A prospective efficacy & safety study of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia

Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide with 2.26 million [95% UI, 2.24–2.79 million] new cases in 2020. Anaemia in cancer patients is still a relevant problem and is the most common complication in them. Anaemia affects both general health and quality of life.  It has an incidence rate ranging from 22.7% to 63% and increasing to 89% following chemotherapy. It can be classified into two important forms: (1) anaemia occurring as an adverse event consequent to the toxic effect of anticancer treatment (chemotherapy-induced anaemiaâ€) and (2) anaemia occurring as a manifestation of the disease itself, more aptly called “cancer related anaemia,†resulting from systemic processes and immune system activation in cancer. Anaemia may be induced by the direct myelotoxic effect of the chemotherapeutic agents or indirectly by drug-induced renal damage resulting in low levels of erythropoietin (EPO). FCM is reported to be safe and effective in providing a rapid correction of serum ferritin levels and Hb in IDA patients. Despite the availability of several other iron formulations like LMW Iron dextran, Ferric gluconate, and Ferumoxytol, the use of FCM has improved the physical performance and quality of life in iron-deficient patients compared to other iron formulations FCM is reported to be with occurrence of less adverse events compared to other formulations. This study attempts to assess the safety and efficacy of IV FCM in increasing the Hb in IDA in Breast Cancer patients who are on follow-up and thereby decreasing eventual and inevitable blood transfusions. It will be a prospective, non-randomized, single-arm study in breast cancer patients with iron deficiency anaemia (IDA) who have completed chemotherapy and are in follow-up stage.