Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy

Delvyn C. Case, Ronald M. Bukowski, Robert W. Carey, Ellioth H. Fishkin, David H. Henry, Robert J. Jacobson, Steven E. Jones, Allan M. Keller, John W. Kugler, Craig R. Nichols, Sydney E. Salmon, Richard T. Silver, Anna Maria Storniolo, Galen L. Wampler, Cathleen M. Dooley, Kay M. Larholt, Richard A. Nelson, Robert I. Abels

Research output: Contribution to journalArticle

191 Citations (Scopus)

Abstract

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 myelosuppressive 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 questionnaires 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

Original languageEnglish (US)
Pages (from-to)801-806
Number of pages6
JournalJournal of the National Cancer Institute
Volume85
Issue number10
StatePublished - 1993
Externally publishedYes

Fingerprint

Chemotherapy
Erythropoietin
Combination Drug Therapy
Therapy
Cancer
Hematocrit
Neoplasms
Anemia
Percentage Points
Quality of Life
Therapeutics
Placebos
Electron energy levels
Blood
Cisplatin
Drug Therapy
Chronic Disease
Human
Recombinant
Energy Levels

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Physiology (medical)
  • Radiology Nuclear Medicine and imaging

Cite this

Case, D. C., Bukowski, R. M., Carey, R. W., Fishkin, E. H., Henry, D. H., Jacobson, R. J., ... Abels, R. I. (1993). Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. Journal of the National Cancer Institute, 85(10), 801-806.

Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. / Case, Delvyn C.; Bukowski, Ronald M.; Carey, Robert W.; Fishkin, Ellioth H.; Henry, David H.; Jacobson, Robert J.; Jones, Steven E.; Keller, Allan M.; Kugler, John W.; Nichols, Craig R.; Salmon, Sydney E.; Silver, Richard T.; Storniolo, Anna Maria; Wampler, Galen L.; Dooley, Cathleen M.; Larholt, Kay M.; Nelson, Richard A.; Abels, Robert I.

In: Journal of the National Cancer Institute, Vol. 85, No. 10, 1993, p. 801-806.

Research output: Contribution to journalArticle

Case, DC, Bukowski, RM, Carey, RW, Fishkin, EH, Henry, DH, Jacobson, RJ, Jones, SE, Keller, AM, Kugler, JW, Nichols, CR, Salmon, SE, Silver, RT, Storniolo, AM, Wampler, GL, Dooley, CM, Larholt, KM, Nelson, RA & Abels, RI 1993, 'Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy', Journal of the National Cancer Institute, vol. 85, no. 10, pp. 801-806.
Case DC, Bukowski RM, Carey RW, Fishkin EH, Henry DH, Jacobson RJ et al. Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. Journal of the National Cancer Institute. 1993;85(10):801-806.
Case, Delvyn C. ; Bukowski, Ronald M. ; Carey, Robert W. ; Fishkin, Ellioth H. ; Henry, David H. ; Jacobson, Robert J. ; Jones, Steven E. ; Keller, Allan M. ; Kugler, John W. ; Nichols, Craig R. ; Salmon, Sydney E. ; Silver, Richard T. ; Storniolo, Anna Maria ; Wampler, Galen L. ; Dooley, Cathleen M. ; Larholt, Kay M. ; Nelson, Richard A. ; Abels, Robert I. / Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. In: Journal of the National Cancer Institute. 1993 ; Vol. 85, No. 10. pp. 801-806.
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title = "Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy",
abstract = "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 myelosuppressive 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 questionnaires 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",
author = "Case, {Delvyn C.} and Bukowski, {Ronald M.} and Carey, {Robert W.} and Fishkin, {Ellioth H.} and Henry, {David H.} and Jacobson, {Robert J.} and Jones, {Steven E.} and Keller, {Allan M.} and Kugler, {John W.} and Nichols, {Craig R.} and Salmon, {Sydney E.} and Silver, {Richard T.} and Storniolo, {Anna Maria} and Wampler, {Galen L.} and Dooley, {Cathleen M.} and Larholt, {Kay M.} and Nelson, {Richard A.} and Abels, {Robert I.}",
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T1 - Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy

AU - Case, Delvyn C.

AU - Bukowski, Ronald M.

AU - Carey, Robert W.

AU - Fishkin, Ellioth H.

AU - Henry, David H.

AU - Jacobson, Robert J.

AU - Jones, Steven E.

AU - Keller, Allan M.

AU - Kugler, John W.

AU - Nichols, Craig R.

AU - Salmon, Sydney E.

AU - Silver, Richard T.

AU - Storniolo, Anna Maria

AU - Wampler, Galen L.

AU - Dooley, Cathleen M.

AU - Larholt, Kay M.

AU - Nelson, Richard A.

AU - Abels, Robert I.

PY - 1993

Y1 - 1993

N2 - 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 myelosuppressive 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 questionnaires 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

AB - 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 myelosuppressive 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 questionnaires 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

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