Feasibility of Intravenous Iron Isomaltoside to Improve Anemia and Quality of Life During Palliative Chemotherapy for Esophagogastric Adenocarcinoma

Abstract

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.

Acknowledgments

We would like to thank Peter Fardouly, the Biomedical Research Unit Nottingham and the Clinical Trials nurses of Royal Wolverhampton Hospital for their contributions to the trial.

Disclosure Statement

The authors declare that they have no conflicts of interest.

Additional information

Funding

AA’s research department has received grant support from Syner-Med, UK and Vifor Pharma, Switzerland. AA has received honoraria or travel support for consulting/lecturing/advisory board attendance from the following companies: Ethicon Endosurgery, Johnson and Johnson Ltd, UK, Olympus, Essex, UK. Vifor Pharma Ltd, Glattbrugg, Switzerland and Pharmacosmos, Denmark. None of the above companies have had any input or influence on the delivery or write up of this study.