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:
-- A significantly greater proportion of chemotherapy-treated patients
received transfusions when ESA treatment was initiated at Hb levels
below 10 g/dL compared with patients having Hb levels of 10 to 11 g/dL
prior to ESA administration: 31% vs. 14%, respectively, p<0.0001.
-- Greater blood utilization was observed in those initiated on ESA
therapy at Hb levels less than 10 g/dL compared with Hb levels of 10 to
11 g/dL: 0.89 vs. 0.44 Units/study patient, respectively, p<0.0001.
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.
-- ESAs shortened overall survival and/or time-to-tumor progression in
clinical studies in patients with advanced breast, head and neck,
lymphoid, and non-small cell lung malignancies when dosed to target a
hemoglobin of greater than or equal to 12 g/dL.
-- The risks of shortened survival and tumor progression have not been
excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and
thrombovascular events, use the lowest dose needed to avoid red blood
-- Use only for treatment of anemia due to concomitant myelosuppressive
-- Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
PROCRIT is contraindicated in patients with uncontrolled hypertension
or with known hypersensitivity to albumin (human) or mammalian cell-derived
Additional Important Safety Information
-- The dose of PROCRIT should be titrated for each patient to achieve and
maintain the following hemoglobin levels:
-- Chronic renal failure patients -- hemoglobin levels between 10 to 12
g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL
despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and
ADMINISTRATION in the PROCRIT Prescribing Information.
-- Cancer or HIV patients -- the lowest hemoglobin level sufficient to
avoid transfusion and not to exceed 12 g/dL.
-- Monitor hemoglobin regularly during therapy, more frequently following
a dosage adjustment or until hemoglobin becomes stable.
-- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or
without other cytopenias, associated with neutralizing antibodies to
erythropoietin have been reported in patients with chronic renal
failure receiving PROCRIT by subcutaneous administration. If any
patient develops a sudden loss of response to PROCRIT, accompanied by
severe anemia and low reticulocyte count, and anti-erythropoietin
antibody-associated anemia is suspected, withhold PROCRIT and other
erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or
1-888-227-5624) to perform assays for binding and neutralizing
antibodies. If erythropoietin antibody-mediated anemia is confirmed,
PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT therapy have not been established in
patients with a known history of a seizure disorder or underlying
hematologic disease (e.g., sickle cell anemia, myelodysplastic
syndromes or hypercoagulable disorders).
-- In some female patients, menses have resumed following PROCRIT therapy;
the possibility of pregnancy should be discussed and the need for
-- Prior to and regularly during PROCRIT therapy monitor iron status;
transferrin saturation should be greater than or equal to 20% and
ferritin should be greater than or equal to 100 ng/mL. During therapy
absolute or functional iron deficiency may develop and all patients
will eventually require supplemental iron to adequately support
erythropoiesis stimulated by PROCRIT.
-- During PROCRIT therapy, blood pressure should be monitored carefully
and aggressively managed, particularly in patients with an underlying
history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever (pyrexia),
diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or
loss of strength or weakness (asthenia, fatigue), shortness of breath,
high blood pressure, headache, joint pain (arthralgias), abnormal skin
sensations (as tingling or tickling or itching or burning;
paresthesia), rash, constipation and upper respiratory infection.
Please visit http://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 http://www.orthobiotech.com.
|SOURCE Ortho Biotech Products, L.P.|
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