PWE-290 An open-label, randomised controlled trial comparing the efficacy of intravenous and oral iron in the preoperative management of colorectal cancer anaemia: ivica trial

Abstract

<h3>Introduction</h3> Perioperative allogeneic red blood transfusions (ARBT) are associated with impaired short and long term outcomes.¹Consequently, perioperative ARBT should be avoided, yet preoperative anaemia increases this need. The study aimed to compare the efficacy of preoperative intravenous (IVI) and oral iron (OI) in reducing ARBT use in anaemic patients undergoing colorectal cancer (CRC) surgery. <h3>Method</h3> 116 anaemic patients with non-metastatic CRC adenocarcinoma were recruited preoperatively and randomised to receive either OI (ferrous sulphate) or IVI (ferric carboxymaltose). Perioperative changes in Haemoglobin (HB) and ARBT were recorded across groups. Parametric data was compared with 2 tailed T-test and non-parametric data with Wilcoxon Rank test, and Mann-Whitney U test. Nominal data was compared with 2 tailed Chi squared test. <h3>Results</h3> There was no difference in demographic data between groups. HB levels at recruitment were comparable (OI 10.4g/dL 95% CI 10.1–10.7; IVI 10.2g/dL 95% CI 9.8–10.5;<i>P = 0</i>.24), as was median treatment duration (OI 21days IQR15–33; IVI 21days IQR15–34;<i>P = 0</i>.75). However, HB was higher on day of Surgery with IVI (11.9g/dL 95% CI 11.5–12.3 vs OI 11g/dL 95% CI 10.6–11.4;<i>P &lt; 0</i>.01). Median preoperative HB change in patients not transfused preoperatively was higher with IVI (1.5g/dL IQR0.9–2.6 vs. OI 0.5g/dL IQR-0.1–1.3;<i>P &lt; 0</i>.01). There were fewer anaemic patients at surgery in the IVI group after treatment (75% vs. 90%<i>; P &lt; 0</i>.05). OI patients received a mean 0.63u (95% CI 0.26–1) from recruitment to day 28 postoperatively vs. mean 0.47u (95% CI 0.1–0.84) for IVI. Neither number of patients transfused (<i>P = 0</i>.33) nor mean units transfused (<i>P = 0</i>.54) differed over this period. When patients with heavy intraoperative losses (&gt;1.5L) were excluded, a significant difference in mean units of blood transfused was seen up to 7 days post operatively (<i>n = 1</i>08; OI 0.6u 95% CI 0.23–0.96; IVI 0.16u 95% CI 0.01–0.3<i>; P &lt; 0</i>.05) and significantly less IVI patients were transfused (10% vs. 25%;<i>P &lt; 0</i>.05). <h3>Conclusion</h3> In patients undergoing CRC surgery, IVI appears more efficacious than OI at treating preoperative anaemia. It does not appear to minimise overall ARBT requirement, but may reduce ARBT use in the immediate perioperative period when the implications of ARBT are probably at their greatest.² <h3>Disclosure of interest</h3> B. Keeler: None Declared, J. Simpson: None Declared, O. Ng: None Declared, H. Padmanabhan: None Declared, M. Brookes Grant/ Research Support from: MB’s research department has received grant support from Syner-Med, UK, and Vifor Pharma, Switzerland, Speaker Bureau of: He has received honoraria or travel support for consulting or lecturing from the following companies: Vifor Pharma Ltd, Glattbrugg, Switzerland; Merck Sharp and Dohme Limited, UK. MB is also an advisory board member to Vifor International and to Sanofi UK, A. Acheson Grant/ Research Support from: AA’s research department has received grant support from Syner-Med, UK, Vifor Pharma, Switzerland, and Pharmacosmos A/S, Denmark, Consultant for: He is an advisory board member for Pharmacosmos A/S, Denmark., Conflict with: received honoraria or travel support for consulting or lecturing from the following companies: Ethicon Endosurgery, Johnson and Johnson Ltd, UK; Olympus, Essex, UK; and Vifor Pharma Ltd, Glattbrugg, Switzerland. <h3>References</h3> Acheson AG; Brookes MJ; Spahn DR. Effects of allogeneic red blood cell transfusions on clinical outcomes in patients undergoing colorectal cancer surgery:a systematic review and meta-analysis. Ann Surg. 2012;256(2):235–44 Nielsen HJ. Detrimental effects of perioperative blood transfusion. BJS 1995;82(5):582–7