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Abstract
Objectives:
The CHOICE study was a prospective, multicentre, observational study designed to assess the level of adherence in current clinical practice to the European product label and the EORTC guidelines for the treatment of chemotherapy-induced anaemia with darbepoetin alfa (DA).
Methods:
Hb levels and red blood cell (RBC) transfusion requirements were evaluated among 1900 patients with solid tumours in 11 European countries. The primary outcome measure was the proportion of patients with a target Hb level of ≥10–≤12 g/dL after 9 weeks’ DA treatment.
Results:
The full analysis set (FAS) comprised 1887 patients (mean ± SD age 62.4 ± 11.4 years) divided into categories by baseline Hb < 9 g/dL (n = 281); 9–<10 g/dL (n = 770); 10–<11 g/dL (n = 695); ≥11 g/dL (n = 114). The proportion of patients who remained on the study at week 9 achieving the target Hb level was 37% (n = 60), 48% (n = 217), 54% (n = 210) and 38% (n = 23) in the subgroups with a baseline Hb level of <9 g/dL, 9–<10 g/dL, 10–<11 g/dL and ≥11 g/dL, respectively. In the <9 g/dL, 9–<10 g/dL, 10–<11 g/dL and ≥11 g/dL subgroups of the FAS, the number of patients maintaining Hb levels ≥10 g/dL after their first achievement of an Hb value of 10 g/dL was 95 (34%), 372 (48%), 476 (68%) and 87 (76%), respectively. The Kaplan–Meier percentages of patients who required an RBC transfusion from week 5 until end of treatment period were: 29%, 20%, 12% and 17% in the <9 g/dL, 9–<10 g/dL, 10–<11 g/dL and ≥11 g/dL subgroups, respectively. Kaplan–Meier percentages of patients reaching an Hb level of >13 g/dL were 10%, 9%, 21% and 29%, respectively. Potential bias could not be excluded due to the study’s observational nature.
Conclusions:
DA initiation and target Hb ranges adhered to current guidelines in the majority of patients. Furthermore, this study demonstrates faster achievement of the target range and reduced transfusion requirements are associated with initiation of DA at Hb levels of 9–<10 g/dL and 10–<11 g/dL rather than <9 g/dL.
Transparency
Declaration of funding
This study was supported by Amgen (Europe) GmbH.
Declaration of financial/other relationships
S.V.B., A.S.-S., C.K., J.-L.L., A.G. and J.G.A. have disclosed that they were investigators of this study. S.V.B. has also disclosed that he is a consultant for Amgen Belgium SA/NV. T.W. and B.P. have disclosed that they are employees of Amgen (Europe) GmbH.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgements
The authors thank the patients who participated in this study and the medical staff of each centre. We would also like to thank everyone involved in the preparation of this manuscript, in particular Archimed Medical Communication AG for their writing support (funded by Amgen [Europe] GmbH).
Previous presentations – Interim analysis data of the CHOICE study are published in: Van Belle S, Karanikiotis C, Labourey J-L et al. Current practice of darbepoetin alfa in the management of haemoglobin levels in cancer patients undergoing chemotherapy – data from the CHOICE study. Curr Med Res Opin 2011;27:987-94. Final data of the CHOICE study were presented at: The European Multidisciplinary Cancer Congress, Stockholm, 23–27 September 2011: Van Belle S, Galid A, Karanikiotis C et al. Use of darbepoetin alfa for the treatment of chemotherapy-induced anaemia in European clinical practice – data from the CHOICE study. SIOG Congress, Paris, 4–5 November 2011: Van Belle S, Swieboda-Sadlej A, Karanikiotis C et al. Current use of darbepoetin alfa for the treatment of chemotherapy-induced anaemia in patients <65, ≥65 or ≥70 years – data from the CHOICE study.