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					Colorectal Cancer: Michigan Issues and Liability

Developed with support from the Michigan Department of Community Health (MDCH) through a subcontract with the Michigan Public Health Institute (MPHI) Expert clinical review provided by John L. Pfenninger, M.D., Director of The National Procedures Institute
Changes or adaptations to slide content are referenced, with the understanding that they may not reflect the views of supporting organizations

Colorectal Cancer Screening
Objectives:
– Review current burden of colorectal cancer in Michigan – Explain the Michigan Cancer Consortium Colorectal Cancer Early Detection Recommendations – Discuss the importance of risk assessment as standard of care for colorectal cancer for Advance Practice Nurses in Primary Care – Describe liability issues associated with colorectal cancer

Percentage of Breast Cancer Cases Localized at Diagnosis by County
1988-1990 1998-2000

Ke we e na w Hou ghton

Ke we e na w Hou ghton

Onto na gon Gog eb ic

Onto na gon B ar ag a M a rqu ette Iro n Dic kinso n Alge r Sc ho olcr a ft De lta Luc e C hippe w a M a ck in ac Gog eb ic M a rqu ette Iro n Dic kinso n Alge r Sc ho olcr a ft De lta B ar ag a Luc e C hippe w a M a ck in ac

M e nom ine e

Em m e t C he boyga n C ha rle voix Antr im Lee la na u Otse go P re sque Isle M ontm o re nc y Alpe na

M e nom ine e

Em m e t C he boyga n P re sque Isle C ha rle voix Antr im Lee la na u M ontm o re nc y Otse go Alpe na

Osc od a Gr an d Ka lkas ka Alc ona B en zie C ra wf or d Tra ve rs e M issa uke e Oge m a w M a nistee Iosc o We xf or d R osc om m on M a son

Osc od a Gr an d Ka lkas ka Alc ona B en zie Tra ve rs e C ra wf or d M issa uke e Oge m a w M a nistee Iosc o R osc om m on We xf or d M a son Hur on Oc e an a Ne wa ygo M usk ego n Osc e ola Lak e M e co sta Ar en ac C la r e Gla dw in

Percentage of cases Less than 34.1% 34.1 - 43.3% 43.4 - 54.3% Greater than 54.3%

Lak e

Osc e ola M e co sta

Ar en ac C la r e Gla dw in

Oc e an a

Ne wa ygo M usk ego n

B ay M idla nd Isa be lla Sa gin aw Gr atiot

M ontc a lm

Tusc ola Sa nila c Lap ee r St C la ir

B ay M idla nd Isa be lla Sa gin aw Gr atiot

Hur on

Tusc ola

M ontc a lm

Sa nila c

Otta wa Ke nt

Ge ne se e C lin ton Ionia Sh iaw as see

Otta wa Ke nt

Ge ne se e C lin ton Ionia Sh iaw as see

Lap ee r St C la ir

Alle ga n Va n B ur en

B ar ry Ea ton

M a co m b Ingh am Oa kla nd Livingston

Alle ga n Va n B ur en

B ar ry Ea ton

M a co m b Ingh am Oa kla nd Livingston

Wa sh te na w C alho un Jac kso n Wa yne Ka lam a z oo M onr oe St Jose ph Hillsda le B ra nc h Len aw e e

Wa sh te na w C alho un Jac kso n Wa yne Ka lam a z oo St Jose ph M onr oe Hillsda le B ra nc h Len aw e e

B er rie n

C ass

B er rie n

C ass

An MCC priority objective for breast cancer is that by the year 2003, 80% of women will have received age-appropriate annual breast cancer screening with clinical breast examinations and mammography.

