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The 2014 Cancer Program Annual Public Reporting of Outcomes/Annual Site Analysis Statistical Data from 2013 More than 70 percent of all newly diagnosed cancer patients are treated in the more than 1,500 Commission on Cancer (CoC)-accredited cancer programs nationwide. For patients and the community, the quality standards established by the CoC ensure a comprehensive approach to care and information about clinical trials and new treatment options. MMH has been a CoC accredited Cancer Program since November 2000. To earn accreditation, we must successfully complete an on-site CoC review every three years that assesses our compliance with the CoC standards, including assurance that patients are afforded access to a full range of diagnostic and treatment services. It is recognition of the quality of our comprehensive, multidisciplinary patient care. ECHN strives to provide access to enhanced cancer care and services in a comfortable environment close to home. Patients are guided through the continuum of care with continued support, while they experience precise treatment and management plans tailored to their individual needs. Our team takes pride in the fact that we are continually working to enhance services, treatments and technologies available to our patients. Annually, the Cancer Program publishes a Public Reporting of Outcomes/Annual Site Analysis. We have selected prostate cancer as our focus this year due to the common nature of this malignancy and the potential benefits derived from early diagnosis. In addition, the American College of Surgeons, Commission on Cancer encourages hospitals, treatment centers and facilities to improve the quality of patient care through a variety of improvement programs. One of the latest revisions to the program standards includes patient outcomes. The goal is to ensure that evaluation and treatments conform to evidence-based national treatment guidelines. Each year a physician performs a study to assess whether ECHN cancer patients are evaluated and treatment according to evidence based national treatment guidelines. ECHN is extremely proud to share our patient’s outcomes results in this report. Analyses of the 2013 newly diagnosed prostate cancer patients indicate ECHN exceeds the national and state average in many areas. Analysis of Prostate Cancer at Easter Connecticut Health Network Using Cancer Registry Data Goal: To determine whether a community-based comprehensive cancer program can provide care to prostate cancer patient’s that is competitive to care provided at academic/tertiary care centers in terms of techniques and outcomes. The ECHN Cancer Registry and national data base were used for this comparative study. Criteria: Data includes records of newly diagnosed patients seen at ECHN or referred from another facility for complete or part of first course of treatment. Comparative retrospective analyses were performed using the National Cancer Data Base (NCDB) including Comprehensive Community Cancer Hospitals in all states. Source: Cancer Registry Data Base at ECHN. 1 Number of Prostate Cancer Cases Diagnosed and/or Treated by Year New Cases: According to the American Cancer Society (ACS) it is estimated there are nearly 3 million men with a history of prostate cancer living in the US as of January 1st, 2014 and an additional 233,000 men will be diagnosed in 2014. Prostate cancer is the most frequently diagnosed cancer in men aside from skin cancer. For reasons that remain unclear, incidence rates are about 60% higher in African-Americans than in non-Hispanic whites. Incidence rates for prostate cancer changed substantially between the mid-1980’s and mid1990’s and have since fluctuated widely from year to year, in large part reflecting changes in the use of the prostate-specific antigen (PSA) blood test for screening. Comparative analysis of the NCDB data to ECHN data (please see below) notes a decrease in the number of newly cases from 2011 to 2012 both locally and nationally. In 2011 ECHN diagnosed 117 new cases with 87 cases diagnosed in 2012. Although this shows a 25% decrease in the number of cases diagnosed annually, it remains our third most common malignancy diagnosed and treated at ECHN. Similarly, the NCDB shows 55,894 newly diagnosed cases in 2011 and 45,084 diagnosed in 2012 (data was not available to compare for 2013). This represents a decrease of 19%. The decrease in volume could be attributed to the new PSA screening criteria introduced at that time. Until recently, many doctors and professional organizations encouraged yearly PSA screening for men beginning at age 50. Some organizations recommended that men, who are at higher risk of prostate cancer, including African American men and men whose father or brother had prostate cancer, begin screening at age 40 or 45. However, as more has been learned about both the benefits and harms of prostate cancer screening a number of organizations have begun to caution against routine population screening. Although some organizations continue to recommend PSA screening, there is widespread agreement that any man who is considering getting tested should first be informed in detail about the potential harms and benefits. 2 Number of Prostate Cancer Cases Diagnosed and/or Treated by Year 118 117 115 92 87 ECHN Newly Diagnosed Prostate Cancer Cases 2009 - 2013 2010 2009 ECHN 118 115 59064 55454 2011 2012 2013 117 87 92 55894 45084 NCDB Newly Diagnosed Prostate Cancer Cases 2009-2012 NCDB 2009 59064 2010 55454 2011 55894 2012 45084 3 Age Group of Prostate Cancer ECHN versus Comprehensive Community Cancer Programs in All States 714 Hospitals (NCDB) Newly Diagnosed Prostate Cancers ECHN vs NCDB Age at Diagnosis 25% 43% 39% 25% 23% 24% 9% 2% 7% 3% 40-49 50-59 60-69 70-79 80+ ECHN 2% 25% 39% 25% 9% NCDB 3% 23% 43% 24% 7% Risk Factors: The only well established risk factors for prostate cancer are increasing age, African ancestry, or a family history of the disease. Studies suggest that a diet high in processed meat or dairy foods may be a risk factor and obesity appears to increase the risk of aggressive prostate cancer. Above, NCDB data shows 74% of all prostate cancer cases were diagnosed in men 60 years of age or older and 97% occurred in men 50 or older. Similar to the NCDB data, ECHN diagnosed 73% of men age 60 or older with 98% diagnosed in men 50 or older. Grade & Stage of Prostate Cancer at Diagnosis Every cancer has a system of staging and grading that is specific to that type of cancer. Stage describes how advanced a cancer is, whereas grade describes how much or little it looks like normal tissue and how likely it is to spread. The stage and grade can help select and predict the prognosis of the cancer. The most commons grading system for prostate cancer is the Gleason score. It is based on how the tissue sample looks. Grade 1 looks most like normal tissue and grade 5 looks very different. Because more than one pattern is frequently seen in a sample, the 2 most commonly seen patterns are added together to give you a Gleason score. It is uncommon to see scores less than 6. Gleason 6 cancers are called low grade, Gleason 7 are intermediate grade and Gleason 8, 9 and 10 are high grade. Images of the grades can be seen below: 4 Prostate cancer is staged by the tumor, node and metastasis (TNM) staging system. ECHN, as well as nationally, identify most newly diagnosed cases at Stage II. This means the majority of prostate cancers are discovered in the local or regional stages for which the 5year survival rate approaches 100%. Stage at Diagnosis: ECHN versus Comprehensive Community Cancer Programs in All States - 714 Hospitals (NCDB) 57% 57% Newly Diagnosed Prostate Cancer ECHN versus NCDB Stage at Diagnosis 32% 23% 10% 5% 6% 6% 0% 3% STAGE I STAGE II STAGE III STAGE IV UNKNOWN ECHN 32% 58% 5% 5% 0% NCDB 24% 57% 10% 6% 3% Stage: ECHN continues to diagnose and treat early stage cases in a manner higher than the national average. 89% of ECHN patients were diagnosed with Stage I or II disease compared to the NCDB at 80%. Only 10% of ECHN patients were diagnosed with late stage disease compared with 16% nationally. 5 Treatment at Diagnosis Decision making regarding initial treatment choice is made as a collaborative effort between clinicians and the patient, taking into consideration the patient’s physical status, possible co-morbidities, social economic support systems, treatment options and personal preferences. The approach to treatment is influenced by age stage and grade of cancer, as well as co-existing medical conditions and should be discussed with the individual patient. Surgery (open, laparoscopic or robotic-assisted), external beam radiation or radioactive seed implants (brachytherapy) may be used to treat early stage disease. Data show similar survival rates for patients with early stage disease treated with any of these methods and there is no current evidence supporting a “best” treatment for prostate cancer. Hormonal therapy may be added in some cases. More advanced disease is treated with hormonal therapy, radiation therapy and or other treatments. Side effects of various forms of treatment should be considered in selecting appropriate management. First Course Treatment: ECHN versus Comprehensive Community Cancer Programs in All States - 714 Hospitals (NCDB) 52% Newly Diagnosed Prostate Cancer ECHN vs NCDB First Course Treatment 35% 18% 19% 20% 15% 12% 10% 7% 7% 3% 2% Surgery Only Radiation Only RT & Hormone Hormone Only Active Surveillance Other ECHN 35% 18% 15% 10% 20% 2% NCDB 52% 19% 12% 3% 7% 7% Treatment: The above table reflects the treatment pattern comparison between ECHN and national data. ECHN data reflects a much higher rate of active surveillance (20% vs 7%) and a much lower rate of surgery only (35% vs 52%). Accumulating evidence suggests that careful observation (active surveillance), rather than immediate treatment, is an appropriate option for men with less aggressive tumors and for older men. An approach such as this may be recommended if your cancer is not causing any symptoms, is expected to grow slowly (based on Gleason score), and is small and contained within the prostate. This type of approach is not likely to be a good option if you have a fast-growing cancer (for example, a high Gleason score) or if the cancer is likely to have spread outside the prostate (based on PSA levels). Men who are young and healthy are less likely to be offered active surveillance, out of concern that the cancer will become a problem over the next 20 or 30 years. 6 During active surveillance, prostate cancer is carefully monitored for signs of progression. A PSA blood test and digital rectal exam (DRE) are usually administered periodically along with a repeat biopsy of the prostate at one year and then at specific intervals thereafter. If symptoms develop, or if tests indicate the cancer is growing, treatment might be warranted. Survival The majority (83%) of prostate cancer cases are discovered in the local or regional stages, for which the 5-year survival rate approaches 100%. Over the past 25 years, the 5 year survival rate for all stages combined has increased from 68% to almost 100%. Obesity and smoking are associated with an increased risk of dying from prostate cancer. According to the most recent data, 10 and 15 year survival rates are 99% and 94% respectively. Due to the minimal number of cases with higher stage disease treated at ECHN, survival rates could only be calculated with Stage II disease. Comparative analysis shown below reveals that survival analysis for Stage II patients compare favorably and are relatively the same (91.5% vs 90.8%). Survival for Prostate Cancer Case Diagnosed and/or Treated at ECHN ECHN Survival Data Stage of Disease 0.0 yr 1.0 yr 2.0 yr 3.0 yr 4.0 yr 5.0 yr 95% Confidence Interval Stage II 100.0 99.6 98.5 96.3 93.4 91.5 88.1 - 94.9 NCDB Survival Data Stage of Disease 0.0 yr 1.0 yr 2.0 yr 3.0 yr 4.0 yr 5.0 yr 95% Confidence Interval Stage II 100.0 98.7 97.1 95.3 93.2 90.8 90.7 - 90.9 Physician Critique Each year, a Cancer Program Physician performs a study to assess whether ECHN cancer patients are evaluated and treated according to evidence based national guidelines. In 2014, an analysis of prostate cancer was performed using ECHN and NCDB data. The area reviewed was for prostate cancer patients diagnosed in 2013 as that was the latest year of complete data available at the time of review. The NCDB data included cases from 714 hospitals accredited by the Commission on Cancer (CoC). The guidelines referenced were the National Comprehensive Cancer Network (NCCN). This study must determine that the diagnosis evaluation is adequate and the treatment plan is concordant with the NCCN guidelines. Should any problems be identified in either area, they could be used for a performance improvement. As part of our chart review we utilized the NCCN Guidelines Version 2.2014, Prostate Cancer, to assess if concordant therapy was selected for the patients treatment plan. 7 Our analysis included all 2013 newly diagnosed prostate cancer cases looking at their age at diagnosis, PSA value, Gleason Score, DRE, clinical stage at diagnosis, risk group, work up and treatment received and then determined if the chart was concordant with the NCCN recommendations. If the case was not, we then sought documentation as to why that particular treatment option was selected. Assessment and Evaluation of Treatment Planning Age at Diagnosis: As noted earlier, the majority of men diagnosed with prostate cancer are 60 years or older. Keeping with national statistics ECHN data shows 73% of men age 60 years old greater compared to NCDB at 74%. In addition, only a small percentage of men are diagnosed younger than 50 years of age (ECHN = 2% vs NCDB= 3%). Overall, 98% of the men diagnosed in 2013 were age 50 or greater. AJCC Clinical Stage Completed by the Managing Physician All patients with prostate cancer should be assigned a clinical stage at diagnosis. Stage describes how advanced a cancer is. Prostate cancer is staged by the tumor (T), node (N) and metastasis (M), as well as the Digital Rectal Exam (DRE), PSA and Gleason grade score. Clinically staging the patient’s disease at diagnosis allows for efficient treatment planning. It also enables the comparison of outcome results with national benchmarks, screening for clinical research accruals and provides a baseline for prognostic information. 