2013 CANCER PROGRAM ANNUAL REPORT

2003-2012 COLORECTAL CANCER

Praneetha Narahari, MD

Ellen Malek, CTR®

Saint Agnes Medical Center

Cancer Registry

1303 East Herndon Avenue

Fresno, CA 93720559 450-3570

www.samc.com

INTRODUCTION Colorectal cancer (CRC) is cancer that starts in the colon or the rectum,

both part of the large intestine. It can be also be referred to separately as Colon or Rectal Cancer. Of note, the Rectosigmoid (colon/junction) is an anatomical point which serves to distinguish the colon (proximal sigmoid) and the extraperitoneal portion of the rectum.

Colorectal cancer is the third most common cancer for both men and women in the United States. The estimated number of CRC cases for 2013 in the US are 102,480 new cases of colon cancer and 40,340 new cases of rectal cancer (1) and 300 expected new cases of colon cancer in Fresno County (2).

Overall lifetime risk of developing colorectal cancer is about 1 in 20 (5%). The risk is slightly lower for women than men.

While most people diagnosed with colorectal cancer do not have a family history of the disease those that do, have a significantly higher chance of being diagnosed with CRC. It is important to know your Family History (3) and share that information with your healthcare provider.

Colorectal cancer is the third leading cause of death in the United States when men and women are considered separately and second leading cause when both sexes are combined.

But the good news is that colorectal cancer is one of the most preventable cancers. The American Cancer Society believes that preventing colorectal cancer, not just finding it early, should be the reason for getting tested. For people of average risk for CRC screening should begin at age 50. This suggestion along with healthy lifestyle and dietary choices are important considerations. (4)

ANATOMY OF THE COLON

Rectosigmoid

DATA For the purposes of analysis, data includes analytic cases, those diagnosed and/or received

all or part of first course treatment at SAMC and for comparison, include histologies per National Cancer Data Base (6) criteria which excludes cases of lymphoma but does include neuroendocrine/carcinoid tumors (20) and sarcomas (2).

During the study period, 2003-2012 there were 1,477 analytic colorectal cancer cases diagnosed and/or treated at Saint Agnes Medical Center.

Between 2003-2007 the average number of analytic cases seen per month was 172. In contrast, between 2008-2012 that number was 123 cases per month.

Over the ten year period, 51% (753) were men and 49% (724) were women. Median age at diagnosis was 72. Age distribution of the observed patients was 20-

29 years old 0.5% (8), 30-39 1% (18), 40-49 7% (98), 50-59 15% (227), 60-69 20% (294), 70-79 27% (400), 80-89 24.5% (361), 90 years old and older 5% (71).

When compared to National Cancer Data Base data, Saint Agnes colorectal cancer patients appear to reflect a slightly older population with a higher portion, 29.5% compared to 22%, age 80 and older.

The race/ethnicity breakdown noted Non-Hispanic White accounted for 74% (1087), Hispanic 16% (231), Asian 7% (108), Black 3% (48) and Other (3).

Cases comprised 66% (972) Colon Cancer and 34% (505) Rectum and Rectosigmoid Cancers.

98.5% of the colorectal cancer cases were diagnosed by positive histology. As expected the majority of the cases 96.5% were adenocarcinomas. The remainder

encompassed 2% (32) carcinoma, nos, 1% (20) neuroendocrine (carcinoids tumors) and 0.5% included (3) squamous cell, (2) small cell, nos and (2) sarcoma.

Stage at diagnosis was found to be similar to state and national data; although, Saint Agnes Cancer Registry data demonstrated notably less unknown stage at diagnosis, 3% compared to 9%.

2003-2012 SAMC COLORECTAL CANCERCOMPARISON TO NATIONAL CANCER DATA BASEAGE AT DIAGNOSIS

49 & Under 50-59 60-69 70-79 80 & Over

9%

15%

20%

27%30%

10%

18%

23%

27%

22%

SAMC N=1477NCDB (1659 hospitals)

Resources: SAMC Cancer Registry, NCDB Benchmark Comparison Reports 2000-2011

o Polyp: Most colon cancers develop

from non-cancerous growths often arising from adenomatous polyps or polypoid adenoma.

o Stage 0 (in situ): Cancer has formed, but is not yet growing inside the colon or rectum walls.

o Stage I (local): Cancer is now growing in the colon or rectum walls; nearby tissue is not affected.

o Stage II-III (regional): Growth beyond the colon or rectum walls and into tissue or lymph nodes.

o Stage IV (distant): Cancer has spread to other parts of the body such as liver or lungs.

