annual report 2014 The Cancer Program at Memorial Hospital

annual report 2014 The Cancer Program at Memorial Hospital

our mission The mission of The Cancer Center reflects the goal of the National Cancer Institute: To reduce deaths and suffering caused by cancer. To do that, we partner with physicians in the community and specialists of all fields to combine personalized, compassionate care for our patients with the best that science can offer.

Table of Contents Introduction 4 The Cancer Committee at MHRI 5 The Cancer Program accreditations 5 Cancer services 6 Treatment services 6 Supportive services 7 Research 9 Community outreach 9 Cancer statistics: 2014 11 Patient care evaluation study 11 Directions 16

The Cancer Center at Memorial Hospital of Rhode Island exists to provide expert diagnosis and treatment for patients with various forms of cancer and their families in a convenient location in the community. Backed by the expansive specialties of Memorial Hospital and its affiliate, the Care New England Health System, and as part of The Warren Alpert Medical School of Brown University network, The Cancer Center offers more personal care than larger programs, access to cutting-edge research protocols, services like genetic counseling, palliative care, and integrative care that can help make the cancer journey more bearable. Adam Olszewski, MD Chair, Cancer Committee Anthony Thomas, DO, FACP Division Chief Hematology-Oncology Director, The Cancer Program Ours is also a nationally-recognized program that regularly earns three-year accreditation from the Commission on Cancer after thorough site visits, and was certified by the Quality Oncology Practice Initiative (QOPI ) certification program, an affiliate of the American Society of Clinical Oncology (ASCO). This three-year certificate is awarded to outpatient hematology-oncology practices that meet the highest standards for cancer care. We earn such key national designations because staff at The Cancer Center at Memorial strives for excellence in patient care and has developed a robust program that combines all the elements of cancer care. We follow a Tumor Board-style structure through which each cancer diagnosis is vetted by a multidisciplinary board that meets weekly and decides the best course of action for the patient. This individualized approach is key to our strong survival rates and the strength of our network of specialists, both within the hospital and in the larger health system. Cancer continues to affect hundreds of thousands of people and families a year in the United States. At The Cancer Center at Memorial Hospital, our philosophy is focused entirely on the patients and their families, providing quality and compassionate care locally, and guiding them along their journey. Peter Gill, MD Surgeon-in-chief Cancer Liaison Physician 4

The Cancer Committee at MHRI Memorial Hospital s cancer program is coordinated by the Cancer Committee, which includes representatives of medical, surgical, radiation, palliative care and other physician services, hospital staff and administration, community outreach advocates and coordinators. The committee meets at least quarterly and is led by Chair Dr. Adam Olszewski and the American College of Surgeons Commission on Cancer (CoC) liaison physician Dr. Peter Gill. The committee supervises all activities conducted as part of the CoC accreditation, including quality improvement projects and annual program and clinical goals. Initiatives accomplished in 2014 included: Provision of ambulatory infusion pump service for the delivery of home infusional chemotherapy for cancer patients; this initiative allows our patients to receive chemotherapy which needs to be infused over 24 to 48 hours in the comfort of their home rather than through a hospital admission. Improvement in documenting a palliative care plan for patients with advanced lung cancer. These patients derive a significant benefit in terms of quality of life and even better survival with early initiation of palliative therapy. By modifying the templates of physician documentation and engaging the available palliative care resources in the Care New England system, we now assure that patients diagnosed with advanced cancer can access to palliative services quickly and all relevant symptoms are systematically addressed. Quality improvement projects. In 2014, the committee reviewed the process of patient education after placement of percutaneous gastrostomy tubes in the hospital, and documentation of advance directives among cancer patients treated at Memorial. The committee also supervised the implementation of an improved process of information flow between inpatient and outpatient units for the administration of chemotherapy, new workflow and policy for the management of oral chemotherapy, and improvements in patient education prior to starting chemotherapy. The committee also monitors attendance, content and guideline compliance of the multidisciplinary Tumor Board, important forums where treatment plans for cancer patients diagnosed at Memorial are formed by a team of surgeons, radiologists, pathologists and radiation and medical oncology specialists. The Tumor Board meets weekly, and the Thoracic Tumor Board meets monthly. The Cancer Committee reviews the quality of pathology reports and cancer registry records. The Cancer Program accreditations Commission on Cancer Memorial maintains the CoC accreditation after the most recent 2013 survey. To earn voluntary CoC accreditation, a cancer program must meet 34 quality care standards, be evaluated every three years in a survey, and maintain levels of excellence in the delivery of comprehensive patient-centered care. The CoC accreditation 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. Memorial earned a three-year accreditation as a Community Cancer Program, continuing accreditation first earned in 1991 as one of more than 1,500 cancer programs representing 30 percent of all hospitals in the U.S. and Puerto Rico. Quality Oncology Practice Initiative (QOPI ) In 2014, The Cancer Center at Memorial received a renewed Quality Oncology Practice Initiative (QOPI ) certification after a successful audit by the American Society of Oncology (ASCO). Since 2011, Memorial has maintained this certification as one of only 278 oncology practices nationwide. This certification is granted after evaluation against a comprehensive set of quality measures and standards, and is subject to continual re-assessment. As part of the process, the certified practices must also meet the Safety Standards for Safe Chemotherapy Administration developed by ASCO and the Oncology Nursing Society. The QOPI Certification Program recognizes hematology/oncology practices that are committed to delivering the highest quality of cancer care. 5

