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Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy

. 2020 Mar;69(3):523-530. doi: 10.1136/gutjnl-2018-318198. Epub 2019 Aug 27. Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy Marco Zappa², Cinzia Campari³, Sergio Crotta⁴, Paola Armaroli⁵, Arrigo Arrigoni⁶, Paola Cassoni⁷, Rossana Colla³, Mario Fracchia⁸, Fabrizio Gili⁹, Grazia Grazzini¹⁰, Roberto Lolli¹¹, Patrizia Menozzi³, Lorenzo Orione¹², Salvatore Polizzi¹³, Stefano Rapi¹⁴, Emilia Riggi⁵, Tiziana Rubeca¹⁰, Romano Sassatelli³, Carmen Visioli², Nereo Segnan⁵

Affiliations

¹ SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy carlo.senore@cpo.it.
² Clinical Epidemiology Unit, ISPRO, Florence, Italy.
³ Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
⁴ AUSL Valle d'Aosta, Aosta, Italy.
⁵ SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy.
⁶ University Gastroenterology Unit, Ospedale San Giovanni Antica Sede, Turin, Italy.
⁷ Department of Medical Sciences, Universita degli Studi di Torino, Turin, Italy.
⁸ Gastroenterology Unit, Mauriziano Umberto I Hospital, Turin, Italy.
⁹ Colorectal Cancer Screening Laboratory, University Hospital Città della Salute e della Scienza, Turin, Italy.
¹⁰ Screening Unit, ISPRO, Florence, Italy.
¹¹ Gastroenterology Unit, Regional Hospital, Aosta, Italy.
¹² Screening Unit, ASL CN1, Cuneo, Italy.
¹³ Screening Unit, ASL TO5, Moncalieri, Italy.
¹⁴ Laboratory, Careggi Hospital, Florence, Italy.

PMID: 31455608
DOI: 10.1136/gutjnl-2018-318198

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Faecal haemoglobin concentration among subjects with negative FIT results is associated with the detection rate of neoplasia at subsequent rounds: a prospective study in the context of population based screening programmes in Italy

Carlo Senore et al. Gut. 2020 Mar.

. 2020 Mar;69(3):523-530. doi: 10.1136/gutjnl-2018-318198. Epub 2019 Aug 27. Authors Carlo Senore¹, Marco Zappa², Cinzia Campari³, Sergio Crotta⁴, Paola Armaroli⁵, Arrigo Arrigoni⁶, Paola Cassoni⁷, Rossana Colla³, Mario Fracchia⁸, Fabrizio Gili⁹, Grazia Grazzini¹⁰, Roberto Lolli¹¹, Patrizia Menozzi³, Lorenzo Orione¹², Salvatore Polizzi¹³, Stefano Rapi¹⁴, Emilia Riggi⁵, Tiziana Rubeca¹⁰, Romano Sassatelli³, Carmen Visioli², Nereo Segnan⁵ Affiliations

¹ SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy carlo.senore@cpo.it.
² Clinical Epidemiology Unit, ISPRO, Florence, Italy.
³ Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
⁴ AUSL Valle d'Aosta, Aosta, Italy.
⁵ SSD Epidemiologia e screening - CPO, University Hospital Città della Salute e della Scienza, Turin, Italy.
⁶ University Gastroenterology Unit, Ospedale San Giovanni Antica Sede, Turin, Italy.
⁷ Department of Medical Sciences, Universita degli Studi di Torino, Turin, Italy.
⁸ Gastroenterology Unit, Mauriziano Umberto I Hospital, Turin, Italy.
⁹ Colorectal Cancer Screening Laboratory, University Hospital Città della Salute e della Scienza, Turin, Italy.
¹⁰ Screening Unit, ISPRO, Florence, Italy.
¹¹ Gastroenterology Unit, Regional Hospital, Aosta, Italy.
¹² Screening Unit, ASL CN1, Cuneo, Italy.
¹³ Screening Unit, ASL TO5, Moncalieri, Italy.
¹⁴ Laboratory, Careggi Hospital, Florence, Italy.

PMID: 31455608
DOI: 10.1136/gutjnl-2018-318198

Item in Clipboard

Abstract

Objective: To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer-CRC-or advanced adenoma).

Design: Prospective cohort of subjects aged 50-69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy.

Methods: All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method.

Results: The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels.

Conclusion: The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

Keywords: CRC screening; FIT; advanced adenoma.

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Conflict of interest statement

Competing interests: None declared.