STAGES OF COLORECTAL CANCER

2003-2012 SAMC COLORECTAL CANCERCOMPARISON TO NATIONAL CANCER DATA BASESTAGE AT DIAGNOSIS

0 I II III IV UNK

5%

26%27%

21%

17%

3%

7%

22%24%

23%

15%

9%7%

22%23% 23%

16%

9%

SAMC N=1477Comp Comm CA Programs (all states)NCDB (1659 hospitals)

StageResources: SAMC Cancer Registry, NCDB Benchmark Comparison Reports 2000-2011

2003-2012 SAMC COLON CANCER TREATMENT BY STAGE N=972

Stage 0 N=46

I N=24

2

II N=28

6

III N=20

9IV

N=163SAMC TOTAL

Comp Comm CA ProgramsN=512,688

NCDB N=888,824

Surgery 93.5%

94%

77%

35%

29% 64% 62% 61%

Surg + Chemo 0% 1% 21%

62%

39% 27% 26% 26%

Other Specified Tx

2% 0% 2% 3% 15% 4% 6% 7%

None 4.5% 5% 0% 0% 17% 5% 6% 6%

*SURVIVAL Overall 5 Year 61.0% 55.2% Similar treatment practice was observed when comparing Colon

Cancer treatment by stage of those seen at Saint Agnes Medical Center between 2003-2012 and data compiled by the National Cancer Data Base for the years 2000-2011 for Comprehensive Community Cancer Programs from 815 hospitals and aggregate national data from 1660 hospitals; therefore, only overall comparison data is displayed. *National Cancer Data Base comparison of overall 5 year survival for the years 2003-2006 is provided.

Resource: 2003-2006 NCDB Survival Reports

2003-2012 SAMC RECTOSIGMOID COLON CANCER TREATMENT BY STAGE N=143

Stage 0 N=8

I N=35

II N=31

III N=37

IV N=25

SAMC TOTAL

Comp Comm CA ProgramsN=54,578

NCDB N=97,343

Surgery 88% 86% 48% 32% 28% 50% 50% 48%Surg + Chemo 0% 0% 26% 46% 40% 25% 18% 19%Surg + Rad + Chemo

12% 11% 26% 19% 12% 18% 18% 19%

Other Specified Tx 0% 0% 0% 3% 20% 4% 8% 9%

None 0% 3% 0% 0% 0% 3% 5% 5%*SURVIVAL Overall 5 Year 67.1% 58.3% Similar treatment practice was observed when comparing Rectosigmoid

Colon Cancer treatment by stage of those seen at Saint Agnes Medical Center between 2003-2012 and data compiled by the National Cancer Data Base for the years 2000-2011 for Comprehensive Community Cancer Programs from 802 hospitals and aggregate national data from 1622 hospitals; therefore, only overall comparison data is displayed. *National Cancer Data Base comparison of overall 5 year survival for the years 2003-2006 is provided. Resource: 2003-2006 NCDB Survival

Reports

2003-2012 SAMC RECTUM CANCER TREATMENT BY STAGE N=362

Stage 0 N=16

I N=113

II N=75

III N=70

IV N=57

SAMC TOTAL

Comp Comm

CA Program

sN=145,59

2

NCDB N=266,36

5

Surgery 88% 54% 24% 11.5%

7% 31% 36% 35%

Surg + Chemo 0% 0% 5% 10% 19% 6% 5% 5%Rad + Chemo 0% 4% 12% 4% 14% 8% 8% 8%Surg + Rad + Chemo

6% 33% 58% 71.5%

32% 42% 35% 35%

Other Specified Tx 0% 3% 1% 3% 10.5%

4% 8% 9%

None 6% 6% 0% 0% 17.5%

9% 7% 7%

*SURVIVAL Overall 5 Years

60.6%

59.2%

With minor exception, similar treatment practice was observed when comparing Rectum Cancer treatment by stage of those seen at Saint Agnes Medical Center between 2003-2012 and data compiled by the National Cancer Data Base for the years 2000-2011 for Comprehensive Community Cancer Programs from 805 hospitals and aggregate national data from 1637 hospitals; therefore, only overall comparison data is displayed. *National Cancer Data Base comparison of overall 5 year survival for the years 2003-2006 is provided.

