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2015 ANNUAL PATIENTOUTCOMES REPORT

The Cancer Centerat Roger Williams Medical Center

Cancer Committee Membership

Cancer Committee Members – 2015

Steven Katz, MD – Surgical Oncology / ChairmanJames Koness, MD – Surgical Oncology / Physician Liaison John Coen, MD – Radiation Oncology Peter Libbey, MD – Pathology Mohsin Malik, MD – Blood & Marrow Transplant Bharti Rathore, MD – Hematology OncologyRitesh Rathore, MD – Hematology Oncology Thomas Ruenger, MD – Dermatology Abdul Saied-Calvino, MD – Surgical OncologyMaria Aileen Soriano-Pisaturo, MD – Palliative CareBrian Stainken, MD - Interventional Radiology

Elizabeth Angell, LCSW – Oncology Social Worker / Psychosocial Services CoordinatorBillie Baker – Tumor Board / Cancer Conference CoordinatorMary Beaudette, RN – Case ManagementPatricia Cafaro, RN – Oncology Nurse, Radiation Oncology Ellie Collins, RN, MS, CS – Psychiatry Fran Dallesandro, CCRP – Protocol Office / Clinical Research CoordinatorBrett Davey – Director of Communications / Community Outreach CoordinatorNancy Fogarty – Performance Improvement / Quality Improvement CoordinatorMaryanne Forgione, CCC-sp – Speech Pathologist / Rehabilitation Services Thomas Habershaw, RPh – Cancer Center PharmacistBenjamin Isaiah – Quality ImprovementDonna Castricone, RD, CSO, LDN – Registered Dietitian Annemarie Mullaney, BSN, RN, OCN, CHPN – Cancer Center ManagerJennifer Parker, RN – Manager, Oncology Inpatient UnitsKathy Perry, RN, MBA – Cancer Program AdministratorCheryl Raffel, RHIA, CTR – Cancer Registry / Cancer Registry Quality CoordinatorJames Willsey – Chaplain / Pastoral Care Alexandra Fiore – American Cancer Society C. Kelly Smith – Rhode Island Health Department

Table of Contents

From the Cancer Committee ChairpersonOn behalf of my fellow Cancer Committee members and all our colleagues who are providing excellent patient care, I am pleased to present the 2015 Cancer Program report from Roger Williams Medical Center. This report in-cludes quality measures and other statistics from our Cancer Center, along with studies and information regarding our Immunotherapy, Geriatric Oncol-ogy and Oncology Social Work programs. Additionally, you can learn more about our quality improvement programs, along with our efforts to provide cancer screening and prevention to our community. We take great pride in providing the very best cancer care for the patients of today, and developing novel therapeutic options for the future. This report provides you with a snapshot of our efforts to bring new and better ways to care for cancer patients in Rhode Island and far beyond.

Thank you for taking the time to review the 2015 Annual Patient Outcomes Report. Sincerely, Steven C. Katz, MD, FACSCommittee Chairman

p. 1 Cancer Committee Membership

p. 2 Letter from the Cancer Committee Chairperson

p. 3 & 4: CoC Cancer Program Practice Profile Reports (CP3R) Quality Measures 2015 Review of 2013 Cases

p. 5, 6 & 7: Referral Patterns of Stage IV Colorectal Adenocarcinomas at Roger Williams Medical Center

p. 8 Immun-Oncology Program Summary

P. 9 Quality Study One: Geriatric Oncology

p. 10-16 Quality Study Two: A Project to Assure Quality Cancer Care Roger Williams Medical Center: Phase II: Retrospective Medical Record Review

p. 17 CASES BY PRIMARY SITE BY YEAR -- 2010 to 2015

p. 18 NEWLY DIAGNOSED CANCER CASES -- 2009 TO 2015 - TOP SIX CANCER SITES

p. 19 Prevention & Screening Programs, Quality Improvements & Goals Achieved

CoC Cancer Program Practice Profile Reports (CP3R) Quality Measures – 2015 Review of 2013 Cases (With Comparisons to 2011 & 2012)

The Commission on Cancer (CoC) has defined several quality measures for hospitals with accreditation status. Tracking these measures provides an opportunity for continuous practice improvement to achieve high quality care for our patients.

