title: Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks.
abstract: The objective of this ongoing trial is to study the ability of darbepoetin alfa to reverse chemotherapy-induced anemia in cancer patients, and to relate improvement in hemoglobin with changes in fatigue and functional capacity. Eligible subjects had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic, as defined by a screening hemoglobin < or = 11 g/dL. Darbepoetin alfa was administered at a starting dosage of 3 microg/kg every 2 weeks for up to eight doses (16 weeks) in an open-label, noncomparative setting. A total of 194 oncology practices contributed 1,173 subjects to this interim analysis. The mean increase in hemoglobin was 1.7 g/dL (95% CI: 1.6, 1.8) to last value on study (intent-to-treat analysis) and 2.1 g/dL (95% CI: 1.9, 2.2) for those patients receiving the full 16 weeks of therapy. The Kaplan-Meier estimate of the proportion of subjects with a hematopoietic response (increase in hemoglobin > or = 2 g/dL and/or hemoglobin value > or = 12 g/dL) was 84% (95% CI:81,86). Subjects in the lower baseline hemoglobin category (< 10 g/dL) tended to have a greater hemoglobin response during treatment. The Functional Assessment of Cancer Therapy-Fatigue (FACT-Fatigue) subscale score increased by a mean of 6.8 points (26%) during the study, and improvements in fatigue paralleled the increases observed in hemoglobin. Study treatment-related toxicity was minimal, with the most common event being injection-site pain, seen in 2% of subjects. Experience to date with an every-2-week regimen of darbepoetin alfa indicated efficacy comparable to historical experience with weekly and 3-times-weekly regimens of epoetin alfa in treating chemotherapy-induced anemia in cancer subjects.
authors.affiliation: Section of Cytokines and Targeted Therapies, Anderson Cancer Center, Houston, TX 77030, USA. svadhanraj@mail.mdanderson.org
authors.forename: Saroj
authors.initials: S
authors.lastname: Vadhan-Raj
authors.forename: Barry
authors.initials: B
authors.lastname: Mirtsching
authors.forename: Veena
authors.initials: V
authors.lastname: Charu
authors.forename: Dixon
authors.initials: D
authors.lastname: Terry
authors.forename: Gregory
authors.initials: G
authors.lastname: Rossi
authors.forename: Dianne
authors.initials: D
authors.lastname: Tomita
authors.forename: William P
authors.initials: WP
authors.lastname: McGuire
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000747:Anemia, Hypochromic / Q000139:chemically induced* / Q000188:drug therapy*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005221:Fatigue / Q000139:chemically induced* / Q000188:drug therapy*; D005260:Female; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D018434:Sickness Impact Profile; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa