COMPARING YIELD AND COST OF FOBT AND FS IN AN AVERAGE RISK POPULATION:

RESULTS AFTER 2 SCREENING ROUNDS

N.Segnan MD, Ms EpiCenter for Cancer Prevention (CPO Piemonte) andS. Giovanni Battista Hospital. Torino (Italy)

Ottawa May 10-12, 2006

IBSN Biennial Meeting

SCORE2SCORE2Studio multicentrico italiano per la valutazione

di diverse strategie discreening dei tumori del colon-retto

CPO PiemonteFondo Edo Tempia – ASL 12 Biella

ASL Città di MilanoCSPO FirenzeASL 13 Rimini

Associazione Italiana per la Ricerca sul Cancro

Progetto dimostrativo discreening dei tumori del colon-retto

Regione Piemonte - Assessorato alla Sanita'CPO Piemonte

ASL 1-4AO S. Giovanni Battista-Molinette,

Ospedale Mauriziano "Umberto I" - IRCCMedici di Medicina Generale

Associazione Italiana per la Ricerca sul Cancro

N. Segnan CPO 2006

AIMS (1)

N. Segnan CPO 2006

a)a) To estimate compliance and coverage adopting different screening strategies

b) To compare Detection Rate of different tests (first test, subsequent tests and follow-up) and to estimate screening impact on CRC incidence and mortality

c) To estimate costs of different strategies

d) To define quality indicators of the screening programme

POPULATION• Males and females

aged 55 to 64 years of age

EXCLUSION CRITERIAPrevious CRC, polyps, IBD

Endoscopy within previous 2 years

2 first degree relatives with CRCSevere diseaseSevere psychiatric symptoms

N. Segnan CPO 2006

EXCLUDED*553

TORINO84 GPs

MILANO30 GPs

FIRENZE36 GPs

BIELLA19 GPs

RIMINI21 GPs

PATIENTS(AGE 55-64)

13679

PATIENTS(AGE 55-64)

2923

ELIGIBLE2639

PATIENTS(AGE 55-64)

5333

GPSAMPLE

EXCLUDED*352

EXCLUDED*220

EXCLUDED*228

EXCLUDED*284

RESIDENTS AGED 55 TO 64IN SELECTED DISTRICTSTS

26255 ELIGIBLE STUDY POPULATION

PATIENTS(AGE 55-64)

3025

PATIENTS(AGE 55-64)

3359

ELIGIBLE13126

ELIGIBLE4981

ELIGIBLE2805

ELIGIBLE3131

Source sampling by study center - Fig. 1

Segnan et al. Journal of the National Cancer Institute 2005; 97(5)N. Segnan CPO 2005

SCREENING TEST - FOBT

• IMMUNOLOGICAL TEST (Immunodia-HempSp- Fujirebio. Inc Tokio,Japan)

• AUTOMATED READING IN A CENTRAL LABORATORY

N. Segnan CPO 2006

SCREENING PROCEDURE - FS• SCREENING TEST

Flexible sigmoidoscopy :Scope advanced beyond the sigmoid-descending colon junction (complete

test).Polyps < 10 mm removed during FS cold-snare technique recommended forpolyps < 6 mm

• BOWEL PREPARATION:Single enema (133 ml sodium-phosphate) self-administered 2 hours before the test.

N. Segnan CPO 2006

REFERRAL FOR COLONOSCOPY

• 1 distal polyp >= 10 mm

• >=3 adenomas < 10 mm

• 1 high risk (severe dysplasia or cancer, villous histology)

adenoma < 10 mm

N. Segnan CPO 2006

INTERVENTIONS

• BIENNIAL FOBT

• “ONCE-ONLY” SIGMOIDOSCOPY

• PATIENTS’ CHOICE

• SIGMOIDOSCOPY + BIENNIAL FOBT (PATIENTS WITH NEGATIVE FS)

N. Segnan CPO 2006

55-59 yrs

970 (27.1)Total448 (12.5)Sigmoidoscopy522 (14.6)FOBT

7381 (28.1)26255TOTAL

3579Patient’s choice

3049 (28.1)10867Sigmoidoscopy+ biennial FOBT

1026 (28.1)3650Once-onlysigmoidoscopy

1654 (28.1)5893FOBT by GP or screening facility

682 (30.1)2266FOBT by mail

attended(%)

invitedSCREENING ARM

TOTAL

N. Segnan CPO 2005

Participation rate by sex, age, and screening arm (undelivered invitations are excluded from the denominator) (2)

