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 ≥ 18 years of age, anaemic (haemoglobin [Hb] ≤ 11 g/dL), with non-myeloid malignancies, receiving chemotherapy. DA (150 μg) 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 ≥ 2 g/dL or Hb ≥ 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.

Key words: :

• Anaemia
• Darbepoetin alfa
• Fatigue
• Multi-cycle chemotherapy

* Aranesp is a registered trade name of Amgen Inc., Thousand Oaks, CA, USA

* Aranesp is a registered trade name of Amgen Inc., Thousand Oaks, CA, USA

Acknowledgements

Declaration of interest: This study was supported by Amgen S.A. J.A.G. and J.S. are employees of Amgen S.A. None of the other authors have any conflicts of interest with respect to the contents of this article.

The authors take final and full responsibility for the article, and would like to acknowledge the following assistance: Marta Llorens managed the study together with Patricia Jou, Elisabeth Molina, Paloma Iturralde and Reyes Calzada; Ramón Dosantos was responsible for the statistical analysis; Francesc Sorio managed the safety data; Roser de Castellar, Neus Valveny and Elena Molina assisted with the preparation of the manuscript.

The authors also thank the study coordinators and patients at each of the participating centres. Additional investigators of the AMG-DAR-2002-01 Study Group are listed below:

I. Roig/J. A. Soler (Consorci Hospitalari Parc Taulí, Sabadell); J. C. Bermejo (Hospital Sagrat Cor, Barcelona); A. Palacios/L. Gallur (Hospital Vall d’Hebron, Barcelona); J. Fabregat Mayor (Hospital del Mar, Barcelona); M. A. Cruz Mora (Hospital Virgen de la Salud, Toledo); M. Nogué Aliguer (Hospital General de Vic); M. Centelles (Hospital Sagrado Corazón, Barcelona); F. Hernández (Hospital Universitario La Paz, Madrid); A. Velasco Ortiz de Tarranco (Hospital la Princesa, Madrid); A. Arcusa Lanza (Consorci Hospitalari de Terrassa, Barcelona); M^a J. Allege (Complejo Hospitalario Pontevedra Montecelo, Pontevedra); A. Gúrpide (Clínica Univesitaria Navarra, Pamplona); I. Español Morales (Cruz Roja Hospitalet, L’Hospitalet de Llobregat, Barcelona); J. L. Bello Choupana-Gil Casares (Hospital CU Santiago, Santiago de Compostela); M. García Pinto (Consorci Hospitalari de Terrassa, Terrassa); M. González Barón (Hospital La Paz, Madrid); J. Orriols Benet (Hospital General de Manresa, Manresa); N. Batista (Hospital Clínico Universitario de Las Canarias, Tenerife); M. A. González (Hospital Xeral Calde, Lugo); J. Casal Rubio (Hospital Meixoeiro, Vigo); M. Ramos Vázquez (CO Galicia Quiroga Piñero Labaca, La Coruña); J. García Marco (Hospital Universitario Puerta de Hierro, Madrid); D. Hernández Malaver (M.D. Anderson, Madrid).

Notes

* Aranesp is a registered trade name of Amgen Inc., Thousand Oaks, CA, USA