A prospective observational study of the effectiveness, safety, and effect on fatigue of darbepoetin alfa for the treatment of chemotherapy-induced anaemia.

Abstract

OBJECTIVE:

Anaemia is common in cancer patients treated with chemotherapy. Darbepoetin alfa (DA) is the only erythropoiesis-stimulating protein approved for administration at weekly and every-three-week intervals in cancer patients receiving chemotherapy. This article investigates the effectiveness, tolerability and effect on fatigue of DA.

METHODS:

Prospective, observational study performed in 30 Spanish centres. Eligible patients were > or = 18 years of age, anaemic (haemoglobin [Hb] < or = 11 g/dL), with non-myeloid malignancies, receiving chemotherapy. DA (150 mug) was administered weekly for a maximum of 16 weeks (dosage doubled if Hb increased < 1 g/dL after 4 weeks).

MAIN OUTCOME MEASURES:

Haematopoietic response (Hb increase > or = 2 g/dL or Hb > or = 12 g/dL in the absence of transfusions in the previous 28 days), transfusion required between Weeks 5 and 16 and fatigue measured by the Fatigue subscale of the Functional Assessment of Cancer Therapy.

RESULTS:

293 adults were recruited (56.4% women), with lymphoproliferative malignancies (44.3%) or solid tumours (55.7%). Baseline Hb was 9-11 g/dL in 83.7% of patients. Sixty-four per cent (95% CI: 58.1-69.4%) had a haematopoietic response and 12% required transfusions. After adjusting for performance status, concomitant diseases and chemotherapy type, an increase in Hb level was significantly associated with an improvement in Fatigue subscale (+1.9 points per 1 g/dL). Only 2% of patients had treatment-related adverse events: thromboembolic pulmonary disease (0.3%); hypersensitivity reaction (0.3%); local pain following DA administration (0.3%); insomnia (0.3%); thrombocytosis (0.3%) and deep vein thrombosis (0.3%).

CONCLUSIONS:

Fixed-dose DA administered once weekly seems to be an effective, well-tolerated treatment for chemotherapy-induced anaemia in patients with non-myeloid malignancies, and there is an indication of a possible benefit on fatigue in the clinical practice.

• Authors: J R Mel, A Salar, C A Rodríguez, A Alegre, A González, J Cassinello, J Montesinos, J A Gasquet, J Sánchez, E Saigí, AMG-DAR-2002-01 Study Group
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 24 Issue 10 Pg. 2931-42 (Oct 2008) ISSN: 1473-4877 [Electronic] England
• PMID: 18775103 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Hematinics
• Hemoglobins
• Erythropoietin
• Darbepoetin alfa

Topics

• Adult
• Aged
• Aged, 80 and over
• Anemia (blood, chemically induced, drug therapy)
• Antineoplastic Agents (administration & dosage, adverse effects)
• Darbepoetin alfa
• Erythropoiesis (drug effects)
• Erythropoietin (administration & dosage, adverse effects, analogs & derivatives)
• Fatigue (blood, chemically induced, drug therapy)
• Female
• Hematinics (administration & dosage, adverse effects)
• Hemoglobins (analysis)
• Humans
• Male
• Middle Aged
• Neoplasms (blood, drug therapy)
• Time Factors