Segnan et al. Journal of the National Cancer Institute 2005; 97(5)

1.61 (1.24-2.090)3045Men1.00 (referent)3316Women1.32 (1.01-1.72)378366-64 yrs

1.00 (referent)257855-59 yrs 3.58 (2.49-5.14)4025Sigmoidoscopy arms

1.00 (referent)2336FOBT arms

ALL PATIENTS EXAMINED (excluding those in patient’s choice arm)

OR* (95% CI)n

N. Segnan CPO 2005

Odds ratio for advanced adenomas in FOBT and sigmoidoscopyarms by age and sex and among all patients examined, excluding

those in the patient’s choice arm, by age, sex, and screening test (2)

Segnan et al. Journal of the National Cancer Institute 2005; 97(5)

* Multivariable ORs adjusted for screening center and for all the other variables in the table

N = 42801

N. Segnan CPO 2006

The study has been The study has been enlargedenlarged……....

INTERVENTIONS

• BIENNIAL FOBT (17,730)

• “ONCE-ONLY” SIGMOIDOSCOPY (5,057)

• (PATIENTS’ CHOICE) stopped

• SIGMOIDOSCOPY + BIENNIAL FOBT (PATIENTS WITH NEGATIVE FS) (20,414)

N. Segnan CPO 2006

invited17730Attenders (1st

screening round)4599 (25.9%)

Attenders (at least 1 invitation over 2 screening rounds)

5837 (32.9%)

N. Segnan CPO 2006

FOBT FOBT –– compliance compliance

Invited5057Attenders1405(28%)

N. Segnan CPO 2006

FS once FS once onlyonly -- compliancecompliance

Invited20414

Attenders - FS5689(27.9)

Invited after 2 years – FOBT 5192

Attenders - FOBT3220(62%)

N. Segnan CPO 2006

FS + FOBT FS + FOBT -- compliancecompliance

36.7%PPV1.71%0.34%327 (5.6%)POSITIVE

100205837PATIENTS

at least 1 test (over 2 rounds)28.6%PPV

0.86%0.09%112 (3.3%)POSITIVE2933368TESTS

2nd test (1st neg.)40.9%PPV

1.21%0.29%215 (3.7%)POSITIVE71175837N. TESTS

1 test: 1st or 2nd

round

AADCCR

N. Segnan CPO 2006

FOBT FOBT –– Detection Detection RatesRates

36.7%PPV0.34%1.37%0.12%0.22%327 (5.6%)POSITIVE

20807135837PATIENTS

at least 1 test (over 2 rounds)

