The 2015 Cancer Program Annual Public Reporting of Outcomes/Annual Site Analysis Statistical Data from 2014

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The 2015 Cancer Program Annual Public Reporting of Outcomes/Annual Site Analysis Statistical Data from 2014 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. 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. The CoC challenges cancer programs to enhance the care they provide by addressing patient-centered needs and measuring the quality of the care they deliver against national standards. 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. It recognizes the high standard of care provided to our oncology patients and the commitment of our physicians, staff, and administration to providing such care. MMH has been a CoC accredited Cancer Program since November 2000. In 2015, we received a full three year accreditation from the CoC, with 7 areas receiving a commendation rating the most a facility can receive. 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 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 treated according to evidence based national treatment guidelines. We have selected uterine cancer (endometrial) as our focus this year. ECHN is extremely proud to share our patient s outcomes results in this report. Analyses of the 2014 newly diagnosed endometrial cancer patients indicate ECHN exceeds the national average in many areas. Analysis of Uterine Cancer at Easter Connecticut Health Network Using Cancer Registry Data Goal: To determine whether a community-based comprehensive cancer program can provide care to uterine 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 (585 hospitals). Source: Cancer Registry Data Base at ECHN. 1

Incidence In 2015, an estimated 54,870 women in the United States (810 in Connecticut) will be diagnosed with uterine endometrial cancer. It is estimated that 10,170 deaths from this disease will occur during this timeframe. The incidence of endometrial cancer is rising, due largely to increased incidence of obesity, which is an important risk factor for this disease. Uterine cancer is the fourth most common cancer and the seventh most common cause of cancer death for women in the United States. Although uterine cancer rates are slightly higher among white women than black women, black women are more likely to die from uterine cancer than white women. It is estimated, one in 37 women will develop uterine cancer in their life-time. Fortunately, this type of cancer is usually detected early and is highly curable, with a five year survival rate of 84%. It is mainly a disease of higher-income countries, where the highest incidence is in North America and Central and Eastern Europe and the lowest incidence in Middle and Western Africa. Early Detection There is no standard or routine screening test for women at average risk. At the time of menopause women should be informed about the risks and symptoms of endometrial cancer and strongly encouraged to report any unexpected bleeding or spotting to their physicians. Irregular vaginal bleeding is an early sign, the foremost symptom and the reason why the majority of patients with the highly curable endometrial tumor are diagnosed with Stage 1 disease. Risk Factors Several factors may increase the risk of uterine cancer, although there is no way to determine with certainty who will develop this type of cancer. Obesity and abdominal fatness increase the risk, most likely by increasing the amount of circulating estrogen, which is a strong risk factor. Other factors that increase estrogen exposure include menopausal estrogen therapy, late menopause (after the age of 55), never having children and a history of polycystic ovary syndrome. Tamoxifen, a drug used to reduce breast cancer risk, increases risk slightly because it has estrogen like effects on the uterus. Medical conditions that increase risk include Lynch Syndrome and diabetes. Pregnancy, use of oral contraceptives or intrauterine devices and physical activity are associated with reduced risk. Cellular classification of endometrial cancer (Histology) Clinically, endometriod cancers fall into two categories: endometriod (type I) and serous (type II) tumor. Type I may arise from complex atypical hyperplasia and is linked to unopposed estrogenic stimulation, obesity and a favorable diagnosis, While type II is more common in older women, develops from atrophic endometrium, is not hormonally driven and generally has a less favorable outcome. There are many different types of endometrial cancer reported. Endometrioid Carcinoma is the most reported histopathologic type. Mucinous, squamous and undifferentiated tumors are extremely rare. The overall frequency of endometrial cancer cell types follows in Table 1 below. NCDB data shows 73% of all uterine cancer cases are endometriod carcinoma, similar to ECHN with 66% diagnosed. 2

