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These analyses were conducted using data from the ongoing prospective,observational Dosing and Outcomes Study of Erythropoiesis-StimulatingTherapies (DOSE) Registry, sponsored by Centocor Ortho Biotech Services,L.L.C.
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"Observational data reflect real-world clinical practice and thereforethese findings are important in helping to understand transfusion patterns,"said Kay Larholt, Sc.D., Vice President, Biometrics at Abt Associates, abiopharmaceutical research and consulting firm, and lead author of bothanalyses presented today. "The analyses indicate that the presence of a lowerhemoglobin when ESA therapy was initiated was associated with a higher needfor transfusion, and suggest initiation at a hemoglobin between 10 to 11 g/dLmay reduce the need for transfusion."
Methodology and Results
For both analyses, real-world data on ESA-treated patients in 48 U.S.oncology clinics were analyzed from the DOSE Registry. Data were collectedfrom participating hospital- and community-based outpatient practices betweenDecember 2003 and July 2007.
In the first analysis of 969 patients, transfusion data were analyzed fromadult chemotherapy-treated oncology patients that received at least two ESAdoses. Results of the analysis were as follows:
In a second analysis of 314 patients who received transfusion, Hb valueswithin three days before transfusion were assessed and summarized. Theobserved Hb levels prior to transfusion ranged from 5.4 to 11 g/dL, including64 percent of transfusions in patients with Hb levels greater than or equal to8 g/dL. Nineteen percent of transfusions occurred at Hb levels greater thanor equal to 9 g/dL and four percent occurred at Hb > 10 g/dL.
About the DOSE Registry
DOSE is an ongoing, prospective, observational registry collecting data onreal-world practice patterns and outcomes in oncology patients treated witherythropoietic agents in U.S. community clinics and hospital centers. Theregistry provides outcomes data in oncology patients receiving chemotherapyfrom more than 80 sites that provide a national representation.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types ofcancer receiving chemotherapy, with chronic renal failure who are on dialysisand those who are not on dialysis, who are being treated with zidovudine forHIV infection, and to reduce the need for transfusion in anemic patients whoare scheduled for elective noncardiac, nonvascular surgery. Depending on thecountry in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR andTHROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and seriouscardiovascular events when administered erythropoiesis-stimulating agents(ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve andmaintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses inpatients not receiving prophylactic anticoagulation. Consider deep venousthrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncon
