Table 6.

Larger studies on erythropoietin (Epo) alone or Epo in combination with G-CSF.

Author
Year
Treatment
No. Pts.
Inclusion Criteria
Erythroid Response
Favorable Variables/Comments
Hellstrom-Lindberg40  meta-analysis   1995   Epo   205   Various, all studies since 1995   16%* (8% RARS)   S-Epo < 200 U/L RA/RAEB, no transfusions  
Rose41  phase II   1995   Epo   116   Hb < 80 g/L, S-Epo < 500 U/L   28%** (18% red. transf)   S-Epo < 100 U/L, RA  
Italian Study Group42  phase III   1998   Epo / placebo   87   Hb < 90 g/L Blasts < 10%   37% vs 11%** (p = 0.007)   Response significant in RA and in non-transfused pts  
Negrin44  phase II   1996   Epo + G-CSF   55   Hb < 100 g/L   48%**, duration median 10 mo.   S-Epo  
Hellstrom-Lindberg45  phase II   1998   Epo + G-CSF   71   Hb < 100 g/L   38%*, duration 24 months   S-Epo, transfusion need  
Remacha47  phase II   1999   Epo + G-CSF   32   Hb < 100 g/L S-Epo < 250 U/L   50%**  Predictive model (Figure 5)  
Mantovani49   2000   Epo + G-CSF   33   Blasts < 20%   61%* (12 weeks) 80% (36 weeks)   50% response after 2 years  
Abbreviations: S-Epo, serum Epo level; G-CSF, granulocyte colony-stimulating factor  
Author
Year
Treatment
No. Pts.
Inclusion Criteria
Erythroid Response
Favorable Variables/Comments
Hellstrom-Lindberg40  meta-analysis   1995   Epo   205   Various, all studies since 1995   16%* (8% RARS)   S-Epo < 200 U/L RA/RAEB, no transfusions  
Rose41  phase II   1995   Epo   116   Hb < 80 g/L, S-Epo < 500 U/L   28%** (18% red. transf)   S-Epo < 100 U/L, RA  
Italian Study Group42  phase III   1998   Epo / placebo   87   Hb < 90 g/L Blasts < 10%   37% vs 11%** (p = 0.007)   Response significant in RA and in non-transfused pts  
Negrin44  phase II   1996   Epo + G-CSF   55   Hb < 100 g/L   48%**, duration median 10 mo.   S-Epo  
Hellstrom-Lindberg45  phase II   1998   Epo + G-CSF   71   Hb < 100 g/L   38%*, duration 24 months   S-Epo, transfusion need  
Remacha47  phase II   1999   Epo + G-CSF   32   Hb < 100 g/L S-Epo < 250 U/L   50%**  Predictive model (Figure 5)  
Mantovani49   2000   Epo + G-CSF   33   Blasts < 20%   61%* (12 weeks) 80% (36 weeks)   50% response after 2 years  
Abbreviations: S-Epo, serum Epo level; G-CSF, granulocyte colony-stimulating factor  
*

The definition of response required a total stop in transfusion need in transfusion-dependent patients.

**

The definition of response required a 50% reduction in transfusion need in transfusion-dependent patients.

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