[Epoetin beta for the treatment of chemotherapy-induced anaemia in solid and haematological malignancies. Results of an open-label, multicentric clinical trial].
OBJECTIVE
Evaluate efficacy and safety of epoetin beta in anaemic patients receiving chemotherapy for a non-myeloid malignancy.


METHODS
This open-label, multicentric, clinical trial was conducted in France among 691 anaemic patients (haemoglobin < or = 12 g/dL) with a solid or haematological malignancy to evaluate the benefit of epoetin beta 30,000 IU/week subcutaneously for 16 weeks. The primary endpoint was the rate of therapeutic response.


RESULTS
The overall response rate was 60.4% (CI 95%: [56.6%-64.1]). According to initial haemoglobin level < 11 g/dL or between 11 and 12 g/dL, it was 61.2% and 57.5% respectively. Response rates by tumour type (solid and haematological) were similar. The mean haemoglobin level increases were respectively 1.1 g/dL, approximately 2 and 2.2 g/dL at 4, 9, and 12 weeks after treatment initiation. In patients with haemoglobin level < 11 g/dL at inclusion the mean increases in haemoglobin level were respectively 1.17, 2.03 and 2.45 g/dL at 4, 9 and 12 weeks. During study period, 23% of patients required red blood cell transfusion. Overall treatment with epoetin beta was well-tolerated and 7.1% of patients only experienced thromboembolic events.


CONCLUSIONS
For treating chemotherapy-induced anaemia in patients with solid or haematological malignancy (especially if haemoglobin level < 11 g/dL), epoetin beta 30.000 IU subcutaneously once-weekly (450 IU/kg/week) is rapidly effective and overall well-tolerated.
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Centre d'oncologie de Gentilly, 2, rue Marie-Marvingt, F-54100 Nancy, France. oncomed@wanadoo.fr
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000139:chemically induced / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005602:France; D006397:Hematinics / Q000008:administration & dosage / Q000627:therapeutic use*; D019337:Hematologic Neoplasms / Q000188:drug therapy; D006441:Hemoglobin A / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy; D011446:Prospective Studies; D011994:Recombinant Proteins; D055815:Young Adult
D000970:Antineoplastic Agents; D006397:Hematinics; D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin; D006441:Hemoglobin A