Percentage of Colorectal Cancer Cases Localized at Diagnosis by County
1988-1990 1998-2000

Ke we e na w Hou ghton

Ke we e na w Hou ghton

Onto na gon Gog eb ic

Onto na gon B ar ag a M a rqu ette Iro n Dic kinso n Alge r Sc ho olcr a ft De lta Luc e C hippe w a M a ck in ac Gog eb ic M a rqu ette Iro n Dic kinso n Alge r Sc ho olcr a ft De lta B ar ag a Luc e C hippe w a M a ck in ac

M e nom ine e

Em m e t C he boyga n C ha rle voix Antr im Lee la na u Otse go P re sque Isle M ontm o re nc y Alpe na

M e nom ine e

Em m e t C he boyga n P re sque Isle C ha rle voix Antr im Lee la na u M ontm o re nc y Otse go Alpe na

Osc od a Gr an d Ka lkas ka Alc ona B en zie C ra wf or d Tra ve rs e M issa uke e Oge m a w M a nistee Iosc o We xf or d R osc om m on M a son

Osc od a Gr an d Ka lkas ka Alc ona B en zie Tra ve rs e C ra wf or d M issa uke e Oge m a w M a nistee Iosc o R osc om m on We xf or d M a son Hur on Oc e an a Ne wa ygo M usk ego n Osc e ola Lak e M e co sta Ar en ac C la r e Gla dw in

Percentage of cases Less than 22.2% 22.2 - 27.7% 27.8 - 37.4% Greater than 37.4%

Lak e

Osc e ola M e co sta

Ar en ac C la r e Gla dw in

Oc e an a

Ne wa ygo M usk ego n

B ay M idla nd Isa be lla Sa gin aw Gr atiot

M ontc a lm

Tusc ola Sa nila c Lap ee r St C la ir

B ay M idla nd Isa be lla Sa gin aw Gr atiot

Hur on

Tusc ola

M ontc a lm

Sa nila c

Otta wa Ke nt

Ionia

Ge ne se e C lin ton Sh iaw as see

Otta wa Ke nt

Ionia

Ge ne se e C lin ton Sh iaw as see

Lap ee r St C la ir

Alle ga n Va n B ur en

M a co m b Ingh am Oa kla nd B ar ry Ea ton Livingston

Alle ga n Va n B ur en

M a co m b Ingh am Oa kla nd B ar ry Ea ton Livingston

Wa sh te na w C alho un Jac kso n Wa yne Ka lam a z oo M onr oe St Jose ph Hillsda le B ra nc h Len aw e e

Wa sh te na w C alho un Jac kso n Wa yne Ka lam a z oo St Jose ph M onr oe Hillsda le B ra nc h Len aw e e

B er rie n

C ass

B er rie n

C ass

An MCC priority objective for colorectal cancer is that by the year 2004, 50% of average-risk people will have received appropriate colorectal cancer screening.

Objective
• Review current burden of colorectal cancer in Michigan

Invasive Colorectal Cancer Incidence in Michigan by Stage at Diagnosis
50 45 40 35 30 25 20 15 10 5 0 2000
Source: MDCH Invasive colorectal cancer incidence by stage at Diagnosis 2002

47.9 35.8

InSitu Localized
11.4 4.9

Regional/Distant Unknown

Number of Colorectal Cancer Deaths and Cases Diagnosed in Michigan
• 1,899 deaths in Year 2001: -Males : 931
-Females: 968

• 5,142 new cases in Year 2000:
-Males: 2,585 -Females: 2,556

Estimated CRC Deaths By State 2003 - Top 10
5,000 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 0 California New York Florida Texas

2,000

Pennsylvania Ohio llinois Michigan New Jersey North Carolina

Source: American Cancer Society Facts & Figures 2003

Number of Michigan Colorectal Cancer Deaths by Age & Gender 2001
1,000 900 800 700 600 500 400 300 200 100 0
931 968 551 396 340 419

Male Female

112 4 5

72

All Ages Under 35

35-54

55-74

75+

Source MPHI: Michigan Resident Death Files, provided by MDCH, Division of Vital Records and Health Statistics.

