In a large, 16-week, prospective study of 2,964 anemic patients with various
cancers undergoing
chemotherapy, once-weekly subcutaneous administration of 40,000 U of
epoetin alfa,with potential escalation to 60,000 U, increased
hemoglobin (Hgb) levels, decreased transfusion requirements, and improved quality of life (QOL) as assessed using the Linear Analog Scale Assessment (
LASA) for energy, activity, and overall QOL and the Functional Assessment in
Cancer Therapy-
Anemia (FACT-An) QOL instrument. A retrospective subset analysis conducted in 244
colorectal cancer patients enrolled in the study showed statistically significant improvements from baseline to final readings in
LASA energy, activity, and overall QOL and FACT-An
Anemia Symptoms and
Fatigue subscale scores (P < 0.02). Moreover, patients who achieved larger improvements in Hgb levels also demonstrated greater percentage improvements in QOL over baseline measurements. Mean Hgb levels increased by 1.2 g/dL after 4 weeks of treatment and by 1.6 g/dL by study end, independent of
red blood cell transfusion within 28 days prior to the Hgb assessment. Hematopoietic response (Hgb level > or = 12 g/dL and/or increase in Hgb level > or = 2 g/dL, independent of transfusion) was observed in 61% of patients (139/229). Additionally, the proportion of patients receiving transfusions decreased from 17% at baseline to 4% during the final month of
therapy.
Epoetin alfa was well tolerated, with no evidence of unexpected adverse events. Except for significantly higher QOL scores at baseline, results for the cohort of
colorectal cancer patients were similar to those for patients with other
cancer types in the main study population.