Resource: 2003-2006 NCDB Survival Reports

STAGE II/III RECTUM CANCER N= 145 SPHINCTER SPARING SURGERY

The treatment of cancers of the mid to lower rectum and, generally of Stage II or Stage III disease, can often result in a permanent stoma (opening in the body) referred to as a colostomy. However, skilled surgeons aided by a change in the sequencing of treatment, in many cases can remove the tumors while preserving bodily function. Most often this is accomplished using ‘neoadjuvant’ treatment, the combination of chemotherapy and radiation before surgery to reduce the size of the tumor and make it easier to remove with clear surgical margins which allows preservation of the anal sphincter (surgery less than a total proctectomy).

As mentioned, 362 rectum cancers were accessioned into the SAMC Cancer Registry between 2003-2012 and 145 of these were Stage II/III cases. Of note, data collection codes do not allow a distinction to be made for upper, mid or lower rectum and must be considered in the interpretation of the data.

Of the 145 Stage II/III cases, 9% (13) did not undergo a surgical resection as treatment for their disease. 91% (132) were felt to be appropriate for surgery. Of those who had surgery, 65% (86) had less than a than a total proctectomy and 35% (46) required a total proctectomy.

To evaluate the use of combined treatment for sphincter preservation we analyzed 70 Stage II/III rectum cancer cases that had neoadjuvant chemo and radiation. During the 5 year intervals between 2003-2007 35% (11) required less than a total proctectomy and 65% (20) required total proctectomy. However, during 2008-2012 we see a reversal of the percentages, with 64% (25) undergoing less than a total proctectomy and 36% (14) having had a total proctectomy.

STAGE II COLORECTAL CANCER (T3,T4, LYMPH NODE NEGATIVE)

WHO RECEIVED CHEMOTHERAPY N=137 Adjuvant chemotherapy is not recommended for routine use in patients with Stage II

colorectal cancer. However, for certain subgroups that may be at higher than average risk for recurrence, it may be reasonable to consider its use. Features in Stage II CRC that are associated with increased risk of recurrence include inadequate lymph node sampling (<12), T4 disease, involvement of the visceral peritoneum and poorly differentiated histology. Other consideration include presence of lymphovascular invasion, obstruction, perforation, positive surgical margin (7). Evidence is inconsistent that adjuvant chemotherapy is associated with improved overall survival when compared to surgery alone. The decision to use adjuvant chemotherapy is complicated and requires thoughtful consideration by both the patient and their physician (8).

During the study period, 2003-2012 there were 392 Stage II colorectal cancers accessioned into the Cancer Registry. Of these, 35% (137) received chemotherapy as part of first course treatment. When this practice was reviewed over a twenty year period 1993-2012, Saint Agnes oncologists utilized chemotherapy for Stage II CRC in a consistent manner which was comparable with national patterns of care; although, NCDB comparison data does not display the sequence in which chemotherapy was given i.e. neoadjuvant versus adjuvant.

Of the 377 Stage II CRC cases treated by surgical resection, 21% (81) received adjuvant chemotherapy. Of those, 37% (30) had less than 12 regional lymph nodes removed/examined at the time of surgery which likely contributed to the decision to treat with adjuvant chemotherapy.

When we looked at the survival of patients treated at Saint Agnes Medical Center with Stage II colorectal cancer over the years 1993-2012 an increased survival was observed for those who received chemotherapy when compared to those who did not. 2003-2006 NCDB comparison data indicates our survival numbers for colorectal cancer are better than average as far as the institution of chemotherapy and survival.