Colorectal Cancer 5-Year Relative Survival Rates in Michigan by Stage and Race
Stage at Diagnosis

Total % 61.9 90.1
65.2 8.8 36.2

White % 62.6 90.7
65.9 9.0 36.5

Black % 52.8 84.2
57.4 7.6 35.4
Source: SEER Cancer Statistics Review 1973-1999

All Stages Localized
Regional Distant Unknown

Objective
• Explain the Michigan Cancer Consortium Colorectal Cancer Early Detection Recommendations

The Michigan Cancer Consortium Initiative
• Organizations working together to reduce the human and economic impact of cancer in Michigan

• Consensus Recommendations for Screening & Early Detection of Colorectal Cancer (adopted March 21, 2001) • Follow-Up guidelines for Abnormal Colorectal Cancer Screening Results
(adopted March 21, 2001)

MCC Priority Objective Colorectal Cancer
By 2004, increase to 50 percent the proportion of average-risk people in Michigan who have: • Received appropriate colorectal cancer screening • Received appropriate follow-up of abnormal screening results

Colorectal Cancer Screening - Michigan
50
P E R C E N T

45 40 35 30 25 20 15 10 5 0 15.3

18.6

17.6

FOBT and Colonsocopy Sigmoidoscopy (10yr) (1yr/5yr)

DCBE 5yr

Source - Michigan Cancer Consortium Data

Michigan Cancer Behavioral Risk Factor (CBRFS) Survey
• Phone survey done in 2001- 2002 • Provides population-based estimate of health related behaviors relevant to cancer morbidity & mortality in Michigan • Looked at CRC screening behaviors in adults over 50 years of age

CBRFS 2001-2002: Fecal Occult Blood Test (FOBT)
80 70
P E R C E N T 61.9 77.1 70.2

60 50 40 30 20 10 0
29.5 37.0 34.9

Ever Had FOBT FOBT in Past Year

50-64

65-74
Age

75+
Source: MPHI Special Behavioral Risk Factor Survey 2001-2002

CBRFS 2001-2002: Flexible Sigmoidoscopy (FS)
70 60 50 40 30 20 10 0
50 - 64 65-74 75 + 22.5 13.2 44.0 54.2 37.8 25.9 20.4 13.2 61.5

Ever Had Sigmoidoscopy Sigmoidoscopy in Last 5 Years Sig w/in 5 yrs + FOB w/in last yr.

Age
Source: MPHI Special Behavioral Risk Factor Survey 2001-2002

CBRFS 2001-2002: Colonoscopy Exam (CE)
45 40 35 30 % 25 20 15 10 5 0
41 32.5 34.2 23.9

21.8 15.5

Ever Had CE Had CE Past 10 Yrs.

50-64

65-74
Age

75+

Source: MPHI Special Behavioral Risk Factor Survey 2001-2002

CBRFS 2001-2002: Double Contrast Barium Enema (DCBE)
60 50 40 % 30 20 10 0 50 - 64 65 - 74 Age
Source: MPHI Special Behavioral Risk Factor Survey 2001-2002

47.0 41.3

51.0

Ever Had DCBE
20.5 15.3 20.8

Had Screening DCBE Past 5 Yrs.

75 +

MCC Guidelines - Average-Risk Women and Men Ages 50 and Older
Risk Category Recommendation# Age to Begin Age 50 Age 50 1. Interval

All people ages 50 and over not in the moderate risk or high risk categories on the next two slides

Either: 1. Fecal occult blood testing plus flexible sigmoidoscopy or 2. TCE***

2.

FOBT* every year, and flexible sigmoidoscopy every 5 years Colonoscopy every 10 years or DCBE every 5-10 years

* Single sampleFOBT done at the time of a digital rectal exam is not considered an acceptable form of CRC Screening. # Digital rectal examination should be done at the same time as sigmoidoscopy or colonoscopy.

***TCE includes either colonoscopy or DCBE. The choice of procedure should depend on the medical status of the patient and the relative quality of the medical examinations available in a specific community. FOBT = fecal occult blood testing TCE = total colon examination DCBE = double contrast barium enema

MCC Guidelines - Moderate-Risk

Women and Men
Risk Category People with a single, small (<1 cm) adenomatous polyp. Age to Begin At time of initial polyp diagnosis Recommendation Colonoscopy Comment Colonoscopy within 3 years after initial polyp removal; if normal, as per average risk recommendations (preceding slide)

People with a large (≥ 1 cm) adenomatous polyp or multiple adenomatous polyps of any size

At time of initial polyp diagnosis

Colonoscopy

Colonoscopy within 3 years after initial polyp removal; if normal, colonoscopy every 5 years

Personal history of curativeintent resection of colorectal cancer

Within 1 year after resection

Colonoscopy

If normal, colonoscopy in 3 years; if still normal, colonoscopy every 5 years

(Cont.)

