Abstract

Background: Clinical trial evidence has demonstrated greater anemia-related fatigue at lower hemoglobin (Hb) levels in ESA-treated patients with chemotherapy-induced anemia (CIA). To understand these patient-reported outcomes (PROs), during ESA treatment in a real-world setting, data were analyzed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry, an ongoing, prospective, observational study.

Methods: Patients included for analysis were required to have a baseline Hb prior to ESA administration and at least two ESA administrations. PROs were measured using the Functional Assessment of Cancer Therapy: Fatigue subscale (FACT-F), a 13-question measure of anemia-associated fatigue with lower scores indicating greater fatigue in patients with CIA. Patients were to have completed up to three FACT-F questionnaires within seven days of a post-baseline Hb level. If multiple Hb values were identified, the Hb value closest to the FACT-F assessment was reported. The association between FACT-F scores and Hb levels was tested in a repeated-measures analysis. Mean FACT-F scores were calculated for specified Hb ranges.

Results: 740 CIA patients from 63 sites were identified between 12/03 and 7/08. 1088 concurrent FACT-F and Hb level assessments were available during ESA treatment. Mean FACT-F scores were lower when patients had lower Hb levels (table). The association between FACT-F scores and Hb levels showed a significant positive trend (p<.0001).

Hb≤ 8.0 g/dL8.01–9.0 g/dL9.01–10.0 g/dL10.01–11.0 g/dL11.01–12.0 g/dL
n (concurrent FACT-F and Hb assessments) 19 63 212 336 458 
Mean FACT-F score (SD) 21.26 (11.01) 22.95 (12.44) 25.64 (12.40) 26.84 (11.70) 29.34 (12.04) 
Hb≤ 8.0 g/dL8.01–9.0 g/dL9.01–10.0 g/dL10.01–11.0 g/dL11.01–12.0 g/dL
n (concurrent FACT-F and Hb assessments) 19 63 212 336 458 
Mean FACT-F score (SD) 21.26 (11.01) 22.95 (12.44) 25.64 (12.40) 26.84 (11.70) 29.34 (12.04) 

Conclusions: This analysis of FACT-F assessments in CIA patients suggests that lower Hb levels were associated with greater anemia-related fatigue. These findings are consistent with clinical trial evidence and provide observational PRO data to patients and providers regarding anemia-related fatigue during ESA treatment.

Disclosures: Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Hoaglin:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Apgar:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Bookhart:Centocor Ortho Biotech Services, LLC: Employment. Corral:Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.

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