Cancer services A comprehensive community program, The Cancer Center at Memorial Hospital offers the services our patients, their families and even their referring physicians need along the cancer journey. Treatment services Diagnostic imaging Memorial s Department of Diagnostic Imaging provides ongoing, state-of-the-art imaging services for cancer patients. Available modalities include high-field strength MRI with high-performance gradient technology, helical CT scanning, PET- CT, ultrasound, conventional radiography, angiography and special procedures, digital mammography, nuclear medicine, and fluoroscopy. In September 2013, Memorial acquired a new digital mammography unit, which is faster and the images are sharper than those from traditional film-based services. Patients spend less time in uncomfortable positions and radiologists can interpret the images better by adjusting brightness or contrast, which helps in patients with dense breast tissue. Medical oncology and hematology A division of the Department of Medicine at Memorial, medical oncology and hematology includes the services of four physicians who are all board certified in hematology and oncology, 10 specialty nurses, and other support staff who provide evidence-based care to more than 5,000 patients a year. The Cancer Center offers medical oncology, surgical oncology, radiation therapy, pathology, radiology, oncology nursing in infusion, a nurse navigator program, laboratory services, social workers, nutritionists, and rehabilitation through occupational, physical and speech therapy. Our Infusion Center provides intravenous chemotherapy, blood transfusions, and immunotherapy. The physicians collaborate with those at other facilities in Rhode Island and Massachusetts, including large tertiary research institutes in Boston. Patients have the opportunity for a second opinion and to form treatment plans with world-class specialists, and then complete or continue treatment and follow up close to home in a community center of excellence. Radiation oncology Radiation oncology services are provided off-site through affiliations with centers in the area, with consultations and treatments coordinated by Cancer Center staff. Patients have access to cutting-edge, precision radiation therapy techniques, including 3D conformal and intensity-modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS) and stereotactic ablative radiotherapy (SABR) for non-surgical management of early lung and other cancers, or brachytherapy ( radioactive seeds ) for treatment of early-stage prostate cancer. Surgery Surgery plays a major role in the diagnosis, staging and treatment of malignancy. Most patients diagnosed with cancer require surgical input, if not actual surgery, at some point. Even if curative surgery is not possible, surgeons can play a major role in the management of chemotherapy access, nutritional support and palliation for cancer pain. Memorial s Department of Surgery provides curative procedures for virtually all sites, including the GI tract, lungs, head and neck, breast, urologic organs, skin and soft tissue. Palliative procedures are available in cases not suitable for curative resection. All patients seen by surgeons are presented at Tumor Board to determine the best plan of care. Recently, we have also experienced a significant increase in the enrollment of surgical patients in research protocols through the Tumor Board and the research arm of The Cancer Center. 6