Quality Measure

RWMC 2011

RWMC 2012

RWMC 2013

CoC / NCDB Required Performance Rate

Breast Cancer

Breast conservation surgery rate for women with AJCC clinical stage 0, I or II breast cancer (Surveillance).

85.7% (18/21)

76.2% (16/21)

70.0% (7/10)

Not Yet Established

Image or palpation-guided needle biopsy (core or FNA) of the primary site performed to establish diagnosis of breast cancer (Quality Improvement).

85.7% (12/14)

88.2% (15/17)

92.3% (12/13)

>=80%

Tamoxifen or other third generation aromatase inhibitor is considered or administered within 1 year (365 days) of diagnosis for women with AJCC T1c or Stage IB-III hormone receptor positive breast cancer (Accountability).

88.2% (15/17)

82.6% (19/23)

100% (9/9)

>= 90%

Radiation therapy is considered or administered following any mastectomy within 1 year (365 days) of diagnosis of breast cancer for women with >= 4 positive regional lymph nodes (Accountability).

100% (4/4)

50% (1/2)

100% (1/1)

>= 90%

Radiation is administered within 1 year (365 days) of diagnosis for women under the age of 70 receiving breast conservation surgery for cancer (Accountability).

100% (11/11)

92.3% (12/13)

81.8% (9/11)

>= 90%

Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1c N0 or Stage IB-III hormone receptor negative breast cancer (Accountability).

100% (2/2)

100% (2/2)

100% (2/2)

>= 90%

Colorectal Cancer

Adjuvant chemotherapy is considered / administered within 4 months (120 days) of diagnosis for patients under age 80 with AJCC Stage III (lymph node positive) colon cancer (Accountability).

100%

(4/4)

100%

(7/7)

100%

(5/5)

>= 90%

At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer (Quality Improvement).

100% (9/9)

100% (19/19)

94.4% (17/18)

>= 85%

Pre-op chemo & radiation are administered for clinical AJCC T3N0, T4N0 or Stage III or postoperative chemo & radiation administered within 180 days of diagnosis for clinical AJCC T1-2N0 with pathologic AJCC T3N0, T4N0 or Stage III, or treatment is considered for patients under age 80 with resection for rectal cancer (Quality Improvement).

100%

(1/1)

100%

(5/5)

100%

(4/4)

Not Yet

Established

Quality Measure

RWMC 2011

RWMC 2012

RWMC 2013

CoC / NCDB Required Performance Rate

Gastric Cancer

At least 15 regional lymph nodes are removed and pathologically examined for resected gastric cancer (Quality Improvement).

33.3% (2/6)

100% (2/2)

50% (1/2)

Not Yet Established

Lung Cancer

At least 10 regional nodes are removed & pathologically examined for AJCC Stage IA, IB, IIA and IIB resected NSCLC (Surveillance).

50.0% (1/2)

50.0% (1/2)

66.7% (2/3)

Not Yet Established

Surgery is not the first course of treatment for cN2, M0 lung cancer cases (Quality Improvement).

100% (2/2)

100% (4/4)

100% (4/4)

Not Yet Established

Systemic chemotherapy is administered within 4 months to day preoperatively or day of surgery to 6 months postoperatively, or it is considered for surgically resected cases with pathologic lymph node-positive (pN1) and (pN2) NSCLC (Quality Improvement).

100% (2/2)

66.7% (2/3)

No Cases

Not Yet Established

Cervical Cancer

Radiation therapy completed within 60 days of initiation of radiation for women diagnosed with any stage cervical cancer (Surveillance).

No Cases

No Cases

No Cases

Not Yet Established

Use of brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer (Surveillance).

No Cases

No Cases

No Cases

Not Yet Established

Endometrial Cancer

Chemotherapy and/or radiation administered to patients with Stage IIIC or Stage IV Endometrial cancer (Surveillance).

