The Effectiveness of Ferric Carboxymaltose on the Improvement of Chronic Iron Deficiency Anemia in Patients With Colon Cancer: A Controlled Randomized Clinical Trial

Background Anemia is prevalent in 32% to 60% of patients with cancer due to an underlying disease, nutritional deficiencies and complications of medication used in chemotherapy. National Comprehensive Cancer Network (NCCN) recommends the use of oral or intravenous iron supplementation in patients with iron deficiency anemia. Objectives The current study aimed to determine the effectiveness of ferric carboxymaltose to improve the chronic iron deficiency anemia in patients with stage III/IV colon cancer compared with that of oral iron therapy. Methods The study was a controlled randomized clinical trial performed on patients with stage III/IV colon cancer referred to the Rasoul-Akram hospital in Tehran, Iran, in 2015. Hemoglobin levels less than 13 g/dL in males and less than 12 g/dL in females, ferritin levels less than 30 μg/L, serum iron levels less than 50 μg/dL and total iron binding capacity (TIBC) levels less than 360 μg/dL are considered as chronic iron deficiency anemia. Patients with stage III/IV colon cancer and chronic iron deficiency anemia were enrolled. Non-compliance with the treatment regimen, intolerable side effects and lack of follow-up were the measures of exclusion from the study. Patients were selected based on the block balanced randomization and divided into two groups. The first group received the standard treatment of oral ferrous sulfate (65 mg three times a day for two months), and the second group received injection vials of ferric carboxymaltose (1500 mg for patients weighing less than 70 kg, 2000 mg for more than 70 kg). Results Ten patients (five in the first group and five in the second group) were excluded due to lack of follow-up tests. In each group, 30 patients were considered in the final analysis. Analysis showed that patients who received ferric carboxymaltose had higher levels of hemoglobin and ferritin compared to patients who received ferrous sulfate (P = 0.000). The results showed that increased levels of hemoglobin in iron sulfate had no significant differences regarding gender (male or female) and the stage of the disease; although in the carboxymaltose group, improved levels of hemoglobin were significantly better in females than males (P = 0.034). Also, the level of ferritin in iron sulfate group showed a better increase in females compared to males (P = 0.007). Conclusions Findings of the study showed that using the parenteral iron formulation of carboxymaltose had an excellent efficacy in improving iron deficiency anemia in patients with high rates of colon cancer compared with that of oral ferrous sulfate. This effect is mostly related to the proper formulation of ferric carboxymaltose, which results in a stable and continuous increase in the levels of ferritin and hemoglobin in patients.