Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial

Talboom, Kevin; Borstlap, Wernard A. A.; Roodbeen, Sapho X; Bruns, Emma R J; Buskens, Christianne J.; Hompes, Roel; Tytgat, Kristien M. A. J.; Tuynman, Jurriaan B.; Consten, Esther C. J.; Heuff, Gijsbert; Kuiper, Teaco; Geloven, A. A. W. van; Veldhuis, G.J.; Hoeven, Joost A. B. van der; Gerhards, Michael F.; Sietses, C.; Spinelli, Antonino; Ven, Anthony W. H. van de; Zaag, Edwin S. van der; Westerterp, Marinke; Westreenen, Henderik L. van; Dijkgraaf, Marcel L; Juffermans, Nicole P.; Bemelman, W. A.; Zweeden, Annette A. van; Hess, Daniël A.; Swank, Hilko A; Scholten, Lisette; Bilt, Jarmila D. W. van der; Jansen, Marilou A; Duijvendijk, Peter van; Bezuur, Donna; Carvello, Michele; Foppa, Caterina; Cappel, Wouter H. de Vos tot Nederveen; Geitenbeek, Ritch T J; Woensel, Lara van; Castro, S. M. M. de; Wientjes, Caroline; Oostendorp, S. E. van

doi:10.1016/s2352-3026(22)00402-1

Cited by 26 publications

(20 citation statements)

References 24 publications

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“…The primary endpoint of the study was determined as the rate of patients whose hemoglobin level was normalized. While no difference was observed between the groups on the second week, the response rate was reported to be 60% in the intravenous arm and 21% in the oral treatment arm on day 30 [25]. The underlying reason for the worse response rate in this study compared to our analysis may be that the patients underwent colon surgery during the study period.…”

Section: Discussioncontrasting

confidence: 68%

Seven-Year Single-Center Experience of the Efficacy and Safety of Ferric Carboxymaltose in Cancer Patients with Iron-Deficiency Anemia

Aktaş,

Ata,

Çeşmeci

et al. 2023

Current Oncology

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Anemia remains an essential concern affecting the quality of life and the survival of cancer patients. Although there are different approaches to treating anemia in cancer patients, the number of studies reporting the efficacy of iron replacement in cancer patients is limited. In this study, the efficacy and safety of iron carboxymaltose, a parenteral iron treatment option, in the treatment of anemia, were examined retrospectively. A total of 1102 adult patients who received IV ferric carboxymaltose treatment at Hacettepe Oncology Hospital between 2014 and 2020 were included. The mean hemoglobin change observed at the end of the 12th week was 1.8 g/dL, and the rate of patients with an increase in hemoglobin of 1 g/dL or more was 72.1%. It was observed that the treatment demonstrated effectiveness in patients receiving active cancer treatment in all tumor types. The treatment was generally safe, and no grade 3–5 side effects were observed in the patients included in the study. According to one of the most extensive series published in the literature, iron carboxymaltose is an efficient and safe alternative for cancer patients with iron-deficiency anemia.

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Section: Discussioncontrasting

confidence: 68%

Seven-Year Single-Center Experience of the Efficacy and Safety of Ferric Carboxymaltose in Cancer Patients with Iron-Deficiency Anemia

Aktaş,

Ata,

Çeşmeci

et al. 2023

Current Oncology

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“…All studies included a comparator arm, except for Bojesen et al [ 28 ], Lima et al [ 29 ] and, Verhaeghe et al [ 30 ] where all patients received IV iron. Of the RCTs, Keeler et al [ 31 ], Keeler et al [ 32 ], and Talboom et al [ 33 ] compared ferric carboxymaltose (FCM) to oral iron, while Laso-Morales et al [ 34 ] compared FCM to iron sucrose (IS), and Ng et al [ 35 ] compared iron isomaltoside to standard of care. The comparator arms in 11 studies [ 36 – 46 ] were patients who received no specific treatment or oral iron.…”

Section: Resultsmentioning

confidence: 99%

Intravenous iron and iron deficiency anemia in patients with gastrointestinal cancer: A systematic review

