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Supportive Care in Cancer

, Volume 20, Issue 9, pp 2089–2096 | Cite as

Hematologic outcomes and blood utilization in cancer patients with chemotherapy-induced anemia (CIA) pre- and post-national coverage determination (NCD): results from a multicenter chart review

  • David H. HenryEmail author
  • Corey J. Langer
  • R. Scott McKenzie
  • Catherine Tak Piech
  • Mekré Senbetta
  • Kathy L. Schulman
  • Edward J. Stepanski
Original Article

Abstract

Purpose

In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.

Methods

Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy.

Results

Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034).

Conclusions

Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.

Keywords

Chemotherapy-induced anemia Erythropoiesis-stimulating agents Transfusions Hemoglobin 

Notes

Sources of support

This was an industry-sponsored study supported by Janssen Scientific Affairs, LLC.

Financial disclosures

David H. Henry: consulting and research support from Janssen Biotech, Inc.; Corey J. Langer: no conflicts; R. Scott McKenzie, Catherine Tak Piech, and Mekré Senbetta: employees of Janssen Scientific Affairs, LLC; Kathy L. Schulman: consulting support from Janssen Scientific Affairs, LLC; Edward J. Stepanski: no conflicts.

References

  1. 1.
    Groopman JE, Itri LM (1999) Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst 91:1616–1634PubMedCrossRefGoogle Scholar
  2. 2.
    Ludwig H, Van Belle S, Barrett-Lee P, Birgegard G, Bokemeyer C, Gascon P, Kosmidis P, Krzakowski M, Nortier J, Olmi P, Schneider M, Schrijvers D (2004) The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. Eur J Cancer 40:2293–2306PubMedCrossRefGoogle Scholar
  3. 3.
    Rodgers GM (2008) Managing patients with chemotherapy-induced anemia. Adv Stud Med 8:346–351Google Scholar
  4. 4.
    Feinberg B, Gilmore J, Gondesen T et al (2009) Impact of NCD guidelines on Medicare patients with chemotherapy-induced anemia receiving erythropoiesis-stimulating agents: results from a community oncology practice. Commun Oncol 6:257–261CrossRefGoogle Scholar
  5. 5.
    Shord SS, Auerbach M (2009) Treating chemotherapy-induced anemia following the revised labeling for ESAs. Commun Oncol 6:279–282CrossRefGoogle Scholar
  6. 6.
    Rizzo JD, Somerfield MR, Hagerty KL, Seidenfeld J, Bohlius J, Bennett CL, Cella DF, Djulbegovic B, Goode MJ, Jakubowski AA, Rarick MU, Regan DH, Lichtin AE (2008) Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update. Blood 111:25–41PubMedCrossRefGoogle Scholar
  7. 7.
    Leyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E (2005) Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol 23:5960–5972PubMedCrossRefGoogle Scholar
  8. 8.
    Henke M, Laszig R, Rube C, Schafer U, Haase KD, Schilcher B, Mose S, Beer KT, Burger U, Dougherty C, Frommhold H (2003) Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 362:1255–1260PubMedCrossRefGoogle Scholar
  9. 9.
    Arbuckle RB, Griffith NL, Iacovelli LM, Johnson PE, Jorgenson JA, Kloth DD, Lucarelli CD, Muller RJ (2008) Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: perspectives and issues on policy-guided health care. Pharmacotherapy 28:1S–15SPubMedCrossRefGoogle Scholar
  10. 10.
    Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA (2008) Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol 26:1040–1050PubMedCrossRefGoogle Scholar
  11. 11.
    Hedenus M, Adriansson M, San Miguel J, Kramer MH, Schipperus MR, Juvonen E, Taylor K, Belch A, Altes A, Martinelli G, Watson D, Matcham J, Rossi G, Littlewood TJ (2003) Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol 122:394–403PubMedCrossRefGoogle Scholar
  12. 12.
    Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, Szechtman B, Roa W, Mulroy L, Rudinskas L, Gagnon B, Okawara GS, Levine MN (2007) Randomized, double-blind, placebo-controlled trial of erythropoietin in non–small-cell lung cancer with disease-related anemia. J Clin Oncol 25:1027–1032PubMedCrossRefGoogle Scholar
  13. 13.
