Elsevier

Digestive and Liver Disease

Volume 47, Issue 9, September 2015, Pages 797-804
Digestive and Liver Disease

Oncology
An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test

https://doi.org/10.1016/j.dld.2015.05.004Get rights and content

Abstract

Background

European health systems have developed referral guidelines for the selection of patients for the urgent investigation of suspected colorectal cancer.

Aim

To evaluate whether quantitative faecal immunochemical testing performs better than commonly used high-risk symptoms based strategies for fast-tracking cancer referrals.

Methods

We prospectively studied 1054 symptomatic patients referred for a colonoscopy who provided a sample for faecal immunochemical testing. The usefulness of faecal immunochemical testing and two current guidelines for urgent referral were compared for their efficacy in the detection of colorectal cancer and advanced neoplasia.

Results

The guidelines detected 46.7% and 43.3% of cases of colorectal cancer while faecal haemoglobin concentration ≥15 μg Hb/g detected 96.7% of cases. The diagnostic accuracy of both the guidelines and faecal haemoglobin concentration ≥15 μg Hb/g for the detection of advanced neoplasia was: sensitivity 38.3%, 36.1%, 57.1% and specificity 71.8%, 69.5%, 86.6%, respectively. Male gender (OR 2.35; p < 0.001), age (1.34; p = 0.002), and faecal haemoglobin concentration ≥10 μg Hb/g (7.81; p < 0.001) were independent predictive factors of advanced neoplasia.

Conclusions

A faecal immunochemical test based-strategy performs better than current high-risk symptoms based strategies for fast-tracking cancer referrals. A score that combines gender, age and a faecal immunochemical test could accurately estimate the risk of advanced neoplasia.

Introduction

Colorectal cancer (CRC) is the second most common type of cancer and the second leading cause of cancer related death in Europe [1], [2], [3]. Prognosis depends strongly on tumour stage at diagnosis [1], [3], [4]. A delay in cancer diagnosis and its clinical implications have led several European health systems to develop referral systems for early diagnosis [1], [5], [6], [7]. The recently updated CRC guidelines of the National Institute for Health and Care Excellence (NICE) and the Scottish Intercollegiate Guidelines Network (SIGN) consider rectal bleeding associated with a change in bowel habit, the presence of an abdominal or rectal mass and/or the presence of iron deficiency anaemia (IDA) to be relevant symptoms for the selection of individuals for urgent referral [1], [5]. The efficacy of these systems has been questioned extensively [8], [9], [10], [11]. Scoring systems for the identification of symptomatic CRC that combine symptoms with other variables such as gender, age and family or personal history have been developed [12], [13], [14], [15]. However, none of these strategies have obtained satisfactory results either because of their low diagnostic accuracy, their complexity or the difficulty of their implementation in clinical practice [12], [14].

Colonoscopy is the accepted gold standard test for diagnosing CRC. Investigating digestive symptoms is recommended by several clinical guidelines [1], [5]. However, it is unclear which abdominal symptoms improve the diagnostic yield of colonoscopy in the detection of neoplasia [7], [16], [17], [18], [19], [20], [21], [22], [23].

Faecal immunochemical testing (FIT) provides high sensitivity in the detection of CRC and is a widely accepted strategy for CRC screening in the average-risk population [24], [25]. However, the accuracy of FIT in the detection of advanced adenoma is limited. Multivariable risk models, including FIT and risk factors for CRC increase the accuracy of FIT-based CRC screening programmes [26], [27]. Furthermore, there have been a number of important recent works on the use of FIT in symptomatic patients [28], [29], [30], [31], [32]. The idea that age and gender can be used along with FIT in risk scoring in symptomatic patients has also been suggested recently [29], [33].

We hypothesized that quantitative FIT, either alone or in combination with signs and/or symptoms, may have a greater association with CRC or advanced neoplasia (AN) than high-risk symptoms.

The objective of this study is therefore to evaluate whether a quantitative FIT based strategy performs better than commonly used high-risk symptoms based strategies (NICE and SIGN Guidelines) for fast tracking suspected cancer referrals. We also sought to create a risk score to stratify risk for advanced colorectal neoplasia in symptomatic adults.

Section snippets

Study design and patients

This is a prospective study comparing the diagnostic accuracy of the NICE and SIGN guidelines and the quantitative FIT for the detection of CRC with colonoscopy as the diagnostic gold standard. The study was carried out following the STARD guidelines (Supplementary Table S1) at the Endoscopy Department of Bellvitge University Hospital.

The study included patients of more than 18 years of age referred for diagnostic colonoscopy between September 2011 and October 2012. We excluded patients

Descriptive findings

During the study period, 1054 patients were referred for colonoscopy as part of the study of abdominal symptoms and were potentially eligible for the study; 51 were excluded (Fig. 1). Among the 1003 patients enrolled in the study, 665 patients were referred from primary care departments (66.3%) and 338 patients from secondary or tertiary care departments (33.7%, Supplementary Table S3). A total of 30 patients had CRC (3.0%) and 133 patients were found to have AN (13.3%) including 103 patients

Discussion

There is currently no practical system in implementation that accurately prioritizes colorectal referrals in symptomatic patients with suspected CRC with an acceptable degree of sensitivity and specificity. Our study demonstrates that the quantitative FIT-based prioritization strategy for CRC detection performs better than current urgent referral strategies based on high-risk symptoms or signs.

The urgent referral guidelines arose from the need to offer a high-quality system by integrating

Conflict of interest

None declared.

Funding

This work was supported by a grant from the Societat Catalana de Digestolologia (SCD), Catalonia, Spain. Also the Instituto de Salud Carlos III, FIS grants PI11/01439 and PI11/01593. The sponsor of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report

Acknowledgments

We would like to thank Esther Quilez for her administrative support, Natividad Valera for her technical support and David Bridgewater for his helpful advice and manuscript corrections.

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