Objective: Anemia results in fatigue and impairment in health-related quality of life (HRQoL). For patients with metastatic cancer, it is critical that clinicians not only prolong life, but also maintain optimal quality of life through the most favorable control of symptoms resulting from treatment or cancer. Information for clinicians and patients regarding symptom control in the palliative care setting is sparse but valuable. Epo corrects cancer-related anemia and, thereby, improves quality-of-life. The evaluation of the impact of erythropoietin on hemoglobin and mood state in 100 MBC mildly anemic women (Hgb< 12.0gm/dl) was attempted. Design: Randomized, controlled, open label and intent to treat design. After informed consent was obtained, subjects were randomized to group using sequential, opaque, sealed envelopes with the order unknown to the investigators. Population: Women ages 18 and older with metastatic breast cancer. Setting: Outpatient clinics at the University of Pittsburgh Cancer Institute. Methods: Subjects randomized to usual care (n=13) received transfusions as necessary and education regarding non-pharmacological interventions for fatigue (sleep hygiene, energy maximization techniques and physical activity). Those randomized to drug treatment (n=14) received usual care + erythropoietin at 40,000 units sq once a week. Erythropoietin was clinic or home administered, if desired, after injection teaching. Epo was begun at 40,000U SQ qw. At 4 weeks, dose was increased to 60,000U SQ qw without a >1.0 gm/dl Hgb increase and discontinued at 8 weeks if hemoglobin improvement was< 1.0 gm/dl. Both groups completed the Profile of Mood States (POMS) at 0, 4 and 8 weeks. Findings: Repeated measures analysis of variance (ANOVA) was used to compare differences between groups (erythropoietin, usual care) over time (baseline, 4, 8 weeks) for hemoglobin, POMS total score and the fatigue subscale. The fourth time point (12 weeks) was eliminated from analysis due to missing data resulting from early termination of the study. As initially projected, with effect size at 0.60, significance set at 0.05, the proposed sample size was 50 subjects per group. The study was terminated early (n=27, G1=13, G2=14) when 4/14 (28.5%) subjects in G2 developed thrombotic events (n=1DVT, n=1DVT + PE, n=1 DVT + PE 1 month after epo discontinuation, n=1 brachial vein thrombosis with infected Mediport). In all 4 patients, Hgb levels were normal at the time of the event. No patient in G1 developed a thrombotic event. There were no significant differences in demographic characteristics or current chemotherapy regimen in G1 vs. G2 although 2 patients in G1 (15.3%) and 1 patient in G2 (7.1%) received concomitant coumadin. No differences between G1 and G2 were seen in hemoglobin level or mood states. The historic incidence (January, 99 – June 01) of thrombotic events in the University of Pittsburgh Cancer Institute metstatic breast cancer population was 5.5% (10/181). Conclusions: The increased incidence of thrombotic events in the epo (G2) arm exceeds that in prior MBC studies and prior epo trials. This may relate to the administration of epo in this high-risk population, but the small sample size precludes definitive conclusions. Implications: Further study is needed to determine the etiology of thrombotic events within this population. Further study is needed to determine the optimal treatment method for mild anemia in a metastatic breast cancer population.
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