rouracil in nodepositive breast cancer: The results of 20 years of follow-up. N Engl J Med. 332 (1995) 901-906
33. Bonadonna G., and Valagussa P. Dose-response effect of adjuvant chemotherapy in breast cancer. N Engl J Med. 304 (1981) 10-15
34. Colleoni M., Li S., Gelber R.D., et al., the International Breast Cancer Study Group. Relation between chemotherapy dose, oestrogen receptor expression, and body-mass index. Lancet 366 (2005) 1108-1110
35. Hershman D., McBride R., Jacobson J.S., et al. Racial disparities in treatment and survival among women with early-stage breast cancer. J Clin Oncol. 23 (2005) 6639-6646
36. Centers for Medicare & Medicaid Services. 2006 ASP Drug Pricing Files. Medicare Part B drug average sales price. http://www.cms.hhs. gov/McrPartBDrugAvgSalesPrice/02_aspfiles.asp Accessed March 18, 2008
37. American Medical Association (AMA). Current Procedural Terminology: 2006 (2006), AMA, Chicago, Ill
38. Centers for Medicare & Medicaid Services. 2006Medicare physician fee schedule. http://www.cms.hhs.gov/PFSlookup/ Accessed March 18, 2008
39. Doan Q.V., Gleeson M., Kim J., et al. Economic burden of cardiovascular events and fractures among patients with end-stage renal disease. Curr Med Res Opin. 23 (2007) 1561-1569
40. Weycker D., Malin J., Edelsberg J., et al. Cost of neutropenic complications of chemotherapy. Ann Oncol. 19 (2008) 454-460
41. Timmer-Bonte J.N., Adang E.M., Smit H.J., et al. Cost-effectiveness of adding granulocyte colony-stimulating factor to primary prophylaxis with antibiotics in patients with small-cell lung cancer. J Clin Oncol. 24 (2006) 2991-2997
42. Bennett C.L., and Calhoun E.A. Evaluating the total costs of chemotherapy-induced febrile neutropenia: Results from a pilot study with community oncology cancer patients. Oncologist 12 (2007) 478-483
43. US Dept of Labor. US Bureau of Labor Statistics: Occupational Employment Statistics: May 2006 national occupational employment and wage estimates. http://www.bls.gov/oes/2006/may/oes_nat.htm Accessed February 23, 2007
44. Liou S.Y., Stephens J.M., Carpiuc K.T., et al. Economic burden of haema-tological adverse effects in cancer patients: A systematic review. Clin Drug Investig 27 (2007) 381-396
45. Lyman G.H., and Kuderer N.M. The economics of the colony-stimulating factors in the prevention and treatment of febrile neutropenia. Crit Rev Oncol Hematol 50 (2004) 129-146
46. 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 (2006) 4129-4134
47. Chamilos G., Bamias A., Efstathiou E., et al. Outpatient treatment of low-risk neutropenic fever in cancer patients using oral moxifloxacin. Cancer. 103 (2005) 2629-2635
48. Uys A., Rapoport B.L., and Anderson R. Febrile neutropenia: A prospective study to validate the Multinational Association of Supportive Care of Cancer (MASCC) risk-index score. Support Care Cancer 12 (2004) 555-560
49. Hillner B.E., Smith T.J., and Desch C.E. Efficacy and cost-effectiveness of autologous bone marrow transplantation in metastatic breast cancer. Estimates using decision analysis while awaiting clinical trial results. JAMA 267 (1992) 2055-2061
50. Brown R.E., Hutton J., and Burrell A. Cost effectiveness of treatment options in advanced breast cancer in the UK. PharmacoEconomics 19 (2001) 1091-1102
51. Brown R.E., and Hutton J. Cost-utility model comparing docetaxel and paclitaxel in advanced breast cancer patients. Anticancer Drugs. 9 (1998) 899-907
52. Armstrong K., Chen T.M., Albert D., et al. Cost-effectiveness of raloxifene and hormone replacement therapy in postmenopausal women: Impact of breast cancer risk. Obstet Gynecol 98 (2001) 996-1003
53. Liljegren G., Karlsson G., Bergh J., and Holmberg L. The cost-effectiveness of routine postoperative radiotherapy after sector resection and axillary dissection for breast cancer stage I. Results from a randomized trial. Ann Oncol. 8 (1997) 757-763
54. Lyman G.H., Lyman C.H., and Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist 10 (2005) 427-437
55. Shayne M., Crawford J., Dale D.C., et al. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 100 (2006) 255-262
56. Lyman G.H., Dale D.C., and Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: A nationwide study of community practices. J Clin Oncol. 21 (2003) 4524-4531
57. Leonard R.C., Miles D., Thomas R., Nussey F., and the UK Breast Cancer Neutropenia Audit Group. Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients. Br J Cancer 89 (2003) 2062-2068
58. Surveillance, Epidemiology, and End Results (SEER). SEER Data, 1973-2005 SEER 9 Registries Database. http://seer.cancer.gov/data/index.html Accessed November 16, 2007
59. Arias E., United States Life Tables, and 2002. National Vital Statistics Reports. (2004) 53. http://www.cdc.gov/nchs/data/nvsr/nvsr53/nvsr53_06.pdf Accessed February 23, 2007
60. US Dept of Health and Human Services, Centers for Disease Control and Prevention (CDC). Compressed Mortality File 1999-2002. http://wonder.cdc.gov/wonder/help/cmf.html" Accessed July 31, 2006
61. German recommendations for health care economic evaluation studies. Revised version of Hannover consensus. Hannover Consensus Group [in German]. Med Klin (Munich) 95 (2000) 52-55
62. Hillner B.E., Weeks J.C., Desch C.E., and Smith T.J. Pamidronate in prevention of bone complications in metastatic breast cancer: A cost-effectiveness analysis. J Clin Oncol. 18 (2000) 72-79
63. Zbrozek A.S., Cantor S.B., Cardenas M.P., and Hill Jr. D.P. Pharmacoeconomic analysis of ondansetron versus metoclopramide for cisplatin-induced nausea and vomiting. Am J Hosp Pharm. 51 (1994) 1555-1563
64. Elkin E.B., Weinstein M.C., Winer E.P., et al. HER-2 testing and trastu-zumab therapy for metastatic breast cancer: A cost-effectiveness analysis. J Clin Oncol. 22 (2004) 854-863
65. Lister-Sharp D., McDonagh M.S., Khan K.S., and Kleijnen J. A rapid and systematic review of the effectiveness and cost-effectiveness of the taxanes used in the treatment of advanced breast and ovarian cancer. Health Technol Assess. 4 (2000) 1-113
66. Lyman G., Lalla A., Barron R., and Dubois R.W. Cost-effectiveness of pegfil-grastim versus 6-day filgrastim primary prophylaxis in patients with non-Hodgkin's lymphoma receiving CHOP-21 in United States. Curr Med Res Opin. 25 (2009) 401-441
67. Eldar-Lissai A., Cosler L.E., Culakova E., and Lyman G.H. Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health. 11 (2008) 172-179
68. Girmenia C., Russo E., Carmosino I., et al. Early hospital discharge with oral antimicrobial therapy in patients with hematologic malignancies and low-risk febrile neutropenia. Ann Hematol 86 (2007) 263-270
69. Weinstein M.C., Siegel J.E., Gold M.R., et al. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA 276 (1996) 1253-1258