2013 newly diagnosed prostate cancer cases were reviewed and 100% had AJCC clinical stage completed by the managing physician. Of those, 96% were diagnosed in local or regional stages. According to the most recent data, the 10 year survival rate for this stage of disease is 99%. Results: 100% of the cases were concordant with staging completed by the managing physician. Risk Groups: Criteria to determine the patient’s appropriate risk group include the Gleason score, PSA value, number of biopsy cores positive and stage of disease. The 2013 ECHN Risk Groups are as follows: Very Low 19% Low 10% Intermediate 50% High 19% Very High 0% Metastatic 2% Staging Work Up: NCCN guidelines recommend a staging work up completed for those individuals with certain T values, Gleason scores and suspicion of lymph node involvement for those patients with a life expectancy greater than 5 years or symptomatic. Results: 41% of the patients underwent a bone scan, pelvic CT or MRI. Review of each case noted concordance with NCCN guidelines when ordering the tests and there were no patients that did not receive the appropriate work up – 100% concordance. 8 Treatment: Decision making regarding initial treatment choice is made in a collaborative effort between clinicians and the patient, taking into consideration the patient’s physical status, possible co-morbidities, social economic support systems and treatment options. The approach to treatment is influenced by age and co-existing medical problems. According to NCCN guidelines primary treatment options vary depending on age, stage and grade of cancer, as well as other medical conditions, Early stage disease may be treated with active surveillance, surgery (open, laparoscopic or robotic-assisted), external beam radiation or radioactive seed implants (brachytherapy). Data show similar survival rates for patients with early stage disease treated with any of these methods and there is no current evidence supporting a “best” treatment for prostate cancer. More advanced disease is treated with hormonal therapy, chemotherapy, radiation therapy and/or other treatments. NCCN guidelines recommend treatment based on the patients risk group, as well as expected survival (<10 years versus ≥ 10 years life expectancy). Risk Group → Treatment Very Low Active Surveillance – 75% Low Active Surveillance – 0% Surgery – 17% RT – 8% Surgery – 40% RT – 60% Intermediate Active Surveillance – 24% RT/Lupron – 30% Surgery – 22% Hormone – 6% RT – 15% Refused – 3% Surgery – 38% Hormone -23% RT – 0% No Treatment (expired) – 8% High Active Surveillance – 0% RT/Lupron – 31% Results: Intermediate – active surveillance cases were reviewed – active surveillance is recommended for those patients with less than a 10 year life expectancy – review noted all cases had documentation as why this treatment option was selected. 100% concordance Overall Treatment Looking below at ECHN vs NCDB data, ECHN reflects a higher rate of active surveillance (20% vs 7%) and a lower rate of surgery (35% vs 52%). Accumulating evidence (NCCN guidelines) suggests careful observation (active surveillance), rather than immediate treatment, is an appropriate option for men with less aggressive tumors and for older men. ECHN NCDB Surgery Radiation RT & Hormone Hormone Active Surveillance Other 35% 18% 15% 10% 20% 2% 52% 19% 12% 3% 7% 7% 9 Survival: Nationally the majority (83%) of prostate cancer cases are discovered in the local or regional stages, for which the 5-year survival rate approaches 100%. Over the past 25 years, the 5 year survival rate for all stages combined has increased from 68% to almost 100%. Obesity and smoking are associated with an increased risk of dying from prostate cancer. According to the most recent data, 10 and 15 year survival rates are 99% and 94% respectively. Survival rates at ECHN (91.5%) are comparative to those nationally (90.8%) Conclusion/Analysis: Overall the diagnosis, treatment and outcomes of prostate cancer at ECHN and the NCDB are relatively similar. ECHN exceeds in the area of stage at diagnosis and is on par with age, and survival when compared to national standards. Review of NCCN guidelines shows that ECHN met 100% concordance in staging work up and treatment recommendations for all risk groups. Therefore, we have determined that ECHN can and does provide care to our prostate cancer patient’s that is comparative to care provided at academic/tertiary care centers in terms of techniques and outcomes. Prostate cancer continues to be a disease seen frequently in our country, state and community. Cure rates are clearly related to early diagnosis. The continued monitoring of trends in the patterns of care of prostate care at ECHN to national patterns will ensure that our patients continue to receive the best possible care. Our comprehensive team approach combines state-of-the-art technology, clinical expertise and compassionate care. We bring together experts from all disciplines to develop a complete diagnosis, treatment and support plan to fight your particular cancer, and to get you back to living life. We at ECHN will continue our commitment to provide a unique continuum of care driven by advanced technology, supportive resources and the extraordinary dedication of a highly skilled team of compassionate professionals providing patients and their families with the highest quality diagnosis and cancer treatment close to home. Submitted by David Rosenberg, MD, Urologist 10