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Abstract
Objectives:
The CHOICE study was a prospective, multicentre, observational study designed to assess levels of adherence in current clinical practice to the European product label and EORTC guidelines for the treatment of chemotherapy-induced anaemia (CIA) with darbepoetin alfa (DA). Here we present data split by tumour types: breast, colorectal, ovarian and lung.
Methods:
Haemoglobin (Hb) levels and red blood cell transfusion requirements were evaluated among 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.
Results:
The full analysis set included 1887 patients (mean ± SD 62.4 ± 11.4 years); 1585 (84%) had a current disease stage of ≥3. Common chemotherapy regimens were non-platinum + non-taxane based (n = 696 [37%]) or platinum + non-taxane based (n = 660 [35%]).
Breast cancer (n = 575):
The mean ± SD Hb level at baseline was 9.9 ± 0.8 g/dL (n = 568). Target Hb level was reached by 187 (55%) patients.
Colorectal cancer (n = 310):
At baseline the mean ± SD Hb level was 9.8 ± 0.8 g/dL (n = 306). Target Hb level was reached by 107 patients (56%).
Ovarian cancer (n = 301):
The mean ± SD Hb level at baseline was 9.7 ± 0.8 g/dL (n = 294). Target Hb level was reached by 81 patients (44%).
Lung cancer (n = 701):
At baseline the mean ± SD Hb level was 9.8 ± 0.9 g/dL (n = 692). Target Hb level was reached by 142 patients (39%).
Safety:
Five severe or life-threatening adverse drug reactions were seen (three patients with breast cancer, one patient with colorectal cancer and one patient with ovarian cancer).
Limitations:
Potential bias could not be excluded due to the study’s observational nature.
Conclusions:
This study demonstrates that the recommendations are adhered to in clinical practice, with the mean starting Hb level <10 g/dL irrespective of tumour type. Furthermore, DA is likely to be effective and well tolerated for the treatment of CIA in patients with breast, colorectal, ovarian or lung cancer.
Transparency
Declaration of funding
This study was supported by Amgen (Europe) GmbH.
Declaration of financial/other relationships
J.G.A., A.S.-S., C.K., J.-L.L., A.G. and S.V.B. 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 presentation – 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.