Table 1: Frequency of Uterine Cancer Cell Types Frequency of Uterine Cancer Cell Types (Histology) Cell Types NCDB ECHN Endometrioid Carcinoma 66% 73% Mixed Cell Adenocarcinoma 5% 6% Papillary Serous Cystadenocarcinoma 3% 3% Adenocarcinoma, NOS 12% 6% Mullerian Mixed Tumor 3% 2% Adenocarcinoma with Mixed Subtypes 2% 3% Mucinous Adenocarcinoma 2% 1% Adenosarcoma 2% 1% Villous Adenocarcinoma 2% 1% Serous Cystadenocarcinoma, NOS 3% 4% Source: CoC NCDB and ECHN Cancer Registry Data Base - ECHN was compared to the NCDB Data Base: Comprehensive Community Cancer Program Hospitals thru out the United States (585 hospitals). Age at Diagnosis Endometrial cancer rarely occurs in women under the age of 40. Most cases are found in women age 50 and over, usually around the time menopause begins. More than half of all endometrial cancer cases are diagnosed in the 50 to 60 age group. As seen in the comparison chart below, 92% of the newly diagnosed cases at ECHN were age 50 or older, consistent with the NCDB Data noting 90%. Chart 1: Age at Diagnosis 43% 37% 28% 26% 14% 19% ECHN NCDB 1% 2% 7% 8% 7% 8% 30-39 40-49 50-59 60-69 70-79 80 & over Source: CoC NCDB and ECHN Cancer Registry Data Base - ECHN was compared to the NCDB Data Base: Comprehensive Community Cancer Program Hospitals thru out the United States (585 hospitals). 3

Endometrial Cancer Staging Specialists at ECHN perform multiple tests for the work up (staging) of endometrial cancer Pelvic exam Transvaginal ultrasound, CT scan or MRI Biopsy dilatation and curettage and hysteroscopy Pipelle tumor marker studies Staging of uterine cancer has been adopted by the International Federation of Gynecology and Obstetrics (FIGO) and the American Joint Committee of Cancer (AJCC). Stage I is when cancer is confined to the uterus. Stage II cancer extends beyond the uterus into the cervix. Stage III the disease extends beyond the uterus but not beyond the pelvis. Stage IV means that the cancer that has extended into the bowel or bladder or has metastasized beyond the pelvis. As stated earlier, irregular vaginal bleeding is an early sign, the foremost symptom and the reason why the majority of patients with the highly curable endometrial tumor are diagnosed with Stage 1 disease. As noted in Chart 2 below, ECHN continues to diagnose and treat early stage cases in a manner higher than the national average. 79% of ECHN patients were diagnosed with Stage I disease compared to the NCDB at 69%. Only 1% of ECHN patients were diagnosed with late stage (III) disease compared with 11% nationally. A smaller percentage of unknown cases are captured in the ECHN data base (0% versus 8%). Chart 2: Stage at Diagnosis Source: CoC NCDB and ECHN Cancer Registry Data Base - ECHN was compared to the NCDB Data Base: Comprehensive Community Cancer Program Hospitals thru out the United States (585 hospitals) Treatment Our multidisciplinary team of experts includes specialists in oncology, gynecology, radiology, urology, and surgery. Our team of medical staff and allied health professionals meets monthly for a gynecologic cancer care conference. They discuss patient evaluations, for both prospective and continuing care and plans for the future care of selected patients with malignancies. Uterine 4

cancers are usually treated with surgery, radiation, hormones and/or chemotherapy. Your physician will discuss what approach is best suited to your situation. Surgery Recent progress in the development of new tools and surgical techniques has transformed the treatment of uterine cancer, resulting in greater surgical precision and fewer complications. For many women, we are able to perform minimally invasive operations that enable them to go home the same day or require a hospital stay of only one day. Minimally invasive operations offer such benefits as decreased pain, improved cosmetic results, and a relatively fast recovery. With laparoscopic surgery, the surgeon first examines the pelvic cavity with a laparoscope a thin, lighted tube with a video camera at its tip which projects an image onto a large viewing screen. Guided by the laparoscope, the surgeon operates through tiny surgical ports (small tubes placed into the abdomen) using specially designed instruments to remove the uterus through the vagina. With robot-assisted laparoscopic vaginal hysterectomy, specially trained surgeons use an advanced robotic device called the da Vinci Surgical System to assist them during the procedure. To use the robot, a surgeon is seated at a multifunctional console positioned next to the patient. He or she views the area of the operation on the console via a magnified, threedimensional, high-definition visual system. The surgeon performs the operation using finger and foot controls on the console, with the robot precisely copying his or her every movement. As the surgeon uses the robot to operate, the surgical team at the bedside monitors the patient throughout the procedure, assisting as necessary. CoC Quality Outcomes: Endoscopic, laparoscopic or robotic surgery performed for Endometrial Cancer (excluding lymphoma & sarcoma), for all stages except Stage IV There are several types of measures approved by the CoC. Evidence-based measures or accountability measures promote improvements in care delivery and are the highest standard for measurement. These measures demonstrate provider accountability, influence payment for services, and promote transparency. The quality improvement measure function is to monitor the need for quality improvement or remediation. Generally, these measures are for individual program use. Surveillance measures are used to identify the status quo, generate information for decision making, and/or to monitor patterns and trends of care. The Cancer Program Practice Profile Reports (CP3R) was first released by the CoC in January 2005, and includes several evidence measures for multiple cancer sites. This reporting tool has demonstrated that improvements in data quality can demonstrate the quality of patient care when the entire cancer committee supports system-level enhancements to ensure complete and precise documentation. Recent CP3R reports include a surveillance measure looking at the percentage of patients undergoing endoscopic, laparoscopic or robotic surgery for all endometrial cancer stages (excluding stage 4), with a recommendation of a minimum of 80%. Analysis of our cases revealed in 2013 we met the 80% recommendation, compared to 76.6% for all CoC accredited Comprehensive Community Cancer Programs (CCCP) throughout the United States. In 2014, our performance rate was 90%, far exceeding the CoC recommendation. For the majority of our patients, we were able to perform minimally invasive operations that enabled them to go home the same day or required a hospital stay of only one day. As stated earlier, these minimally 5

