Prepared by:
Blue Cross and Blue Shield Association
Technology Evaluation Center
Jerome Seidenfeld, Ph.D.
Principal Investigator
Naomi Aronson, Ph.D.
Margaret Piper, Ph.D., M.P.H.
Carole Redding Flamm, M.D., M.P.H.
Vic Hasselblad, Ph.D.
Kathleen M. Ziegler, Pharm.D.
Investigators
File Name Description Software Version File Size __________________________________________________________________________________________________________ 01front.doc Microsoft Word® Document MS Word® 97 SR-1 39KB 7 pages Contents: Cover, Title Page, Preface, Structured Abstract 02conts.doc Microsoft Word® Document MS Word® 97 SR-1 26KB 3 pages Contents: Table of Contents 03summ.doc Microsoft Word® Document MS Word® 97 SR-1 105KB 14 pages Contents: Summary: Overview; Reporting the Evidence; Methodology; Findings; Future Research 04chap1.doc Microsoft Word® Document MS Word® 97 SR-1 165KB 36 pages Contents: Chapter 1. Introduction: Scope and Objectives; Prevalence and Severity of Anemia in Cancer Patients; Table 1. Grading systems for anemia; Table 2. Signs and symptoms of anemia in cancer patients; Differential Diagnosis Determines Treatment; Red Blood Cell Transfusion and Epoetin in Anemia Treatment; Table 3. FDA-approved uses of epoetin alfa and dosing recommendations; Anemia and Quality of Life in Cancer Patients; Community-Based Trials of Epoetin Therapy; Table 4. Comparison of two single-arm trials of epoetin and quality of life; Analyses Comparing Costs of Epoetin to Costs of Transfusion; Background on Key Clinical Issues for Each Population Addressed in this Systematic Review 05chap2.doc Microsoft Word® Document MS Word® 97 SR-1 150KB 20 pages Contents: Chapter 2. Methodology: Overview; Search Strategy for the Identification of Articles; Methods of the Review; Table 5. Reasons for study exclusion-oncology; Meta-Analysis 06chap3.doc Microsoft Word® Document MS Word® 97 SR-1 643KB 72 pages Contents: Chapter 3. Results and Conclusions I: Anemia Resulting Primarily From Cancer Therapy: Objective; Key Questions; Overview of the Evidence; Table 6. Study arm comparability; Table 7. Reporting on Elements of Study Arm Comparability; Table 8. Evidence on subpopulations; Table 9. Two-Arm Studies of Subcutaneous Epoetin; Table 10. Three-arm subcutaneous studies- direct comparison of dosage; Table 11. Studies of intravenous epoetin; Table 12. Evidence to compare outcomes by baseline mean or median hemoglobin; Table 13. Adverse events reported by studies on patients being treated for malignancy; Table 14. Assessment of study quality; Results; Table 15. Hematologic outcomes for studies grouped by baseline Hb levels; Table 16. Transfusion outcomes for studies grouped by baseline Hb levels; Table 17. Transfusion rates of epoetin-treated patients and variance in baseline hemoglobin; Table 18. Comparison of nonresponse rates and transfusion rates of epoetin-treated patients; Table 19. Studies selected for meta-analysis of the risk of transfusion; Table 20. Effect of study quality on the risk of transfusion: 450 Weekly Dose Category; Figure 1. Effect of Epoetin on the Odds of Transfusion in Patients with Anemia due to Cancer Therapy; Figure 2. Effect of Study Quality on the Odds Ratio of Transfusion; Table 21. Summary: Meta-Analysis of the effect of epoetin on transfusion; Table 22. Quality of life outcomes for studies grouped by baseline Hb levels: Comparisons between control and epoetin-treated study arms; Table 23. Quality of life outcomes for studies grouped by baseline Hb levels: Within-arm comparisons of baseline to final values; Table 24. Effect of duration of epoetin treatment, dosing regimen, and dose category on the risk of transfusion; Table 25. Direct comparison of epoetin doses in three-arm studies, subcutaneous administration; Table 26. Hematologic outcomes by weekly dose, two-arm studies of subcutaneous epoetin; Table 27. Transfusion outcomes by weekly dose, two-arm studies of subcutaneous epoetin; Table 28. Outcomes for subpopulations differing by type of malignancy; Table 29. Outcomes for subpopulations differing