Specialized nursing care Memorial provides specialized in- and outpatient hematology/oncology nursing care. The Infusion Center staff provides care with a variety of same-day treatments, including blood transfusions, chemotherapy, injections, therapeutic phlebotomies and assorted infusions. Registered nurses are: - Responsible for planning, coordinating and evaluating care for the patient/family from admission through discharge and during all outpatient encounters. - Empowered to make decisions affecting the nursing care for the patient/family. - Accountable for the outcomes of the nursing care provided. The nursing staff is involved in continuing education through the American Cancer Society and the Oncology Nursing Society. Programs and in-services are offered throughout the year to keep staff informed of new treatment modalities and clinical protocols. Once patients are discharged, in-home nursing care can be provided by the VNA of Care New England. The Palliative Care Team is led by a certified palliative care physician and palliative care nurse who help coordinate services for end-of-life care. Tumor Board Meeting weekly, Tumor Board is a multidisciplinary, prospective, consultative planning group made up of surgeons, medical oncologists, radiation oncologists, pathologists, radiologists, research associates, and the tumor registrar who collectively evaluate, stage and manage all types of malignancy to determine optimal treatment. A separate Thoracic Tumor Board for thoracic cancers meets monthly. Most cancer cases are presented at Tumor Board before therapy begins to be sure the staging evaluation is complete and appropriate disciplines have been involved to optimize treatment. In addition to discussions of curative efforts, meetings also focus on psychosocial problems, pain management, nutritional support and, if needed, end-of-life care. Tumor Board has also been key in identifying patients eligible for research protocols and assuring that the care of cancer patients follows the National Comprehensive Cancer Network guidelines. Supportive services Home care Partnered with the VNA of Care New England, we offer skilled in-home care for patients who need help with their cancer treatment. This includes nursing care, rehabilitation therapy, social services, and home health aides. Hospice Memorial offers inpatient hospice services on our cancer unit, where staff focuses on keeping the patients comfortable and helping the family cope. In addition, we offer outpatient hospice through the VNA of Care New England. The team of experts there includes nurses, home health aides, social workers, a chaplain, physicians and pharmacists, all of whom work toward providing care and comfort when a patient has discontinued curative treatment. Symptom management may include physical, emotional and spiritual support to ensure optimal comfort and quality of life for the patient, while meeting the needs of the family or caregivers so they are able to fully enjoy special moments together. Care is usually provided at home, but can also be provided in a nursing home, assisted living or residential care facility. Nutrition services Registered dietitians work on Memorial s in-patient units and can consult with patients on an outpatient basis by request. All patients admitted to the hospital receive basic screening for nutrition risk factors. Those with high risk factors are referred to a dietitian who can help the patient come up with a plan to meet his or her nutritional needs. If more extensive counseling is needed, the patient and family are referred to Memorial s outpatient Nutrition Education Center. 7

Palliative care Through Memorial s affiliation with Care New England, we can offer the expertise of physicians and nurses trained in meeting the physical, psychological, social, spiritual and related needs of patients dealing with terminal cancer. The goal is to help patients maintain the best possible quality of life through pain management, control of symptoms, and the return to daily activities as much as possible. Specialists are sensitive to individual cultural, religious and social concerns in the process. Care New England also participates in The Conversation Project, which encourages people to discuss their wishes for end-of-life care so those wishes can be respected when the time arrives. Rehabilitation Cancer rehabilitation physical, occupational, speech pathologists and recreation therapists helps survivors improve their physical, psychological and social functioning within the limits imposed by the disease and any side effects of treatment. This includes a unique speech and swallow clinic just for cancer patients. We are sensitive to the varied needs of our patients. Some can reasonably expect to return to full function, while others need our help learning how to live fully with their new disability. We also focus on returning them to their home quickly, tapping in-home rehabilitation care services. Social services Our social workers play an important role in the cancer treatment, supporting patients and their families as they cope with the diagnosis. In addition to coordinating the hospital s support groups, social workers address a variety of problems that can result from a cancer diagnosis, including: - Loss of autonomy and dependency on others. - Transportation issues. - Changes in family members roles and relationships. - Loss of financial security and stability. - End-of-life issues. Support groups In addition to the support groups available to cancer patients in the community, Memorial s Social Services staff organizes regular group meetings and other cancer-centric programs on the hospital campus. In addition, patients can attend meetings for more specific populations BRCA positive women, caregivers, etc. at other Care New England operating units. A sample of activities at Memorial includes: - Look Good Feel Better Offered periodically to help female patients deal with the side effects of chemotherapy and radiation therapy using makeup and wig styling. - Reach to Recovery A program designed to help breast cancer patients psychologically adjust to recovery. - You Are Not Alone This support group meets the first and third Wednesday of each month from 6 to 7:30 p.m., at the hospital. 8

