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Supportive Care in Cancer

, Volume 20, Issue 8, pp 1649–1657 | Cite as

Trends in anemia management in lung and colon cancer patients in the US Department of Veterans Affairs, 2002–2008

  • Elizabeth TarlovEmail author
  • Kevin T. Stroupe
  • Todd A. Lee
  • Thomas W. Weichle
  • Qiuying L. Zhang
  • Laura C. Michaelis
  • Howard Ozer
  • Margaret M. Browning
  • Denise M. Hynes
Original Article

Abstract

Purpose

In 2007, growing concerns about adverse impacts of erythropoiesis-stimulating agents (ESAs) in cancer patients led to an FDA-mandated black box warning on product labeling, publication of revised clinical guidelines, and a Medicare coverage decision limiting ESA coverage. We examined ESA therapy in lung and colon cancer patients receiving chemotherapy in the VA from 2002 to 2008 to ascertain trends in and predictors of ESA use.

Methods

A retrospective study employed national VA databases to “observe” treatment for a 12-month period following diagnosis. Multivariable logistic regression analyses evaluated changes in ESA use following the FDA-mandated black box warning in March 2007 and examined trends in ESA administration between 2002 and 2008.

Results

Among 17,014 lung and 4,225 colon cancer patients, those treated after the March 2007 FDA decision had 65% (lung OR 0.35, CI95% 0.30–0.42) and 53% (colon OR 0.47, CI95% 0.36–0.63) reduced odds of ESA treatment compared to those treated before. Declines in predicted probabilities of ESA use began in 2006. The magnitude of the declines differed across age groups among colon patients (p = 0.01) and levels of hemoglobin among lung cancer patients (p = 0.04).

Conclusions

Use of ESA treatment for anemia in VA cancer care declined markedly after 2005, well before the 2007 changes in product labeling and clinical guidelines. This suggests that earlier dissemination of research results had marked impacts on practice patterns with these agents.

Keywords

Lung neoplasms Colon neoplasms Anemia/drug therapy Physician's practice patterns Age factors 

Notes

Acknowledgements

This research was supported by the US Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service (Project Number: IIR 08-354-1). Dr. Hynes was also supported by a VA Research Career Scientist Award.

Financial disclosures

Dr. Ozer is on the Speakers Bureau for Amgen, which produces darbepoetin alpha. Drs. Tarlov, Stroupe, Lee, and Hynes; Ms. Zhang; Ms. Browning; and Mr. Weichle are employed by the US Department of Veterans Affairs. Dr. Michaelis is employed by Loyola University Medical Center.

Conflict of interest

This research was funded solely by the US Department of Veterans Affairs, as noted previously (Acknowledgements). The authors have full control of all primary data and agree to allow the journal to review their data if requested.

