RESUMO
BACKGROUND: Anemia is common with esophagogastric adenocarcinoma, increasing mortality, blood transfusions, and reducing quality of life (QOL). No clear evidence exists for safe and effective treatment. METHODS: Anemic patients (Hb <12 g/dl women, <13 g/dl men) with esophagogastric adenocarcinoma were recruited before initiation of palliative chemotherapy. Patients were randomized to standard care or single dose of intravenous iron isomaltoside (IVI) before chemotherapy. Post-chemotherapy changes in hemoglobin (Hb), ferritin, transferrin saturations (TSAT), blood transfusions, and QOL were recorded for three cycles of chemotherapy. RESULTS: Twenty-seven patients were randomized to standard care (n = 13) or IVI (n = 14). No significant change in Hb was seen (standard care MD -0.6 g/dl 95% CI -0.1-1.1 g/dl, P = 0.336; IVI MD +0.5 g/dl 95% CI -0.1-1.1 g/dl, P = 0.903). An increase in ferritin was seen with IVI after cycle one of chemotherapy (standard care 116 ng/ml; IVI 770 ng/ml, P < 0.05). No difference in blood transfusions was seen between groups (P = 0.851). IVI improved QOL with physical well-being, emotional well-being, anemia-specific QOL, trial outcome index, and total scores all exceeding minimum clinically important difference. No improvement was seen with standard care. CONCLUSIONS: This feasibility study suggests IVI improves quality of life and ferritin. Larger adequately powered studies are required to definitively conclude if hemoglobin and blood transfusion changes with IVI.
