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Observational Studies Assess the Potential Impact of Limiting Erythropoiesis-Stimulating Agent Availability on Frequency of Blood Transfusions

Saturday, May 31, 2008 General News J E 4
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CHICAGO, May 30 Data from three observational studiesreported at the American Society of Clinical Oncology (ASCO) Annual Meetingevaluated transfusion-related outcomes in cancer chemotherapy patients withvarious hemoglobin (Hb) levels prior to or during administration oferythropoiesis-stimulating agents (ESAs).

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

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

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

About the Studies

In the Larholt et al. analysis, researchers reviewed observational datafrom an ongoing prospective registry of ESA-treated patients in 56 U.S.oncology clinics between December 2003 and April 2008, including data fromhospital and community-based outpatient practices. Data were analyzed from323 adult chemotherapy-treated oncology patients who had Hb concentrationsless than 10 g/dL prior to ESA administration and received two or more ESAdoses. Patients were categorized by mean achieved Hb levels (Hb 9.1 to 10g/dL: n=117; Hb 10.1 to 11 g/dL: n=142; Hb 11.1 to 12 g/dL: n=64); the percentof patients transfused was 43%, 23% and 19% for each of the respectivecategories. The analysis suggested a difference (p < 0.01) in the percentageof patients transfused between levels of mean achieved Hb.

In the study conducted by Burton et al., data from 1,059 patients (ESAinitiated 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, whoreviewed data from patients treated between December 2003 and November 2007,found that a greater proportion of patients received a transfusion when thebaseline Hb was less than 10 g/dL (31%) than when the baseline Hb was between10 and 11 g/dL (15%).

Gilmore et al. conducted a retrospective observational study of anelectronic medical record database from a large oncology/hematology practice.They analyzed 401 Medicare cancer chemotherapy patients who had received twoor more ESA doses. Study cohorts were defined based on the dates of ESAadministration (pre-NCD cohort: January 1, 2007 through July 31, 2007; post-NCD cohort: August 1, 2007 through April 15, 2008). A total of 401 Medicarepatients received ESAs for eight weeks (pre-NCD: n=243; post-NCD: n=158). Thereported Hb levels were significant
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