Once-only sigmoidoscopy in colorectal cancer screening: Follow-up findings of the italian randomized controlled trial - SCORE

Nereo Segnan, Paola Armaroli, Luigina Bonelli, Mauro Risio, Stefania Sciallero, Marco Zappa, Bruno Andreoni, Arrigo Arrigoni, Luigi Bisanti, Claudia Casella, Cristiano Crosta, Fabio Falcini, Franco Ferrero, Adriano Giacomin, Orietta Giuliani, Alessandra Santarelli, Carmen Beatriz Visioli, Roberto Zanetti, Wendy S. Atkin, Carlo Senore

Research output: Contribution to journalArticle

Abstract

Background: A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening. Methods: We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17148) or the control group (no further contact; n = 17144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance. Results: A total of 34272 subjects (17136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio [RR] = 0.82, 95% confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group. Conclusion: A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.

Original languageEnglish
Pages (from-to)1310-1322
Number of pages13
JournalJournal of the National Cancer Institute
Volume103
Issue number17
DOIs
Publication statusPublished - Sep 7 2011

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Sigmoidoscopy
Early Detection of Cancer
Colorectal Neoplasms
Randomized Controlled Trials
Control Groups
Mortality
Incidence
Confidence Intervals
Intention to Treat Analysis
Italy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Once-only sigmoidoscopy in colorectal cancer screening : Follow-up findings of the italian randomized controlled trial - SCORE. / Segnan, Nereo; Armaroli, Paola; Bonelli, Luigina; Risio, Mauro; Sciallero, Stefania; Zappa, Marco; Andreoni, Bruno; Arrigoni, Arrigo; Bisanti, Luigi; Casella, Claudia; Crosta, Cristiano; Falcini, Fabio; Ferrero, Franco; Giacomin, Adriano; Giuliani, Orietta; Santarelli, Alessandra; Visioli, Carmen Beatriz; Zanetti, Roberto; Atkin, Wendy S.; Senore, Carlo.

In: Journal of the National Cancer Institute, Vol. 103, No. 17, 07.09.2011, p. 1310-1322.

Research output: Contribution to journalArticle

Segnan, N, Armaroli, P, Bonelli, L, Risio, M, Sciallero, S, Zappa, M, Andreoni, B, Arrigoni, A, Bisanti, L, Casella, C, Crosta, C, Falcini, F, Ferrero, F, Giacomin, A, Giuliani, O, Santarelli, A, Visioli, CB, Zanetti, R, Atkin, WS & Senore, C 2011, 'Once-only sigmoidoscopy in colorectal cancer screening: Follow-up findings of the italian randomized controlled trial - SCORE', Journal of the National Cancer Institute, vol. 103, no. 17, pp. 1310-1322. https://doi.org/10.1093/jnci/djr284
Segnan, Nereo ; Armaroli, Paola ; Bonelli, Luigina ; Risio, Mauro ; Sciallero, Stefania ; Zappa, Marco ; Andreoni, Bruno ; Arrigoni, Arrigo ; Bisanti, Luigi ; Casella, Claudia ; Crosta, Cristiano ; Falcini, Fabio ; Ferrero, Franco ; Giacomin, Adriano ; Giuliani, Orietta ; Santarelli, Alessandra ; Visioli, Carmen Beatriz ; Zanetti, Roberto ; Atkin, Wendy S. ; Senore, Carlo. / Once-only sigmoidoscopy in colorectal cancer screening : Follow-up findings of the italian randomized controlled trial - SCORE. In: Journal of the National Cancer Institute. 2011 ; Vol. 103, No. 17. pp. 1310-1322.
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abstract = "Background: A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening. Methods: We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17148) or the control group (no further contact; n = 17144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance. Results: A total of 34272 subjects (17136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18{\%} (rate ratio [RR] = 0.82, 95{\%} confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22{\%} (RR = 0.78; 95{\%} CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31{\%} (RR = 0.69; 95{\%} CI = 0.56 to 0.86) and mortality was reduced by 38{\%} (RR = 0.62; 95{\%} CI = 0.40 to 0.96) compared with the control group. Conclusion: A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.",
author = "Nereo Segnan and Paola Armaroli and Luigina Bonelli and Mauro Risio and Stefania Sciallero and Marco Zappa and Bruno Andreoni and Arrigo Arrigoni and Luigi Bisanti and Claudia Casella and Cristiano Crosta and Fabio Falcini and Franco Ferrero and Adriano Giacomin and Orietta Giuliani and Alessandra Santarelli and Visioli, {Carmen Beatriz} and Roberto Zanetti and Atkin, {Wendy S.} and Carlo Senore",
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TY - JOUR

