2010 Cancer Program Annual Report

Adele R. Decof Cancer Centerat Roger Williams Medical Center

TABLE OF CONTENTS

p. 3 Cancer Committee Membershipp. 4 Message from the Cancer Committee Chairp. 5 Message from the Hospital President and Cancer Center Directorp. 6 & 7 Introduction and Cancer Registry Statisticsp. 8 Top 5 Sites/Residency at Diagnosisp. 9 Gender by Age/State of Disease at Diagnosisp. 10-19 2010 Breast Cancer Patient Outcome Analysis

Departmental Reportsp. 20 Hematology Oncologyp. 20-22 Surgical Oncologyp. 22-23 Radiation Oncologyp. 23 Diagnostic Imagingp. 23 Blood and Marrow Transplantationp. 23 Surgical Researchp. 24 Protocol Officep. 24 Oncology Nursingp. 25 Case Managementp. 25 Cancer Center Pharmacyp. 25 Nutritionp. 25 Outreach

2010 CANCER COMMITTEE MEMBERSHIP

Physician Members

Dr. Ponnandai Somasundar, Surgical Oncology, ChairmanDr. Brian Stainken, Interventional RadiologyDr. Peter Libbey, PathologyDr. Francis Cummings, Medical OncologyDr. Timothy Shafman, Radiation OncologyDr. James Koness, Surgery, Cancer Center LiaisonDr. Timothy Connelly, Anesthesiology, Pain Control/Palliative CareDr. Marshall Kadin, Dermatology

Non Physician Members

Cancer Center Director: Kathy Perry, Cancer Program AdministratorCancer Center Manager: Kathleen Starick, RNOncology nurses: Jennifer Parker, RN; Patricia Cafaro, RNCase Management: Deb Stamp, RN, BSN, MEd, CICCertified Tumor Registrar: Julie SimmonsPerformance Improvement: Nancy Fogarty, Quality Improvement CoordinatorDietary/Nutrition: Sheri RegoCancer Center Pharmacist: Jim MelfiPastoral care/public member of the community served: Jim WillseyAmerican Cancer Society: Lisa StorsHealth Information Management: Laurie Fiore, RHIT, Cancer Registry Data CoordinatorTumor Board: Charlene Deluca-ThibodeauProtocol Office Manager: Robin Davies, RNRehabilitation: Lorraine SloanePsychiatry: Elinor Collins, RN, MS, CS, PPNSPublic Relations: Brett Davey, Community Outreach CoordinatorProtocol Office Director: Karen GeremiaCancer Center Pharmacist: Thomas Habershaw

From the Committee Chairman

It is my privilege to share the 2010 Cancer Committee report fromRoger Williams Medical Center.

Our cancer registry exists to collect information that helps us betterunderstand our patient population and the cancers we treat. Our tumorboard, grand rounds, physician lectures, and cancer committees areplaces where physicians can collaborate and exchange information, allin the goal of providing better treatment for patients in our care.

During this year, we have continued to make tremendous progress inresearch, diagnosis and treatment of cancer. As a teaching affiliate ofBoston University School of Medicine and home to one of only 18surgical oncology fellowships in the country, Roger Williams continues to train and educate the nextgeneration of surgeons, physicians, and researchers dedicated to caring for patients with cancer.

This cancer report contains some of the Cancer-care highlights from 2009. We are pleased toprovide this information as we continue to focus on delivering the best possible cancer care.

Dr. Ponnandai SomasundarCancer Committee Chair

From the Hospital President and Cancer Center Director

On January 20, 2009, the community and the Roger WilliamsMedical Center team held a ribbon cutting to celebrate theexpansion of the Adele R. Decof Cancer Center. This additionincluded a new Chemotherapy Infusion Center, BMT Clinic,Multi-Disciplinary Clinic, and Hematology-Oncology Clinic. Theconcept behind the expansion was to enhance our multi-disciplinary approach by centralizing cancer care for patients inone convenient location.

In a way, this move symbolizes our philosophy of care: patientcentered, multi-disciplinary, with a focus on quality andinnovation.

Roger Williams is recognized in the community and in medical circles as a leader in cancer care. In2009, researchers at Roger Williams -- led by Dr. Richard Junghans -- were awarded $5.9 million toresearch how breast cancer patients’ own T-cells can be modified to fight their disease. This award,from the Department of Defense Breast Cancer Research Program, is believed to be the largest breastcancer research grant ever received in Rhode Island.

