Table 4 Effect of epoetin alfa on transfusion: results of eight randomised, controlled studies

Kurz et al (1997)

R, DB, C (PBO) N=35 (gynaecologic)

EPOα 150 IU kg⁻¹ t.i.w. or PBO

<11 g dl⁻¹ (for inclusion)

Mean:

EPOα: 9.9 g dl⁻¹

PBO: 9.8 g dl⁻¹

EPOα: 21.7%

PBO: 66.6%

(P=0.009)

Dammacco et al (2001)

R, DB with OL phase, C (PBO) N=145 (multiple myeloma)

EPOα 150 IU kg⁻¹ t.i.w. or PBO

<11 g dl⁻¹ (for inclusion)

Mean:

EPOα: 9.3 g dl⁻¹

PBO: 9.6 g dl⁻¹

EPOα: 28%

PBO: 47%

(P=0.017)

Littlewood et al (2001)

R, DB, C (PBO) N=375 (mixed)

EPOα 150 IU kg⁻¹ t.i.w. or PBO

⩽10.5 g dl⁻¹ or >10.5–⩽12.0 g dl⁻¹ after Hb↓ ⩾1.5 g dl⁻¹ per chemo cycle (for enrollment)

Mean:

EPOα: 9.9 g dl⁻¹

PBO: 9.7 g dl⁻¹

Total population:

EPOα: 24.7%

PBO: 39.5%

(P=0.0057)

EPOα stratum:

>10.5 g dl⁻¹: 7.1%

⩽10.5 g dl⁻¹: 28.2%

Pronzato et al (2002)

R, OL, C (BST) N=178 (interim analysis) (breast cancer)

EPOα 10 000 IU t.i.w. or BST

10–12 g dl⁻¹ (for initiation of treatment)

Mean:

EPOα: 10.7 g dl⁻¹

BST: 10.8 g dl⁻¹

EPOα: 6.7%

BST: 16.9%

(P=0.06)

Janinis et al (2003)

R, OL, C (iron only) N=372 evaluable (mixed)

EPOα 10 000 IU t.i.w. + iron or iron only

⩽11 g dl⁻¹ (for randomisation)

Median:

10.5 g dl⁻¹ (both groups)

EPOα + iron: 9%

Iron only: 23%

(P < 0.0001)

Savonije et al (2004)

R, C (BSC) N=315 (mixed)

EPOα 10 000 IU t.i.w. or BSC

<12.1 g dl⁻¹ (for randomisation)

Median:

EPOα: 10.7 g dl⁻¹

BSC: 10.8 g dl⁻¹

EPOα: 37%

BST: 65%

(P<0.05)

Chang et al (2005)

R, OL, C (SOC) N=354 (breast cancer)

EPOα 40 000 IU q.w. or SOC

⩽15 g dl⁻¹ (for entry)

⩽12 g dl⁻¹ (for randomisation)

Mean:

EPOα: 11.2 g dl⁻¹

SOC: 11.3 g dl⁻¹

EPOα: 8.6%

SOC: 22.9%

(P<0.001)

Witzig et al (2005)

R, DB, C (PBO) N=344 (mixed)

EPOα 40 000 IU q.w. or PBO

<11.5 g dl⁻¹ (males)

<10.5 g dl⁻¹ (females) (for enrollment)

Mean:

EPOα: 9.5 g dl⁻¹

PBO: 9.4 g dl⁻¹

EPOα: 25.3%

PBO: 39.6%

(P=0.005)