Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

BACKGROUND: At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. DISCUSSION: This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. TRIAL REGISTRATION: ClincalTrials.gov: NCT02243735 .

Multicentre study of circumferential margin positivity and outcomes following abdominoperineal excision for rectal cancer.

BACKGROUND: Rectal cancer outcomes following abdominoperineal excision (APE) have been inferior to those for anterior resection, including more positive circumferential resection margins (CRMs). An erroneously conservative interpretation of APE (rather than a radical resection termed 'extralevator') has been proposed as the cause. In this multicentre study, factors contributing to CRM positivity were examined following APE according to its original description. METHODS: Data were collected from five hospital databases up to June 2011 including small- and larger-volume units (3 hospitals had 5 or fewer and 2 hospitals had more than 5 APE procedures per year). Primary outcome measures were CRM status; secondary outcomes were local recurrence and death. RESULTS: Of 327 patients, 302 patients had complete data for analysis. Some 50·0 per cent of patients had neoadjuvant chemoradiotherapy. Histopathological examination showed that 62·9 per cent had tumour category T3 or T4 cancers, 42·1 per cent had node-positive disease and the CRM positivity rate was 13·9 per cent. Multivariable analysis showed only pathological tumour category pT4 (odds ratio 19·92, 95 per cent confidence interval 6·48 to 68·61) and node positivity (odds ratio 3·04, 1·32 to 8·05) to be risk factors for a positive circumferential margin. CRM positivity was a risk factor for local recurrence (P = 0·022) and decreased overall survival (P = 0·001). Hospital volume had no impact on the likelihood of CRM positivity (P = 0·435). CONCLUSION: In patients undergoing APE by appropriately trained surgeons using a standardized approach, margin positivity was dictated by tumour stage, but not by centre or surgeon.

Familial colorectal cancer: Patient assessment, surveillance and surgical management.

Germline mutations account for 5-10% of colorectal cancer. Most mutations are autosomal dominant with high penetrance and affected patients benefit greatly from appropriate treatment. This review presents the current knowledge regarding familial colorectal cancer and provides practical information based on international guidelines and the best available evidence regarding patient assessment, surveillance and surgical management. Surgeons are often the first point of contact and frequently, the main provider of care for families with cancer syndromes or patients with familial cancer. Patients with a polyposis phenotype should undergo appropriate genetic testing. In non-polyposis patients with a cancer diagnosis, tumor testing for Lynch syndrome can guide the use of genetic testing. In patients without a personal history of cancer or polyposis, a carefully obtained family history with testing of available tumor tissue or of a living relative affected by colorectal cancer informs the need for genetic testing. Surveillance and surgical management should be planned following thorough assessment of familial cancer risk. Evidence exists to provide guidance as to the surveillance strategies required, the specific indications of genetic testing and the appropriate timing of operative intervention. A carefully obtained family history with selective genetic testing should inform surveillance and surgical management in patients who have a genetic predisposition for the development of colorectal cancer.