The Resource Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment : comparative effectiveness update, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center ; investigators, Mark D. Grant, M.D., M.P.H., Margaret Piper, Ph.D., M.P.H., Julia Bohlius, M.D., M.Sc.P.H., Thomy Tonia, M.Sc., Nadège Robert, M.Sc., Vikrant Vats, Ph.D., Claudia Bonnell, R.N., M.L.S., Kathleen M. Ziegler, Pharm.D., and Naomi Aronson, Ph.D

Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment : comparative effectiveness update, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center ; investigators, Mark D. Grant, M.D., M.P.H., Margaret Piper, Ph.D., M.P.H., Julia Bohlius, M.D., M.Sc.P.H., Thomy Tonia, M.Sc., Nadège Robert, M.Sc., Vikrant Vats, Ph.D., Claudia Bonnell, R.N., M.L.S., Kathleen M. Ziegler, Pharm.D., and Naomi Aronson, Ph.D

Label
Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment : comparative effectiveness update
Title
Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment
Title remainder
comparative effectiveness update
Statement of responsibility
prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center ; investigators, Mark D. Grant, M.D., M.P.H., Margaret Piper, Ph.D., M.P.H., Julia Bohlius, M.D., M.Sc.P.H., Thomy Tonia, M.Sc., Nadège Robert, M.Sc., Vikrant Vats, Ph.D., Claudia Bonnell, R.N., M.L.S., Kathleen M. Ziegler, Pharm.D., and Naomi Aronson, Ph.D
Creator
Contributor
Author
Issuing body
Subject
Genre
Language
eng
Summary
OBJECTIVES: To update the 2006 systematic review of the comparative benefits and harms of erythropoiesis-stimulating agent (ESA) strategies and non-ESA strategies to manage anemia in patients undergoing chemotherapy and/or radiation for malignancy (excluding myelodysplastic syndrome and acute leukemia), including the impact of alternative thresholds for initiating treatment and optimal duration of therapy. DATA SOURCES: Literature searches were updated in electronic databases (n=3), conference proceedings (n=3), and Food and Drug Administration transcripts. Multiple sources (n=13) were searched for potential gray literature. A primary source for current survival evidence was a recently published individual patient data meta-analysis. In that meta-analysis, patient data were obtained from investigators for studies enrolling more than 50 patients per arm. Because those data constitute the most currently available data for this update, as well as the source for on-study (active treatment) mortality data, we limited inclusion in the current report to studies enrolling more than 50 patients per arm to avoid potential differential endpoint ascertainment in smaller studies. REVIEW METHODS: Title and abstract screening was performed by one or two (to resolve uncertainty) reviewers; potentially included publications were reviewed in full text. Two or three (to resolve disagreements) reviewers assessed trial quality. Results were independently verified and pooled for outcomes of interest. The balance of benefits and harms was examined in a decision model. RESULTS: We evaluated evidence from 5 trials directly comparing darbepoetin with epoetin, 41 trials comparing epoetin with control, and 8 trials comparing darbepoetin with control; 5 trials evaluated early versus late (delay until Hb d9 to 11 g/dL) treatment. Trials varied according to duration, tumor types, cancer therapy, trial quality, iron supplementation, baseline hemoglobin, ESA dosing frequency (and therefore amount per dose), and dose escalation. ESAs decreased the risk of transfusion (pooled relative risk [RR], 0.58; 95% confidence interval [CI], 0.53 to 0.64; I2 = 51%; 38 trials) without evidence of meaningful difference between epoetin and darbepoetin. Thromboembolic event rates were higher in ESA-treated patients (pooled RR, 1.51; 95% CI, 1.30 to 1.74; I2 = 0%; 37 trials) without difference between epoetin and darbepoetin. In 14 trials reporting the Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale, the most common patient-reported outcome, scores decreased by 0.6 in control arms (95% CI, 6.4 to 5.2; I2 = 0%) and increased by 2.1 in ESA arms (95% CI, 3.9 to 8.1; I2 = 