1993-2012 SAMC STAGE II COLORECTAL CANCERRECEIVED SYSTEMIC TREATMENT BY 5 YEAR INTERVALS

1993-1997 N=147

1998-2002 N=249

2003-2007 N=239

2008-2012 N=153

39% 41%

34%37%

Adjuvant Chemo

36%

AdjuvantChemo

34%AdjuvantChemo

23%

Adjuvant Chemo

24%

Resource: SAMC Cancer Registry

NATIONAL CANCER DATA BASE COMPARISON2000-2011 STAGE II COLORECTAL CANCERRECEIVING SYSTEMIC TREATMENT

Chemo Given29%

30%

31%

32%

33%

34%

35%

36%

37%

38%37%

32%

33%

SAMC N=520Comp Comm CA Programs (all states)NCDB (all hospitals)

Resources: SAMC Cancer Registry, NCDB Benchmark Comparison Reports 2000-2011

1993-2012 SAMC STAGE II COLORECTAL CANCERSURVIVAL BY YEARN=788

YR 1 YR 2 YR 3 YR 4 YR 5 0%

20%

40%

60%

80%

100%

120%

84.8%77.2%

70.6%60.2%

51.3%

96.6%89.7% 85.4%

79.9% 76.1%

No Chemo N=428Chemo Given N=297

Resource: SAMC Cancer Registry

NATIONAL CANCER DATA BASE COMPARISON2003-2006 STAGE II COLORECTAL CANCER5 YEAR SURVIVAL

70.5%SAMC N=131

66.1% NCDB

N=75,512

Resources: SAMC Cancer Registry, NCDB Survival Reports

NATIONAL CANCER DATA BASE CANCER PROGRAM PRACTICE PROFILE REPORTS (CP3R) FOR COLON & RECTAL CANCERS CP3R performance rates provided match the specifications of the colon and

rectal cancer care measures endorsed by the National Quality Forum. The American College of Surgeons Commission on Cancer’s National Cancer

Data Base ratings are based on Cancer Registry annual data submissions. The ratings provide approved cancer programs such as Saint Agnes Cancer

Program, an opportunity to evaluate the proportion of colorectal cancer patients treated according to evidence based practice guidelines which ensures that we achieve and maintain the highest level of care for our patients. Colon measure (ACT): adjuvant chemotherapy is considered or administered

within 4 months (120 days) of diagnosis for patients under age of 80 with AJCC Stage III (lymph node positive) colon cancer.

Colon measure (12RLN): at least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer.

Rectum measure (AdjRT): Radiation therapy is considered or administered within 6 months (180 days) of diagnosis for patients under age 80 with clinical or pathologic AJCC T4N0M0 or Stage III receiving surgical resection for rectal cancer.

Saint Agnes Medical Center’s Cancer Program met and/or exceeded compliance for each of the three colorectal cancer performance measures evaluated by the National Cancer Data Base for 2009, 2010 and 2011. Findings are displayed on the following 3 graphs.

NATIONAL CANCER DATA BASE COMPARISONCANCER PROGRAM PERFORMANCECOLON MEASURE ACT

2009 2010 2011

100%

83% 86%84% 84% 83%88% 90% 89%

SAMC CalifNCDB (all hospitals)

Resource: NCDB Cancer Program Practice Profile Reports (CP3R)

NATIONAL CANCER DATA BASE COMPARISONCANCER PROGRAM PERFORMANCECOLON MEASURE 12RLN

2009 2010 2011 2012

89%80%

88%83%84% 85% 87%85% 87% 88%

SAMC Calif NCDB (all hospitals)

Resources: SAMC Cancer Registry, NCDB Cancer Program Practice Profile Reports (CP3R)

NATIONAL CANCER DATA BASE COMPARISONCANCER PROGRAM PERFORMANCERECTUM MEASURE ADJRT

2009 2010 2011

83%

100% 100%94% 91% 90%94% 93% 93%

SAMC Calif NCDB (all hospitals)

Resource: NCDB Cancer Program Practice Profile Reports (CP3R)

2003-2012 SAMC COLORECTAL CANCERDIAGNOSED AGE 50 & UNDER N=147 Studies acknowledge that the patient population, age 50 and younger, is more

likely to be diagnosed with late-stage colorectal cancer. It is believed that many people may not suspect cancer when symptoms like bleeding, abdominal pain, or a change in bowel habits strike someone in their 30s or 40s. The result is often a delay in diagnosis. (9)

During the study period 2003-2012 there were 147 (10%) cases of colorectal cancer that were diagnosed at age 50 or younger (inclusive of one patient diagnosed with two simultaneous colon primaries). Of the 147 cases, stage at diagnosis distribution showed 5% (6) were Stage 0, 27% (40) Stage I, 18% (26) Stage II, 29% (43) Stage III and 18% (26) were Stage IV. When comparing stage at diagnosis by age our findings clearly reflect a higher stage at diagnosis for those age 50 and under. Additionally, 11% (16) of these patients had a personal history of at least one other primary cancer.

