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Protocol
Ferric derisomaltose and Outcomes in the Recovery of Gynecologic oncology: ERAS (Enhanced Recovery After Surgery) (FORGE) – a protocol for a pilot randomised double-blinded parallel-group placebo-controlled study of the feasibility and efficacy of intravenous ferric derisomaltose to correct preoperative iron-deficiency anaemia in patients undergoing gynaecological oncology surgery
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  • Published on:
    Re: IV Iron before surgery

    We appreciate the interest and questions posed by Professor Richards regarding the FORGE trial. The PREVENTT trial was a well-designed and executed trial, however the primary limitation of the trial is the “Two-week rule” described by the author in their letter and discussed in our introduction. It is well known that the biochemical response to all iron replacement improves with time, with most studies noting a larger response at 3 to 4 weeks post infusion[1,2]. In the PREVENTT study, the median time from infusion to surgery was 14 days in the iron infusion group, with an interquartile range (IQR) of 12-21 days. This is perhaps an explanation as to why the study demonstrated a hemoglobin increase of only 4.7g/L while other studies with median time from infusion to surgery demonstrated greater responses[1]. The study by Derman and colleagues found that at 2 weeks only 30% of patients obtained an increase of hemoglobin concentration greater than 20g/L in response to IV ferric derisomaltose (FDI), while at 3 weeks this increased to nearly 50% of patients[2]. Similarly, the work by Froessler and colleagues in 2016 found only an 8g/L difference in hemoglobin when IV iron (ferric carboxymaltose) was administered a median of 8 days (IQR 6-13 days) prior to surgery[3].

    Although expedited surgery for malignancies is often the ideal, in many jurisdictions, this is not feasible, or advisable based on patient, disease, and health system factors. The COVID-19 pandemic afforded a...

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    Conflict of Interest:
    None declared.
  • Published on:
    IV iron before surgery

    We read with interest the proposal for the FORGE trial. We are concerned that the authors are repeating work that has already been undertaken, without learning from previous trials. The authors criticise the PREVENTT trial, but fail to elaborate their reasons and then proceed to essentially duplicate the very same protocol.

    In summary, the PREVENTT RCT (1) was the largest multicentre RCT to assess the role of IV iron compared to placebo in patients before major abdominal surgery. Included were 138 patients undergoing gynaecological surgery and most common operation was a Wertheim’s hysterectomy, a debulking procedure in gynaecological oncology. Of note about two thirds had Tsats < 20% (table 10), essentially representing the same PICO (and size) as proposed in the FORGE trial. There are a couple of key aspects of relevance to FORGE aside from the key question of why they need to repeat the data powered for change in haemoglobin?

    A. A key limitation in recruitment was the ‘2-week rule’ whereby patients listed for cancer surgery are mandated to have their operation within 2 weeks (Chapter 4 of the NIHR report (1)). How do the authors propose to overcome this hurdle in FORGE?

    B. The benefit of modern IV iron is the ability to give a full treatment dose, normally 20mg/kg, why are the authors proposing a lower dose?

    We applaud the authors undertaking a randomised controlled trial but urge them to learn from existing studies to avoid future mist...

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    Conflict of Interest:
    None declared.