Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy

Thomas E. Witzig, Peter T. Silberstein, Charles L. Loprinzi, Jeff A. Sloan, Paul J. Novotny, James A. Mailliard, Kendrith M. Rowland, Steven R. Alberts, James E. Krook, Ralph Levitt, Roscoe F. Morton

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Abstract

Purpose: To determine whether weekly epoetin alfa could improve hemoglobin (HgB) levels, reduce RBC transfusions, and improve quality of life (QOL) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy. Patients and Methods: This double-blind, placebo-controlled study randomly assigned patients to placebo or epoetin alfa (Ortho Biotech, Bridgewater, NJ) 40,000 U subcutaneous weekly for 16 weeks. QOL, HgB, and RBC transfusions were measured pretreatment and monthly. Results: The study accrued 344 patients; 330 were assessable for efficacy and 305 were assessable for QOL. Placebo-treated patients had a mean increase in HgB of 0.9 g/dL (range, -3.8 to +5.3) compared with 2.8 g/dL (range, -2.2 to +7.5) for epoetin-treated patients (P <.0001). During the study, 31.7% of placebo-treated patients achieved a > 2 g/dL HgB increase compared with 72.7% of epoetin-treated patients (P <.0001). The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6% and 25.3% (P = .005), respectively. The placebo group received 256 units of RBCs compared with 127 units in the epoetin group (P <.0001 ). The incidence of toxicity in the groups was similar. Changes in the average QOL scores from baseline to the end of the study were similar in the two groups (P = not significant). The HgB responders (irrespective of treatment arm) had a mean change in Functional Assessment of Cancer Therapy (FACT) fatigue score from a baseline of +5.1 compared with -2.1 for the nonresponders (P = .006). Conclusion: Epoetin alfa significantly improved HgB and reduced transfusions in this patient population. These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia.

Original languageEnglish
Pages (from-to)2606-2617
Number of pages12
JournalJournal of Clinical Oncology
Volume23
Issue number12
DOIs
StatePublished - Apr 20 2005

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Epoetin Alfa
Double-Blind Method
Placebos
Drug Therapy
Hemoglobins
Quality of Life
Anemia
Neoplasms
Incidence

All Science Journal Classification (ASJC) codes

  • Cancer Research
  • Oncology

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Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. / Witzig, Thomas E.; Silberstein, Peter T.; Loprinzi, Charles L.; Sloan, Jeff A.; Novotny, Paul J.; Mailliard, James A.; Rowland, Kendrith M.; Alberts, Steven R.; Krook, James E.; Levitt, Ralph; Morton, Roscoe F.

In: Journal of Clinical Oncology, Vol. 23, No. 12, 20.04.2005, p. 2606-2617.

Research output: Contribution to journalArticle

Witzig, TE, Silberstein, PT, Loprinzi, CL, Sloan, JA, Novotny, PJ, Mailliard, JA, Rowland, KM, Alberts, SR, Krook, JE, Levitt, R & Morton, RF 2005, 'Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy', Journal of Clinical Oncology, vol. 23, no. 12, pp. 2606-2617. https://doi.org/10.1200/JCO.2004.10.020
Witzig, Thomas E. ; Silberstein, Peter T. ; Loprinzi, Charles L. ; Sloan, Jeff A. ; Novotny, Paul J. ; Mailliard, James A. ; Rowland, Kendrith M. ; Alberts, Steven R. ; Krook, James E. ; Levitt, Ralph ; Morton, Roscoe F. / Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 12. pp. 2606-2617.
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abstract = "Purpose: To determine whether weekly epoetin alfa could improve hemoglobin (HgB) levels, reduce RBC transfusions, and improve quality of life (QOL) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy. Patients and Methods: This double-blind, placebo-controlled study randomly assigned patients to placebo or epoetin alfa (Ortho Biotech, Bridgewater, NJ) 40,000 U subcutaneous weekly for 16 weeks. QOL, HgB, and RBC transfusions were measured pretreatment and monthly. Results: The study accrued 344 patients; 330 were assessable for efficacy and 305 were assessable for QOL. Placebo-treated patients had a mean increase in HgB of 0.9 g/dL (range, -3.8 to +5.3) compared with 2.8 g/dL (range, -2.2 to +7.5) for epoetin-treated patients (P <.0001). During the study, 31.7{\%} of placebo-treated patients achieved a > 2 g/dL HgB increase compared with 72.7{\%} of epoetin-treated patients (P <.0001). The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6{\%} and 25.3{\%} (P = .005), respectively. The placebo group received 256 units of RBCs compared with 127 units in the epoetin group (P <.0001 ). The incidence of toxicity in the groups was similar. Changes in the average QOL scores from baseline to the end of the study were similar in the two groups (P = not significant). The HgB responders (irrespective of treatment arm) had a mean change in Functional Assessment of Cancer Therapy (FACT) fatigue score from a baseline of +5.1 compared with -2.1 for the nonresponders (P = .006). Conclusion: Epoetin alfa significantly improved HgB and reduced transfusions in this patient population. These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia.",
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T1 - Phase III, randomized, double-blind study of epoetin alfa compared with placebo in anemic patients receiving chemotherapy

