title: Clinical benefits of once-weekly epoetin alfa in anemic patients with colorectal cancer receiving chemotherapy.
abstract: 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.
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut 06520, USA. chueyale@yahoo.com
authors.forename: Edward
authors.initials: E
authors.lastname: Chu
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Einhorn
authors.forename: Patrick
authors.initials: P
authors.lastname: Lefebvre
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000740:Anemia / Q000139:chemically induced / Q000150:complications / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005221:Fatigue / Q000209:etiology; D006454:Hemoglobins / Q000032:analysis / Q000187:drug effects; D006801:Humans; D011788:Quality of Life; D011994:Recombinant Proteins; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; C020622:hemoglobin B