References

  1. 1.
    Bohlius J, Schmidlin K, Brillant C et al (2009) Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. Lancet 373(9674):1532–1542PubMedCrossRefGoogle Scholar
  2. 2.
    Bohlius J, Tonia T, Schwarzer G (2011) Twist and shout: one decade of meta-analyses of erythropoiesis-stimulating agents in cancer patients. Acta Haematol 125(1–2):55–67PubMedCrossRefGoogle Scholar
  3. 3.
    Wilson J, Yao GL, Raftery J et al (2007) A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha in anaemia associated with cancer, especially that attributable to cancer treatment. Health Technol Assess 11(13):1-ivGoogle Scholar
  4. 4.
    Drugs@FDA. (Web site online). U.S. Department of Health & Human Services, U.S. Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda. Accessed April 18, 2011
  5. 5.
    Henke M, Laszig R, Rube C et al (2003) Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 362(9392):1255–1260PubMedCrossRefGoogle Scholar
  6. 6.
    Leyland-Jones B (2003) Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol 4(8):459–460PubMedCrossRefGoogle Scholar
  7. 7.
    Approved risk evaluation and mitigation strategies (REMS). (Web site online). U.S. Department of Health & Human Services, U.S. Food and Drug Administration. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm. Accessed April 18, 2011
  8. 8.
    Phurrough S, Jacques L, Ciccanti M, Long K, Koller E. Decision memo for erythropoiesis stimulating agents (ESAs) for non-renal disease indications (CAG-00383N). U.S. Department of Health & Human Services, Centers for Medicare and Medicaid Services; 2007 Jul 30. Available at: http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx
  9. 9.
    Rizzo JD, Somerfield MR, Hagerty KL et al (2008) Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. J Clin Oncol 26(1):132–149PubMedCrossRefGoogle Scholar
  10. 10.
    Rodgers GM, III, Becker PS, Bennett CL et al. (2008) Cancer- and chemotherapy-induced anemia. J Natl Compr Canc Netw 6(6):536–564PubMedGoogle Scholar
  11. 11.
    Ferrajoli A, Buzdar AU, Dejesus Y, Cheng L, Michaud LB, Rodriguez MA (2011) Usage of erythropoiesis-stimulating agents in cancer patients at an academic cancer center and experience with specific care management tools for anemia. Cancer 117(14):3268–3275PubMedCrossRefGoogle Scholar
  12. 12.
    Hess G, Nordyke RJ, Hill J, Hulnick S (2010) Effect of reimbursement changes on erythropoiesis-stimulating agent utilization and transfusions. Am J Hematol 85(11):838–843PubMedCrossRefGoogle Scholar
  13. 13.
    Lal LS, Raju A, Miller LA, Chen H, Arbuckle R, Sansgiry SS (2010) Impact of changes in reimbursement policies and institutional practice algorithm for utilization of erythropoietic-stimulating agents on treatment patterns and costs in anemic lymphoma patients. Support Care Cancer 19(2):251–259PubMedCrossRefGoogle Scholar
  14. 14.
    Naeim A, Glaspy JA. Changes in RBC supportive medications and transfusions in cancer patients undergoing chemotherapy before and after FDA and Medicare actions in 2007. Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings 26[15S]. 2008Google Scholar
  15. 15.
    Vadhan-Raj S, Zhou X, Sizer K et al (2010) Impact of safety concerns and regulatory changes on the usage of erythropoiesis-stimulating agents and RBC transfusions. Oncologist 15(12):1359–1369PubMedCrossRefGoogle Scholar
  16. 16.
    Greene FL (2002) In: American Joint Committee on Cancer (ed) AJCC cancer staging manual, 6th edn. Springer-Verlag, New YorkGoogle Scholar
  17. 17.
    Commission on Cancer. Facility oncology registry data standards (FORDS). American College of Surgeons; 2002Google Scholar
  18. 18.
    VHA vital status files. VA Information Resource Center (Web site online). Available at: http://www.virec.research.va.gov. Accessed February 15, 2011
  19. 19.
    VA Information Resource Center. VIReC research user guide: FY2006 VHA medical SAS® inpatient datasets. Edward J. Hines, Jr. VA Hospital, Hines, IL: U.S. Department of Veterans Affairs. VA Information Resource Center; 2007Google Scholar
  20. 20.
    VA Information Resource Center. VIReC research user guide: FY2006 VHA medical SAS® outpatient datasets. Edward J. Hines, Jr. VA Hospital, Hines, IL: U.S. Department of Veterans Affairs. VA Information Resource Center; 2007Google Scholar
  21. 21.
    VA Information Resource Center. VIReC research user guide: VHA pharmacy prescription data, 2nd ed. Edward J. Hines, Jr. VA Hospital, Hines, IL: U.S. Department of Veterans Affairs, VA Information Resource Center; 2009Google Scholar
  22. 22.
    Klabunde CN, Potosky AL, Legler JM, Warren JL (2000) Development of a comorbidity index using physician claims data. J Clin Epidemiol 53(12):1258–1267PubMedCrossRefGoogle Scholar
  23. 23.
    Klabunde CN, Harlan LC, Warren JL (2006) Data sources for measuring comorbidity: a comparison of hospital records and Medicare claims for cancer patients. Med Care 44(10):921–928PubMedCrossRefGoogle Scholar
  24. 24.
