Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011
Phase III, randomized study of the effects of parenteral iron, oral iron, or no iron supplementation on the erythropoietic response to darbepoetin alfa for patients with chemotherapy-associated anemia.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 8 syntheses or guidelines pooled it, 121 citations in OpenAlex.
- Intravenous Iron Therapy to Treat Anemia in Oncology: A Mapping Review of Randomized Controlled Trials.Current oncology (Toronto, Ont.) · 2023Pooled it
- Intravenous iron versus oral iron versus no iron with or without erythropoiesis- stimulating agents (ESA) for cancer patients with anaemia: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2022Pooled it
- Risk of Infection Associated With Administration of Intravenous Iron: A Systematic Review and Meta-analysis.JAMA network open · 2021Pooled it
- The role of iron in the management of chemotherapy-induced anemia in cancer patients receiving erythropoiesis-stimulating agents.The Cochrane database of systematic reviews · 2016Pooled it
- Iron therapy in anaemic adults without chronic kidney disease.The Cochrane database of systematic reviews · 2014Pooled it
- Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials.BMJ (Clinical research ed.) · 2013Pooled it
- Erythropoietin or darbepoetin for patients with cancer.The Cochrane database of systematic reviews · 2012Pooled it
- Addition of iron to erythropoiesis-stimulating agents in cancer patients: a meta-analysis of randomized trials.Journal of cancer research and clinical oncology · 2012Pooled it
- Randomized trial of sucrosomial iron supplementation in patients with chemotherapy-related anemia treated with ESA.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Trial
- Trial
- Anemia of Chronic Disease: Pathophysiology, Diagnosis and Management.Hematology reports · 2026Review
- A prospective study of intravenous iron effectiveness on quality of life and functional outcomes in patients with cancer.Scientific reports · 2026Observational
- Efficacy and safety of preoperative intravenous iron versus standard care in colorectal cancer patients with iron deficiency anemia: a systematic review and meta-analysis.Annals of medicine and surgery (2012) · 2024Article
- Functional iron deficiency anemia in patients with cancer.Blood research · 2024Review
- The frequency of medical reversals in a cross-sectional analysis of high-impact oncology journals, 2009-2018.BMC cancer · 2021Article
- Cancer Related Anemia: An Integrated Multitarget Approach and Lifestyle Interventions.Nutrients · 2021Review
- Experimental Drugs for Chemotherapy- and Cancer-Related Anemia.Journal of experimental pharmacology · 2021Review
- Iron Supplementation Interferes With Immune Therapy of Murine Mammary Carcinoma by Inhibiting Anti-Tumor T Cell Function.Frontiers in oncology · 2020Article
- Hospital cost associated with anemia in elective colorectal surgery: a historical cohort study.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2019Article
- Pathogenesis and Treatment Options of Cancer Related Anemia: Perspective for a Targeted Mechanism-Based Approach.Frontiers in physiology · 2018Review
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
purposeFunctional iron deficiency may impair response to erythropoiesis-stimulating agents (ESAs) in iron-replete patients with chemotherapy-associated anemia (CAA). This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA. PATIENTS AND
methodsThis prospective, multicenter, randomized trial enrolled 502 patients with hemoglobin (Hb) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies. All patients received darbepoetin alfa once every 3 weeks and were randomly assigned to receive either ferric gluconate 187.5 mg intravenously (IV) every 3 weeks, oral daily ferrous sulfate 325 mg, or oral placebo for 16 weeks.
resultsThere was no difference in the erythropoietic response rate (ie, proportion of patients achieving Hb ≥ 12 g/dL or Hb increase ≥ 2 g/dL from baseline): 69.5% (95% CI, 61.9% to 76.5%) of IV iron-treated patients achieved an erythropoietic response compared with 66.9% (95% CI, 59.1% to 74.0%) who received oral iron and 65.0% (95% CI, 57.2% to 72.3%) who received oral placebo (P = .75). There were also no differences in the proportion of patients requiring red cell transfusions, changes in quality of life, or the dose of darbepoetin administered. Adverse events (AEs) tended to be more common in the IV iron arm: grade 3 or higher AEs occurred in 54% (95% CI, 46% to 61%) of patients receiving IV iron compared with 44% (95% CI, 36% to 52%) who received oral iron and 46% (95% CI, 38% to 54%) who received oral placebo (P = .16).
conclusionIn patients with CAA, addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.