Original Article

You have full text access to this OnlineOpen article

Quality-of-life and health benefits of early treatment of mild anemia

A randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies†

  1. David J. Straus MD1,‡,§,*,
  2. Marcia A. Testa MPH, PhD2,
  3. Brenda J. Sarokhan MPH3,¶,
  4. Myron S. Czuczman MD4,
  5. Anil Tulpule MD5,
  6. Ralph R. Turner PhD, MPH6,‖,
  7. Shirley A. Riggs MD7,††

Article first published online: 14 SEP 2006

DOI: 10.1002/cncr.22221

Issue

Cancer

Cancer

Volume 107, Issue 8, pages 1909–1917, 15 October 2006

Additional Information

How to Cite

Straus, D. J., Testa, M. A., Sarokhan, B. J., Czuczman, M. S., Tulpule, A., Turner, R. R. and Riggs, S. A. (2006), Quality-of-life and health benefits of early treatment of mild anemia. Cancer, 107: 1909–1917. doi: 10.1002/cncr.22221

Author Information

  1. 1

    Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, New York

  2. 2

    Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts

  3. 3

    Ortho Biotech Clinical Affairs, LLC, Bridgewater, New Jersey

  4. 4

    Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York

  5. 5

    Department of Medicine-Hematology, University of Southern California Norris Cancer Center Hospital, Los Angeles, California

  6. 6

    Phase V Technologies, Inc., Wellesley Hills, Massachusetts

  7. 7

    Department of Lymphoma/Myeloma, University of Texas M. D. Anderson Cancer Center, Houston, Texas

  1. ‡

    Dr. Straus has participated in clinical consultant meetings as well as acted as a speaker and author in continuing medical education activities supported by Ortho Biotech, for which he has received honoraria. He has also received small amounts of salary support to conduct investigator-initiated clinical trials supported by Ortho Biotech.

  2. §

    Fax: (646) 422-2291.

  3. Dr. Sarokhan is an employee of Ortho Biotech Clinical Affairs LLC, and owns stock in Johnson & Johnson.

  4. ‖

    Dr. Turner owns stock in Johnson & Johnson.

  5. ††

    Dr. Riggs presented a few discussions for Ortho more than 10 years ago.

*Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021

  1. †

    Clinical Investigators: 45–80 subjects: Fernando Cabanillas, MD, and Shirley A. Riggs, MD (University of Texas M. D. Anderson Cancer Center); Myron S. Czuczman, MD (Roswell Park Cancer Institute); David J. Straus, MD (Memorial Sloan-Kettering Cancer Institute); and Anil Tulpule, MD (USC Norris Cancer Center Hospital); 10–30 subjects: Hamid Al-Mondhiry, MD (Kissinger Health Systems); Philip Cohen, MD (Georgetown University Medical Center) John P. Greer, MD (Vanderbilt University Medical Center), Stephanie A. Gregory, MD (Rush University Medical Center), Sandra J. Horning, MD (Stanford University Medical Center), Joseph O. Moore, MD (Duke University Medical Center), Peter J. Rosen, MD (UCLA School of Medicine), and Todd M. Zimmerman, MD (University of Chicago); <10 subjects: Richard Ambinder MD (Johns Hopkins Hospital); James Berenson, MD (Cedars Sinai); Dennis Berman, MD (Chester County Hematology/Oncology Services); Reed E. Drews, MD (Beth Israel Deaconess Medical Center) David Irwin MD (Alta Bates Comprehensive Cancer Center); Sanford Kempin, MD (St. Vincent Comprehensive Cancer Center); Brad L. Pohlman, MD (Cleveland Clinic Taussig Cancer Center); Hussain I. Saba, MD (H. Lee Moffitt Cancer and Research Center); Robert S. Siegel, MD (George Washington University); and Mitchell R. Smith, MD (Fox Chase Cancer Center)

Publication History

  1. Issue published online: 3 OCT 2006
  2. Article first published online: 14 SEP 2006
  3. Manuscript Accepted: 27 JUL 2006
  4. Manuscript Revised: 26 JUL 2006
  5. Manuscript Received: 1 MAR 2006

Funded by

  • Ortho Biotech Clinical Affairs, LLC, Bridgewater, NJ

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (222K)