Research Clinical research is the cornerstone of progress in medicine and particularly in oncology, where getting treatment through participation on a clinical trial is almost always considered the best standard of care. As part of our affiliation with The Warren Alpert Medical School of Brown University, we are committed to researching better ways to prevent, diagnose and treat various types of cancer. Our research protocol office is staffed by a clinical trials coordinator and research nurse. In 2014, Memorial maintained 22 clinical trials in hematology/oncology, including 11 open for accrual, and 30 of our patients participated in them. The studies offered come from several sources: Brown University Oncology Research Group (BrUOG) Memorial is one of the founding hospitals in this research collaboration the mission of which is to improve cancer care through innovative, multidisciplinary cancer clinical trials. Alliance for Clinical Trials in Oncology Through a formal association with Dana Farber Cancer Institute, Memorial is an affiliate member in this nationwide research group, gaining access to the most important cancer treatment trials available through the Clinical Trials Support Unit. Pharmaceutical companies Selected clinical trials are reviewed by The Cancer Center physicians and deemed valuable to our patients. These often involve new forms of supportive care that can alleviate the side effects of cancer therapy. Community Outreach In addition to providing excellent care at The Cancer Center, the staff at Memorial Hospital is dedicated to bringing health care screenings and information to the community through a variety of convenient venues. Some of that outreach takes place through our collaboration with the American Cancer Society (ACS). ACS programs offer information, day-to-day help and emotional support at no cost, as well as help with transportation for patients. In 2014, Memorial offered our varied support groups on the hospital campus, as well as the following community outreach activities relating to cancer awareness: Cancer Survivors Social Memorial honored more than 100 cancer survivors and their families on Sunday, June 22, at Savor the Sweet Life. The program included an ice cream social, chair massages and useful cancer care information. The Doctor Is In Wellness Lecture Series The series offers a diverse menu of health and wellness programs, including those focused on cancer. Cancer Care Facts You Should Know offered information on breast, colorectal, ovarian, cervical and skin cancer. Skin cancer, cholesterol and blood pressure screenings were available. Your Health and Wellness, Memorial s Spanish Lecture Series at Progreso Latino in Central Falls Offered in October, this free program was in Spanish and included information on breast and lung cancer. Representatives of the ACS and American Lung Association (ALA) were also present. 9

Knights of Columbus talk In December, a Memorial oncologist/ hematologist and a surgeon spoke about prostate and colon cancer to this group in Lincoln, RI. Hope Bus The Gloria Gemma Breast Cancer Resource Foundation s Hope Bus provided free services for our cancer patients, their families and members of the community outside The Cancer Center once a month. Various services include: healing arts and spa treatments; advice on breast cancer treatments; support groups; and classes on breast health. Pawtucket Cancer Control Task Force Memorial representatives sit on this task force, which meets once a month at our Cancer Center. Its mission is to reduce the incidence of cancer in the city through community education and advocacy for early detection and screening. Rhode Island Cancer Partnership Annual Summit In June, Memorial joined with the Partnership To Reduce Cancer in Rhode Island to offer an information table staffed by our experts at the summit. Walks Memorial staff participate in various fundraising walks to benefit cancer-related causes. These include: - Relay for Life The 12-member You Are Not Alone Support Group raised money for ACS in June. - Light the Night The Memorial team raised money for cancer research in September. - Making Strides Against Breast Cancer Memorial s Team Sara raised money for ACS in October. Wellness Night at McCoy Stadium Memorial experts teamed with the Pawtucket Red Sox to offer a healthy dose of prevention and education at the game in August. Doctors, nurses, laboratory technologists and staff provided a free Wellness Night before and during a Pawsox game. There were opportunities to ask questions of our doctors, including an oncologist, and glucose and blood pressure screenings. Representatives of the Pawtucket Cancer Control Task Force was also on hand. 10

