COLON CANCER PROFILE 2012} Cancer Outcomes Analysis Report. The Institute for. Cancer Care

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1 COLON CANCER PROFILE 2012} Cancer Outcomes Analysis Report The Institute for Cancer Care

2 FACT} People with a first-degree relative (parent, sibling, or children) who has colon cancer are between two and three times the risk of developing the cancer than those without a family history.

3 Message from the Chairman and Physician Liaison With many accomplishments in 2012, The Institute for Cancer Care at Mercy is proud once again to receive the Commission on Cancer Gold Status Accreditation with Commendation. This prestigious accreditation is the seal of approval for cancer programs from the American College of Surgeons and formally acknowledges Mercy s commitment to providing high-quality cancer care to our community. Equally gratifying, U.S. News and World Report named Mercy Medical Center a Best Regional Hospital in Cancer. Each year the Cancer Committee at Mercy selects an outcome study for analysis. In 2012, the Cancer Committee selected one of Mercy s top 10 primary sites to profile: colon cancer. This profile on colon cancer highlights the occurrences at Mercy utilizing the Mercy Cancer Registry database and referencing data from the National Cancer Database (NCDB) Commission on Cancer. Comparisons from the data reported to the NCDB for the State of Maryland and the NCDB American Cancer Society South Atlantic Region is used. With regular screening, colon cancer can be found and treated for most effective results. At Mercy, colon cancer screenings are encouraged and are made possible for the underinsured and the uninsured with a grant from CDC in coordination with the Maryland Department of Health and Mental Hygiene. At Mercy, we continue to treat our cancer patients in a multi-disciplinary program that offers the highest quality of care. Please read this report that outlines how Mercy s colon cancer data compares to local and national data. Marvin J. Feldman, M.D. Chair, Cancer Committee Armando Sardi, M.D. Commission on Cancer Physician Liaison ONE

4 Dr. Armando Sardi, Medical Director, The Institute for Cancer Care at Mercy, Dr. Kurtis Campbell, surgical oncologist, and Dr. Peter Ledakis, medical oncologist, are among the best cancer doctors in Maryland to treat colon cancer. TWO

5 THE COLON CANCER PROFILE About Colon Cancer Colon cancer is cancer of the large intestine, also known as the colon. Rectal cancer is cancer in the last few inches of the colon. Colon and rectal cancer together are known as colorectal cancer. in This compares to 1,027 patients with newly diagnosed colon cancer in the State of Maryland. Gender The gender distribution shows a female predominance (66% females vs. 34% males) which is actually higher than that in the South Atlantic Region (52% females vs. 48% males). The incidence has been slowly declining in the U.S over the past 15 years. The incidence of colorectal cancer in the United States is approximately 143,000 patients per year. Approximately 100,000 of them are colon cancers. It is the second leading cause of death in the United States with approximately 50,000 deaths annually. Lifestyle factors and their combined impact on the risk of colorectal polyps. Fu Z. Shrubsole MJ, Smalley WE, Wu H, Chen Z, Shyr, Ness RM, Zheng W. AM J Epidemiol Nov 1;176(9): doi: /aje/kws 157.Epud 2012 Oct. 18 Klabunde CN, Cronin KA, Breen N, et. al. Trends in colorectal cancer test use among vulnerable populations in the United States. Cancer Epidemiol Biomarkers Prev 2011; GENDER This colon cancer profile outlines Mercy Medical Center s experience from Data will be compared to the National Cancer Data Base (NCDB) for the State of Maryland and for the NCDB American Cancer Society South Atlantic Region, which includes the District of Columbia, Delaware, Florida, Maryland, Virginia and West Virginia. Percent of Cases 70% 60% 50% 40% 30% 20% 10% Mercy n = 86 NCDB - MD n = 1,027 NCDB - SAD n = 6,207 The profile will disclose the pattern of disease development, screening, stages of the disease, treatments, and survival. 0% Mercy NCDB - State of MD MALE FEMALE 34% 66% 46% 54% There were 86 new cases of colon cancer at Mercy Medical Center NCDB - ACS-SAD 48% 52% THREE

