Efficacy and safety of oral lactoferrin supplementation in combination with rHuEPO-beta 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-beta, 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.

Figure 1.

Consort diagram. Abbreviation: rHuEPO, recombinant human erythropoietin.

Figure 2.

Hemoglobin (Hb) levels from baseline to the end of the study at week 12. Bars represent mean Hb levels. Hb changes (g/dl) from baseline were not significantly different between arms (*p calculated by Student’s t-test for independent data). Hb levels over time increased significantly in both treatment groups after 4, 8, and 12 weeks versus baseline (†p calculated by analysis of variance). Abbreviation: NS, not significant.

Figure 3.

Percentages of hemoglobin (Hb) responders in the two treatment arms. Responders were patients who achieved the target Hb level of ≥12 g/dl (Hb correction) or an increase in Hb of ≥2 g/dl (Hb response) without transfusion use at any time point during the study. The p-value was calculated using the χ² test.