Cancer Statistics: 2014 According to Memorial s cancer registry, 278 cancer cases were diagnosed in the institution in 2014, a decrease of 11 percent from 312 cases in 2013. The most common type of cancer was lung (20 percent), followed by head and neck (12 percent), hematologic (blood and bone marrow, 11 percent) and breast (9 percent). Most patients were diagnosed at an early stage. Lung cancer Head and neck Blood, bone marrow Breast Other or unknown Kidney, bladder Colorectal Skin, melanoma Liver, pancreas Lymphoma Stomach, esophagus Thyroid Female genital 6 7 10 9 14 13 21 21 25 24 Prostate Brain 6 5 0 10 20 30 40 50 60 30 32 Number of cases 55 Types of cancer by primary site MHRI, 2014 Proportion of cases 40% 35% 30% 25% 20% 15% 10% 5% 0% Cancer stage distribution at Memorial, 2014.25.19.16.14.12.08.05 Non-invasive Stage I Stage II Stage III Stage IV * Cancers of the blood, brain, or of unknown primary Not applicable* Unknown Patient care evaluation study 2015 Locoregional therapy of early-stage breast cancer at MHRI, 2000-2014 Introduction: Early-stage (stage I, II) breast cancer is a curable malignancy, and treatment typically encompasses surgical removal of the primary tumor followed by adjuvant therapy. The adjuvant treatment modalities include endocrine therapy, radiation therapy and chemotherapy, and the extent of adjuvant therapy prescribed to each patient depends on the patient s personal risk of recurrence, as well as the underlying medical status. The risk of recurrence is principally determined from the stage of the cancer, classified according to the TNM (tumor, nodes, metastasis) schema. In order to obtain adequate stage and plan adjuvant therapy, axillary staging is typically performed, which involves surgical removal of non-palpable lymph nodes in order to determine if the cancer had spread to them. Although in the past extensive axillary lymph node dissection (ALND) was performed for this purpose, this practice has been nearly completely replaced by a limited procedure ( sentinel lymph node biopsy or SNB), which provides adequate staging information with a lower risk of adverse effects 1. However, a number of patients are not eligible to receive aggressive adjuvant therapy (particularly chemotherapy) because of underlying medical problems, or decline to consider it. Previous studies demonstrated that among patients who are older than 70 years at diagnosis, who have favorable tumor characteristics (tumor smaller than 2 cm, no palpable lymph nodes, positive estrogen receptor or ER status) and who receive endocrine therapy, adjuvant radiation can be omitted without any detriment survival 2. The value of performing axillary staging in such patients is uncertain, because axillary staging has been demonstrated to have principally a prognostic value, and not a therapeutic value when there are no palpable lymph nodes 3. The objective of this study was to evaluate the practice of locoregional therapy, including axillary staging, among patients with early-stage breast cancer treated at Memorial over the past 15 years. 11

