© 1993 by Oxford University Press
Journal of the National Cancer Institute, Vol. 85, No. 10, 801-806,
May 19, 1993
© 1993 Oxford University Press
Recombinant Human Erythropoietin Therapy for Anemic Cancer Patients on Combination Chemotherapy
Maine Medical Center Portland
Cleveland Clinic/Cancer Center Cleveland, Ohio
Department of Medical Oncology, Massachusetts General Hospital Boston
Oncology Department, Elizabeth General Medical Center Elizabeth, N.J.
Oncology/Hematology Department, Graduate Hospital, University of Pennsylvania Philadelphia
Division of Hematology, Georgetown University Hospital Washington, D.C.
Department of Oncology, Sammons Cancer Center Dallas, Tex.
Cancer Care Associates Tulsa, Okla
Oncology/Hematology Associates of Central Illinois Peoria
Section of Hematology, University Hospital Indianapolis, Ind.
Department of Oncology, The University of Arizona College of Medicine Tucson
Hematology/Oncology Department. New York Hospital New York
Hematology/Oncology Department, University of California San Diego Medical Center San Diego
Department of Hematology/Oncology, Medical College of Virginia Richmond
The Robert Wood Johnson Pharmaceutical Research Institute Raritan, N.J.
Correspondence to: Delvyn C. Case, Jr., M.D., Maine Medical Center, 22 Bramhall St., Portland, ME 04102.
Background: Patients with advanced cancer frequently experience clinically significant anemia, which is often exacerbated by myelosuppressive chemotherapy. Consistent with the anemia of chronic disease, studies have documented serum erythropoietin levels that are inappropriately low for the degree of anemia in cancer patients. Myelosuppressive chemotherapy impairs erythropoiesis, which may not fully recover between treatment cycles. Recombinant human erythropoietin (rHuEPO) has been used safely and effectively to treat anemia in AIDS patients receiving zidovudine (AZT) and in patients with chronic renal failure. Purpose: This study was designed to evaluate the clinical role of rHuEPO in reducing symptomatic anemia in patients with advanced cancer who were receiving myelosup-pressive chemotherapy (excluding cisplatin). Methods: We studied 153 anemic cancer patients receiving cyclic combination chemotherapy in a prospective multicenter, double-blind, placebo-controlled trial. The patients were randomly assigned to receive either rHuEPO (150 U/kg) or placebo subcutaneously three times a week for a maximum of 12 weeks or until the hematocrit level increased to 38%–40%. If the hematocrit reached this target level before 12 weeks, the rHuEPO dose could be reduced to maintain the hematocrit at that level for the duration of the study. Response to rHuEPO therapy was assessed by measuring changes in hematocrit level, transfusion requirements, and quality of life. Quality-of-life. assessment was based on patients' responses to question-naires before and after the courses of therapy. Results: The increase in hematocrit in the rHuEPO-treated group compared with hematocrit in the placebo-treated group was statistically significant (P = .0001) as measured by percentage point of change from baseline to final evaluation, by an increase in hematocrit level of six percentage points or more unrelated to transfusion, and by a rise in hematocrit level to 38% or more unrelated to transfusion. There was a trend toward the reduction in mean units of blood transfused per patient during months 2 and 3 of therapy combined in rHuEPO-treated patients compared with placebo-treated patients (0.91 U versus 1.65 U; P = .056). In addition, rHuEPO-treated patients experienced a statistically significant improvement in energy level and ability to perform daily activities (P
.05). The two treatment groups showed no statistically significant differences in toxic effects except for increased incidence of diaphoresis (P<.05) and diarrhea (P = .05) in the rHuEPO-treated group. Conclusions: We conclude that rHuEPO is safe and effective for reversing anemia related to advanced cancer or to chemotherapy for cancer. [J Natl Cancer Inst 85: 801–806, 1993]
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