REFERENCES

  • 1
    Ludwig H, Van Belle S, Barrett-Lee P, et al. 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. 2004; 40: 2293–2306.
  • 2
    Holzner B, Kemmler G, Greil R, et al. The impact of hemoglobin levels on fatigue and quality of life in cancer patients. Ann Oncol. 2002; 13: 965–973.
  • 3
    Cella D. Factors influencing quality of life in cancer patients: anemia and fatigue. Semin Oncol. 1998; 25( Suppl 7): 43–46.
  • 4
    Curt GA, Breitbart W, Cella D, et al. Impact of cancer-related fatigue on the lives of patients: new findings from the fatigue coalition. Oncologist. 2000; 5: 353–360.
  • 5
    Vogelzang NJ, Breitbart W, Cella D, et al. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. Semin Hematol. 1997; 34( Suppl 2): 4–12.
  • 6
    Lind M, Vernon C, Cruickshank D, et al. The level of haemoglobin in anaemic cancer patients correlates positively with quality of life. Br J Cancer. 2002; 86: 1243–1249.
  • 7
    Crawford J, Cella D, Cleeland CS, et al. Relationship between changes in Hb level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy. Cancer. 2002; 95: 888–895.
    Direct Link:
  • 8
    Shasha D, Cremieux P, Harrison L. Relationship between hemoglobin levels and quality of life during radiation therapy plus concomitant or sequential chemotherapy in patients with cancer and anemia treated with epoetin alfa. J Natl Compr Cancer Netw. 2004; 2: 509–517.
  • 9
    Seidenfeld J, Piper M, Flamm C, et al. Epoetin treatment of anemia associated with cancer therapy: a systematic review and meta-analysis of controlled clinical trials. J Natl Cancer Inst. 2001; 93: 1204–1214.
  • 10
    Rizzo JD, Lichtin AE, Woolf SH, et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J Clin Oncol. 2002; 20: 4083–4107.
  • 11
    Rodgers GM, Cella D, Chanan-Khan A, et al. Cancer and treatment-related anemia. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology v. 2. 2006. Available at URL: http://www.nccn.org[ accessed August 28, 2006].
  • 12
    Dammacco F, Castoldi G, Rodjer S. Efficacy of epoetin alfa in the treatment of anaemia of multiple myeloma. Br J Haematol. 2001; 113: 172–179.
    Direct Link:
  • 13
    Gabrilove JL, Cleeland CS, Livingston RB, Sarokhan B, Winer E, Einhorn LH. Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in Hb and quality of life are similar to three-times-weekly dosing. J Clin Oncol. 2001; 19: 2875–2882.
  • 14
    Cazzola M, Beguin Y, Kloczko J, et al. Once-weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production. Br J Haematol. 2003; 122: 386–393.
    Direct Link:
  • 15
    Vansteenkiste J, Pirker R, Massuti B, et al. Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst. 2002; 94: 1211–1220.
  • 16
    Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993; 11: 570–579.
  • 17
    Yellen SB, Cella DF, 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: 63–74.
  • 18
    Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Evanston, IL: Evanston Northwestern Healthcare and Northwestern University; 1997.
  • 19
    Testa MA, Simonson DC. Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial. JAMA. 1998; 280: 1490–1496.
  • 20
    Cella D, Eton DT, Lai JS, 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: 457–561.
  • 21
    Patrick DL, Gagnon DD, Zagari MJ, Mathijs R, Sweetenham J, for the Epoetin Alfa Study Group. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer. 2003; 39: 355–345.
  • 22
    Gisselbrecht C, Tesch H, Jourdan E, et al. Cognitive effects of once weekly (QW) epoetin alfa in anemic patients (pts) with hematologic malignancies receiving chemotherapy (CT): interim results of the EPOLYM trial. Blood. 2004; 104: 609a. Abstract 2217.
  • 23
    Testa MA. Quality-of-life assessment in diabetes research: interpreting the magnitude and meaning of treatment effects. Diabetes Spect. 2000; 13: 36–41.
  • 24
    Testa MA. Interpretation of quality of life outcomes: issues that affect magnitude and meaning. Med Care. 2000; 38( Suppl II): II–166–II–174.
  • 25
    Testa MA. Interpreting quality of life clinical trial data for use in the clinical practice of antihypertensive therapy. J Hypertens. 1987; 5( Suppl 1): S9–S13.
  • 26
    Henke M, Laszig R, Rube C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet. 2003; 362: 1255–1260.
  • 27
    Leyland-Jones B, Semiglazov V, Pawlicki M, et al. 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. 2005; 23: 5960–5972.
  • 28
    Bohlius J, Langensiepen S, Schwarzer G, et al. Recombinant human erythropoietin and overall survival in cancer patients: results of a comprehensive meta-analysis. J Natl Cancer Inst. 2005; 97: 489–498.
  • 29
    Bohlius J, Wilson J, Seidenfeld J, et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst. 2006; 98: 708–714.
  • 30
    Streiner DL, Norman GR. Biases in responding. Health Measurement Scales: A Practical Guide to Their Development and Use. 3rd ed. New York: Oxford University Press; 2003: 80–101.
View Full Article (HTML) Get PDF (222K)