T1 - Once-only sigmoidoscopy in colorectal cancer screening

T2 - Follow-up findings of the italian randomized controlled trial - SCORE

AU - Segnan, Nereo

AU - Armaroli, Paola

AU - Bonelli, Luigina

AU - Risio, Mauro

AU - Sciallero, Stefania

AU - Zappa, Marco

AU - Andreoni, Bruno

AU - Arrigoni, Arrigo

AU - Bisanti, Luigi

AU - Casella, Claudia

AU - Crosta, Cristiano

AU - Falcini, Fabio

AU - Ferrero, Franco

AU - Giacomin, Adriano

AU - Giuliani, Orietta

AU - Santarelli, Alessandra

AU - Visioli, Carmen Beatriz

AU - Zanetti, Roberto

AU - Atkin, Wendy S.

AU - Senore, Carlo

PY - 2011/9/7

Y1 - 2011/9/7

N2 - Background: A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening. Methods: We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17148) or the control group (no further contact; n = 17144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance. Results: A total of 34272 subjects (17136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio [RR] = 0.82, 95% confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group. Conclusion: A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.

AB - Background: A single flexible sigmoidoscopy at around the age of 60 years has been proposed as an effective strategy for colorectal cancer (CRC) screening. Methods: We conducted a randomized controlled trial to evaluate the effect of flexible sigmoidoscopy screening on CRC incidence and mortality. A questionnaire to assess the eligibility and interest in screening was mailed to 236568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17148) or the control group (no further contact; n = 17144), between June 14, 1995, and May 10, 1999. Flexible sigmoidoscopy was performed on 9911 subjects. Intention-to-treat and per-protocol analyses were performed to compare the CRC incidence and mortality rates in the intervention and control groups. Per-protocol analysis was adjusted for noncompliance. Results: A total of 34272 subjects (17136 in each group) were included in the follow-up analysis. The median follow-up period was 10.5 years for incidence and 11.4 years for mortality; 251 subjects were diagnosed with CRC in the intervention group and 306 in the control group. Overall incidence rates in the intervention and control groups were 144.11 and 176.43, respectively, per 100000 person-years. CRC-related death was noted in 65 subjects in the intervention group and 83 subjects in the control group. Mortality rates in the intervention and control groups were 34.66 and 44.45, respectively, per 100000 person-years. In the intention-to-treat analysis, the rate of CRC incidence was statistically significantly reduced in the intervention group by 18% (rate ratio [RR] = 0.82, 95% confidence interval [CI] = 0.69 to 0.96), and the mortality rate was non-statistically significantly reduced by 22% (RR = 0.78; 95% CI = 0.56 to 1.08) compared with the control group. In the per-protocol analysis, both CRC incidence and mortality rates were statistically significantly reduced among the screened subjects; CRC incidence was reduced by 31% (RR = 0.69; 95% CI = 0.56 to 0.86) and mortality was reduced by 38% (RR = 0.62; 95% CI = 0.40 to 0.96) compared with the control group. Conclusion: A single flexible sigmoidoscopy screening between ages 55 and 64 years was associated with a substantial reduction of CRC incidence and mortality.

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