Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE
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 q...
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creator | 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 |
description | 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 236 568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56 532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17 148) or the control group (no further contact; n = 17 144), 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 34 272 subjects (17 136 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 100 000 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 100 000 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. |
doi_str_mv | 10.1093/jnci/djr284 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_888341022</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/jnci/djr284</oup_id><sourcerecordid>2474280971</sourcerecordid><originalsourceid>FETCH-LOGICAL-c479t-cbeaed7fd437fa7b13bfc9b40caeec70629db40d31858c5a89b3bb04ed9d04f3</originalsourceid><addsrcrecordid>eNp9kUFr3DAQhUVoaLZJT70HUUh6KE4kWV7LuRWTbQOBhezejSyNUy2y5Eg2YdM_Hy27aaGHzEUz4ps3Iz2EvlByRUmVX2-cMtd6E5jgR2hG-ZxkjJLiA5oRwspMiJKfoE8xbkiKivGP6IRRUTA25zP0Z-kUZEtnt3hlHntvtI_KD1tsHK699QHUKC2uZcICXqkA4Ix7vMELb61_zqYBL4zT6Spi3-HxN-C71GCkww_Sad-bF9BJyY0hNaR0HYy02apePtyeoeNO2gifD-cpWi9u1_Wv7H75867-cZ8pXlZjplqQoMtO87zsZNnSvO1U1XKiJIAqyZxVOlU6T48SqpCiavO2JRx0pQnv8lP0bS87BP80QRyb3kQF1koHfoqNECLnlDCWyK__kRs_BZd2a0RVCMEI5wn6vodU8DEG6JohmF6GbUNJszOk2RnS7A1J9PlBcmp70H_ZNwcScHEAZFTSdiH9tIn_OF4UnJa73S73nJ-Gdye-AkUSov8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>895882044</pqid></control><display><type>article</type><title>Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>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</creator><creatorcontrib>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 ; SCORE Working Group ; and the SCORE Working Group</creatorcontrib><description>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 236 568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56 532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17 148) or the control group (no further contact; n = 17 144), 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 34 272 subjects (17 136 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 100 000 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 100 000 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.</description><identifier>ISSN: 0027-8874</identifier><identifier>EISSN: 1460-2105</identifier><identifier>DOI: 10.1093/jnci/djr284</identifier><identifier>PMID: 21852264</identifier><identifier>CODEN: JNCIEQ</identifier><language>eng</language><publisher>Cary, NC: Oxford University Press</publisher><subject>Biological and medical sciences ; Clinical outcomes ; Colorectal cancer ; Colorectal Neoplasms - diagnosis ; Colorectal Neoplasms - epidemiology ; Colorectal Neoplasms - mortality ; Colorectal Neoplasms - prevention & control ; Digestive system. Abdomen ; Early Detection of Cancer - methods ; Endoscopy ; Female ; Follow-Up Studies ; Humans ; Incidence ; Investigative techniques, diagnostic techniques (general aspects) ; Italy - epidemiology ; Male ; Mass Screening - methods ; Medical sciences ; Medical screening ; Middle Aged ; Mortality ; Odds Ratio ; Patient Compliance ; Sigmoidoscopy - standards ; Surveys and Questionnaires ; Time Factors ; Tumors</subject><ispartof>JNCI : Journal of the National Cancer Institute, 2011-09, Vol.103 (17), p.1310-1322</ispartof><rights>The Author 2011. Published by Oxford University Press. 2011</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Oxford Publishing Limited(England) Sep 7, 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-cbeaed7fd437fa7b13bfc9b40caeec70629db40d31858c5a89b3bb04ed9d04f3</citedby><cites>FETCH-LOGICAL-c479t-cbeaed7fd437fa7b13bfc9b40caeec70629db40d31858c5a89b3bb04ed9d04f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1578,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24554172$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21852264$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Segnan, Nereo</creatorcontrib><creatorcontrib>Armaroli, Paola</creatorcontrib><creatorcontrib>Bonelli, Luigina</creatorcontrib><creatorcontrib>Risio, Mauro</creatorcontrib><creatorcontrib>Sciallero, Stefania</creatorcontrib><creatorcontrib>Zappa, Marco</creatorcontrib><creatorcontrib>Andreoni, Bruno</creatorcontrib><creatorcontrib>Arrigoni, Arrigo</creatorcontrib><creatorcontrib>Bisanti, Luigi</creatorcontrib><creatorcontrib>Casella, Claudia</creatorcontrib><creatorcontrib>Crosta, Cristiano</creatorcontrib><creatorcontrib>Falcini, Fabio</creatorcontrib><creatorcontrib>Ferrero, Franco</creatorcontrib><creatorcontrib>Giacomin, Adriano</creatorcontrib><creatorcontrib>Giuliani, Orietta</creatorcontrib><creatorcontrib>Santarelli, Alessandra</creatorcontrib><creatorcontrib>Visioli, Carmen Beatriz</creatorcontrib><creatorcontrib>Zanetti, Roberto</creatorcontrib><creatorcontrib>Atkin, Wendy S.