by age; Table 30. Outcomes for subpopulations differing by iron supplementation; Table 31. Outcomes for subpopulations differing by treatment for malignancy; Table 32. Outcomes for Subpopulations Differing by Prior Transfusion History; Table 33. Results for any potential predictor reported by two or more studies; Table 34. Adverse events reported by studies on patients being treated for malignancy; General Conclusions 07chap4.doc Microsoft Word® Document MS Word® 97 SR-1 214KB 29 pages Contents: Chapter 4. Results and Conclusions II: Anemia Due Primarily to Malignant Disease: Objective; Key Questions; Overview of the Evidence; Table 35. Study arm comparability; Table 36. Reporting on elements of study arm comparability; Table 37. Evidence on subpopulations; Table 38. Evidence to compare epoetin interventions; Table 39. Evidence to compare outcomes; Table 40. Reporting on adverse events in studies on anemia of malignancy; Table 41. Assessment of study quality; Results; Table 42. Hematologic and transfusion outcomes for studies grouped by baseline Hb levels; Table 43. Final Hb levels; Table 44. Evidence for direct comparison of epoetin interventions in multiple-arm studies; Table 45. Evidence for indirect comparison of epoetin interventions from two-arm studies; Table 46. Comparison of outcomes of epoetin for different malignancies; Table 47. Comparison of outcomes for subpopulations differing by iron supplementation; Table 48. Comparison of outcomes for subpopulations differing by prior transfusion history; Table 49. Factors tested for significance as predictors of hematologic responses to epoetin in patient with anemia of malignancy; Table 50. Adverse events reported by studies on patients with anemia due to malignancy and no concurrent therapy; Conclusions 08chap5.doc Microsoft Word® Document MS Word® 97 SR-1 220KB 24 pages Contents: Chapter 5. Results and Conclusions III: Outcomes of Anemia Management Strategies in Patients Being Treated for Malignancy with Bone Marrow Ablation and Allogeneic Stem-Cell Support: Objective; Overview of the Evidence; Study Quality; Table 51. Assessment of study quality; Table 52. Study arm comparability; Table 53. Reporting on elements of study arm comparability; Table 54. Evidence on subpopulations; Table 55. Summary of all included studies1 by epoetin dose, route, regimen type, and treatment duration; Table 56. Outcomes reported for epoetin treatment in allogeneic and autologous transplantation studies; Table 57. Adverse events reported by studies on patients being treated for malignancy; Results; Table 58. RBC engraftment outcomes ordered by dose; Table 59. Transfusion outcomes and days in hospital ordered by dose; Table 60. Significant outcomes ordered by epoetin regimen type and treatment duration; Table 61. Outcomes of epoetin treatment vs. control by use of total body irradiation and methotrexate use; Table 62. Adverse events reported by studies on patients being treated for HDC/SCS; Table 63. Effect of epoetin on platelet transfusion; Conclusions 09chap6.doc Microsoft Word® Document MS Word® 97 SR-1 162KB 21 pages Contents: Chapter 6. Results and Conclusions IV: Outcomes of Anemia Management Strategies in Patients Being Treated for Malignancy with Bone Marrow Ablation and Autologous Stem-Cell Support: Objective; Key Questions; Overview of the Evidence; Table 64. Assessment of study quality; Table 65. Study arm comparability; Table 66. Reporting on elements of study arm comparability; Table 67. Evidence to compare subpopulations; Table 68. Summary of all included studies by epoetin dose, route, regimen type, and treatment duration; Table 69. Outcomes reported for epoetin treatment in autologous transplantation studies; Table 70. Adverse events reported by studies on patients being treated for malignancy; Results; Table 71. RBC engraftment outcomes ordered by dose; Table 72. Transfusion and hospitalization outcomes ordered by dose; Table 73. Significant outcomes ordered by epoetin regimen type and treatment duration; Table 74. Adverse events reported