Our mission at the Cancer Center is to build off of the exemplary work of our colleagues. We do thisby bringing together experts from distinct medical fields, all with the common goal of improving cancercare regionally, nationally, and around the world. This level of teamwork and collaboration has alwaysbeen – and will continue to be – at the heart of our philosophy of cancer care.

Kenneth H. Belcher Dr. N. Joseph EspatPresident and CEO Director, Adele R. Decof Cancer CenterRoger Williams Medical Center Chief, Surgical Oncology

INTRODUCTION

The Cancer Registry at RogerWilliams Medical Center isresponsible for capturing a completesummary of a cancer patient’sdisease; from diagnosis through thelifetime of the patient. This summaryor abstract provides an on-goingaccount of the cancer patient’shistory, diagnosis, stage of disease atdiagnosis, treatment, and currentstatus. In addition to data analysis, theCancer Registry also monitors qualityof care and clinical practice guidelines, provides benchmarking services, and providesinformation relating to patterns of care and referrals.

The Cancer Program at Roger Williams Medical Center is accredited through theAmerican College of Surgeons, Commission on Cancer (ACoS). The CancerRegistry database has been in operation since 1983 and is a valuable division of theCancer Program. The Cancer Registry database includes patient demographicinformation, as well as information on the cancer site, histology, stage of disease atdiagnosis, and treatment. In additional follow-up information including the vital status,disease status, recurrence information, and subsequent treatment is collected foranalytic1 cases throughout the lifetime of the patient. The follow-up information isreviewed and used for survival and outcome analysis studies.

The data collected by the Cancer Registry is provided to clinicians, researchers,and administration to assist with administrative planning as well as research andgrant applications. The cases collected by the Cancer Registry are submitted to theState Cancer Registry and all analytic cases are reported to the American Collegeof Surgeons, Commission on Cancer (ACoS) during the Annual Call for Data.

CANCER REGISTRY STATISTICS

The 2010 Cancer Registry report utilizes 2009 calendar year data. In 2009, a totalof 545 cases were accessioned into the database. Of this total, 430 cases wereanalytic and 115 cases were non-analytic2. The Cancer Registry maintains at least a90% follow-up rate on patients diagnosed and treated at Roger Williams MedicalCenter. Due to the longevity of the database, over 4,000 patients are followedannually. In 2009, the Cancer Program at Roger Williams Medical Center wasawarded a 3 year renewed accreditation with commendation.

Top Five Sites for RogerWilliams Medical Center

The five most common analytic can-cer sites in 2009 are (in descendingorder by percent of total incidence)Lung & Bronchus (14.2%), Breast(12.3%), Skin (9.5%), Colon (8.6%),and Pancreas (6.0%). This distribu-tion differs from the American Can-cer Society (ACS) distribution.

In 2009, 1,479,350 new cancer casesare estimated with the five most com-mon cancer sites being (in descend-ing order by percent of total incidence)Lung & Bronchus (14.8%), FemaleBreast (13.0%), Prostate (13.0%),Colon and Rectum (9.9%), and Uri-nary Bladder (4.8%).

Residence at Diagnosis

The Roger Williams Medical Centeris located in Providence County.More than 60% of the hospital’sanalytic cancer patients accessionedin 2009 reside in Providence County.The remainder of the hospital’sanalytic cancer patients are distributedthroughout Rhode Island andMassachusetts.

2009 Cancer Registry Statistics

Gender by Age

In 2009, the gender distribution for RogerWilliams Medical Center was 47% maleand 53% female. This distribution differsfrom the American Cancer Society (ACS)gender distribution. Based on the AmericanCancer Society (ACS) data, the estimatedgender distribution of cancer cases in 2009was 52% male and 48% female. The mostcommon age group for Roger WilliamsMedical Center was 60–69; approximately25% of patients were in this age group atthe time of initial diagnosis.

*99 – AJCC stage is unknown*88 – AJCC stage is not applicable

Stage of Disease at Diagnosis

The cases accessioned into the CancerRegistry database are categorized accord-ing to the tumor/node/metastases (TNM)staging system developed by the Ameri-can Joint Committee on Cancer (AJCC)to describe the extent or spread of dis-ease at diagnosis, which is generally pre-dictive of survival. Of the analytic casesentered into the Cancer Registry databasein 2009, 24 were classified as TNM stage0, 101 as stage I, 54 as stage II, 55 asstage III, 74 as stage IV, 69 were classi-fied as not staged, and 53 were not appli-cable for staging based on the TNM sys-tem.