No Cases

100% (2/2)

No Cases

Not Yet Established

Endoscopic, laparoscopic or robotic performed for all Endometrial cancer (excluding sarcoma & lymphoma) for all stages except Stage IV (Surveillance).

0% (0/1)

0% (0/2)

0% (0/1)

Not Yet Established

Ovarian Cancer

Salpingo-oophorectomy with omentectomy, debulking/cytoreductive surgery or pelvic exenteration in Stages I-IIIC Ovarian cancer (Surveillance).

100% (1/1)

No Cases

No Cases

Not Yet Established

Chemotherapy started within 42 days (before or after) the date of most definitive surgery in Stages IA – IV Ovarian, Fallopian Tube, or Peritoneal cancers (Surveillance).

33% (1/3)

No Cases

100% (1/1)

Not Yet Established

The NCCN guidelines for colon cancer recommend that for potentially surgically curable M1 disease there should be a multidisciplinary evaluation, including a surgeon experienced in the resection of hepatobiliary metastases. In this project, 75 cases of colon cancer with liver metastases from 2004 to 2013 were reviewed to determine if a referral was made to evaluate for possible resection. Of the 75 patients, 49 (65%) were referred to Surgical Oncology. Of those 49 patients referred, 33 had a surgical intervention (67%). Some of the factors affecting whether the patient had a surgical proce-dure were the number of hepatic lesions, CEA level, and if bi-lobar liver disease was present. Most of the patients referred had only hepatic metastases and no other sites of distant disease. Patients who were not referred were mainly those with advanced disease or patients who either chose or were felt appropriate for hospice care. The median survival for patients who were referred was 15 months and for those not referred was 1.5 months. After analyzing the data, the referral pattern for these patients here at Roger Williams Medical Center of 65% is in line with expected rates between 60-70% and is felt to be adequate.

Referral Patterns of Stage IV Colorectal Adenocarcinomas at Roger Williams Medical Center

65% (N=49)

35% (N=26)

0%

20%

40%

60%

80%

100%

Yes No

Yes No

Referral to Liver Surgeon

Surgical Intervention

67% (N=33)

33% (N=16)

0%

20%

40%

60%

80%

100%

Yes No

Intervention on Referred ptsYes No

RESULTS: Univariate Comparison

Odds Ratio(OR) 95% CI P-value

Number of hepatic metastases

≤3 Reference

>3 0.30 0.10 - 0.88 0.029

Size

≤5cm Reference

>5cm 1.10 0.32 - 3.74 0.878

CEA Level (Median 17.45)

≤17.45 Reference

>17.45 0.57 0.19 - 1.71 0.313

Extra-hepatic metastases

No Reference

Yes 0.40 0.14 - 1.07 0.069

Median SurvivalReferred 15 monthsNot Referred 1.5 months

Referral Patterns of Stage IV Colorectal Adenocarcinomas

RESULTS: Survival Analysis

Immuno-Oncology Program SummaryPrincipal Investigator: Steven C. Katz, MD Co-Investigator: N. Joseph Espat, MD Medical Monitor: Vincent Armenio, MD Trial Nurse: Ashley Moody, RN

The Immuno-Oncology (IO) Program at Roger Williams Medical Center(RWMC) is focused on ge-netically modified or CAR-T cell-centered research trials and clinical programs, including Rhode Island’s only High Dose Interleukin-2 (HD IL-2) program for stage IV melanoma and kidney can-cer. All efforts, both research and clinical, are focused on harnessing the body’s immune system to help fight cancer. The active and completed CAR-T clinical trials employed the Hepatic Im-munotherapy for Metastases (HITM) platform. This platform involves regional delivery of CAR-T cells directly into the liver, targeting metastases from solid tumors.

With two HITM trials complete and a third underway, our program continues to grow. Future plans include a phase II, multi-institutional HITM trial with RWMC as the lead site and new phase I trial work focused on treating inoperable abdominal cavity or peritoneal metastases. Our liv-er and peritoneal delivery platforms optimize patient safety while enabling deeper clinical re-sponses. We have also discovered a novel CAR-T production method to reverse age-related cell performance defects, which will be crucial in addressing advanced cancer in the elderly. Roger Williams also has the only CAR-T cell manufacturing facility in Rhode Island.

