1. Results and cost of a population-based biennial faecal occult blood colorectal cancer screening program Bernard DENIS, Philippe PERRIN, Jean François VIES, Jean Paul MILLELIRI, Frédéric VAGNE, Guy VENTRE, Jean Marc BOYAVAL, Fernand PLANCHON Results according to age Despite strong evidence that screening reduces both colorectal cancer (CRC) mortality and incidence, CRC screening tests remain underutilized. Aim: To report the results and cost of a population-based biennial faecal occult blood (FOBT) CRC screening program in the French area of Haut- Rhin (710 000 inhabitants), an area with one of the highest CRC incidence in Europe. Methods: All 188,438 residents aged 50-74 years were invited by mail for a CRC screening using a non rehydrated FOBT (Hemoccult II). FOBTs were first provided by the GPs and then directly mailed to persons who didn’t comply after 2 invitations. The processing of FOBTs was centralized. Results: 87,790 people (46.6%) completed a FOBT and 18,995 (10.1%) were excluded for recent CRC screening, high risk of CRC or concurrent severe disease, so that adjusted participation rate was 51.8%. Participation was higher in women (54.2%) than in men (49.4%)(p<0.001) and ranged from 45.4% to 59.8% according to districts. Participation was lower below 60 years (47.5%) than after (56.6%). FOBT positivity rate was 3.3%, higher in men (3.9%) than in women (2.8%)(p<0.001). To date 2,408 colonoscopies were performed. The positive predictive value was 10% for CRC (women 7.2%, men 12.5%), 20.8% for advanced adenomas (women 13.4%, men 26.9%) and 42.2% for neoplasia (women 30.6%, men 51.8%). Detection rates for neoplasia and CRC were 11.6 and 2.8 per 1,000 people screened. 27.2% of CRC were in situ, 50% of invasive CRC were stage I and 23.4% stage II. The rate of proximal advanced neoplasia increased with age (16.5% below 65 years, 25.4% after) but didn’t differ with gender. Flexible sigmoidoscopy alone would have missed 21.4% of people with advanced neoplasia, without significant difference according to age and gender. The overall cost of this biennial screening program (without the fees related to colonoscopies) was $2.7 million: fixed cost was $1.88 million ($5 per year per eligible person) and variable cost $0.82 million ($4 per screened person). The cost per screened person was $30 and the cost to find an early-stage neoplasia (advanced adenoma or in situ CRC or stage I CRC) was $4,300. Conclusion: Participation and diagnostic yield of randomised controlled trials of FOBT screening are reproducible at a reasonable cost in the real world through an organized population-based program involving GPs. Efforts should be made to enhance the participation of men and people below 60 years. Despite strong evidence that screening reduces both colorectal cancer (CRC) mortality and incidence, CRC screening tests remain underutilized Aim to report the results and cost of a population-based biennial faecal occult blood (FOBT) CRC screening program - French area of Haut-Rhin (0.71 million inhabitants) one of the highest CRC incidence in Europe - Residents aged 50-74 years were invited twice by mail to visit their GP for a CRC screening. The recall letter included a reply coupon which could be used to specify reasons for non participation. 12 to 15 months after the 1 st invitation, FOBTs were mailed to persons who didn’t complete the test and a last recall letter was sent if necessary 6 weeks later. - Biennial non rehydrated FOBT (Hemoccult II) without dietary restriction. - FOBT analysis was centralized in the Centre d’Examens de Santé of the CPAM in Mulhouse - FOBTs were provided free of charge. Financing was ensured through the French Social Security and the Haut-Rhin Administration (Conseil Général du Haut-Rhin). - Start of the program was spread out according to districts over a year from September 2003 to September 2004. Results below are those assessed in April 2006. - Participation and diagnostic yield of randomized controlled trials of FOBT screening are reproducible at a reasonable cost in the real world through an organized population-based program involving GPs - Efforts should be made to enhance the participation of men and people below 60 years Digestive Disease Week, Los Angeles, 21 May 2006 Results : invitation / exclusion / participation invited population population aged 50-74 years186,660 exclusions recent CRC screening12,115 (6.5%) high risk of CRC6,109 (3.3%) concurrent severe disease842 (0.5%) total population excluded19.351 (10.4%) participation crude participation90,863 (48.7%) adjusted participation90,863 (54.3%) Association pour le Dépistage du Cancer colorectal dans le Haut-Rhin (ADECA 68), 39 avenue de la Liberté, Colmar, FRANCE Abstract Background Results : FOBT / colonoscopy - 618 GPs (98.6%) provided FOBTs - 77.3% of completed FOBTs were provided by GPs - 85.1% of the FOBTs provided by GPs were completed - mean number of persons having completed a FOBT = 108 / GP (range 0 – 472) menwomenp adjusted participation51.9%56.6%< 0.01 FOBT positivity rate3.9%2.8%< 0.01 PPV for neoplasia52.2%31.0%< 0.01 detection rate for neoplasia17.5‰7.5‰< 0.01 detection rate for cancer4.3‰1.8‰< 0.01 CRC stagen (%) in situ72 (27.0%) invasive195 (73.0%) stage 172 (49.7%) stage 235 (24.1%) stage 329 (20.0%) stage 49 (6.2%) stage unknown50 FOBT: 93,458 tests completed - 3,086 (3.3%) positive - 2,975 (3.2 %) uninterpretable, 2,293 (77.1%) were completed again - 84.1% of positive FOBT were followed by a colonoscopy FOBT positivity rate3.3% PPV for neoplasia42.6% PPV for cancer10.3% PPV for advanced adenoma21.0% detection rate for neoplasia12.2‰ screened detection rate for cancer2.9‰ screened detection rate for advanced adenoma6.0‰ screened Results : diagnostic yield Results according to gender Methods Results : GP’s involvement 50-5455-5960-6465-6970-74 adjusted participation %53.348.857.761.154.9 FOBT positivity rate %2.53.13.64.04.4 PPV for neoplasia %35.139.542.048.347.4 detection rate neoplasia ‰7.410.212.916.217.0 detection rate cancer ‰1.12.43.14.05.1 Colonoscopy: 2,595 recorded - 94.5% complete Wintzenheim Thann Dannemarie Masevaux Altkirch Hirsingue Cernay Guebwiller Saint-Amarin Munster Rouffach Soultz Lapoutroie Sainte-Marie-aux-Mines Wittenheim Mulhouse Ferrette Sierentz Huningue Illzach Habsheim Ensisheim Kaysersberg Ribeauville Neuf-Brisach Colmar Andolsheim 46 – 50 % 50 – 54 % 54 – 58 % 58 – 62 % advanced neoplasia location< 65y> 65yp rectum16.9%14.4%NS distal colon66.6%60.2%= 0.03 proximal colon16.5%25.4%< 0.001 57.4% 17.6% 25.0% Results - Costs advanced neoplasia locationmenwomenp rectum13.6%20.8%< 0.01 distal colon63.8%60.9%NS proximal colon22.6%18.3%NS CRC location A screening strategy with flexible sigmoidoscopy would have missed 21.4% of people with advanced neoplasia, without significant difference according to age and gender. - Overall cost $2.7 million (without the fees related to colonoscopies):. fixed cost $1.88 million ($5 a year per eligible person). variable cost $0.82 million ($4 per screened person) - Cost per screened person: $30 - Cost to find. 1 early-stage neoplasia: $4,300 (advanced adenoma or in situ or stage I CRC). 1 colorectal cancer: $11,200 Conclusions