Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: A retrospective real-life approach

Giordano, Giulio; Mondello, Patrizia; Tambaro, Rosa; Perrotta, Nicola; D’Amico, Fabio; D'Aveta, Antonietta; Berardi, Giuseppe; Carabellese, Bruno; Patriarca, Andrea; Corbi, Graziamaria; Marzio, L; Licianci, Antonietta; D, Berardi; Lullo, Liberato Di; Marco, Roberto Di

doi:10.3892/mco.2015.555

Cited by 21 publications

(15 citation statements)

References 25 publications

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“…An observational study by Giordano et al [39] on sucrosomial iron in patients with sideropenic anemia confirmed the reduction of the typical side effects of a conventional martial treatment, determining at the same time an improvement of the patient’s anemic condition in terms of serum iron, Hb, and ferritin [24, 25, 39]. Another study by Pisani et al [27] in patients with chronic kidney disease demonstrated the non-inferiority of the oral sucrosomial iron compared to IV iron therapy in terms of increase in Hb levels.…”

Section: Discussionmentioning

confidence: 99%

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

Mafodda

Giuffrida²,

Prestifilippo³

et al. 2017

Support Care Cancer

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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.

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Section: Discussionmentioning

confidence: 99%

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

Mafodda

Giuffrida²,

Prestifilippo³

et al. 2017

Support Care Cancer

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“…The only RCT in patients with cancer 30 had a high likelihood of bias based on inadequate sample size, lack of an intent-to-treat analysis, and industry funding and authorship. The quality of the four included cohort studies of biosimilars [31][32][33][34] in patients with cancer was not formally assessed.…”

Section: Resultsmentioning

confidence: 99%

“…The systematic review of biosimilar ESAs included two metaanalyses 27,28 and one RCT 29 in patients with CKD, and one RCT 30 and three cohort studies [31][32][33] in patients with cancer. In a 2017 meta-analysis of RCTs in CKD, Amato et al 27 reported that efficacy and safety outcomes did not differ significantly between patients treated with epoetin alfa originator or biosimilar but described the quality of evidence as low to very low.…”

Section: Recommendationmentioning

confidence: 99%

“…12 g/dL was 10.5 weeks (range, 3 to 16 weeks) among patients treated with the biosimilar and 12 weeks (range, 4 to 18 weeks) among patients treated with the originator product. 31 Finally, a retrospective study of 419 patients with cancer compared biosimilar epoetin alfa with darbepoetin alfa. 32 Mean HgB increase was similar in the two groups.…”

Section: Recommendationmentioning

confidence: 99%

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Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical Practice Guideline Update

Bohlius

Bohlke

Castelli

et al. 2019

JCO

107

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PURPOSE To update the American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. METHODS PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and meta-analyses of RCTs in patients with cancer published from January 31, 2010, through May 14, 2018. For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer due to limited RCT evidence in the cancer setting. ASCO and ASH convened an Expert Panel to review the evidence and revise previous recommendations as needed. RESULTS The primary literature review included 15 meta-analyses of RCTs and two RCTs. A growing body of evidence suggests that adding iron to treatment with an ESA may improve hematopoietic response and reduce the likelihood of RBC transfusion. The biosimilar literature review suggested that biosimilars of epoetin alfa have similar efficacy and safety to reference products, although evidence in cancer remains limited. RECOMMENDATIONS ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to < 10 g/dL. RBC transfusion is also an option. With the exception of selected patients with myelodysplastic syndromes, ESAs should not be offered to most patients with nonchemotherapy-associated anemia. During ESA treatment, hemoglobin may be increased to the lowest concentration needed to avoid transfusions. Iron replacement may be used to improve hemoglobin response and reduce RBC transfusions for patients receiving ESA with or without iron deficiency. Additional information is available at www.asco.org/supportive-care-guidelines and www.hematology.org/guidelines .

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“…In our recent studies we successfully used liposomal iron (Sideral ® Pharmanutra), a new generation iron (ferric phosphate) supplement containing phospholipids and sucrose esters of fatty acids assuring its high bioavailability and tolerability [81]. The efficacy of this drug in correcting iron deficiency attested by the restoration of physiological hemoglobin levels has been proven in human and animal studies [82,83]. We show that liposomal iron given orally to suckling piglets is a suitable feed additive for the reinforcement of iron status in piglets in the critical period from birth to weaning.…”

Section: Oral Supplementationmentioning

confidence: 99%

Iron Supplementation in Suckling Piglets: an Ostensibly Easy Therapy of Neonatal Iron Deficiency Anemia

Szudzik

Starzyński

Jończy

et al. 2018

Preprint

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In pigs, iron deficiency anemia (IDA) is the most prevalent deficiency disorder during the early postnatal period frequently developing into a critical illness. Meanwhile, in humans, only low-birth-weight infants, including premature infants are especially susceptible to developing IDA. In both human and pig neonates, the initial cause of IDA is low birth iron stores. In piglets this shortage of stored iron results mainly from genetic selection over the past few decades for large litter size and high birth weight. In consequence, pregnant sows cannot provide sufficient amount of iron to the increasing number of developing fetuses. Supplementation with iron is a common practice for the treatment of IDA in piglets. For decades, the preferred procedure for delivering iron supplements during early life stages has been through the intramuscular injection of large amount of iron dextran. However, this relatively simple therapy, which in general, efficiently corrects IDA, may generate toxic effects, and by inducing hepcidin expression, may decrease bioavailability of supplemental iron. New iron supplements are considered now with the aim to combine improvement of hematological status, blunting hepcidin expression, and minimizing toxicity of the administered iron. We propose that iron-deficient piglets constitute a convenient animal model for performing pre-clinical studies with iron supplements.

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Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: A retrospective real-life approach

Cited by 21 publications

References 25 publications

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

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

Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical Practice Guideline Update

Iron Supplementation in Suckling Piglets: an Ostensibly Easy Therapy of Neonatal Iron Deficiency Anemia

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