Percentage of patients 100 80 60 40 20 2) Methods: Cases of early-stage breast cancer were selected from the Memorial registry, using the following criteria: Disease site: breast (C501-C509) Year of diagnosis: 2000-2014 Tumor stage T1 or T2 Out of 433 patients, 35 cases treated outside of Memorial were excluded, because reliable treatment formation follow-up was not collected. Proportions were compared using Fisher s exact test. Trends by epoch were compared using the Mantel-Haenszel odds ratio. Survival was compared using the log-rank test. 3) Patient characteristics: 398 patients were identified. Certain characteristics (HER2 status) were only collected since 2004. Most patients were female, white, with ER+, HER2- negative ductal carcinoma. 4) Utilization of surgery: A larger proportion of patients underwent breast conservation surgery over time (P=0.0016). Patients who were older than 80 years old at diagnosis had a higher rate of mastectomy or no surgery. Type of surgery, by epoch P=0.0016 2 2 5 59 74 74 39 0 2000-04 2005-09 2010-14 No surgery Lumpectomy Mastectomy 39 21 Percentage of patients 100 80 60 40 20 0 Type of surgery, by age group P=0.041 74 69 5) Adjuvant radiation therapy (excluding patients without surgery): The proportion of patients undergoing radiation therapy was relatively stable, and significantly decreased with age. Radiation was administered to 80.5 percent of patients undergoing breast conservation surgery and 24 percent of patients undergoing mastectomy (P<0.0001). None of the patients managed without surgery received radiation therapy. 26 31 4 5 73 47 <50y 50-64y 66-79y 80+y 24 44 Factor Value N 398 Age at diagnosis, median (IQR) 65.5 (52, 77) Female 389 (97.7%) Race White 376 (94.5%) Other 22 (5.5%) Previous cancer 77 (19.3%) Estrogen Receptor (ER) positive 298 (79.7%) HER2 status positive (2004+ only) 6 (8%) Histology Ductal 282 (70.9%) Lobular 35 (8.8%) Mixed 13 (3.3%) Mucinous 12 (3.0%) Other 56 (14.1%) Tumor grade I 92 (23.1%) II 166 (41.7%) III 116 (29.1%) Unrecorded 24 (6.0%) T-stage 1, unspecified 49 (12.3%) 1A 23 (5.8%) 1B 68 (17.1%) 1C 143 (35.9%) 2 115 (28.9%) Type of surgery Breast conservation surgery 267 (67.1%) Mastectomy 120 (30.2%) No surgery 11 (2.8%) Axillary staging None 46 (11.6%) Biopsy or aspiration 1 (0.3%) SNB 35 (8.8%) Some regional nodes removed 5 (1.3%) 1 to 3 nodes removed 86 (21.6%) 4 or more nodes removed 115 (28.9%) SNB and regional nodes removed 94 (23.6%) Separate SNB and regional nodes 16 (4.0%) Node-positive 60 (15.1%) Chemotherapy 159 (39.9%) Endocrine therapy 277 (69.6%) Radiotherapy 244 (61.3%) Recurrence None 357 (89.7%) Locoregional 9 (2.3%) Distant 28 (7.0%) Unknown 4 (1.0%) Table 1. Clinical characteristics of patients with earlystage breast cancer treated at Memorial, 2000-2014. 12

Radiation therapy, by epoch P=0.875 Radiation therapy, by age group P<0.0001 100 39 31 43 100 17 27 36 77 Percentage of patients 80 60 40 20 61 69 57 Percentage of patients 80 60 40 20 83 73 64 23 0 2000-04 2005-09 2010-14 No Yes 0 <50y 50-64y 65-79y 80+y 6) Adjuvant chemotherapy (excluding patients without surgery): Similarly, the proportion of patients receiving adjuvant chemotherapy was relatively stable (although lower after 2010), and significantly decreased with age. Chemotherapy was administered to 37 percent of patients undergoing breast conservation surgery and 48 percent of patients undergoing mastectomy (P=0.044). The rate was also dependent on the T-stage: 4.3 percent for T1a, 19 percent for T1b, 47 percent for T1c and 56 percent for T2 (P<0.0001). It was also significantly higher for patients with histologically positive node (77 percent) than those without it (33 percent, P<0.0001), higher for patients with ER-negative disease (71 percent versus 33 percent, P<0.0001) or with HER2-positive tumors (80 percent versus 23 percent, P=0.017). Percentage of patients 100 80 60 40 20 Chemotherapy, by epoch P=0.139 59 41 0 2000-04 2005-09 2010-14 No Yes 53 47 74 26 Percentage of patients 100 80 60 40 20 0 22 78 Chemotherapy, by age group P<0.0001 46 54 <50y 50-64y 65-79y 80+y 74 26 95 5 7) Adjuvant endocrine therapy: Endocrine therapy was administered to 74 percent of patients undergoing breast conservation surgery, 63 percent of patients undergoing mastectomy and 36 percent of patients who did not undergo surgery. Endocrine therapy was recorded for 86 percent of ER-positive and 18 percent of ER-negative patients, and without a difference with regard to positive or negative lymph node status (71 percent versus 70 percent, P=0.88). 8) Axillary staging (excluding patients who did not undergo surgery): There were significant differences between patients who did and did not undergo axillary staging (SNB or ALND). Patients who did not undergo axillary staging were significantly older, had a non-significantly lower rate of mastectomy, and a significantly lower rate of chemotherapy or radiation therapy. There was no difference in the number of recurrences, although there were proportionally more local recurrences among patients managed without axillary staging, and more systemic recurrences in the other group. 9) Survival outcomes: The recurrence-free survival (RFS) was not significantly different between patients who did or did not undergo axillary staging (P=0.49). RFS was worse for very young (<50 years old) and very old ( 80 years old) patients (P=0.03). 13