    Overgaard J, Hoff CM, Hansen HS et al (2007) Randomized study of the importance of novel erythropoiesis stimulating protein (Aranesp®) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC)—the Danish Head and Neck Cancer Group DAHANCA 10 randomized trial. Eur J Cancer Suppl 5:6LBGoogle Scholar
  14. 14.
    Oncologic Drugs Advisory Committee briefing document: continuing reassessment of the risks of erythropoiesis-stimulating agents (ESAs) administered for the treatment of anemia associated with cancer chemotherapy. Available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b2-02-FDA.pdf. Accessed 15 March 2010
  15. 15.
    Background information for Oncologic Drugs Advisory Committee: safety of erythropoiesis-stimulating agents (ESAs) in oncology. Available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b2-01-01-Amgen.pdf. Accessed 15 March 2010
  16. 16.
    Decision memo for erythropoiesis-stimulating agents (ESAs) for non-renal disease indications (CAG-00383N). The use of erythropoiesis stimulating agents in cancer and related neoplastic conditions. Available at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203. Accessed 15 March 2010
  17. 17.
    Information on erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp). Available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109375.htm. Accessed 15 March 2010
  18. 18.
    Naeim A, Glaspy J (2008) Changes in RBC supportive medications and transfusions in cancer patients undergoing chemotherapy before and after FDA and Medicare actions in 2007. J Clin Oncol 26:20595CrossRefGoogle Scholar
  19. 19.
    Burton T, Larholt K, Apgar E et al (2008) Pre- vs. post-National Coverage Determination (NCD) blood utilization and hemoglobin values among Medicare patients treated with erythropoiesis-stimulating agents (ESAs) for chemotherapy-induced anemia (CIA). In: American Society of Hematology, 50th Annual Meeting and Exposition, December 6–9, 2008, San Francisco, CAGoogle Scholar
  20. 20.
    Centocor Ortho Biotech Products, L.P. (2010) Procrit® (epoetin alfa) full prescribing information. Centocor ortho Biotech Products, LP, Raritan, NJGoogle Scholar
  21. 21.
    Amgen Inc. (2010) Aranesp® (darbepoetin alfa) full prescribing information. Amgen Inc., Thousand Oaks, CAGoogle Scholar
  22. 22.
    Vansteenkiste J, Pirker R, Massuti B, Barata F, Font A, Fiegl M, Siena S, Gateley J, Tomita D, Colowick AB, Musil J (2002) Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst 94:1211–1220PubMedCrossRefGoogle Scholar
  23. 23.
    Witzig TE, Silberstein PT, Loprinzi CL, Sloan JA, Novotny PJ, Mailliard JA, Rowland KM, Alberts SR, Krook JE, Levitt R, Morton RF (2005) Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. J Clin Oncol 23:2606–2617PubMedCrossRefGoogle Scholar
  24. 24.
    Ludwig H, Crawford J, Osterborg A, Vansteenkiste J, Henry DH, Fleishman A, Bridges K, Glaspy JA (2009) Pooled analysis of individual patient-level data from all randomized, double-blind, placebo-controlled trials of darbepoetin alfa in the treatment of patients with chemotherapy-induced anemia. J Clin Oncol 27:2838–2847PubMedCrossRefGoogle Scholar
  25. 25.
    Hulnick SA, Hess G, Hill J et al (2009) Erythropoiesis stimulating agent (ESA) administration at Hb <10 g/dL for chemotherapy-induced anemia (CIA) following the National Coverage Decision (NCD). J Clin Oncol 27:e20627Google Scholar
  26. 26.
    Shapira I, Raftopoulos H, Gralla RJ et al (2009) The impact of randomized trial results and altered regulatory policies on ESA use, transfusions, and thrombosis: a longitudinal analysis over a 3-year period of resource utilization data from a large comprehensive oncology program. J Clin Oncol 27:6611Google Scholar

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • David H. Henry
    • 1
    Email author
  • Corey J. Langer
    • 2
  • R. Scott McKenzie
    • 3
  • Catherine Tak Piech
    • 3
  • Mekré Senbetta
    • 3
  • Kathy L. Schulman
    • 4
  • Edward J. Stepanski
    • 5
  1. 1.Joan Karnell Cancer CenterPennsylvania HospitalPhiladelphiaUSA
  2. 2.University of PennsylvaniaPhiladelphiaUSA
  3. 3.Health Economics & Outcomes ResearchJanssen Scientific Affairs, LLCHorshamUSA
  4. 4.HealthcareThomson ReutersCambridgeUSA
  5. 5.ACORN Research, LLCMemphisUSA

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