WASHINGTON, Feb. 1 /PRNewswire/ -- Two new analyses of observational data presented at today’s Community Oncology Conference reported a significantly lower proportion of patients receiving transfusions when erythropoiesis- stimulating agents (ESAs) treatment was initiated at hemoglobin (Hb) levels between 10 to 11 grams per deciliter (g/dL) of blood compared with patients having Hb levels less than 10 g/dL prior to ESA treatment. In addition, wide variability in hemoglobin levels prior to transfusion was reported.
These analyses were conducted using data from the ongoing prospective, observational Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry, sponsored by Centocor Ortho Biotech Services, L.L.C.
“Observational data reflect real-world clinical practice and therefore these findings are important in helping to understand transfusion patterns,” said Kay Larholt, Sc.D., Vice President, Biometrics at Abt Associates, a biopharmaceutical research and consulting firm, and lead author of both analyses presented today. “The analyses indicate that the presence of a lower hemoglobin when ESA therapy was initiated was associated with a higher need for transfusion, and suggest initiation at a hemoglobin between 10 to 11 g/dL may 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 collected from participating hospital- and community-based outpatient practices between December 2003 and July 2007.
In the first analysis of 969 patients, transfusion data were analyzed from adult chemotherapy-treated oncology patients that received at least two ESA doses. Results of the analysis were as follows:
In a second analysis of 314 patients who received transfusion, Hb values within three days before transfusion were assessed and summarized. The observed Hb levels prior to transfusion ranged from 5.4 to 11 g/dL, including 64 percent of transfusions in patients with Hb levels greater than or equal to 8 g/dL. Nineteen percent of transfusions occurred at Hb levels greater than or 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 on real-world practice patterns and outcomes in oncology patients treated with erythropoietic agents in U.S. community clinics and hospital centers. The registry provides outcomes data in oncology patients receiving chemotherapy from 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 of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients’ health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Stephanie Fagan, office, +1-908-541-4029, or cell,
+1-201-572-9581, sfagan@obius.jnj.com
Web site: http://www.orthobiotech.com/
http://www.procrit.com/