The primary purpose of any Cancer Registry is to collect complete, timely, high quality data to reflect all aspectsof a patient’s disease. As the data is combined with that from other medical centers and from other communities,researchers can learn and understand more about cancer and the overall disease process. The Cancer Registryworks with physicians, researchers, and hospital administration to assist with cancer program development. TheCancer Registry is also committed to assisting the Cancer Program’s multidisciplinary health care team to ensurecompliance with the required standards and maintain accreditation by the American College of Surgeons, Commissionon Cancer (ACoS). -- Tara Szymanski, CTR

ENDNOTES1 Analytic – cases diagnosed at the accessioning facility and/or administered any of the first course treatment afterthe registry’s reference date.2 Non-analytic – case that was diagnosed and all of the first course treatment was performed elsewhere, or thecase was diagnosed and/or treated prior to the registry’s reference date, or the case was diagnosed at autopsy, orthe case was diagnosed and received all of the first course treatment in a staff physician office, or the case was apathology report only (patient does not enter the accessioning facility at any time for diagnosis or treatment), or thediagnosis was established by death certificate only. These cases are not included in treatment or survival statistics.

Symptoms/Signs of Early Breast Cancer None, firm lump in the breast or armpit Change in the size, shape, or feel of the breast or nipple Fluid expressed from the nipple

2010 Breast Cancer PatientOutcome Analysis________________________________________________________________________

From 2005 through 2009, theRoger Williams Medical CenterCancer Registry accessioned294 patients with breast cancer.

2010 Breast Cancer Patient Outcome Analysis

Source: Roger Williams Medical Center Cancer Registry

Symptoms/Signs of Advanced Breast Cancer Malaise/Fatigue Weight Loss Nipple Retraction Bone Pain Swelling of breast or arm on the same side

as the affected breast Breast pain or discomfort Skin Ulceration

Risk Factors

1. Age and gender The risk of developing breast cancer increases with age. The majority ofadvanced breast cancer cases are found in women over the age of 50.

2. Family history of Approximately 20-30% of women with breast cancer have a family history ofthe breast cancer disease.

3. Genes The most common genetic defects are found in the BRCA1 and BRCA2genes and an estimated 10% of breast cancers have these genetic defects.

4. Menstrual cycle Women who get their period early (before age 12) or go throughmenopause late (after age 55) have an increased risk of breast cancer.

5. Hormone replacement Receiving hormone replacement therapy for several years can increase thetherapy (HRT) risk of developing breast cancer.

6. Radiation Receiving radiation therapy as a child or young adult to treat cancer of thechest can significantly increase the risk of developing breast cancer (8-25 fold).

In 2009, an estimated 194,280 new cases of female breast cancer were diagnosedin the United States and an estimated 810 female residents in Rhode Island will bediagnosed with breast cancer in 2009.

Breast cancer is the most commonly diagnosed cancer in women with an incidencerate of 1 in 8. Women are 100 times more likely than men to develop breast cancer.Several of the well-established risk factors for breast cancer are listed below.

Hospital comparison benchmark reports are available from the NCDB for the years2000 to 2008. Various comparisons can be made by primary site, hospital type(Community Hospital Comprehensive Cancer Program), by geographical location(individual state, ACS Division, or all states) and diagnostic year (2000, 2001,2002, 2003, 2004, 2005, 2006, 2007, and 2008 or combined).

Throughout this report are samples of hospital comparison benchmarks on breastcancer generated for all ACoS approved Cancer Programs in the United Statesand the ACoS Cancer Programs in Rhode Island. This will be a valuable tool forassessing our diagnostic and therapeutic efforts as more data from proceeding yearsis added to the database.

The table below is based on information obtained from the National Cancer DataBase (NCDB) and illustrates a case distribution comparison between Roger WilliamsMedical Center and the other hospitals within the state of Rhode Island.

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010

ACoS Commission on Cancer -- National Cancer DatabaseHospital Comparison Benchmark Reports

Breast Cancer Diagnosed 2000 to 2008 by YEAR

Roger Williams Medical Center, Providence, RI vs.All Types of Hospitals in the State of Rhode Island

In 2009 an estimated 194,280 females will learn they have breast cancer. The highestoverall breast incidence rates are in Caucasian, non-Hispanic women, while KoreanAmerican women have been noted to have the lowest incidence rates. For women age 40– 50 African American women have a higher incidence than Caucasian women. AfricanAmerican women also have the highest mortality rate from breast cancer, while ChineseAmerican women have been noted to have the lowest mortality rates.