0%). There were fewer thromboembolic and on-study mortality adverse events when ESA treatment was delayed until baseline Hb was less than 10 g/dL, in keeping with current treatment practice, but the difference in effect from early treatment was not significant, and the evidence was limited and insufficient for conclusions. No evidence informed optimal duration of therapy. Mortality was increased during the on-study period (pooled hazard ratio [HR], 1.17; 95% CI, 1.04 to 1.31; I2 = 0%; 37 trials). There was one additional death for every 59 treated patients when the control arm on-study mortality was 10 percent and one additional death for every 588 treated patients when the control-arm on-study mortality was 1 percent. A cohort decision model yielded a consistent result--greater loss of life-years when control arm on-study mortality was higher. There was no discernible increase in mortality with ESA use over the longest available followup (pooled HR, 1.04; 95% CI, 0.99 to 1.10; I2 = 38%; 44 trials), but many trials did not include an overall survival endpoint and potential time-dependent confounding was not considered. CONCLUSIONS: Results of this update were consistent with the 2006 review. ESAs reduced the need for transfusions and increased the risk of thromboembolism. FACT-Fatigue scores were better with ESA use but the magnitude was less than the minimal clinically important difference. An increase in mortality accompanied the use of ESAs. An important unanswered question is whether dosing practices and overall ESA exposure might influence harms
Member of
Cataloging source
NLM
http://library.link/vocab/creatorName
Grant, Mark D
Funding information
Conducted by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ)
Government publication
federal national government publication
Illustrations
illustrations
Index
no index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
WH 155
http://library.link/vocab/relatedWorkOrContributorDate
1953-
http://library.link/vocab/relatedWorkOrContributorName
  • Piper, Margaret
  • Bohlius, Julia
  • Tonia, Thomy
  • Robert, Nadège
  • Vats, Vikrant
  • Bonnell, Claudia
  • Ziegler, Kathleen M.
  • Aronson, Naomi
  • United States
  • Blue Cross and Blue Shield Association
  • Effective Health Care Program (U.S.)
Series statement
  • Comparative effectiveness review
  • AHRQ publication
Series volume
  • number 113
  • no. 13-EHC077-EF
http://library.link/vocab/subjectName
  • Anemia
  • Comparative Effectiveness Research
  • Drug-Related Side Effects and Adverse Reactions
  • Erythropoietin
  • Hematinics
  • Neoplasms
  • United States
  • United States
http://bibfra.me/vocab/relation/supportingbody
  • SGEpYsXqBGk
  • RzTDSdffmEM
Label
Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment : comparative effectiveness update, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center ; investigators, Mark D. Grant, M.D., M.P.H., Margaret Piper, Ph.D., M.P.H., Julia Bohlius, M.D., M.Sc.P.H., Thomy Tonia, M.Sc., Nadège Robert, M.Sc., Vikrant Vats, Ph.D., Claudia Bonnell, R.N., M.L.S., Kathleen M. Ziegler, Pharm.D., and Naomi Aronson, Ph.D
Instantiates
Publication
Note
"April 2013."
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Control code
855729985
Extent
1 online resource (267 pages)
Form of item
online
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)855729985
Label
Epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment : comparative effectiveness update, prepared for Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services ; prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center ; investigators, Mark D. Grant, M.D., M.P.H., Margaret Piper, Ph.D., M.P.H., Julia Bohlius, M.D., M.Sc.P.H., Thomy Tonia, M.Sc., Nadège Robert, M.Sc., Vikrant Vats, Ph.D., Claudia Bonnell, R.N., M.L.S., Kathleen M. Ziegler, Pharm.D., and Naomi Aronson, Ph.D
Publication
Note
"April 2013."
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Control code
855729985
Extent
1 online resource (267 pages)
Form of item
online
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)855729985

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