% CI % CI Axillary staging Yes 90.8 87.0-93.5 84.0 79.4-87.6 No 86.1 66.9-94.6 41.6 25.6-56.8 Age group <50 years 85.9 75.6-92.4 90.3 79.6-95.6 50-64 years 93.6 86.9-96.9 92.3 85.7-95.9 65-79 years 93.1 86.7-96.5 77.4 68.5-84.1 80+ years 83.6 70.5-91.2 49.0 35.8-60.9 Recurrence-free survival, stratified by receipt of axillary staging, and by age group. Factor Group Recurrence Free Survival No axillary staging N 36 351 SNB or ALND Overall Survival Age, median (IQR) 79(70.5, 83) 63 (51, 74) <0.001 Female 34(94.4%) 344 (98.0%) 0.20 White 34 (94.4%) 331 (94.3%) 1.00 First primary 25 (69.4%) 289 (82.3%) 0.073 ER-positive 25 (78.1%) 267 (79.9%).82 HER2 positive (2004+) 1 (17%) 4 (6%).37 Histology 0.30 Ductal 30 (83.3%) 248 (70.7%) Lobular 1 (2.8%) 34 (9.7%) Mixed 0 (0.0%) 12 (3.4%) Mucinous 2 (5.6%) 10 (2.8%) Other 3 (8.3%) 47 (13.4%) Grade.50 I 12 (33.3%) 79 (22.5%) II 15 (41.7%) 147 (41.9%) III 8 (22.2%) 106 (30.2%) Unrecorded 1 (2.8%) 19 (5.4%) T.91 1 5 (13.9%) 43 (12.3%) 1A 3 (8.3%) 19 (5.4%) 1B 6 (16.7%) 61 (17.4%) 1C 13 (36.1%) 130 (37.0%) 2 9 (25.0%) 98 (27.9%) Node-positive 0 (0.0%) 56 (16.0%) 0.005 Period of diagnosis 0.10 2000-04 22 (61.1%) 161 (45.9%) 2005-09 7 (19.4%) 128 (36.5%) 2010-14 7 (19.4%) 62 (17.7%) Surgery 0.058 Breast conservation 30 (83.3%) 237 (67.5%) Mastectomy 6 (16.7%) 114 (32.5%) Chemotherapy administered 2 (5.6%) 155 (44.2%) <0.001 Endocrine therapy 21 (58.3%) 252 (71.8%) 0.12 Radiotherapy administered 12 (33.3%) 232 (66.1%) <0.001 Recurrence 0.39 None 33 (91.7%) 315 (89.7%) Locoregional 2 (5.6%) 7 (2.0%) Distant 1 (2.8%) 26 (7.4%) Unknown 0 (0.0%) 3 (0.9%) P-value Patients who were not selected for axillary staging had a markedly lower overall survival (OS), which correlated to age. OS for all patients was 79.4 percent (CI, 74.7-83.3). The cumulative incidence of recurrence at five years was 8.9 percent with axillary staging and 9.9 percent without. The cumulative incidence of a competing event (death) was 9.9 percent with axillary staging and 54.7 percent without. 10) Comparative outcomes from the National Cancer Data Base (NCDB): Survival estimates were obtained from the NCDB for patients with stage I breast cancer, diagnosed in 2003-2008, with no prior malignancies, by age group. The analogous values for MHRI patients (but our selected cohort included stage II patients with positive lymph nodes) were: 91.5 percent for patients 18-64 years old (CI, 86.3-94.8) and 67.6 percent for those aged 65+ years (CI, 60.1-74.1). Age group Enter 5-year 95%Cl 18-64 years 208,072 96.5 96.5-96.6 65+ 145,108 85.5 85.3-85.7 All cases 353,180 92.0 91.9-92.1 14

