Table 4

Summary of systematic review outcomes

StudyThrombosis
Transfusion
No. of TrialsNo. of Patients
Events: ESA ArmsControl ArmsRelative Risk95% CIEvents: ESA ArmsControl ArmsRelative Risk95% CINo. of TrialsNo. of Patients
Seidenfeld et al 
    EPO v DAR 58/948 (DAR) 66/931 (EPO) 0.86 0.61 to 1.21  189 252/1169 198/989 1.10 0.93 to 1.29 2158 
    EPO v control 218/3355 112/2737 1.69 1.36 to 2.10 30 6092 864/2859 1110/2351 0.63 0.59 to 0.67 34 5210 
    DAR v control 7/155 5/159 1.44 0.47 to 4.43  314 165/566 196/384 0.61 0.52 to 0.72 950 
Bohlius et al3,39  229/3,728 118/3,041 1.67 1.35 to 2.06 35 6,769 1118/3,637 1385/2,873 0.64 0.60 to 0.68 42 6,510 
Quirt et al DVT-2 studies report: Schwartzberg (2004): EPO, n = 1/155, DAR, n = 1/157; Rosenzweig (2004): EPO, n = 4/14; pulmonary embolism, 2 studies report: Schwartzberg (2004): EPO, n = 1/155; DAR, n = 0/157; Rosenzweig (2004): EPO, n = 2/14 Rosenzweig (2004): control n = NA for both DVT + PE NR    385/1,750 588/1,419 0.52 0.46 to 0.60 30 trials (33 comparisons) 3,169 
Shehata et al Thrombosis: EPOα or β frequency, range, 3%–7%, control frequency, range, 2%–6%; DARα, not reported, 5 trials  NR EPO α or β absolute risk reduction ranged from 15%−24%, 6 trials; DARα absolute risk reduction ranged from 17%−30%, 2 trials 
Wilson et al Study 1: vascular: BP,VT,PE,CVA 20/180; study 2: thrombic events 4/14; study 3: thrombic events 7/156 Study 1: vascular 9/171; study 2: NR; study 3: thrombic events 5/158 NR    834/2,637 988/1,976 0.63 0.58 to 67 35 4,613 
Overall Survival
Tumor Response
Events: ESA ArmsControl ArmsHazard Ratio95% CINo. of TrialsNo. of PatientsEvents: ESA ArmsControl ArmsRelative Risk95% CINo. of TrialsNo. of Patients
Seidenfeld et al 
    EPO v DAR 29/180 23/178 1.25 0.76 to 2.07 358       
    EPO v control 1,008/3,825 830/3,093 1.11 1.00 to 1.22 35 6,918 216/344 211/344 1.00 0.92 to 1.10 688 
    DAR v control 181/583 183/390 0.96 0.78 to 1.17 973       
Bohlius et al3,39  NR NR 1.08 0.99 to 1.18 42 8,167 413/1509 324/1,324 1.12 1.01 to 1.23 13 2,833 
Quirt et al NR NR  NR   NR  NR    
Shehata et al Littlewood et al (2001) report EPOα = 60% for patients with solid tumors and hematologic malignancies, control = 40% (P = .13); Osterborg et al (2005) report EPOα = 65%, control = 63%, HR = 1.04 (0.80–1.36); DARα HR = 0.95, P = .619, 4 trials            
Wilson et al 675/2,986 deaths 545/2,322 1.03 0.92 to 1.16 28 5,308 169/723 91/537 1.31 1.08 to 1.60 1,260 
StudyThrombosis
Transfusion
No. of TrialsNo. of Patients
Events: ESA ArmsControl ArmsRelative Risk95% CIEvents: ESA ArmsControl ArmsRelative Risk95% CINo. of TrialsNo. of Patients
Seidenfeld et al 
    EPO v DAR 58/948 (DAR) 66/931 (EPO) 0.86 0.61 to 1.21  189 252/1169 198/989 1.10 0.93 to 1.29 2158 
    EPO v control 218/3355 112/2737 1.69 1.36 to 2.10 30 6092 864/2859 1110/2351 0.63 0.59 to 0.67 34 5210 
    DAR v control 7/155 5/159 1.44 0.47 to 4.43  314 165/566 196/384 0.61 0.52 to 0.72 950 
Bohlius et al3,39  229/3,728 118/3,041 1.67 1.35 to 2.06 35 6,769 1118/3,637 1385/2,873 0.64 0.60 to 0.68 42 6,510 
Quirt et al DVT-2 studies report: Schwartzberg (2004): EPO, n = 1/155, DAR, n = 1/157; Rosenzweig (2004): EPO, n = 4/14; pulmonary embolism, 2 studies report: Schwartzberg (2004): EPO, n = 1/155; DAR, n = 0/157; Rosenzweig (2004): EPO, n = 2/14 Rosenzweig (2004): control n = NA for both DVT + PE NR    385/1,750 588/1,419 0.52 0.46 to 0.60 30 trials (33 comparisons) 3,169 
Shehata et al Thrombosis: EPOα or β frequency, range, 3%–7%, control frequency, range, 2%–6%; DARα, not reported, 5 trials  NR EPO α or β absolute risk reduction ranged from 15%−24%, 6 trials; DARα absolute risk reduction ranged from 17%−30%, 2 trials 
Wilson et al Study 1: vascular: BP,VT,PE,CVA 20/180; study 2: thrombic events 4/14; study 3: thrombic events 7/156 Study 1: vascular 9/171; study 2: NR; study 3: thrombic events 5/158 NR    834/2,637 988/1,976 0.63 0.58 to 67 35 4,613 
Overall Survival
Tumor Response
Events: ESA ArmsControl ArmsHazard Ratio95% CINo. of TrialsNo. of PatientsEvents: ESA ArmsControl ArmsRelative Risk95% CINo. of TrialsNo. of Patients
Seidenfeld et al 
    EPO v DAR 29/180 23/178 1.25 0.76 to 2.07 358       
    EPO v control 1,008/3,825 830/3,093 1.11 1.00 to 1.22 35 6,918 216/344 211/344 1.00 0.92 to 1.10 688 
    DAR v control 181/583 183/390 0.96 0.78 to 1.17 973       
Bohlius et al3,39  NR NR 1.08 0.99 to 1.18 42 8,167 413/1509 324/1,324 1.12 1.01 to 1.23 13 2,833 
Quirt et al NR NR  NR   NR  NR    
Shehata et al Littlewood et al (2001) report EPOα = 60% for patients with solid tumors and hematologic malignancies, control = 40% (P = .13); Osterborg et al (2005) report EPOα = 65%, control = 63%, HR = 1.04 (0.80–1.36); DARα HR = 0.95, P = .619, 4 trials            
Wilson et al 675/2,986 deaths 545/2,322 1.03 0.92 to 1.16 28 5,308 169/723 91/537 1.31 1.08 to 1.60 1,260 

Abbreviations: EPO-α, epoetin α; EPO-β, epoetin β; DAR, darbepoetin; NA, not applicable; NR, not reported.

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