Table C53

KQ3: Study Characteristics, Part I

study authorparticipants randomizedDrugIntervention (Early)Control Lateweight based or fixedMaximum duration of EPO medication (weeks)dose adjustmentirontransfusion trigger (when transfusion assessed)publicationprimary and secondary outcomes of the study
Rearden 2004 204 E: 102 L: 102Darbepoetin alfa300 μg Q3WObservation until Hb ≤ 10 g/dl then start treatment 300μg Q3W [38 patients, 37.3%]Fixed12 (darbepoetin treatment period); chemotherapy and follow-up continued for 22 weeksIncrease to 500μg/Dose-. for Early: if Hb <10g/dl; for Late: if Hb <9 g/dl or if after 2 consecutives doses of DA Hb <10 g/dlNRNRAbstract + slidesproportions with: Hb drop below 10 g/dl by week 12; Hb drop during therapy; RBC transfused during therapy; also, mean Hb over time; mean change in FACT-Fatigue subscale score; proportion maintaining Hb 11.0 to 13.0 (target)
Straus 2003 269 E: 135 L: 134Epoetin alfa40000 IU QWObservation until Hb ≤9 g/dl after 2nd chemotherapy cycle, then start treatment: 40,000 IU QW [29 pt (19.4%)]Fixed16Increased to 60000 in either group if after 4w of Epo treatment Hb I ≤1g/dlNRNRAbstract + poster copyHb response; RBC transfusions, QoL; Safety Health Care utilization Work/Productivity
Crawford 2003 216 E: 109 L: 107Epoetin alfa40000 IU QWObservation until Hb ≤ 10 g/dl, then start treatment at 40,000 IU QW (44% of controls had Hb<10 g/dL and received late epoetin)Fixed16Increased to 60,000 IU QW if ≥2 g/dL Hb decrease; dose withheld if Hb >15 g/dL twice consecutively; re-start with dose decreased by 20,000 IU weekly when Hb ≤13 g/dLas needed (ferritin <100 ng/mL or Tsat<20%)NRAbstract + slides (presented as poster)Hb changes over time; proportion transfused; RBC units/patient; QoL changes with Fact-An, LASA, BFI; tumor size; survival; adverse events; lab tests; blood pressure

From: Appendix C, Evidence Tables

Cover of Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment
Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment [Internet].
Comparative Effectiveness Reviews, No. 3.
Seidenfeld J, Piper M, Bohlius J, et al.

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