Proportion surviving without relapse 1.00.90.80.70.60.50.40.30.20.10 0 Number at risk <50 years 50-64 years 66-79 years 80+ years P=0.03 <50 years 50-64 years 66-79 years 80+ years 0 2 4 6 8 10 Analysis time 69 60 51 45 33 24 122 109 93 73 49 31 135 117 87 61 37 20 72 57 30 20 11 5 Proportion surviving without relapse 1.00.90.80.70.60.50.40.30.20.10 0 Number at risk snb=no snb=yes P=0.49 Axillary staging No axillary staging 0 2 4 6 8 10 Analysis time 46 27 17 10 6 5 352 316 244 189 124 75 11) Conclusions: The proportions of patients undergoing breast conservation surgery or mastectomy, and those receiving specific adjuvant therapy modalities, are in the range reported nationwide. The association of treatments with age, nodal status and histologic subtype of breast cancer is also consistent with general experience in oncology. About 10 percent of early-stage breast cancer patients at Memorial do not undergo axillary staging. Those patients are typically older (median age is almost 80 years) and also have low rates of receipt of adjuvant chemotherapy, radiation therapy or endocrine therapy. Despite the fact that patients who do not undergo axillary staging have markedly worse overall survival (reflecting their advanced age and likely medical comorbidities), they do not have a worse recurrencefree survival. These results are similar to our recent larger study in 364 early-stage older breast cancer patients treated at Women & Infants Hospital, who were recommended no adjuvant radiation or chemotherapy after their surgery. The cumulative incidence of recurrence at five years among those patients was 6.6 percent without axillary staging and 4.3 percent with axillary staging, while there were significant differences in overall survival, which was 77.5 and 89.3 percent, respectively. 4 Patients who are very young or very old have worse PFS, indicating complex effects of age, comorbidities, but also potentially of variable disease biology. 12) References: 1. Lyman, G.H., et al., American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. Journal of Clinical Oncology, 2005. 23(30): p. 7703-20. 2. Hughes, K.S., et al., Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. New England Journal of Medicine, 2004. 351(10): p. 971-7. 3. Giuliano, A.E., et al., Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. Journal of the American Medical Association, 2011. 305(6): p. 569-75. 4. Saleh, M.N., et al. Breast cancer recurrence in older patients with clinically node-negative T1-T2 tumors managed without sentinel node biopsy (SNB) and without adjuvant radiation therapy. in Journal of Clinical Oncology, 2015 ASCO Annual Meeting. 2015. 15

Directions From points south Take 95 North to Exit 28, School Street. Turn right onto School Street. After the second light, turn left onto Pond Street. Go through one traffic light. Turn right onto Brewster Street and take the first right into the hospital s main entrance driveway. From points north Take 95 South to Exit 27. Turn left at the traffic light at the top of the exit ramp onto George Street. Turn left at the first light onto Division Street. Turn right just before the second light onto Water Street. Go through one light. Turn left onto Pond Street, go through one traffic light. Turn right onto Brewster Street and take the first right into the hospital s main entrance driveway. Visitor parking is located to the left and right of the driveway. When you are sick, you want to be treated close to home, close to your family and friends. That is especially true when you face one of the more challenging times in your life with a cancer diagnosis. The Cancer Center at Memorial Hospital is a full-service center for patients with many different types of cancer. We ve brought all the services under one roof for your convenience, so you can come to one place for doctor s appointments, treatment and lab work. Call us at (401) 729-2700 16

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A MEMBER OF 111 Brewster Street Pawtucket, Rhode Island 02860 401-729-2000 mhri.org A Major Teaching Affiliate of