Effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia

Journal of Community and Supportive Oncology

Volumn 14, Issue 8, 2016, Pages 342-350

  Strauss, William E ^a   Dahl, Naomi V ^a   Vadhan Raj, Saroj ^b   Acaster, Sarah ^c   Bernard, Kristine ^a   Dickerhoof, Rene ^c   Li, Zhu ^a   Allen, Lee F ^a  

^a AMAG PHARMACEUTICALS INC   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^c ICON PLC   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

FERUMOXYTOL; PLACEBO;

ADULT; ARTICLE; CLINICAL ASSESSMENT TOOL; CLINICAL EVALUATION; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERANCE; FEMALE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; HUMAN; IRON DEFICIENCY ANEMIA; IRON THERAPY; LINEAR ANALOGUE SCALE ASSESSMENT; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; OUTCOME ASSESSMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SHORT FORM 36; TREATMENT RESPONSE;

EID: 84988614955     PISSN: 23307749     EISSN: None     Source Type: Journal    
DOI: 10.12788/jcso.0232     Document Type: Article

References (31)

1. World Health Organization. In: de Benoist B, McLean E, Egli I, Cogswell M (eds). Worldwide prevalence of anaemia 1993-2005: WHO global database on anaemia. Geneva, Switzerland: World Health Organization; 2008.
2. Croker JR, Beynon G. Gastro-intestinal bleeding-a major cause of iron deficiency in the elderly. Age Ageing. 1981;10:40-43.
3. Niv E, Elis A, Zissin R, Naftali T, Novis B, Lishner M. Iron deficiency anemia in patients without gastrointestinal symptoms: a prospective study. Fam Pract. 2005;22(1):58-61.
4. Lieu PT, Heiskala M, Peterson PA, Yang Y. The roles of iron in health and disease. Mol Aspects Med. 2001;22(1-2):1-87.
5. Haas JD, Brownlie T IV. Iron deficiency and reduced work capacity: a critical review of the research to determine a causal relationship. J Nutr. 2001;131(2 suppl):676S-88S; discussion 688S-90S
6. Beard JL. Iron biology in immune function, muscle metabolism and neuronal functioning. J Nutr. 2001;131(2S-2):568S-579S.
7. Food and Drug Administration. Guidance for industry. Patientreported outcome measures: use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Published December 2009. Accessed May 15, 2015.
8. Calvert M, Blazeby J, Altman DG, et al. Reporting of patientreported outcomes in randomized trials: The CONSORT PRO Extension. JAMA. 2013;309(8):814-822.
9. Anthony LB, Gabrail NY, Ghazal H, et al. IV iron sucrose for cancer and/or chemotherapy-induced anemia in patients treated with erythropoiesis-stimulating agents. Comm Oncol. 2011;8(6):270-278.
10. Ando K, Morita S, Higashi T, et al. Health-related quality of life among Japanese women with iron-deficiency anemia. Qual Life Res. 2006;15(10):1559-1563.
11. Kaltwasser JP, Kessler U, Gottschalk R, Stucki G, Möller B. Effect of recombinant human erythropoietin and intravenous iron on anemia and disease activity in rheumatoid arthritis. J Rheumatol. 2001;28(11): 2430-2436.
12. Patterson AJ, Brown WJ, Powers JR, Roberts DC. Iron deficiency, general health and fatigue: results from the Australian Longitudinal Study on Women's Health. Qual Life Res. 2000;9(5):491-497.
13. Van Wyck DB, Mangione A, Morrison J, et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009;49(12):2719-2728.
14. Zhou SJ, Gibson RA, Crowther CA, Baghurst P, Makrides M. Effect of iron supplementation during pregnancy on the intelligence quotient and behavior of children at 4 yrs of age: longterm follow-up of a randomized controlled trial. Am J Clin Nutr 2006;83(5):1112-1117.
15. Henry DH, Dahl NV, The Ferrlecit Cancer Study Group. Does quality of life improvement precede anemia correction in patients with chemotherapy-induced anemia treated with intravenous iron? J Clin Oncol. 2007;(18S):abstract 9082.
16. Vadhan-Raj S, Strauss W, Ford D, et al. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014; 89(1):7-12.
17. Yellen SB, Cella D, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997;13(2):63-74.
18. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473-483.
19. Patrick DL, Gagnon DD, Zagari MJ, et al. Assessing the clinical significance of health-related quality of life (HrQoL) improvements in anaemic cancer patients receiving epoetic alfa. Euro J Cancer. 2003;39(3):335-345.
20. Acaster S, Dickerhoof R, DeBusk K, Bernard K, Strauss W, Allen LF. Qualitative and quantitative validation of the FACIT-fatigue scale in iron deficiency anemia. Health Qual Life Outcomes. 2015;13:60.
21. Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002;94(2):528-538.
22. Cella D, Eton D, Lai J, Peterman AH, Merkel DE. Combining anchor and distribution based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) Anemia and Fatigue Scales. J Pain Symptom Manage. 2002;24(6):547-561.
23. McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31(3):247-263.
24. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41(5):582-592.
25. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21(2):271-292.
26. Walters S, Brazier J. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523-1515.
27. Fryback DG, Dunham NC, Palta M, et al. US Norms for six generic health related quality of life indexes from the national health measurement study. Med Care. 2007;45(12):1162-1170.
28. Maxwell C. Sensitivity and accuracy of the visual analogue scale: A psychophysical classroom experiment. Br J Clin Pharmacol. 1978;6(1):15-24.
29. Glaspy J, Bukowski R, Steinberg D, et al. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. J Clin Oncol. 1997;15(3):1218-1234.
30. Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998;16(10):3412-3425.
31. Bjorner JB, Wallenstein GV, Martin MC, et al. Interpreting score differences in the SF-36 vitality scale: using clinical conditions and functional outcomes to define the minimally important difference. Curr Med Res Opin. 2007;23(4):731-739.