Efficacy and Safety of Oral Lactoferrin Supplementation in Combination with rHuEPO-β for the Treatment of Anemia in Advanced Cancer Patients Undergoing Chemotherapy: Open-Label, Randomized Controlled Study

Abstract

Advanced-stage cancer patients often suffer from anemia that closely resembles the anemia of chronic inflammatory diseases characterized by specific changes in iron homeostasis and absorption. i.v. iron improves the efficacy of recombinant human erythropoietin (rHuEPO) in anemic cancer patients undergoing chemotherapy. We report the results of an open-label, randomized, prospective trial aimed at testing the efficacy and safety of treatment with oral lactoferrin versus i.v. iron, both combined with rHuEPO, for the treatment of anemia in a population of 148 advanced cancer patients undergoing chemotherapy. All patients received s.c. rHuEPO-␤, 30,000 UI once weekly for 12 weeks, and were randomly assigned to ferric gluconate (125 mg i.v. weekly) or lactoferrin (200 mg/day). Both arms showed a significant hemoglobin increase. No difference in the mean hemoglobin increase or the hematopoietic response, time to hematopoietic response, or mean change in serum iron, C-reactive protein, or erythrocyte sedimentation rate were observed between arms. In contrast, ferritin decreased in the lactoferrin arm whereas it increased in the i.v. iron arm. In conclusion, these results show similar efficacy for oral lactoferrin and for i.v. iron, combined with rHuEPO, for the treatment of anemia in advanced cancer patients undergoing chemotherapy. The Oncologist 2010;15:894 -902

Protective Effects of Human Lactoferrin during Aggregatibacter actinomycetemcomitans-Induced Bacteremia in Lactoferrin-Deficient Mice

“…It has been reported that hLF treatment can decrease the serum CRP levels in many systemic diseases (30). The present study documents the decrease of splenic and hepatic immune responses and iNOS and MPO expression.…”

The role of inflammation, iron, and nutritional status in cancer-related anemia: results of a large, prospective, observational study

“…The present findings suggest that a careful evaluation of cancer patients should be performed before starting treatment for anemia: in addition to including erythropoiesis-stimulating agents, the treatment of CRA should include the correction of nutritional deficiencies, personalized iron supplementation 42,43,51 and, in some cases, antioxidant treatment. 52 Moreover, our results suggest that patients with different cancer types and at various stages may have different factors influencing the pathogenesis and severity of anemia and, therefore, need specific individualized mechanism-based treatment of CRA.…”

“…iron. 43 Cancer growth and associated inflammation also induce changes in energy metabolism and food intake (canceranorexia), potentially contributing to anemia. These conditions lead to severely altered glycemia, albumin, and cholesterol levels, with consequent reduced circulating leptin levels.…”

A Comparative Study to Evaluate the Efficacy of Oral Lactoferrin Fortified Bovine Colostrum with Oral Iron in the Treatment of Iron Deficiency Anemia

“…This significant improvement is contrary to that observed in Maccio et al, (2010) study where cancer patients with anemia of chronic disease were administered lactoferrin along with erythropoietin. 24 Hence, the beneficial effect of lactoferrin, seen in cases of nutritional ID, does not extrapolate to anemia of chronic disease. Since there was no statistically significant difference in the iron parameters and Hb levels in post therapy compared to baseline, it can be quoted that there are no hematological benefits of combining OFS with OLFBC.…”