</creatorcontrib><creatorcontrib>Senore, Carlo</creatorcontrib><creatorcontrib>SCORE Working Group</creatorcontrib><creatorcontrib>and the SCORE Working Group</creatorcontrib><title>Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE</title><title>JNCI : Journal of the National Cancer Institute</title><addtitle>J Natl Cancer Inst</addtitle><description>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 236 568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56 532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17 148) or the control group (no further contact; n = 17 144), 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 34 272 subjects (17 136 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 100 000 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 100 000 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.</description><subject>Biological and medical sciences</subject><subject>Clinical outcomes</subject><subject>Colorectal cancer</subject><subject>Colorectal Neoplasms - diagnosis</subject><subject>Colorectal Neoplasms - epidemiology</subject><subject>Colorectal Neoplasms - mortality</subject><subject>Colorectal Neoplasms - prevention & control</subject><subject>Digestive system. Abdomen</subject><subject>Early Detection of Cancer - methods</subject><subject>Endoscopy</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Incidence</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Italy - epidemiology</subject><subject>Male</subject><subject>Mass Screening - methods</subject><subject>Medical sciences</subject><subject>Medical screening</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Odds Ratio</subject><subject>Patient Compliance</subject><subject>Sigmoidoscopy - standards</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>Tumors</subject><issn>0027-8874</issn><issn>1460-2105</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUFr3DAQhUVoaLZJT70HUUh6KE4kWV7LuRWTbQOBhezejSyNUy2y5Eg2YdM_Hy27aaGHzEUz4ps3Iz2EvlByRUmVX2-cMtd6E5jgR2hG-ZxkjJLiA5oRwspMiJKfoE8xbkiKivGP6IRRUTA25zP0Z-kUZEtnt3hlHntvtI_KD1tsHK699QHUKC2uZcICXqkA4Ix7vMELb61_zqYBL4zT6Spi3-HxN-C71GCkww_Sad-bF9BJyY0hNaR0HYy02apePtyeoeNO2gifD-cpWi9u1_Wv7H75867-cZ8pXlZjplqQoMtO87zsZNnSvO1U1XKiJIAqyZxVOlU6T48SqpCiavO2JRx0pQnv8lP0bS87BP80QRyb3kQF1koHfoqNECLnlDCWyK__kRs_BZd2a0RVCMEI5wn6vodU8DEG6JohmF6GbUNJszOk2RnS7A1J9PlBcmp70H_ZNwcScHEAZFTSdiH9tIn_OF4UnJa73S73nJ-Gdye-AkUSov8</recordid><startdate>20110907</startdate><enddate>20110907</enddate><creator>Segnan, Nereo</creator><creator>Armaroli, Paola</creator><creator>Bonelli, Luigina</creator><creator>Risio, Mauro</creator><creator>Sciallero, Stefania</creator><creator>Zappa, Marco</creator><creator>Andreoni, Bruno</creator><creator>Arrigoni, Arrigo</creator><creator>Bisanti, Luigi</creator><creator>Casella, Claudia</creator><creator>Crosta, Cristiano</creator><creator>Falcini, Fabio</creator><creator>Ferrero, Franco</creator><creator>Giacomin, Adriano</creator><creator>Giuliani, Orietta</creator><creator>Santarelli, Alessandra</creator><creator>Visioli, Carmen Beatriz</creator><creator>Zanetti, Roberto</creator><creator>Atkin, Wendy S.</creator><creator>Senore, Carlo</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20110907</creationdate><title>Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-cbeaed7fd437fa7b13bfc9b40caeec70629db40d31858c5a89b3bb04ed9d04f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Biological and medical sciences</topic><topic>Clinical outcomes</topic><topic>Colorectal cancer</topic><topic>Colorectal Neoplasms - diagnosis</topic><topic>Colorectal Neoplasms - epidemiology</topic><topic>Colorectal Neoplasms - mortality</topic><topic>Colorectal Neoplasms - prevention & control</topic><topic>Digestive system. Abdomen</topic><topic>Early Detection of Cancer - methods</topic><topic>Endoscopy</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Incidence</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Italy - epidemiology</topic><topic>Male</topic><topic>Mass Screening - methods</topic><topic>Medical sciences</topic><topic>Medical screening</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Odds Ratio</topic><topic>Patient Compliance</topic><topic>Sigmoidoscopy - standards</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Segnan, Nereo</creatorcontrib><creatorcontrib>Armaroli, Paola</creatorcontrib><creatorcontrib>Bonelli, Luigina</creatorcontrib><creatorcontrib>Risio, Mauro</creatorcontrib><creatorcontrib>Sciallero, Stefania</creatorcontrib><creatorcontrib>Zappa, Marco</creatorcontrib><creatorcontrib>Andreoni, Bruno</creatorcontrib><creatorcontrib>Arrigoni, Arrigo</creatorcontrib><creatorcontrib>Bisanti, Luigi</creatorcontrib><creatorcontrib>Casella, Claudia</creatorcontrib><creatorcontrib>Crosta, Cristiano</creatorcontrib><creatorcontrib>Falcini, Fabio</creatorcontrib><creatorcontrib>Ferrero, Franco</creatorcontrib><creatorcontrib>Giacomin, Adriano</creatorcontrib><creatorcontrib>Giuliani, Orietta</creatorcontrib><creatorcontrib>Santarelli, Alessandra</creatorcontrib><creatorcontrib>Visioli, Carmen Beatriz</creatorcontrib><creatorcontrib>Zanetti, Roberto</creatorcontrib><creatorcontrib>Atkin, Wendy S.</creatorcontrib><creatorcontrib>Senore, Carlo</creatorcontrib><creatorcontrib>SCORE Working Group</creatorcontrib><creatorcontrib>and the SCORE Working Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>JNCI : Journal of the National Cancer Institute</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Segnan, Nereo</au><au>Armaroli, Paola</au><au>Bonelli, Luigina</au><au>Risio, Mauro</au><au>Sciallero, Stefania</au><au>Zappa, Marco</au><au>Andreoni, Bruno</au><au>Arrigoni, Arrigo</au><au>Bisanti, Luigi</au><au>Casella, Claudia</au><au>Crosta, Cristiano</au><au>Falcini, Fabio</au><au>Ferrero, Franco</au><au>Giacomin, Adriano</au><au>Giuliani, Orietta</au><au>Santarelli, Alessandra</au><au>Visioli, Carmen Beatriz</au><au>Zanetti, Roberto</au><au>Atkin, Wendy S.</au><au>Senore, Carlo</au><aucorp>SCORE Working Group</aucorp><aucorp>and the SCORE Working Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE</atitle><jtitle>JNCI : Journal of the National Cancer Institute</jtitle><addtitle>J Natl Cancer Inst</addtitle><date>2011-09-07</date><risdate>2011</risdate><volume>103</volume><issue>17</issue><spage>1310</spage><epage>1322</epage><pages>1310-1322</pages><issn>0027-8874</issn><eissn>1460-2105</eissn><coden>JNCIEQ</coden><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 236 568 men and women, aged 55-64 years, who were randomly selected from six trial centers in Italy. Of the 56 532 respondents, interested and eligible subjects were randomly assigned to the intervention group (invitation for flexible sigmoidoscopy; n = 17 148) or the control group (no further contact; n = 17 144), 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 34 272 subjects (17 136 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 100 000 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 100 000 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.</abstract><cop>Cary, NC</cop><pub>Oxford University Press</pub><pmid>21852264</pmid><doi>10.1093/jnci/djr284</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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ispartof | JNCI : Journal of the National Cancer Institute, 2011-09, Vol.103 (17), p.1310-1322 |
issn | 0027-8874 1460-2105 |
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source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
subjects | Biological and medical sciences Clinical outcomes Colorectal cancer Colorectal Neoplasms - diagnosis Colorectal Neoplasms - epidemiology Colorectal Neoplasms - mortality Colorectal Neoplasms - prevention & control Digestive system. Abdomen Early Detection of Cancer - methods Endoscopy Female Follow-Up Studies Humans Incidence Investigative techniques, diagnostic techniques (general aspects) Italy - epidemiology Male Mass Screening - methods Medical sciences Medical screening Middle Aged Mortality Odds Ratio Patient Compliance Sigmoidoscopy - standards Surveys and Questionnaires Time Factors Tumors |
title | Once-Only Sigmoidoscopy in Colorectal Cancer Screening: Follow-up Findings of the Italian Randomized Controlled Trial-SCORE |
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