by studies on patients being treated for HDC/AuSCS; Table 75. Effect of epoetin on platelet transfusion; Conclusions 10chap7.doc Microsoft Word® Document MS Word® 97 SR-1 29KB 3 pages Contents: Chapter 7. Future Research Priorities 11refs.doc Microsoft Word® Document MS Word® 97 SR-1 73KB 9 pages Contents: References 12etI1.doc Microsoft Word® Document MS Word® 97 SR-1 49KB 5 pages Contents: Evidence Table I-1. Study description 13etI2.doc Microsoft Word® Document MS Word® 97 SR-1 66KB 4 pages Contents: Evidence Table I-2. Baseline study characteristics 14etI3.doc Microsoft Word® Document MS Word® 97 SR-1 61KB 3 pages Contents: Evidence Table I-3. Report for hematologic outcomes 15etI4.doc Microsoft Word® Document MS Word® 97 SR-1 63KB 3 pages Contents: Evidence Table I-4. Report for RBC transfusion use 16etI5.doc Microsoft Word® Document MS Word® 97 SR-1 60KB 3 pages Contents: Evidence Table I-5. QoL and miscellaneous outcomes report 17etI6.doc Microsoft Word® Document MS Word® 97 SR-1 96KB 3 pages Contents: Evidence Table I-6. Adverse events report 18etII1.doc Microsoft Word® Document MS Word® 97 SR-1 28KB 2 pages Contents: Evidence Table II-1. Study description 19etII2.doc Microsoft Word® Document MS Word® 97 SR-1 38KB 2 pages Contents: Evidence Table II-2. Baseline study characteristics 20etII3.doc Microsoft Word® Document MS Word® 97 SR-1 34KB 1 page Contents: Evidence Table II-3. Report for hematologic outcomes 21etII4.doc Microsoft Word® Document MS Word® 97 SR-1 35KB 2 pages Contents: Evidence Table II-4. Report for RBC transfusion use 22etII5.doc Microsoft Word® Document MS Word® 97 SR-1 33KB 1 page Contents: Evidence Table II-5. QoL and miscellaneous outcomes report 23etII6.doc Microsoft Word® Document MS Word® 97 SR-1 41KB 1 page Contents: Evidence Table II-6. Adverse events report 24etIII1.doc Microsoft Word® Document MS Word® 97 SR-1 24KB 1 page Contents: Evidence Table III-1. Study description 25etIII2.doc Microsoft Word® Document MS Word® 97 SR-1 32KB 1 page Contents: Evidence Table III-2. Baseline study characteristics 26etIII3.doc Microsoft Word® Document MS Word® 97 SR-1 34KB 1 page Contents: Evidence Table III-3. Report for RBC transfusion use 27etIII4.doc Microsoft Word® Document MS Word® 97 SR-1 34KB 1 page Contents: Evidence Table III-4. Report for RBC engraftment 28etIII5.doc Microsoft Word® Document MS Word® 97 SR-1 41KB 1 page Contents: Evidence Table III-5. Adverse events report 29etIV1.doc Microsoft Word® Document MS Word® 97 SR-1 24KB 1 page Contents: Evidence Table IV-1. Study description 30etIV2.doc Microsoft Word® Document MS Word® 97 SR-1 29KB 1 page Contents: Evidence Table IV-2. Baseline study characteristics 31etIV3.doc Microsoft Word® Document MS Word® 97 SR-1 32KB 1 page Contents: Evidence Table IV-3. Report for RBC engraftment 32etIV4.doc Microsoft Word® Document MS Word® 97 SR-1 32KB 1 page Contents: Evidence Table IV-4. Report for RBC transfusion use 33etIV5.doc Microsoft Word® Document MS Word® 97 SR-1 39KB 1 page Contents: Evidence Table IV-5. Adverse events report 34biblio.doc Microsoft Word® Document MS Word® 97 SR-1 231KB 29 pages Contents: Bibliography 35appa.doc Microsoft Word® Document MS Word® 97 SR-1 30KB 5 pages Contents: Appendix A. Technical Advisory Group; External Reviewers; Medical Advisory Panel 36appb.doc Microsoft Word® Document MS Word® 97 SR-1 82KB 6 pages Contents: Appendix B. Study Sponsorship 37appc.doc Microsoft Word® Document MS Word® 97 SR-1 86KB 8 pages Contents: Appendix C. Data Abstraction Form 38appd.doc Microsoft Word® Document MS Word® 97 SR-1 23KB 2 pages Contents: Appendix D. Acronyms __________________________________________________________________________________________________________
AHRQ Publication No. 01-E009
Current as of June 2001
Internet Citation:
Uses of Epoetin for Anemia in Oncology. File Inventory, Evidence Report/Technology Assessment Number 30. AHRQ Publication No. 01-E009, June 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/epoetinv.htm
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