29.4%PPV

0.3%0.8%0.1%0.0%51 (4.1%)POSITIVE410101238TESTS

1st test (2nd round)28.6%PPV

0.21%0.65%0.03%0.06%112 (3.3%)POSITIVE722123368TESTS

2nd test (1st neg.)44.5%PPV

0.20%1.04%0.11%0.24%164 (3.6%)POSITIVE9485114599N. TESTS

PROXIMALDISTALPROXIMALDISTAL1st testAADCCR

N. Segnan CPO 2006

FOBT FOBT –– Detection Detection RatesRates

0.3%4.87%0.11%0.39%17272622total

0.31%0.22%0.12%0.03%114POSITIVE107413220FOBT TESTS

subsequent tests0.13%4.74%0.04%0.38%

72652215585FS TESTSPROXIMALDISTALPROXIMALDISTAL1st test

AADCCR

N. Segnan CPO 2006

FS + FOBT FS + FOBT -- Detection Detection RatesRates

0.07%5.65%0.00%0.36%DR %

178051381FS TESTS

PROXDISTPROXDISTAADCCR

N. Segnan CPO 2006

FS onceFS once--onlyonly -- Detection RateDetection Rate

Detection rate by screening armTotal%

n AAD%

n CRC%

PATIENTS

84 6.07

795.70

5 0.36

1385FS

317 5.67

2895.17

280.50

5585FS + FOBT

120 2.06

1001.71

200.34

5837FOBT,2 rounds invit

Detection rate by intention to treatTotal%

n AAD %

n CRC%

Invited

84 1.66

791.56

5 0.1

5057FS

317 1.56

2891.42

280.14

20414FS + FOBT

120 0.70

1000.58

200.12

17330FOBT,2 rounds invit

ADVANCED ADENOMAS DETECTION RATES PER 1000 BY AGE AND GENDER

0

10

20

30

40

50

60

70

80

1 TE

ST

2ND

TE

ST

FIR

ST

NE

G

1 0R

2TE

ST

FS O

NC

EO

NLY

FS A

ND

FS

+FO

BT

FOB

T IN

FSN

EG

ATI

VE

FS A

ND

FS

+FO

BT

FOBT FS +FOBT

55-5960-64womenmen

NNS per detected les ion

0

200

400

600

800

1000

1200

1 TEST 1 OR 2 TESTS 2 TESTS

FOBT FS ONLY FS FOBT IN FS NEGATIVE FS AND FS +FOBT

CA

AAD

TOT

NNS per detected les ion

020406080

100120140160180200

1 TEST 1 OR 2 TESTS 2 TESTS

FOBT FS ONLY FS FOBT IN FS NEGATIVE FS AND FS +FOBT

CA

AAD

TOT

COST

• FS: 132 $• FOBT: 37$

The cost includes the assessment (referral to colonoscopy, histology …) and the organization

Cost per Detected Lesion

$0.00

$5,000.00

$10,000.00

$15,000.00

$20,000.00

$25,000.00

$30,000.00

$35,000.00

$40,000.00

$45,000.00

1 TEST 1 OR 2TESTS

2 TESTS

FOBT FS ONLY FS FOBT INFS

NEGATIVE

FS ANDFS

+FOBT

CA AADTOT

Cost per Detected Lesion

$0.00

$2,000.00

$4,000.00

$6,000.00

$8,000.00

$10,000.00

$12,000.00

FS

1 TEST 1 OR 2TESTS

2 TESTS FOBT +FOBT IN

NEG

FS ANDFS

+FOBT

FOBT FS ONCEONLY

FS + FOBT

AADTOT

After 2 FOBT screening rounds, the cumulative yield of advanced adenomas was about one third for FOBT compared to FS, while CRC yield was similar.

The participation to FOBT (in the screening programs recently started in the study areas attendance is above 40%) might influence the estimates of the relative difference in neoplasia yield.

N. Segnan CPO 2006

ConclusionsConclusions 11

*At the prevalent round:- the cost per detected CRC is lower for FOB Test than

for FS- the cost per detected AAD is higher for FOB Test

than for FS

* after 2 FOB Tests, the cost per detected lesion is higher both for CRC and for AAD compared to FS

* The detetection rate of AAD is the same at 55-59 years and at 60-64 years both in men and in women, supporting the observation of a plateau of prevalence of AAD around 60 years

N. Segnan CPO 2006

ConclusionsConclusions 22

Carlo Senore CPO Piemonte, TorinoBruno Andreoni, Surgery Unit, European Institute of Oncology,

Milano, Luigi Bisanti, Epidemiology Unit. ASL "Citta' di Milano", Milano,Guido Castiglione, Gastroenterology Unit, CSPO, Firenze,

Arnaldo Ferrari, Gastroenterology Unit, Maria Vittoria Hospital, Torino,Alberto Foco, Gastroenterology Unit, S Giovanni AS Hospital , Torino,

Stefano Gasperoni, Gastroenterology Unit, Infermi Hospital, AUSL Rimini, Rimini, Giuseppe Malfitana, Gastroenterology Unit, Infermi Hospital, ASL 12, Biella,

Angelo Pera, Gastroenterology Unit, Mauriziano "Umberto I" Hospital, Torino, Serafino Recchia, Gastroenterology Unit, S Giovanni Bosco Hospital, Torino,

Mario Rizzetto, Gastroenterology Unit, S Giovanni Battista-Molinette Hospital, Torino, Marco Zappa, CSPO, Firenze, Italy