MCC Guidelines - Moderate-Risk

Women and Men (continued)
Risk Category Colorectal cancer or adenomatous polyp in firstdegree relative before age 60 Age to Begin Age 40 (or 10 years before the youngest case in the family, whichever is earlier) Age 40 (or 10 years before the youngest case in the family, whichever is earlier) Recommendation Colonoscopy Every 5 years Comment

Colorectal cancer or adenomatous polyps in two or more first-degree relatives of any age Colorectal cancer in any other relatives (not included above)

Colonoscopy

Every 5 years

As per average risk recommendations (above); may consider beginning screening before age 50

MCC Guidelines - High-Risk

Women and Men
Risk Category Age to Begin Recommendation Comment

Family history of familial adenomatous polyposis (FAP)

Puberty

Early surveillance with endoscopy, counseling to consider genetic testing, and referral to a specialty center

If familial polyposis is confirmed, consider colectomy otherwise endoscopy every 1-2 years

Family history of hereditary non-polyposis colon cancer (HNPCC) Inflammatory bowel disease*

Age 21

Colonoscopy and counseling to consider genetic testing Colonoscopy with biopsies for dysplasia

Every 2 years until age 40, then every year

8 years after the start of colitis

Every 1-2 years

*The available scientific evidence is much stronger for ulcerative colitis than it is for other forms of inflammatory bowel disease such as Crohn’s disease.

Objective
• Discuss the importance of risk assessment as standard of care for colorectal cancer for Advance Practice Nurses in Primary Care

Etiology of CRC
• CRC is a multifactoral disease
–Nonhereditary forms of CRC involve diet, lifestyle and environmental factors

• Most CRC’s Start as Benign Polyps

Causes of CRC
FAP Familial
12 - 20%
<1%

HNPCC
5 - 6%

IBD
1- 2%

Sporadic
65 - 85%

HNPCC IBD Sporadic Familial FAP

Risk Factors for CRC
• Major Risk Factors for CRC include:
– Blood relatives with CRC or Polyps or known mutation in a hereditary colon cancer gene (ie: FAP or HNPCC) – Personal hx of CRC, Polyps or Inflammatory bowel disease (ulcerative colitis, Crohn’s disease)*

• Average Risk or General Population Risk for CRC include persons:
– Who have no personal or family history of colon cancer/polyps or IBD – With no symptoms that could be related to CRC/polyps/IBD
*There is no known association between Irritable Bowel & CRC

Familial Risk In CRC
Familial Setting Approximate Lifetime Risk of CRC

General population risk - US One FDR w/CRC Two FDR w/CRC FDR w/CRC < 50 years One SDR or TDR w/CRC SDR w/CRC FDR w/adenomatous Polyp

6% 2-3 Fold Increase 3-4 Fold Increase 3-4 Fold Increase ~1.5 fold increased ~2-3 fold increased ~2 fold increased

Definitions: FDR = First Degree Relative (parents, children, or siblings) SDR = Second Degree Relative (grandparents, uncles, aunts) TDR = Third Degree Relative (cousins or great-grandparents
Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin B, Woolf S, Johnson D, Kirk L, Litin S, Simmang C. Colorectal cancer screening and surveillance: Clinical guidelines and rationale - Update based on new evidence. Gastroenterology Feb. 2003. Vol 124, Number 2

Hereditary Colon Cancer Syndromes
• Familial Adenomatous Polyposis (FAP)
– Formerly known as Gardner’s Syndrome

– Attenuated FAP (AFAP) – Turcot’s Syndrome

• Hereditary Non-Polyposis Colon Cancer (HNPCC)
– Also known as Lynch Syndrome I & II

– Muir-Torre’s Syndrome – Turcot’s Syndrome

• • • • •

I1307K APC Mutation (in persons of Ashkenazi Jewish descent) Peutz-Jeghers Syndrome (PJS) Li-Fraumeni Syndrome Juvenile Polyposis (JP) Cowden’s Disease

Familial Adenomatous Polyposis (FAP)
• Autosomal dominant Inheritance - 1:10,000 births • High penetrance • ~1/3 represent new mutations = NO PRIOR