The HITM trial (NCT01373047, RW335-99) was completed in 2013 and demonstrated the safety of CAR-T hepatic artery infusion (HAI). Patients enrolled from across the nation and globe. The HITM trial provided encouraging signals of clinical activity in a heavily pre-treated population with large tumor burdens. A single HITM patient lived for more than 4 years following CAR-T treatment. HITM-SIR (NCT02416466, RW383-74) was completed in 2016 and confirmed the safe-ty of CAR-T HAI in combination with y-90 SIRT (radioactive bead) therapy and low-dose infusion-al IL-2. HITM-SIR provided encouraging signals of clinical activity, several decreases in serum tu-mor marker levels, and evidence of extrahepatic disease regression. HITM-SURE (NCT02850536, RW350-74), a phase Ib trial of CAR-T HAI delivered using the Surefire infusion system for liver metastases, is underway. Infusions are carried out using Surefire infusion devices, which are FDA-approved catheters proven to minimize reflux of therapeutics, while also enhancing intra-tumoral penetration of therapeutic agents.

We recently launched a HD IL-2 program for patients with stage IV melanoma and kidney cancer. This is the only HD IL-2 program available for patients between major Connecticut and Massa-chusetts hospitals. HD IL-2 is an FDA-approved cancer immunotherapy treatment for patients with metastatic renal cell carcinoma and metastatic melanoma. HD IL-2 has proven to be effec-tive and induce long lasting responses in select patients battling these diseases. Our first patient (melanoma) completed treatment in February of this year and had vision restored, which was impaired following spread of the melanoma to his eye. Four additional patients will be recruited to fulfill a five patient pilot.

With highly supportive hospital and corporate leadership, the RWMC IO program is well posi-tioned to play a leading role in development and testing of novel therapies for presently incur-able disease. We look forward to treating and bettering the lives of patients in Rhode Island and far beyond.

OverviewRoger Williams Medical Center is home to the state’s first -- and only -- Geriatric Oncology Program, which we call COPE (Comprehensive Oncology Program for Elders). Dr. Ponnandai Somasundar, a board certified surgeon with fellowship training in surgical oncology, serves as Director of Geriatric Oncology. As a recog-nized leader in both cancer and elder care, Roger Williams is focused on the latest tools in diagnoses, treat-ment and care of older patients with cancer. It is for this reason the COPE program was founded in 2012.

Program GoalClosely follow patients through their cancer treatment; assess and improve the lives and functionality of cancer patients as they undergo treatment. There are four assessment periods:• Pretreatment: when the patient is diagnosed• 30 days after treatment initiation• 90 days after treatment initiation• 180 days after treatment initiation

ResultsThe program was initiated in November of 2012. Through 15 January 2015, 157 patients had been admit-ted into the program. Of those 157 patients:• 156 had pretreatment appointments (28 of them presented and were either diagnosed as being can-

cer-free, opted out of treatment, or passed away prior to the start of treatment so they had no subse-quent follow-ups)

Of the 129 that were eligible for follow-ups:• 41 had 30-day follow ups• 34 had 90-day follow ups• 35 had 180-day follow ups

Conclusions for the Intervention GroupIn the intervention group, PHQ-9, nutrition, and TUG scores all showed significant improvement (on aver-age). In all of these cases, a lower score is better, so these results are promising.

ResultsTUG Score (Timed Up and Go) in Seconds• Pretreatment average: 13.19• 180-Day assessment average: 10.92Nutrition Score• Pretreatment average: 6.56• 180-Day assessment average: 4.67PHQ-9 Score (Depression Assessment) • Pretreatment average: 8.44• 180-Day assessment average: 4.15

FindingsThere were no significant differences between male and female assessment scores overall. Both genders showed significant improvement in TUG and PHQ-9 scores by the 180-Day assessment period. • Female TUG and PHQ scores went down from 12.52 to 10.39 seconds, and from 5.3 to 3.57.• Male TUG and PHQ scores went down from 11.5 to 9.45 seconds, and from 5.79 to 3.46.As the program moves forward and draws more patients, the validity of these tests will improve and we will be able to make stronger conclusions.