6 Colon Cancer Risk Factors Higher incidence correlates with lower socioeconomic status. It appears that consumption of red and processed meat may increase the incidence of colon polyps and cancer. There is also strong evidence that obesity, smoking and low calcium may be associated with malignant and pre-cancerous lesions. There has been a shift in the anatomic distribution of colon cancer from distal to proximal colon. In addition, it appears that non-steroidal anti-inflammatory agents may have a protective effect against the formation and transformation of colon adenomas as well as colon cancer. Inflammatory bowel disease such as ulcerative colitis and Crohn s disease, which both involve the colon, is associated with higher risk. Other risk factors include prior polyps, colon cancer, and first-degree relatives diagnosed before the age of 50. The two most common inherited syndromes of colon cancer are HNPCC (Hereditary Nonpolyposis Colorectal Cancer Lynch syndromes) and FAP (Familial Adenomatous Polyposis). HNPCC is inherited as an autosomal dominant pattern. It is associated with 5% of all colorectal cancers. Patients with Lynch II syndrome may also develop ovarian, pancreatic, endometrial, breast, bladder and other GI tract malignancies. HNPCC cancers are associated with mutations in genes involved in DNA repair, such as MSH-2, MSH-6, MLH-1 among others. Those mutations cause the DNA abnormality of microsatellite instability (MSI). Those tumors are usually characterized as MSI high (MSI-H) meaning that the DNA repair has suffered significant damage. HNPCC is associated with mucinous, more proximally located tumors, younger age at diagnosis, and better overall prognosis. FAP is caused by mutations in the APC gene that regulates the Wntsignaling pathway. These patients develop hundreds or thousands of polyps and are predisposed to developing cancers from a very young age. Interestingly, mutations of the DNA repair genes and the APC genes are also found in 10% and 80% of sporadic cancers respectively. Screening Colon cancer can be successfully treated if detected early. At Mercy, regular colon cancer screening is encouraged in order to detect and treat any possible colon cancer early. The expert surgeons, Dr. Thomas Swope, Director, Dr. Nora Meenaghan, and Dr. Kelly Alexander, at The Center for Minimally Invasive Surgery at Mercy in Baltimore, Maryland, provide minimally invasive surgical treatment options, including colon resection. FOUR The screening tests for colon cancer include: Fecal occult blood testing (FOBT) Digital rectal examination (DRE) Sigmoidoscopy

7 THE COLON CANCER PROFILE AGE AT DIAGNOSIS 30% 25% 20% Mercy n = 86 NCDB - MD n = 1,027 NCDB - SAD n = 6,207 Percent of Cases 15% 10% 5% 0% Mercy 0% 3% 8% 26% 23% 24% 13% 2% NCDB - State of MD 1% 2% 7% 19% 21% 24% 22% 4% NCDB - ACS-SAD 1% 2% 7% 18% 25% 26% 18% 3% Colonoscopy Air-contrast barium enema and virtual CT colonography Despite evidence that screening reduces mortality from colon cancer, the national compliance is less than 50%. Overall, in the past several years there has been a shift towards recommending colonoscopy over annual FOBT combined with sigmoidoscopy. This reflects the need to detect more proximal cancers particularly since there has been a shift in the location to more proximal tumors. Therefore, the most widely accepted recommendation is colonoscopy every five to 10 years for an average risk patient starting at age 50. Colonoscopy should be performed every one to three years beginning at the age 25 in HNPCC and even earlier in FAP. Age at Diagnosis In 2012, the age range of Mercy patients diagnosed with colon cancer was from 30 to 90+ years. The percentage of patients younger than 60 years old was higher than statewide and in the region (37% vs. 29% and 28% respectively). FIVE

8 FACT} There are more than one million colon cancer survivors in the United States. AJCC STAGE Percent of Cases 35% 30% 25% 20% 15% 10% 5% 0% Mercy NCDB - State of MD NCDB - ACS-SAD Mercy n = 86 NCDB - MD n = 1,027 NCDB - SAD n = 6,207 Stage 0 8% 5% 6% Stage I 14% 22% 21% Stage II 23% 27% 26% Stage III 20% 27% 26% Stage IV 33% 17% 18% Unknown 2% 3% 4% Dr. Vadim Gushchin, Director of Gastrointestinal Oncology, provides patients an integrated approach to fight cancer and restore hope and vitality. Stage Over half of colon cancers diagnosed at Mercy were Stage III or IV. Mercy patients with Stage I or II disease (negative lymph nodes) and who traditionally do not require postoperative chemotherapy, were only 37% of the cohort as opposed to 49% statewide and 47% in the South Atlantic Region. The proportion of Stage IV at diagnosis was almost double of that statewide and in the region (33% vs. 17% and 18% respectively). Examining how many of those patients actually had screening colonoscopy would provide further insight in the reasons for that disparity. SIX

