Pilot feasibility study of Ferinject® in patients with esophageal cancer

Esophageal cancer has an incidence of around 2000 times per year in the
Netherlands. The life time prevalence is around 1.5% in men and 0.5% in women.
The patients are often diagnosed in a late stadium of the disease and at higher
age (women older then men). The treatment of esophageal cancer consists of
radio-chemotherapy (RCT) followed by a transhiatal / transthoracic esophagus
cardia resection, which is performed about 500 times a year in the Netherlands.
The overall physical condition of these patients decreases due to a decreased
food intake and weight loss. They also often suffer from an iron deficiency
anemia (IDA) due to a combination of factors. The average hemoglobin (Hb) level
when these patients first visit a MDL physician is about 5.5-7.5 mmol/L.

This pilot study will investigate the effect of intravenous iron suppletion
(Ferinject®) in patients with an IDA due to esophageal cancer. The standard
treatment for IDA is oral iron suppletion, which is slow or (peri-operative)
blood transfusion, which should be avoided according to current insights.

Currently these patients are not treated for their IDA in the pre-(R)CT and
pre-operative stage. The focus of this pilot study is the actual increase in
the absolute Hb level relative to the baseline and the possible side effects of
Ferinject®. In addition, the quality of life peri-operative, the time in the
hospital, the post-operative complications (like anastomotic leakage and
pneumonia) and the number of blood transfusions will be monitored.

The objective of this pilot study is to investigate wether:
- Increased Hb levels prior to the operation can prevent blood transfusions
preoperative, blood transfusions have a negative effect on the survival of
cancer patients
- Treatment with Ferinject increases Hb levels at the start of (R)CT and during
the preoperative period
- Increased Hb levels at the start of (R)CT can cause the patient to become
fitter and better be able in doing her/his exercises
- Treatment with Ferinject prior to the operation can be linked to less
postoperative complications lik anastomotic leakage and pneumonia
Secondary objectives
- Better performance in the fast track recovery system because of the increased
Hb level, which implies a decrease in hospital stay (mean hospital stay = 8-13
days)

A pilot study in 20 patients with esophageal cancer to assess the feasibility
of intravenous iron therapy, therefore this pilot does not use a control group.

Ferinject® will be administered in case of:
- Hb < 7.5 mmol/L in women
- Hb < 8.1 mmol/L in men
In a dose depending on the Hb level and body weight during the first intake pre
(R)CT and pre-surgery. . The purpose is 1 point Hb increase per occasion * dose
determination 1000 mg Fe depending on Hb level and body weight. A strong
deviation in MCV, ferritine and transferrin saturation (TSAT) can be a criteria
for exclusion.

Inclusion criteria:
- Potentially operable and resectable patients with esophageal cancer
- Age 18 year and older
- Hb < 7.5 mmol/L in women and Hb < 8.1 mmol/L in men
- TSAT < 20%, Ferritine < 100 µg/L * absolute iron deficiency
- TSAT < 20%, Ferritine > 100 µg/L * functional iron deficiency

Exclusion criteria:
- T4 carcinomas
- Inoperable due to comorbidity or ASA IV
- Irresectability
- Metastasis
- Erythropoiesis stimulating agents within 3 months before screening
- Ferritine > 500 µg/L

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