invasive operations offer such benefits as decreased pain, improved cosmetic results, and a relatively fast recovery for our patients. 2014 CP3R Endometrial Cancer Report Measure Endometrium Surveillance Definition Endoscopic, laparoscopic or robotic performed for all Endometrial Cancer (excluding lymphoma & sarcoma), for all stages except Stage IV COC Threshold My CoC Program Type (CCCP) ECHN 2013 ECHN 2014 80% 76.6% 80% 90% Radiation Therapy For many women, surgery is the only treatment necessary for uterine cancer. However, depending on the extent of the cancer or the presence of various risk factors, our doctors may recommend additional or alternative treatment approaches. Thanks to increasingly sophisticated tests for assessing the prognosis of uterine cancer based on biopsy findings, for example, the amount of radiation therapy or the use of hormone therapy can be customized to you. Radiation therapy may be applied externally or internally or both, through one of the following approaches. It may also be given alone or in combination with chemotherapy. Intensity-modulated radiation therapy (IMRT) In this approach, radiation is delivered externally over a period of several weeks. This type of external-beam radiation allows for precise treatment planning and the delivery of higher radiation doses with greater safety. Radiation therapists can safely shape pencilthin radiation beams of varying intensity to conform to specific tumor outlines and sizes, reducing the dosage of radiation to healthy tissues and possibly the side effects of treatment. Brachytherapy In high-dose brachytherapy, radioactive material in tiny tubes is implanted through the vagina directly to any vaginal tissue remaining after surgery. Brachytherapy may be used in combination with IMRT. Chemotherapy & Hormone Therapy Based upon the tumor type and other factors, your cancer care team may recommend chemotherapy to eliminate any cancer cells that may remain undetected following surgery, or to treat disease that has already spread. The chemotherapy drugs most frequently used to treat uterine cancer include carboplatin, and paclitaxel, cisplatin, and doxorubicin, often in combination. Hormone-therapy drugs are substances that prevent cancer cells from getting or using the hormones they may need to grow. Your treatment team may recommend this approach to halt the spread of certain types of advanced or recurrent uterine cancer. 6

Chart 3: First Course of Treatment Surgery Only Surgery & RT Surgery, RT & Chemotherapy No 1 st Course RX Radiation Only Chemo Only RT & Chemo Surgery & hormone ECHN 45% 21% 7% 7% 3% 2% 14% 1% NCDB 61% 14% 11% 4% 1% 1% 8% 0% Source: CoC NCDB and ECHN Cancer Registry Data Base - ECHN was compared to the NCDB Data Base: Comprehensive Community Cancer Program Hospitals (CCCP) throughout the United States (585 hospitals) First course of treatment comparison with the National Cancer Data Base (NCDB) data demonstrates the majority of cases are treated with surgery alone. As noted above in Chart 3, 45% of patients at ECHN undergo only surgery compared to 61% nationally, and 21% receive Surgery with RT compared to 14% nationally. Charslon Comorbidity The Charlson Comorbidity Index contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions. Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition. For a physician, it is helpful in knowing how aggressively to treat a condition. Higher scores indicating greater comorbidity (patients with a score > 5 have essentially a 100% risk of dying at one year). For example, a patient may have cancer, but also heart disease and diabetes so severe that the costs and risks of the treatment outweigh the short term benefit from treatment of the cancer. As noted below, ECHN and NCDB data compare relatively the same. Chart 4: Charlson Comorbidity Charlson Comorbidity Score of Uterine Cancer None Only 1 Co-morbid Condition Two or More Co-Morbid Conditions ECHN 72% 22% 6% NCDB 74% 21% 5% Survival The five-year relative survival rate is the percentage of people who survive at least five years after the cancer is found. For uterine cancer, the overall five-year survival rate is 82%. If the cancer is diagnosed as local (without spread) uterine cancer at diagnosis is about 95%. If the cancer is diagnosed with regional spread, the five-year survival rate is about 68%, and if diagnosed after the cancer has spread more distantly, it is 18%. 7

