Oral sucrosomial iron versus intravenous iron in anemic cancer patients without iron deficiency receiving darbepoetin alfa: a pilot study

Abstract

PurposeErythropoiesis-stimulating agents (ESAs) are often used in treatment of patients with chemotherapy-induced anemia. Many studies have demonstrated an improved hemoglobin (Hb) response when ESA is combined with intravenous iron supplementation and a higher effectiveness of intravenous iron over traditional oral iron formulations. A new formulation of oral sucrosomial iron featuring an increased bioavailability compared to traditional oral formulations has recently become available and could provide a valid alternative to those by intravenous (IV) route. Our study evaluated the performance of sucrosomial iron versus intravenous iron in increasing hemoglobin in anemic cancer patients receiving chemotherapy and darbepoetin alfa, as well as safety, need of transfusion, and quality of life (QoL).Materials and methodsThe present study considered a cohort of 64 patients with chemotherapy-related anemia (Hb >8 g/dL <10 g/dL) and no absolute or functional iron deficiency, scheduled to receive chemotherapy and darbepoetin. All patients received darbepoetin alfa 500 mcg once every 3 weeks and were randomly assigned to receive 8 weeks of IV ferric gluconate 125 mg weekly or oral sucrosomial iron 30 mg daily. The primary endpoint was to demonstrate the performance of oral sucrosomial iron in improving Hb response, compared to intravenous iron. The Hb response was defined as the Hb increase ≥2 g/dL from baseline or the attainment Hb ≥ 12 g/dL.ResultsThere was no difference in the Hb response rate between the two treatment arms. Seventy one percent of patients treated with IV iron achieved an erythropoietic response, compared to 70% of patients treated with oral iron. By conventional criteria, this difference is considered to be not statistically significant. There were also no differences in the proportion of patients requiring red blood cell transfusions and changes in QoL. Sucrosomial oral iron was better tolerated.ConclusionIn cancer patients with chemotherapy-related anemia receiving darbepoetin alfa, sucrosomial oral iron provides similar increase in Hb levels and Hb response, with higher tolerability without the risks or side effects of IV iron.Electronic supplementary materialThe online version of this article (doi:10.1007/s00520-017-3690-z) contains supplementary material, which is available to authorized users.

Oral Sucrosomial® iron versus intravenous iron for recovering iron deficiency anaemia in ND-CKD patients: a cost- minimization analysis

“…Sucrosomial iron (Sideral® Forte), a preparation of ferric pyrophosphate conveyed within a phospholipid and sucrose esters of fatty acid membrane, is a new generation of oral iron, which shows a high intestinal absorption and high bioavailability with a low incidence of side effects, due to lack of any direct contact with intestinal mucosa [8][9][10]. In comparison with the other standard oral iron preparations, sucrosomial iron seems to be a promising new strategy of iron replacement in several kinds of patients [11][12][13], and in particular in ND-CKD patients [8].…”

High-dose intravenous versus oral iron in blood donors with iron deficiency: The IronWoMan randomized, controlled clinical trial

“…However, apart from high costs, the administration of an IV drug that takes time and could (rarely) provoke allergic reactions is currently not a realistic option in a high-volume blood donation center. Oral iron therapy is also effective, and new preparations like liposomal/sucrosomial iron [74,75] seem to have less adverse effects and better bioavailability.…”

Intravenous iron therapy in heart failure: a different perspective

“…For example, one of the most innovative preparations of oral iron is ‘sucrosomial’ iron, which is a preparation of ferric pyrophosphate, covered by phospholipids and a sucrose matrix. Preliminary studies suggest that the absorption of this formulation is through a different mechanism (possibly through endocytosis), is not affected by hepcidin, and that it can improve Hb concentration similar to IV formulations without any gastrointestinal side effects . Additionally, ferric citrate has emerged as another effective oral formulation of iron.…”