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

Authors

  • David J. Straus MD,

    Corresponding author
    1. Lymphoma Service, Memorial Sloan-Kettering Cancer Center, New York, New York
    • Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021
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    • 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.

    • Fax: (646) 422-2291.

  • Marcia A. Testa MPH, PhD,

    1. Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts
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  • Brenda J. Sarokhan MPH,

    1. Ortho Biotech Clinical Affairs, LLC, Bridgewater, New Jersey
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    • Dr. Sarokhan is an employee of Ortho Biotech Clinical Affairs LLC, and owns stock in Johnson & Johnson.

  • Myron S. Czuczman MD,

    1. Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York
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  • Anil Tulpule MD,

    1. Department of Medicine-Hematology, University of Southern California Norris Cancer Center Hospital, Los Angeles, California
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  • Ralph R. Turner PhD, MPH,

    1. Phase V Technologies, Inc., Wellesley Hills, Massachusetts
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    • Dr. Turner owns stock in Johnson & Johnson.

  • Shirley A. Riggs MD

    1. Department of Lymphoma/Myeloma, University of Texas M. D. Anderson Cancer Center, Houston, Texas
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    • Dr. Riggs presented a few discussions for Ortho more than 10 years ago.


  • 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)

Abstract

BACKGROUND

Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL).

METHODS

Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for ≥4 months of myelosuppressive chemotherapy were randomized to receive ≤16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to <9 g/dL (late). Those patients with a hemoglobin level >12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total.

RESULTS

In all, 269 patients with a hemoglobin level ≤12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21–7.46) in early patients and decreased 4.37 (95% CI, −7.99 to −0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98–1.46) in early patients but decreased 0.2 g/dL (95% CI, −0.32–0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients.

CONCLUSIONS

Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to <9.0 g/dL. Cancer 2006. © 2006 American Cancer Society.

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