Geriatric Oncology Program Details

Quality Study One

A Project to Assure Quality Cancer Care

Roger Williams Medical CenterPhase II: Retrospective Medical Record Review

Preliminary Data ReportInstitution Code:CCP12

Report Prepared By: Curtis Center Program Evaluation GroupUniversity of Michigan School of Social Work

Overview

Project BackgroundA Project to Assure Quality Cancer Care (APAQCC), funded by the Association of Oncology Social Work (AOSW) through a gift from Takeda Oncology, is a project to assure that cancer patients and families get the psychosocial care they need, when they need it. As of 2015, approximately 1,500 cancer treating institutions (that treat approximately 75% of cancer patients in the United States) will be obligated to demonstrate compliance with the American College of Surgeon’s Commission on Cancer Standard 3.2 for distress screening. They will need to demonstrate that distress screening is being implemented as intended and that patients are being served appropriately.

About Phase IIDuring Phase II, oncology social workers at 57 cancer programs across North America completed a retrospective medial record review over a two-month window to document adherence and respon-siveness to their institution’s distress screening protocol. They also collected data on patient medical service utilization specific to number and length of hospitalizations, use of emergency department, and number of missed appointments. This report provides an overview of the retrospective review completed at your institution, and compares your results, anonymously, to other cancer programs of similar type.

Data presented in this report include:Mean: The average of all of the responses.Standard Deviation (SD): Indicates how much variation there was in the responses. For example, a standard deviation of 1 indicates that the majority of responses (66%) fell within 1.00 point of the mean. The bigger the standard deviation, the more variation there is in the responses to that ques-tion from your institution.

Quality Study Two

Institutional Summary

Location(s) for Data Collection: Roger Williams Bone Marrow UnitTimeframe: 12/2014 –1/2015Pivotal Time Point(s): Patients are screened each time they come to appointmentsDistress Screening Tool Used: Distress Thermometer (with problem checklist); Patient Health Ques-tionnaire (PHQ, any in the series

Considerations for Your Institution

Are our rates of screening adherence and responsiveness equitable?•Is it possible that sub-groups of patients that are more likely to NOT have been screened or have their needs responded to (e.g., male patients, older patients, patients from race/ethnic minority groups, non-English speaking patients)?•What are risks to the patients if not screened?•What are the costs to the cancer program if these patients are not screened?•What might we do to address any inequity?

If we see differences in rates of medical service utilization, what do we think accounts for those differences?•Do sicker patients get screened and subsequently use more services?•Do those patients not screened or responded to when indicated utilize more services? Could use have been prevented had these patients been screened, detected, responded to when clinically indicated, and/or followed over time?

