CHICAGO, May 30 /PRNewswire/ -- Data from three observational studies reported at the American Society of Clinical Oncology (ASCO) Annual Meeting evaluated transfusion-related outcomes in cancer chemotherapy patients with various hemoglobin (Hb) levels prior to or during administration of erythropoiesis-stimulating agents (ESAs).

Two analyses were conducted using observational data from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry. The first study (Larholt et al., abstract number 6637) reported that lower mean Hb levels achieved during ESA therapy were associated with increased transfusion requirements in cancer patients receiving chemotherapy. Another study of oncology patients who initiated ESA therapy at different baseline Hb levels (Burton et al., publication number 20637) concluded that blood utilization was greater when ESA therapy was initiated in patients who had baseline Hb of less than 10 grams per deciliter of blood (g/dL) compared with patients who received ESA therapy with a baseline Hb between 10 and 11 g/dL.

The third study (Gilmore, et al., abstract number 6548) examined hematologic outcomes in ESA-treated cancer chemotherapy patients with chemotherapy-induced anemia before and after implementation of the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for ESAs. The results found lower Hb values and higher transfusion rates in patients covered by Medicare following adoption of the NCD guidelines for reimbursement for ESA therapies.

"As ESA coverage policies have become more restrictive, these findings are important in helping stakeholders understand the potential impact on transfusion patterns. The data demonstrated that when patients achieved lower mean hemoglobin levels during ESA therapy for chemotherapy-induced anemia, the need for transfusions increased," said Kay Larholt, Sc.D., Vice President, Biometrics, at Abt Bio-Pharma Solutions, Inc., a biopharmaceutical research and consulting firm, and lead author of one of the analyses being presented.

About the Studies

In the Larholt et al. analysis, researchers reviewed observational data from an ongoing prospective registry of ESA-treated patients in 56 U.S. oncology clinics between December 2003 and April 2008, including data from hospital and community-based outpatient practices. Data were analyzed from 323 adult chemotherapy-treated oncology patients who had Hb concentrations less than 10 g/dL prior to ESA administration and received two or more ESA doses. Patients were categorized by mean achieved Hb levels (Hb 9.1 to 10 g/dL: n=117; Hb 10.1 to 11 g/dL: n=142; Hb 11.1 to 12 g/dL: n=64); the percent of patients transfused was 43%, 23% and 19% for each of the respective categories. The analysis suggested a difference (p < 0.01) in the percentage of patients transfused between levels of mean achieved Hb.

In the study conducted by Burton et al., data from 1,059 patients (ESA initiated Hb less than 10 g/dL: n=384, ESA initiated Hb 10 to 11 g/dL: n=675) from 59 sites included in the DOSE registry were analyzed. Researchers, who reviewed data from patients treated between December 2003 and November 2007, found that a greater proportion of patients received a transfusion when the baseline Hb was less than 10 g/dL (31%) than when the baseline Hb was between 10 and 11 g/dL (15%).

Gilmore et al. conducted a retrospective observational study of an electronic medical record database from a large oncology/hematology practice. They analyzed 401 Medicare cancer chemotherapy patients who had received two or more ESA doses. Study cohorts were defined based on the dates of ESA administration (pre-NCD cohort: January 1, 2007 through July 31, 2007; post- NCD cohort: August 1, 2007 through April 15, 2008). A total of 401 Medicare patients received ESAs for eight weeks (pre-NCD: n=243; post-NCD: n=158). The reported Hb levels were significantly higher in the pre-NCD cohort compared to the post-NCD cohort at each measured time point (mean Hb, g/dL, pre- vs. post- NCD: baseline, 10.7 vs. 9.7; four-week Hb, 11.0 vs. 10.2; eight-week Hb, 11.2 vs. 10.3). A greater proportion of patients required transfusion in the post- NCD cohort (pre-NCD 9.5 percent vs. post-NCD 18.4 percent).

Ortho Biotech Products, L.P. markets PROCRIT(R) (Epoetin alfa), an ESA.

About the DOSE Registry

The Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) Registry 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 across the United States.

About PROCRIT(R) (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(R) 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.

Note: Data in this release correspond to ASCO abstracts 6637 and 6548 and publication number 20637

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http://www.procrit.com/