    Sohn MW, Zhang H, Arnold N et al (2006) Transition to the new race/ethnicity data collection standards in the Department of Veterans Affairs. Popul Health Metr 4:7PubMedCrossRefGoogle Scholar
  25. 25.
    Stroupe KT, Tarlov E, Zhang Q, Haywood T, Owens A, Hynes DM (2010) Use of Medicare and DOD data for improving VA race data quality. J Rehabil Res Dev 47(8):781–795PubMedCrossRefGoogle Scholar
  26. 26.
    Pritchard RS, Fisher ES, Teno JM et al (1998) Influence of patient preferences and local health system characteristics on the place of death. SUPPORT investigators. Study to understand prognoses and preferences for risks and outcomes of treatment. J Am Geriatr Soc 46(10):1242–1250PubMedGoogle Scholar
  27. 27.
    Sirovich BE, Gottlieb DJ, Welch HG, Fisher ES (2006) Regional variations in health care intensity and physician perceptions of quality of care. Ann Intern Med 144(9):641–649PubMedGoogle Scholar
  28. 28.
    Pollack A. Drug company halts trials of Procrit. New York Times. November 27, 2003Google Scholar
  29. 29.
    Pollack A. F.D.A. wants more study on 2 drugs for anemia. New York Times. May 4, 2004Google Scholar
  30. 30.
    Bohlius J, Wilson J, Seidenfeld J et al (2006) Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 98(10):708–714PubMedCrossRefGoogle Scholar
  31. 31.
    Luo W, Nordstrom BL, Fraeman K et al (2008) Adherence to guidelines for use of erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia: results of a retrospective study of an electronic medical-records database in the United States, 2002–2006. Clin Ther 30(12):2423–2435PubMedCrossRefGoogle Scholar
  32. 32.
    Singh AK, Szczech L, Tang KL et al (2006) Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 355(20):2085–2098PubMedCrossRefGoogle Scholar
  33. 33.
    Balducci L (2010) Anemia, fatigue and aging. Transfus Clin Biol 17(5–6):375–381PubMedCrossRefGoogle Scholar
  34. 34.
    National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: cancer- and chemotherapy-induced anemia—Version 2.2011. National Comprehensive Cancer Network; 2011 Feb 14Google Scholar
  35. 35.
    Rizzo JD, Brouwers M, Hurley P et al. (2010) American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol 28(33):4996–5010PubMedCrossRefGoogle Scholar
  36. 36.
    Alexander D, Waterbor J, Hughes T, Funkhouser E, Grizzle W, Manne U (2007) African-American and Caucasian disparities in colorectal cancer mortality and survival by data source: an epidemiologic review. Cancer Biomark 3(6):301–313PubMedGoogle Scholar
  37. 37.
    Burgess DJ, van RM, Grill J et al (2011) Presence and correlates of racial disparities in adherence to colorectal cancer screening guidelines. J Gen Intern Med 26(3):251–258PubMedCrossRefGoogle Scholar
  38. 38.
    Deswal A, Petersen NJ, Urbauer DL, Wright SM, Beyth R (2006) Racial variations in quality of care and outcomes in an ambulatory heart failure cohort. Am Heart J 152(2):348–354PubMedCrossRefGoogle Scholar
  39. 39.
    Dominitz JA, Samsa GP, Landsman P, Provenzale D (1998) Race, treatment, and survival among colorectal carcinoma patients in an equal-access medical system. Cancer 82(12):2312–2320PubMedCrossRefGoogle Scholar
  40. 40.
    Gordon HS, Johnson ML, Ashton CM (2002) Process of care in hispanic, black, and white VA beneficiaries. Med Care 40(9):824–833PubMedCrossRefGoogle Scholar
  41. 41.
    Robinson CN, Balentine CJ, Marshall CL et al (2010) Ethnic disparities are reduced in VA colon cancer patients. Am J Surg 200(5):636–639PubMedCrossRefGoogle Scholar
  42. 42.
    Trivedi AN, Grebla RC, Wright SM, Washington DL (2011) Despite improved quality of care in the Veterans Affairs health system, racial disparity persists for important clinical outcomes. Health Aff (Millwood) 30(4):707–715CrossRefGoogle Scholar
  43. 43.
    U.S. Department of Veterans Affairs Pharmacy Benefits Management Services. VHA directive 2010–002, list of high cost high risk drugs 2009–10. 2010 Jan 12Google Scholar
  44. 44.
    Bohlius J, Langensiepen S, Schwarzer G et al (2005) Recombinant human erythropoietin and overall survival in cancer patients: results of a comprehensive meta-analysis. J Natl Cancer Inst 97(7):489–498PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Elizabeth Tarlov
    • 1
    Email author
  • Kevin T. Stroupe
    • 1
    • 2
  • Todd A. Lee
    • 1
    • 3
  • Thomas W. Weichle
    • 1
  • Qiuying L. Zhang
    • 1
  • Laura C. Michaelis
    • 2
  • Howard Ozer
    • 4
  • Margaret M. Browning
    • 1
  • Denise M. Hynes
    • 1
    • 4
    • 5
  1. 1.Center for Management of Complex Chronic Care, Edward Hines, Jr. VA HospitalHinesUSA
  2. 2.Stritch School of MedicineLoyola University ChicagoMaywoodUSA
  3. 3.College of PharmacyUniversity of Illinois at ChicagoChicagoUSA
  4. 4.College of MedicineUniversity of Illinois at ChicagoChicagoUSA
  5. 5.Institute for Health Research and PolicyUniversity of Illinois at ChicagoChicagoUSA

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