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Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia.

Publication ,  Journal Article
Reed, SD; Radeva, JI; Daniel, DB; Fastenau, JM; Williams, D; Schulman, KA
Published in: Curr Med Res Opin
October 2005

OBJECTIVE: To examine associations between early hemoglobin response and alternative measures of efficacy following treatment with an erythropoietic agent for chemotherapy-related anemia. RESEARCH DESIGN AND METHODS: Preliminary data from an ongoing randomized, multicenter, 16-week, open-label clinical trial of epoetin alfa versus darbepoetin alfa were used to dichotomize patients based on attainment of early hemoglobin response (> or = 1 g/dL increase in hemoglobin level within 4 weeks of treatment initiation). Measures of efficacy were compared between patients with early hemoglobin response and those without. Sensitivity analyses were then performed to evaluate the impact of various methods for handling censored data and hemoglobin values following blood transfusion. MAIN OUTCOME MEASURES: Efficacy measures included: the proportion of patients with a > or = 1 g/dL increase in hemoglobin by 4 weeks or a > or = 2 g/dL increase by 8 weeks; mean hemoglobin levels at 4, 8, 12, and 16 weeks; area under the curve for change in hemoglobin level; proportion of patients who required a blood transfusion after 4 weeks; proportion of follow-up days on which patients had hemoglobin levels within the therapeutic range of 11 g/dL to 13 g/dL; and proportion of patients who never had a hemoglobin level within this range. RESULTS: A total of 274 patients were included (66.1% female, mean age 62.4), of whom 48.9% had an early hemoglobin response and 51.1% did not. Mean duration of follow-up was 10.1 +/- 5.05 weeks. All metrics indicated superior longer-term response among patients with early hemoglobin response compared to patients without early response. The findings were robust across sensitivity analyses. Although the analysis establishes a significant relationship between early hemoglobin response and alternative efficacy metrics, causality cannot be inferred. CONCLUSIONS: Early hemoglobin response is significantly associated with various metrics of clinical response to erythropoietic agents and is an appropriate measure for evaluating treatment effects.

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Published In

Curr Med Res Opin

DOI

ISSN

0300-7995

Publication Date

October 2005

Volume

21

Issue

10

Start / End Page

1527 / 1533

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sensitivity and Specificity
  • Recombinant Proteins
  • Neoplasms
  • Middle Aged
  • Male
  • Humans
  • Hemoglobins
  • General & Internal Medicine
  • Follow-Up Studies
 

Citation

APA
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MLA
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Reed, S. D., Radeva, J. I., Daniel, D. B., Fastenau, J. M., Williams, D., & Schulman, K. A. (2005). Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia. Curr Med Res Opin, 21(10), 1527–1533. https://doi.org/10.1185/030079905X65394
Reed, Shelby D., Jasmina I. Radeva, Davey B. Daniel, John M. Fastenau, Denise Williams, and Kevin A. Schulman. “Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia.Curr Med Res Opin 21, no. 10 (October 2005): 1527–33. https://doi.org/10.1185/030079905X65394.
Reed SD, Radeva JI, Daniel DB, Fastenau JM, Williams D, Schulman KA. Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia. Curr Med Res Opin. 2005 Oct;21(10):1527–33.
Reed, Shelby D., et al. “Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia.Curr Med Res Opin, vol. 21, no. 10, Oct. 2005, pp. 1527–33. Pubmed, doi:10.1185/030079905X65394.
Reed SD, Radeva JI, Daniel DB, Fastenau JM, Williams D, Schulman KA. Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia. Curr Med Res Opin. 2005 Oct;21(10):1527–1533.

Published In

Curr Med Res Opin

DOI

ISSN

0300-7995

Publication Date

October 2005

Volume

21

Issue

10

Start / End Page

1527 / 1533

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sensitivity and Specificity
  • Recombinant Proteins
  • Neoplasms
  • Middle Aged
  • Male
  • Humans
  • Hemoglobins
  • General & Internal Medicine
  • Follow-Up Studies