Saint Agnes Cancer Program would like to relay the message stressed by experts, “Just because you’re under 50 doesn’t mean you’re not at risk.” Regardless of age, if you experience symptoms such as the ones noted and/or have a family history of colorectal cancer especially in a relative who had CRC before age 50, speak with your healthcare provider immediately to investigate your concerns.

Since 2006 following the Bethesda Guidelines (10), efforts by our Cancer Committee have helped ensure managing physicians of patients age 50 and younger who have a diagnosis of colorectal cancer established at Saint Agnes Medical Center or those identified with other types of cancer meeting criteria, are informed that their patient may be at risk of a hereditary cancer predisposition syndrome. In these instances, genetic consultation and testing may be indicated for better patient care. In hopes of preventing future cancers, we feel that armed with this knowledge, patients, families and their physicians can make informed decisions about their health care now and in the future.

2003-2012 SAMC COLORECTAL CANCER STAGE BY AGE N=1477

0 I II III IV UNK

4%

27%

18%

29%

18%

2%5%

26%27.5%

20.5%

16%

4%

Age 50 & UnderAge Over 50

Resource: SAMC Cancer Registry

SUMMARY / RECOMMENDATIONS Saint Agnes Medical Center strives to provide the highest level of cancer care to those who

put their trust in us. As the data presented reveals our Saint Agnes team of cancer professionals are treating colorectal cancer patients appropriately and consistent with the highest quality cancer care as compared to the national data.

Saint Agnes Medical Center survival numbers for colorectal cancer indicate we are better than average as far as the institution of chemotherapy and Survival.

Our Saint Agnes cancer specialists guided by the vision to deliver optimum care and outcomes for our patients will continue to utilize the best treatments and newest technologies. For example, in the future individualized care plans for colorectal cancer will include the use of genomic assays to guide decisions about chemotherapy rather than the stage of disease.

The American Cancer Society has identified colorectal cancer as a major priority because the application of existing knowledge has such great potential to prevent cancer, diminish suffering, and save lives. With this in mind, Saint Agnes Medical Center would like to convey the importance of knowing the facts about colorectal cancer. Don’t let embarrassment guide your decision to get screened or to seek medical advice if you experience symptoms.

Screening has the potential to prevent colorectal cancer because most colorectal cancers develop from adenomatous polyps. Polyps are noncancerous growths in the colon and rectum. Though most polyps will not become cancerous, detecting and removing them through screening can actually prevent cancer from occurring. Furthermore, being screened at the recommended frequency (beginning at age 50 for those of average risk) increases the likelihood that when colorectal cancer is present, it will be detected at an earlier stage, when it is more likely to be cured, treatment is less extensive, and the recovery is much faster.

In addition to screening, Saint Agnes Medical Center encourages everyone to know their family history. In the case of colorectal cancer, sharing this information can help spare you or your loved ones from a diagnosis of colorectal cancer or provide a significant advantage by catching it early. Know your genes!

SOURCES(1) American Cancer Society; www.cancer.org(2) California Cancer Facts & Figures 2013(3) Family Health Portrait; www.samc.com/genetic-counseling(4) American Cancer Society; www.cancer.org(5) SAMC Cancer Registry database; www.samc.com

*Comment: This report is developed from our hospital based registry experience which is not ‘population based’ data.

(6) American College of Surgeons, Commission on Cancer’s National Cancer Data Base; www.facs.org NCDB Benchmark Comparison Reports Cancer Program Practice Profile Reports (CP3R)

(7) National Cancer Institute; www.cancer.gov(8) American Society of Clinical Oncology Recommendations; www.Cancer.net(9) WebMD article, ‘Colorectal Cancer on the Rise in Adults Under 50’, citing Archives of Internal Medicine, Dec.12, 2011; www.webmd.com/colorectal-cancer/news/20111212(10) National Comprehensive Cancer Network (NCCN) Guidelines for Detection, Prevention & Risk Reduction, Revised Bethesda Guidelines ; www.nccn.org