9 THE COLON CANCER PROFILE Treatment Early Stage The primary treatment for all invasive, nonmetastatic (Stage I, II and III) colon cancers is surgical resection. Laparoscopic surgery provides the same outcomes in colon cancer as open laparotomy. The number of lymph nodes resected (minimum of 12) has prognostic significance. Obviously, stage at diagnosis is associated with outcomes. Additional factors include undifferentiated histology, lymphvascular invasion, signet-ring features, male sex and preoperative high CEA level. Ongoing research aims at identifying molecular features (molecular signatures) that may have prognostic and predictive significance and that might guide our treatment approach. Adjuvant chemotherapy has been established as the standard of care in Stage III colon cancer (lymph node involvement). The current standard adjuvant regimen includes FIRST COURSE OF TREATMENT Percent of Cases Mercy 70% 60% 50% 40% 30% 20% 10% NCDB - State of MD NCDB - ACS-SAD 0% Surgery Only Surgery/ Chemotherapy 56% 31% 8% 5% fluorouracil, folinic acid, oxaliplatin (FOLFOX or FLOX). Updated results in patients over the age of 65 indicate that oxaliplatin does not improve outcomes and instead adds toxicity as compared to the 5-FU/ Leucovorin combination. Neither irinotecan nor bevacizumab both agents utilized in Stage IV disease have an established role in the adjuvant setting. The role of adjuvant chemotherapy in Stage II disease remains controversial and the great majority of patients Other Specified Therapy Mercy n = 86 NCDB - MD n = 1,027 NCDB - SAD n = 6,207 No 1st Course Treatment 45% 42% 9% 3% 59% 29% 7% 5% do not benefit from it. Ongoing investigations aim at identifying Stage II tumors with certain anatomic, histologic, clinical and molecular features that may require and benefit from adjuvant chemotherapy. It appears that the percentage of patients who receive chemotherapy in addition to surgery is higher at Mercy compared to statewide and South Atlantic Region (42% vs. 31% and 29% respectively). SEVEN

10 Advanced (Stage IV) Disease The majority of Stage IV tumors are not curable, and for patients with metastatic disease, the goal of therapy continues to be palliation using systemic chemotherapy. There has been significant improvement in outcomes with the advent of modern agents over the past several years. Available options include cytotoxics such as 5-FU, the oral fluoropyrimidine capecitabine, irinotecan, and oxaliplatin as well as biological agents targeting the vascular endothelial growth factors (VEGF A and B) and their receptors such as bevacizumab and Ziv-aflibercept. The anti- EGFR antibodies cetuximab and panitumumab can be utilized in KRAS wild type cancers and the multikinase inhibitor regorafenib was recently approved in Stage IV cancers that progressed after previous systemic therapy. Molecular testing of the tumor cells for KRAS and BRAF mutations as tools to evaluate the prognosis and guide treatment is supported by multiple recent studies. The current paradigm of care calls for a goal-oriented and individual patient-tailored treatment approach in order to maximize benefit. Metastatic disease should be evaluated upfront Dr. Debra Vachon, Surgical Director, The Center for Inflammatory Bowel and Colorectal Diseases at Mercy, is a recognized surgical specialist in the diagnosis and treatment of colorectal diseases. for resectability and a multidisciplinary team, including surgical oncology, radiation oncology and interventional radiology should participate in the decision-making strategy. Surgical resection of metastases, i.e.: liver lesions, may take place at the time of diagnosis or more often after downsizing by preoperative systemic chemotherapy. At The Institute for Cancer Care at Mercy, patients with tentatively resectable and, therefore, curable Stage IV colon cancer are routinely evaluated by our multi-disciplinary team in one of our cancer conferences. EIGHT

11 THE COLON CANCER PROFILE Multiple studies as well as our Institutional experience have shown that a subgroup of patients with resected liver metastases and systemic chemotherapy may achieve a prolonged diseasefree survival. The average fiveyear survival is approximately 30%, which constitutes a major improvement over the past several years. The optimal timing and choice of perioperative systemic chemotherapy has not been determined yet. In addition, new evidence data shows benefit from resection of metastatic sites outside the liver, such as lung lesions. While the optimal duration of systemic therapy in Stage IV colon cancer is unclear, recent international studies have supported the use of maintenance therapy, often utilizing the VEGF antibody bevacizumab. Our medical oncologists, Dr. Sandy D. Kotiah (center) and Dr. David Riseberg (right), work with a team of cancer specialists, including Case Manager, Diane Bartel (left), to provide comprehensive cancer care for patients. NINE

12 Survival The five-year survival of Mercy patients is 55%, identical to NCDB data. Survival curves per year overlap. Since a higher proportion of our patients are diagnosed with Stage IV disease, one could extrapolate that the median survival of those patients is higher than the rest of the region but that needs to be further examined. Conclusion FIVE-YEAR OBSERVED SURVIVAL Percent of Cases 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Mercy n = 295 NCDB n = 214,540 Colon cancer is a common malignancy among Mercy patients. A higher percentage of our patients are diagnosed with Stage IV disease, although the five-year observed survival is identical to NCDB data. Over the past several years, there has been a significant progress in the outcomes of advanced stage disease with resection of metastatic sites as well as more effective systemic therapies. At Mercy, we are committed to providing excellent state-of-the-art care to patients with colon cancer and we work closely together and coordinate our efforts among our multidisciplinary team. 0% At Diagnosis The Institute for Cancer Care Year 1 Year 2 Year 3 Year 4 Year 5 Mercy 100% 83% 73% 66% 59% 55% NCDB 100% 81% 72% 65% 60% 55% Report prepared by Dr. Peter Ledakis, Medical Oncology and Hematology at Mercy, and Cathy Sudborough, Manager, Mercy Cancer Registry. 227 St. Paul Place Baltimore, Maryland MDheals TEN

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