Table 25

RCTs Reporting Survival: Overall and Subgroup Analyses of Hazard Ratios for Death, Epoetin Compared to Control

OutcomeEpoetin versus ControlDarbepoetin versus Control
Subgroup# Studies#Total Patients#Epo/#Ctl PatientsHazard Ratio for death95% CI (p-value)# Studies#Total Patients#Darbepoetin/#Ctl PatientsHazard Ratio for death95% CI (p-value)
Overall Survival 356,9183,825/3,0931.111.00; 1.224973583/3900.960.78; 1.17
(Heterogeneity)(0.48) (0.03)
Subgroup Analyses: Patient Baseline Characteristics
Bsln Hb <10142,8301,590/1,2400.960.83; 1.103659428/2311.310.95; 1.81
Bsln Hb 10–1271,398782/6161.170.93; 1.491314155/1590.780.60, 1.01
Bsln Hb >12171,696870/8261.271.05; 1.54
Bsln Hb unclear17994583/4111.631.07; 2.49
(Group difference2) (0.025) (0.015)
Solid tumors234,5262,420/2,1061.221.07; 1.382563353/2100.770.60; 1.00
Hematologic61,044626/4181.020.81; 1.292410230/1801.360.98; 1.89
Mixed61,348779/5690.860.68; 1.08
(Group difference2) (0.027) (0.008)
Subgroup Analyses: Treatment Protocols
Chemo, any101,474884/5901.140.74; 1.71314155/1590.780.60; 1.01
Chemo, some plat4955482/4731.010.79; 1.301249198/510.550.11; 2.61
Chemo, no plat133,3021,859/1,4431.060.92; 1.212410230/1801.360.98; 1.89
Chemo+RT or RT81,187600/5871.271.05; 1.55
(Group difference2)(0.4134) (0.027)
Iron, fixed2360181/1791.080.82; 1.42
Iron, as needed193,5221,964/1,5580.990.86; 1.131344175/1691.360.98; 1.89
Iron unknown133,0361,680/1,3561.321.11; 1.553629408/2210.770.60; 1.00
(Group difference2) (0.033) (0.008)
Epo tx 6–9 weeks6823461/3621.250.97; 1.59
Epo tx 12–16 weeks193,6792,009/1,6701.050.90; 1.23(all)
Epo tx >20 weeks71,9581,113/8451.130.95; 1.33
Epo tx ? Weeks3458242/2161.020.71; 1.46
(Group difference2)(0.68)
Subgroup Analyses: Reporting and Quality
High quality204,3842,380/2,0041.141.02; 1.27(all)
Low quality152,5341,445/1,08910.81; 1.24
(Group difference2)(0.3087)
Full Text81,800983/8170.980.84; 1.132315253/620.550.11; 2.61
Abstract3678394/2841.270.79; 2.06
Unpublished data5384199/1850.60.25; 1.41
FDA documents194,0562,249/1,8071.251.08; 1.442658330/3280.960.79; 1.18
(Group difference2)(0.17)(0.48)
Followup <1 year243,3931,998/1,3951.000.77; 1.312315253/620.550.11; 2.61
Followup >1 year113,5251,827/1,6981.121.01; 1.252658330/3280.960.79; 1.18
(Group difference2)(0.43)(0.48)
1

The N93-004 epoetin trial was published in full in December, 2005 (Grote, Yeilding, Castillo, et al., 2005) and included information on baseline Hb which classified it into subgroup Hb >12. A re-categorized analysis of epoetin vs. control trials resulted in subgroup Hb>12 RR 1.28 (95% CI, 1.06, 1.54), an insignificant change. Because this did not alter the interpretation of results, we did not alter our presentation of the overall analysis.

2

p-value for differences among subgroup categories calculated by inverse variance method (see Methods/Data Extraction and Analysis/Statistical Data Analysis).

From: 3, Results

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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