FAMILY HISTORY OF FAP

• • • •

Hundreds or thousands of polyps Average age of first polyp - 15 years 90% develop cancer by age 45 Other manifestations: UGI polyps, osteomas, desmoid tumors, congenital hypertrophy of the retinal pigment epithelium (CHRPE)

FAP
• Undetected Colon Cancer Rates:
– As high as 50-70% without screening – As low as 6% with screening of asymptomatic family members

• Attenuated FAP
– – – – Mutation is in the same gene as FAP 20 to 100 polyps rather than thousands Average age of onset of CRC = 10 years later than FAP Tendency toward right sided colonic adenomas

Bulow, Int. J. Colorect. Dis. 8:34-38,1993 Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin B, Woolf S, Johnson D, Kirk L, Litin S, Simmang C. Colorectal cancer screening and surveillance: Clinical guidelines and rationale - Update based on new evidence. Gastroenterology Feb. 2003. Vol 124, Number 2

Hereditary Non-polyposis Colon Cancer (HNPCC)
• Autosomal dominant (a.k.a. Lynch syndrome) • Early onset colorectal cancers (average age 45 years) • Preponderance of right sided lesions • Excessive rates of synchronous and metachronous lesions • Other malignancies (endometrial, ovarian, gastric, sm. bowel, renal)

HNPCC
• Lifetime risk of CRC is 82% & Endometrial cancer 60%# • Half of gene carriers develop ca before age 50 • Surveillance leads to detection of tumors in earlier stage when outcome is better • Surveillance can lead to reduction of CRC rate by as much as 62%*
#Winawer Gastroenterology 2003; 124:544-560 *Jarvinen, Gastroenterology 2000; 118: 829-834

HNPCC Amsterdam Criteria
• The rule of “Three, Two, One”

• At least 3 first-degree relatives involved
(one of whom must be a first-degree relative of the other 2)

• At least 2 generations involved • 1 member must have had colorectal cancer at <50 years of age • FAP has been ruled out
Vasen, DCR,34:424-425, 1991

Genetic Counseling
• Refer patients w/family hx suggestive of an inherited syndrome for genetic counseling* • Genetic counseling & genetic testing are recommended for high-risk families
• Centers in Michigan with Genetic Counselors for genetic evaluation of CRC
– Henry Ford – Karmanos Cancer institute – Michigan State University - Oakwood Hospital - Spectrum Health - University of Michigan

(Programs may have outreach clinics at other sites as well)
* Advance Practice Nurses who have appropriate training to do genetic counseling and

testing may provide these services within their practice - See ANA Standards

Genetic Testing
• Genetic Testing is available for HNPCC, FAP and I1307K • Involves providing a blood sample • Costs range from ~$325 - $1,950 depending on the test and mutation status of the family • Many insurance plans now cover • Genetic Counseling and Informed Consent are necessary • Michigan Public Act 29 requires written informed consent prior to presymptomatic or predictive genetic tests

Potential Benefits & Risks Associated with Cancer Genetic Testing
   

Medical Financial Psychological Familial

Advanced Practice Nurse’s Role in Primary Care
• Risk assessment + Screening based on identified level of risk • Referral when appropriate • Know the level of support within your practice and the scope of your license • Know your limits

Nursing Genetics
• ANA with ISONG has developed a Scope and Standards of Genetics Clinical Nursing Practice - 1998
– Basic Level - Sets minimum basic level of genetics knowledge & education for all nurses – Advanced Level - Sets minimum standards for knowledge & education for Advanced Practice Nurses (Includes graduate level coursework) – For more information contact the ANA
ANA = American Nurses Association ISONG = International Society of Nurses in Genetics

“Colon cancer can only be found if looked for. Colon cancer can only be cured if found early.”
J. Pfenninger - Introduction to Flexible Sigmoidoscopy

Objectives:
• Review current burden of colorectal cancer in Michigan • Explain the Michigan Cancer Consortium Colorectal Cancer Early Detection Recommendations • Discuss the importance of risk assessment as standard of care for colorectal cancer for Advance Practice Nurses in Primary Care