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 language | English |
|---|---|
| Pages (from-to) | 1310-1322 |
| Number of pages | 13 |
| Journal | Journal of the National Cancer Institute |
| Volume | 103 |
| Issue number | 17 |
| DOIs | |
| Publication status | Published - Sep 7 2011 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
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 journal › Article
}
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.
UR - http://www.scopus.com/inward/record.url?scp=80052676840&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80052676840&partnerID=8YFLogxK
U2 - 10.1093/jnci/djr284
DO - 10.1093/jnci/djr284
M3 - Article
C2 - 21852264
AN - SCOPUS:80052676840
VL - 103
SP - 1310
EP - 1322
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
SN - 0027-8874
IS - 17
ER -