The table below is based on information obtained from the National Cancer Data Base(NCDB) and illustrates a race comparison between National Reporting Hospitals, theother hospitals within the state of Rhode Island, and Roger Williams Medical Center.

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010Source: http://www.webmd.com/breast-cancer/guide/race-ethnicity-risk

Breast Cancer Diagnosed 2000 to 2008 by RACE

All reported cases -- HOSP. TYPE: All Types/Systems

National vs. All Types of Hospitals in the State of Rhode Island vs.Roger Williams Medical Center, Providence, RI

The risk of developing breast cancer increases with age. The age distribution forbreast cancer diagnosis at Roger Williams Medical Center range from 30 to 94. Themajority of breast cancer diagnoses occur in women age 40 and older with a medianage at diagnosis of 61.

The table below is based on information obtained from the National Cancer DataBase (NCDB) and illustrates an age at diagnosis comparison between RogerWilliams Medical Center and the other hospitals within the state of Rhode Island.

Breast Cancer Diagnosed 2000 to 2008 by AGE

All Reported Cases – HOSP. TYPE: All Types/SystemsRoger Williams Medical Center, Providence, RI vs.All Types Hospitals in the State Of Rhode Island

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010Source: http://seer.cancer.gov/statfacts/html/breast.html#incidence-mortality

Infiltrating Ductal Carcinoma Fine Needle Aspiration of Poorly Differentiated, Grade 3 Lobular Carcinoma

Source: American Joint Committee on Cancer, 6th EditionSource: http://www.orienttumor.com/ENGLISH/t&t/breast/012.htmSource: http://www.orienttumor.com/ENGLISH/t&t/breast/015.htm

Histological Types for Both In-Situ and Invasive Breast Cancers

In-situ carcinomas are split into Intraductal (in-situ ductal DCIS or lobular LCIS) and Paget’sdisease. LCIS is not a premalignant condition and is most appropriately described as amarker for developing an invasive cancer mostly of ductal histology. The most commonhistological type of invasive breast cancer is ductal carcinoma with lobular carcinoma beingthe second most common type. The histologic characteristics can have important therapeuticimplications and affect prognosis. Some of the less common histologies of invasive breastcancer include, inflammatory, tubular, medullary, mucinous, papillary, squamous cell, adenoidcystic, metaplastic, neuroendocrine small cell, undifferentiated, phyllodes tumor, lymphomas,and sarcomas.

Tumor Grade

Multiple grading systems have been proposed in an effort to minimize interobserver variability.The Scarff-Bloom-Richardson classification system utilizes mitotic index, tumor differentiationand pleomorphism. It assigns a score of between 1 and 3 to each with an overall score of 3-5 described as well-differentiated (favorable), 6-7 moderately differentiated (moderatelyfavorable), and 8-9 poorly differentiated (unfavorable). This system has been shown to be ofindependent prognostic significance. A group from Nottingham, UK refined this methodology.They evaluate three morphological features: percentage of tubule formation, degree of nuclearpleomorphism, and an accurate mitotic count using a defined field area. They also assign ascore of between 1 and 3 for each and again a strong correlation exists between the scoreand prognosis with the highest scores having a worse prognosis.

Ductal Carcinoma In-Situ Lobular Carcinoma In-Situ

Source: http://www.surgical-tutor.org.uk/default-home.htm?slides/breast.htm~right

The graph below displays the histologic distribution for breast cancers diagnosed at Roger WilliamsMedical Center from 2005 to 2009.

The table on the right is based on informationobtained from the National Cancer Data Base(NCDB) and illustrates a histological com-parison between Roger Williams MedicalCenter and the other hospitals within the Stateof Rhode Island.

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010

Staging System

The most widely used staging scheme is theAJCC Cancer Staging Manual (TNM). TheTNM describes the extent of the primaryTumor (T stage), whether or not the cancerhas spread to regional lymph Nodes (N stage),and the absence or presence or distantMetastases (M stage). Patients diagnosed withbreast cancer after January 1, 2003 are stagedwith the AJCC Cancer Staging Manual SixthEdition.