Ann B. BarshingerCancer InstituteAspirus Regional Cancer CenterAthens Regional Medical CenterAtlanta Cancer CareAvera Cancer InstituteBaptist Health Louisville Cancer CenterBeth Israel Deaconess Medical CenterBon Secours Richmond Health SystemCarolinas HealthCare System Blue RidgeCatawba Valley Medical CenterCentral Maine Medical CenterCity of Hope National Medical CenterDuke Cancer InstituteEllis Fischel Cancer CenterEmory Saint Joseph’s HospitalFaxtonSt. Luke’s HealthcareGood Samaritan Oncology/Hematology AssociatesGW, Medical Faculty AssociatesHannibal Regional Hospital, James E Cary Cancer CenterHealthAlliance Hospital of the Hudson ValleyHuntsman Cancer InstituteMary Bird Perkins, Our Lady of the Lake Cancer CenterMayo Clinic Health System, La CrosseMayo Clinic Health System, MankatoMcLeod Regional Medical CenterMedstarGeorgetown University HospitalMercy Hospital and Medical CenterMercy Oncology Hematology CenterMetroHealthCancer Care CenterMount Auburn HospitalMount Sinai HospitalNash Cancer Treatment CenterOregon Health & Science UniversityPark Ridge HealthPresbyterian Healthcare ServicesPrincess Margaret Cancer CentrePromedicaHickman Cancer CenterProvidence Cancer CenterRoger Williams Medical CenterSharp Memorial Hospital Outpatient Cancer InstituteSt. Dominic Cancer CenterSt. Joseph Comprehensive Cancer CenterSt. Jude CrossonCancer InstituteSt. Luke’s Hospital and Center for Cancer CareSt. Luke’s Mountain State Tumor InstituteSt. Mary’s Hospital CenterSutter Medical CenterThe Center for Cancer Prevention and Treatment, St. Joseph HospitalThe Dale and Frances Hughes Cancer CenterThe DeCesarisCancer Institute, Anne Arundel Medical CenterThe Reading Hospital, McGlinnCancer InstituteUC Davis Comprehensive Cancer CneterUM Upper Chesapeake Medical Center, Kaufman Cancer CenterUniversity of Colorado Cancer CenterUniversity of Kentucky Markey Cancer CenterVermont Cancer Center, Fletcher Allen Health CareWellspanYork Cancer Center

Participating APAQCC institutions

Prevention ProgramsSun Safe program August 2015 at National Night Out at Governor Notty Park in North ProvidenceParticipants were educated on a variety of cancer risks. Samples of sun block were given away. Educa-tion was provided on smoking cessation, smoking avoidance and the dangers of second hand smoke. Dentists provided oral screening for oral cancer and other diseases. The nurse practitioner and patient care navigator from the Breast Care Center at Fatima Hospital provided education on the importance of self-breast exam and mammography. Those women who were uninsured were contacted by the navigator in the Women’s Cancer Screening Program and will have mammograms scheduled.

Gloria Gemma Flames of Hope October 2015 at Waterfire event in downtown ProvidenceHospital staff was available at a booth during this event for patient education including breast self-ex-am, breast health and wellness materials. Offerings at our booth included educational materials on breast self exam including plastic breast models for demonstration. Information distributed also includ-ed general breast health and wellness material.

Lung Cancer Screening ProgramIn 2015, Roger Williams Cancer Center launched a Lung Cancer Screening Program in partnership with Rhode Island Medical Imaging.

Skin Cancer Screening August 2015 at National Night Out at Governor Notty Park in North ProvidenceSkin cancer screening was conducted by ten Dermatologists, who screened 91 people. Five people had suspicious lesions and were contacted to arrange follow-up appointments. Three other people screened were found to have other non-malignant skin conditions that required follow up. Participants were educated on a variety of skin cancer risks. Samples of sun block were offered to all participants.

Screening Programs

The following goals were achieved and Quality Improvements were noted during 2015:

• Addition of Photopheresis Therapy in the Cancer Center. Prior to this, patients had to travel to Boston for this therapy, as it was not available anywhere in Rhode Island.

• Increased Oncologist Outreach in Underserved Areas. Our physicians travel onsite to outside clin-ics to see patients in underserved areas.

• Started a new Lung Cancer Screening Program. Set up a new program in the hospital Radiology Department and started screening patients in October, 2015.

• Increased Spanish language content to Cancer Center website. Added several pages in Spanish to the website with several informational videos and a link to an email contact in Spanish.

• Revision of the Distress Scale for patient evaluation to include a version in Spanish.• Conducted a two-day program to train 12 volunteers from the Latino community to assist with pa-

tient outreach. Educated the volunteers on specific cancer sites including colorectal and breast can-cer to aid them in directing patients to the resources needed for proper diagnosis and treatment.

• Improvement in Patient Satisfaction rates from 90.3 to 93.5% in Geriatric Oncology. • Increased percentage of cases presented at a Cancer Conference with multidisciplinary treatment

planning from 32% to 39% of newly diagnosed cases. Conferences included weekly multi-site Can-cer Conference, twice monthly Thoracic Conference and monthly Melanoma / Skin Conference.

Quality Improvements & Goals Achieved

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