AU - Witzig, Thomas E.

AU - Silberstein, Peter T.

AU - Loprinzi, Charles L.

AU - Sloan, Jeff A.

AU - Novotny, Paul J.

AU - Mailliard, James A.

AU - Rowland, Kendrith M.

AU - Alberts, Steven R.

AU - Krook, James E.

AU - Levitt, Ralph

AU - Morton, Roscoe F.

PY - 2005/4/20

Y1 - 2005/4/20

N2 - Purpose: To determine whether weekly epoetin alfa could improve hemoglobin (HgB) levels, reduce RBC transfusions, and improve quality of life (QOL) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy. Patients and Methods: This double-blind, placebo-controlled study randomly assigned patients to placebo or epoetin alfa (Ortho Biotech, Bridgewater, NJ) 40,000 U subcutaneous weekly for 16 weeks. QOL, HgB, and RBC transfusions were measured pretreatment and monthly. Results: The study accrued 344 patients; 330 were assessable for efficacy and 305 were assessable for QOL. Placebo-treated patients had a mean increase in HgB of 0.9 g/dL (range, -3.8 to +5.3) compared with 2.8 g/dL (range, -2.2 to +7.5) for epoetin-treated patients (P <.0001). During the study, 31.7% of placebo-treated patients achieved a > 2 g/dL HgB increase compared with 72.7% of epoetin-treated patients (P <.0001). The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6% and 25.3% (P = .005), respectively. The placebo group received 256 units of RBCs compared with 127 units in the epoetin group (P <.0001 ). The incidence of toxicity in the groups was similar. Changes in the average QOL scores from baseline to the end of the study were similar in the two groups (P = not significant). The HgB responders (irrespective of treatment arm) had a mean change in Functional Assessment of Cancer Therapy (FACT) fatigue score from a baseline of +5.1 compared with -2.1 for the nonresponders (P = .006). Conclusion: Epoetin alfa significantly improved HgB and reduced transfusions in this patient population. These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia.

AB - Purpose: To determine whether weekly epoetin alfa could improve hemoglobin (HgB) levels, reduce RBC transfusions, and improve quality of life (QOL) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy. Patients and Methods: This double-blind, placebo-controlled study randomly assigned patients to placebo or epoetin alfa (Ortho Biotech, Bridgewater, NJ) 40,000 U subcutaneous weekly for 16 weeks. QOL, HgB, and RBC transfusions were measured pretreatment and monthly. Results: The study accrued 344 patients; 330 were assessable for efficacy and 305 were assessable for QOL. Placebo-treated patients had a mean increase in HgB of 0.9 g/dL (range, -3.8 to +5.3) compared with 2.8 g/dL (range, -2.2 to +7.5) for epoetin-treated patients (P <.0001). During the study, 31.7% of placebo-treated patients achieved a > 2 g/dL HgB increase compared with 72.7% of epoetin-treated patients (P <.0001). The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6% and 25.3% (P = .005), respectively. The placebo group received 256 units of RBCs compared with 127 units in the epoetin group (P <.0001 ). The incidence of toxicity in the groups was similar. Changes in the average QOL scores from baseline to the end of the study were similar in the two groups (P = not significant). The HgB responders (irrespective of treatment arm) had a mean change in Functional Assessment of Cancer Therapy (FACT) fatigue score from a baseline of +5.1 compared with -2.1 for the nonresponders (P = .006). Conclusion: Epoetin alfa significantly improved HgB and reduced transfusions in this patient population. These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia.

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