A prospective, observational study describing the haematological response in patients undergoing chemotherapy treated by tri-weekly darbepoetin alfa for anaemia

Abstract

Objective:

This prospective, observational study investigated the haematological response to darbepoetin alfa (DA) administered every three weeks for the treatment of anaemia. Response was also assessed according to baseline characteristics including iron, folate and vitamin B12 status.

Research design and methods:

Anaemic adult patients with malignant non-myeloid cancer, starting or having already undergone chemotherapy received DA on day of inclusionand were followed up for up to 24 weeks. Concentration of haemoglobin (Hb), as well as iron, vitamin B12 and folate status where available, were recorded at inclusion, after a treatment period of 9 weeks and up to a maximum of 24 weeks or cessation of DA treatment, whichever was sooner.

Main outcome measures:

The main outcome measure assessed in this study was the percentage of patients reaching a Hb concentration of at least 11 g/dL at least once at any time during the study.

Results:

A total of 2912 patients were included. The mean Hb concentration increased from 10.0 g/dL at inclusion to 11.4 g/dL at 9 weeks and 11.8 g/dL at 24 weeks. In 74.6% of patients the target Hb level of 11.0 g/dL or above was reached. After initiation of DA treatment, 9.5% of patients required a blood transfusion by week 9, and 5.6% thereafter. Vitamin B12 and folate status were unknown for 80.3% of patients and the iron status for 73.2% of patients. Compared with patients who remained untreated for vitamin B12 or folate deficiency, a higher percentage of patients with vitamin status within normal limits achieved the target Hb concentration. However, achievement of target Hb level appeared not to be affected by iron status.

Conclusions:

In this study, the mean Hb level increased in anaemic cancer patients treated with DA and the majority of patients achieved the target Hb level. In contrast to the recommendations of guidelines (EORTC) encouraging the measurement of iron and vitamin levels, the present study demonstrated that data were not routinely collected for these factors.

Key words:

• Anaemia
• Cancer
• Chemotherapy
• Darbepoetin alfa
• Iron
• Vitamin

Trial supported by Amgen SAS, drug was prescribed.

Trial supported by Amgen SAS, drug was prescribed.

Transparency

Declaration of funding

This study was sponsored by Amgen Inc.

Declaration of financial/other relationships

I.R.-C., P.L., N.V. and B.A. have disclosed that they were investigators of this study. N.V. also disclosed that he is currently conducting research sponsored by Amgen and received honoraria from that company. M.U. has disclosed that she is an employee of Amgen Inc.

Acknowledgements

Authors thank the patients who participated in this study and the medical staff of each centre. We would also like to thank the people who helped in the preparation of this manuscript, in particular Archimed Medical Communication AG for their editing support (funded by Amgen [Europe] GmbH).

Notes

Trial supported by Amgen SAS, drug was prescribed.