Once-weekly dosing of epoetin-α increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy

Authors

  • Daniel Shasha M.D.,

    Corresponding author
    1. Department of Radiation Oncology, Beth Israel Medical Center, New York, New York
    • The Charles & Bernice Blitman Department of Radiation Oncology, Beth Israel Medical Center, 10 Union Square East, New York, NY 10003
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    • Fax: (212) 844-6556

    • Dr. Shasha and Dr. Harrison are members of the Speaker's Bureau for Ortho Biotech, Inc.

  • Martine J. George M.D.,

    1. Clinical Affairs, Ortho Biotech Products, L.P., Bridgewater, New Jersey
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    • Dr. George was an employee of Ortho Biotech, Inc.

  • Louis B. Harrison M.D.

    1. Department of Radiation Oncology, Beth Israel Medical Center, New York, New York
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    • Dr. Shasha and Dr. Harrison are members of the Speaker's Bureau for Ortho Biotech, Inc.


Abstract

BACKGROUND

The current study was performed to prospectively evaluate the effectiveness, clinical outcomes, and safety of once-weekly (QW) recombinant human erythropoietin (r-HuEPO [epoetin-α]) in anemic cancer patients with nonmyeloid malignancies who were receiving radiation therapy (RT) concomitantly or sequentially with chemotherapy (CT).

METHODS

A total of 777 anemic patients (hemoglobin [Hb] ≤ 11 g/dL) were enrolled in this multicenter, open-label, nonrandomized, 16-week study. Patients initially received epoetin-α at a dose of 40,000 units (U) subcutaneously QW, escalating to a dose of 60,000 U QW if the Hb increased to ≤ 1 g/dL after 4 weeks. Endpoints were changes in hematologic and quality of life (QOL) parameters.

RESULTS

Among the 442 patients evaluable for hematologic response, the mean increase in Hb from baseline to the time of final evaluation was 1.9 ± 1.8 g/dL (P < 0.05). An increase in Hb of ≥ 2 g/dL, in the absence of blood transfusions, occurred in 68.3% of patients (278 of 407 patients) who were on the study for ≥ 30 days. The overall response rate (Hb increase ≥ 2 g/dL or Hb ≥ 12 g/dL in the absence of blood transfusions) was 74.0% (301 of 407 patients). In 359 patients who were evaluable for QOL assessment, epoetin-α therapy was found to significantly (P < 0.05) improve mean Linear Analog Scale Assessment (LASA) scores for energy level, ability to perform daily activities, and overall QOL from baseline to the time of final evaluation. QW epoetin-α therapy was found to be well tolerated.

CONCLUSIONS

Treatment with QW epoetin-α was found to increase Hb levels, decrease transfusion requirements, and improve functional status and QOL in anemic patients with nonmyeloid malignancies who were receiving RT concomitantly or sequentially with CT. Clinical benefits and the safety profile of QW epoetin-α in this setting appear to be similar to those observed in anemic cancer patients receiving CT. Cancer 2003;98:1072–9. © 2003 American Cancer Society.

DOI 10.1002/cncr.11616

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