title: 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.
authors.affiliation: Department of Obstetrics and Gynecology, "Sirai" Hospital, 09013 Carbonia, Italy. a.maccio@tin.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Macciò
authors.forename: Clelia
authors.initials: C
authors.lastname: Madeddu
authors.forename: Giulia
authors.initials: G
authors.lastname: Gramignano
authors.forename: Carlo
authors.initials: C
authors.lastname: Mulas
authors.forename: Eleonora
authors.initials: E
authors.lastname: Sanna
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mantovani
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000740:Anemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D004921:Erythropoietin / Q000097:blood / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage*; D008297:Male; D009369:Neoplasms / Q000097:blood* / Q000188:drug therapy; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D007781:Lactoferrin; C035552:ferric gluconate