Nandakumar,

Singh,

Tharani

et al. 2024

PLoS ONE

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Background Iron deficiency anemia (IDA) is a prevalent hematological complication associated with gastrointestinal (GI) cancers due to an increased loss of iron and decreased iron absorption. The purpose of this systematic review is to evaluate the use of parenteral iron to treat IDA in patients with GI cancer. Methods PubMed, Cochrane, EMBASE, CINHAL and Scopus were searched from January 1, 2010 to September 29, 2023 with no language restrictions. We excluded editorials, case reports, abstracts, conference papers, and poster presentations. Studies were included if they discussed IDA, GI neoplasms, use of iron supplementation (with or without erythropoietin-stimulating agents [ESAs]), defined anemia and had an adult patient population. We assessed the efficacy of parenteral iron in comparison to other iron supplementation methods when treating IDA in patients with GI cancer. The Cochrane Risk of Bias Tool 2 (RoB 2) and the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) assessment tools were used to assess the quality of the included studies. Moreover, the Cochrane Effective Practice and Organization data collection form was used to collect pertinent study information. Results Our search yielded 3,969 studies across all databases. Twenty-one studies were included (6 randomized control trials; 15 non-randomized studies). Of the 15 studies evaluating hemoglobin (Hb) response, seven studies found an increase in Hb levels when patients were treated with IV iron. The 14 studies evaluating red blood cell (RBC) transfusion rates found conflicting differences in RBC transfusion needs when treated with IV iron. Studies analyzing health related outcomes typically found an increase in quality of life and decreased post-operative complications. Discussion This review demonstrates improved outcomes of IDA in patients with GI cancer treated with IV iron instead of other iron supplementation methods. Timely diagnosis and appropriate IDA management can greatly improve quality of life in this patient population, especially if myelosuppressive chemotherapy is required.

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“…Also, Berkel et al found that a lower preoperative haemoglobin level was a risk for the development of complications (20). Furthermore, the FIT trial found that with the treatment of intravenous iron de ciency a signi cant improvement was seen in the preoperative haemoglobin level (23). Subsequently, the optimization of anaemia with intravenous iron was added to the proposed uniform protocols.…”

Section: Discussionmentioning

confidence: 99%

Multimodal prehabilitation for colorectal cancer patients: study protocol of a nationwide multicentre study with uniform prehabilitation protocols

Sabajo,

Dieleman,

Dekker

et al. 2024

Preprint

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Background The aim of prehabilitation is to optimize patient specific modifiable risk factors before major surgery, in order to enhance the individual resilience. In recent years, a considerable amount of research has been done on the effectiveness of prehabilitation. Due to the lack of universal guidelines, prehabilitation has been conducted in various ways, making it difficult to estimate its effect. In the Netherlands, proposed uniform prehabilitation protocols were developed. The aim of this study is to analyse clinical outcomes of prehabilitation when implemented as standard of care according to the proposed uniform protocols. Methods Uniform prehabilitation protocols were created based on the multimodal program of the PREHAB randomized controlled trial. All hospitals in the Netherlands that implemented prehabilitation according to the proposed protocols, for patients undergoing elective colorectal surgery, will be asked to participate. This study will recruit 535 patients who underwent prehabilitation and 535 one-to-one nearest neighbour propensity score matched patients who did not undergo prehabilitation (historical cohort). Clinical outcomes will be compared between the prehabilitation group and the historical cohort group using regression analyses. The primary outcome of interest is 90-day presence of postoperative complications. In addition, length of hospital stay and readmissions will be analysed. Discussion Prehabilitation has been proven to reduce the risk of complications and hospital length of stay. Prehabilitation has however been defined in various ways, since there is no standardized program. This multicentre cohort study will estimate the clinical effect of prehabilitation implemented as standard of care according to proposed uniform protocols. Furthermore, the presented protocols can be used by other hospitals to set up a prehabilitation program.

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Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial

Cited by 26 publications

References 24 publications

Seven-Year Single-Center Experience of the Efficacy and Safety of Ferric Carboxymaltose in Cancer Patients with Iron-Deficiency Anemia

Seven-Year Single-Center Experience of the Efficacy and Safety of Ferric Carboxymaltose in Cancer Patients with Iron-Deficiency Anemia

Intravenous iron and iron deficiency anemia in patients with gastrointestinal cancer: A systematic review

Multimodal prehabilitation for colorectal cancer patients: study protocol of a nationwide multicentre study with uniform prehabilitation protocols

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