Cancer survival statistics should be interpreted with caution. These estimates are based on data from thousands of people with this type of cancer in the United States each year, so the actual risk for a particular individual may be different. It is not possible to tell a woman how long she will live with uterine cancer. Because the survival statistics are measured in five-year intervals, they may not represent advances made in the treatment or diagnosis of this cancer. Survivorship after a Diagnosis of Endometrial Cancer It is well known that more women with the diagnosis of endometrial cancer die of other major health problems (35% cardiovascular deaths, 20% other cancers, 25% other causes) rather from their endometrial cancer (19% cause of death). Supportive care intended to enhance quality of life is also important. At ECHN, therapists, social workers, clergy members and other are available for consultation to create optimal health. Physician Critique (C0C Standard 4.6: Monitoring Compliance with Evidence Based Guidelines) 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 2015, an analysis of endometrial cancer was performed using ECHN and NCDB data. The area reviewed was for endometrial cancer patients diagnosed in 2014 as that was the latest year of complete data available at the time of review. The NCDB data included cases from 585 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 1.2016, Uterine Cancer, to assess if concordant therapy was selected for the patients treatment plan. Our analysis included all 2014 newly diagnosed endometrial cancer cases (14) looking at their age at diagnosis, stage at diagnosis, histology, work up and first course of 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 women diagnosed with endometrial cancer are age 50 years or older, usually around the time menopause begins. Keeping with national statistics ECHN data shows 92% of our patients were age 50 or greater compared to NCDB at 90%. AJCC Stage Completed by the Managing Physician Staging is the process of looking at all of the information the doctors have learned about your tumor to tell how much the cancer may have spread. Endometrial cancer is staged by the extent of the tumor (T), whether the cancer has spread to lymph nodes (N) and whether it has spread to distant sites (M). The stage of the patient s disease is the most important factor in developing a comprehensive cancer treatment plan. Individualized plans include advanced medical treatments and technologies, combined with integrative oncology services to help reduce side effects and keep you strong in body, mind and spirit. Staging each patient also enables the 8

comparison of outcome results with national benchmarks, screening for clinical research accruals and provides a baseline for prognostic information. 2014 newly diagnosed endometrial cancer cases were reviewed and 100% had AJCC stage completed by the managing physician. Of those, 92% were diagnosed in local or regional stages (stage 0-II), compared to 74% nationally. Results: 100% of the cases were concordant with staging completed by the managing physician. Initial Evaluation: NCCN Guidelines, Version 1.2016, initial evaluation recommendations include an H & P, CBC (including platelets), endometrial biopsy and chest imaging. Results: Each case identified (14) was reviewed for all areas stated above. Initial review noted 93% of the patients underwent chest imaging. However, documentation in the patients chart not receiving a chest x-ray revealed the patient wished no further testing or treatment and refused the chest imaging. All charts were concordant with NCCN initial evaluation guidelines or documentation in the patient record noted the reason the testing was not completed. 100% concordance. Treatment: Surgery is the main treatment for most women with this cancer. But in certain situations, a combination of surgery, radiation therapy, chemotherapy and hormonal therapy may be used. At ECHN, decision making regarding initial treatment is made in a collaborative effort between clinicians and the patient, taking into consideration the patient s physical status, possible comorbidities, social economic support systems and treatment options. The approach to treatment options may vary depending on patient age, stage and type of cancer, as well as other medical conditions. ECHN Chart Review: Stage I 10 patients Surgery or surgery & RT Stage II 1 patient RT only Stage III 2 patients Chemo/RT Stage IV 1 patient Chemo Results: Based on the stage of disease at diagnosis, all cases reviewed received the appropriate treatment. 100% concordance Conclusion/Analysis: Overall the diagnosis, treatment and outcomes of endometrial cancer at ECHN and the NCDB are relatively similar. ECHN exceeds in the area of stage at diagnosis and is on par with age. Review of NCCN guidelines shows that ECHN met 100% concordance in staging work up and treatment recommendations for all identified patients. Therefore, we have determined that ECHN can and does provide care to our endometrial cancer patient s that is comparative to care provided at academic/tertiary care centers in terms of techniques and outcomes. 9

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 M. Srodon, MD, Pathologist, Cancer Committee Co-Chair 10