Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients.
OBJECTIVE
To report the design, methodology, implementation and initial results of the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry, the first US patient registry to collect and report on practice patterns and outcomes associated with erythropoiesis-stimulating therapy (EST) for anaemia management in oncology patients.


METHODS
DOSE is a prospective ongoing registry of oncology patients treated with epoetin-alpha or darbepoetin-alpha. Patients from either community or academic centres who meet prespecified entry criteria are eligible for inclusion in the registry. Data collected include patient demographic and clinical characteristics, EST administration, haematological parameters, patient-reported outcomes and medical resource utilization. Patients are followed from EST initiation through to the end of therapy or 16 weeks, whichever is earlier.


RESULTS
Initial results from 45 sites for 861 patients (epoetin-alpha, n = 312; darbepoetin-alpha, n = 549) showed that baseline demographic and disease characteristics were similar between the two treatment groups. Administration of EST at both weekly and > or =2-weekly intervals was observed in both groups, with similar numbers of haemoglobin determinations. However, the mean number of office visits was higher in the darbepoetin-alpha group despite more frequent administration of therapy at > or =2-weekly intervals in this group. Mean treatment duration was approximately 8 weeks for both groups. Mean post-baseline haemoglobin levels of 11-12 g/dL were achieved and maintained at all timepoints assessed with epoetin-alpha but not with darbepoetin-alpha. Both groups had similar rates of packed red blood cell transfusions.


CONCLUSIONS
The DOSE Registry is a valuable source of data relating to anaemia management, practice patterns and outcomes in oncology patients from the perspective of actual clinical practice. Results from this registry should provide patients, clinicians and healthcare decision makers with a better understanding of the relationship between EST dosage and outcomes in the clinical setting.
Larholt
Kay
K
Abt Associates Clinical Trials, Lexington, Massachusetts 02421, USA. Kay_Larholt@abtassoc.com
Pashos
Chris L
CL
Wang
Qin
Q
Bookhart
Brahim
B
McKenzie
R Scott
RS
Piech
Catherine Tak
CT
D000368:Aged; D000740:Anemia / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D000068256:Darbepoetin alfa; D016208:Databases, Factual / Q000706:statistics & numerical data; D000068817:Epoetin Alfa; D017707:Erythrocyte Transfusion / Q000379:methods / Q000706:statistics & numerical data; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000627:therapeutic use; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D020407:Internet; D007501:Iron / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012042:Registries / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014481:United States
D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D000068817:Epoetin Alfa; D007501:Iron