The table to the right is based on informationobtained from the National Cancer Data Base(NCDB) and illustrates a stage comparisonbetween National Reporting Hospitals, theother hospitals within the state of Rhode Is-land, and Roger Williams Medical Center.

Breast Cancer Diagnosed 2000 to 2008 by AGE

All Reported Cases – HOSP. TYPE: All Types/SystemsRoger Williams Medical Center, Providence, RI vs. All Types

Hospitals in the State of Rhode Island

Breast Cancer Diagnosed 2000 to 2008 by STAGE

All Reported Cases – HOSP. TYPE: All Types/SystemsNational vs. All Types Hospitals in the State of Rhode Islandvs. Roger Williams Medical Center, Providence, RI

Source:http://imaging.ubmmedica.com/cancernetwork/journals/oncology/images/unwinding/200411-1623-1.gif

Treatment for Breast Cancer

Treatment for breast cancer is based on many factors including histology, stage, whether or not the cancer expressescertain hormone receptors (estrogen ER and/or progesterone PR) and whether or not the cancer overproducesHER-2/neu. Many studies indicate that patients with hormonal receptors (ER and/or PR) have a significantlyhigher survival rate. Tumors expressing both hormone receptors have the greatest benefit from hormone therapy.

There are several treatment options for patients with breast cancer: surgery, chemotherapy, radiation therapy, andhormone therapy. Most patients will receive a combination of these treatments.

Stage 0 cancers will be treated with lumpectomy plus radiation or mastectomy. Stage I and II cancers will undergolumpectomy plus radiation or mastectomy with lymph node dissection. Hormone therapy, chemotherapy, or abiologic therapy may also be recommended. Stage III cancers will have surgery, chemotherapy, radiation andpossibly hormone therapy, or a biologic therapy. Stage IV cancers may or may not involve surgery and/or radiationbut will include chemotherapy, possibly hormonal therapy, or a combination of these treatments.

The table below is based on information obtained from the NationalCancer Data Base (NCDB) and illustrates a treatment comparisonbetween National Reporting Hospitals, the other hospitals withinthe state of Rhode Island, and Roger Williams Medical Center.

Breast Cancer Diagnosed 2000 to 2008 by TREATMENTAll Reported Cases – HOSP. TYPE: All Types/Systems

National vs. All Types Hospitals in the State of Rhode Island vs.Roger Williams Medical Center, Providence, RI

2010 National Cancer Data Base (NCDB)/Commission on Cancer (COC)/Developer: Florin Petrescy 11/2/2010

The graph below is based on information obtained from the National Cancer Data Base (NCDB)and illustrates the observed survival for breast cancer patients diagnosed in 2003. The data reflectsinformation received from hospitals in the state of Rhode Island (11 hospitals).

The graph below is based on information obtained from the National Cancer DataBase (NCDB) and illustrates the observed survival for breast cancer patientsdiagnosed in 2003. The data reflects information received from 1,327 hospitals.

Clinical ProgramThe Roger Williams SurgicalOncology team is well recognized forexcellence in the treatment ofhepatobiliary cancers. We perform ahigh volume of complex surgicalprocedures, including complex liverand pancreas resections. Thisprogram offers specialized care topatients with diseases of the liver,biliary tract, and the pancreas. Liverand pancreatic diseases are complexand require critical decisions foundedupon intensive training. As a result ofour surgical team’s experience andexpertise, our patients benefit from thelatest techniques and technologies intreating patients with liver andpancreas disease, with managementplans formulated in a multi-disciplinaryfashion.

Roger Williams is one of only a fewcenters across the nation offeringmicrowave ablation therapies for thetreatment of liver tumors. Thephysicians managing these diseasesare all surgical oncology fellowship-trained and well recognized for theirexperience in the use of minimallyinvasive approaches.

SURGICAL ONCOLOGY

OverviewThe Hematology/Oncology Division iscomprised of teaching faculty affiliatedwith Boston University School ofMedicine. The division conductscancer-related clinical, research, andacademic activities including theHematology/Oncology Fellowshipprogram. Additionally, the divisionconducts operations of the CancerProtocol Office.

Clinical ProgramClinics: There were approximately2900 outpatient visits accounting foran increase of over 15% whencompared to 2008.

Quality Care: The division is one offew practices in New England toparticipate in the Quality OncologyPractice Initiative (QOPI) from theAmerican Society of Clinical Oncology(ASCO). The Division scored highlyabove national scores with consistentlyexcellent quality outcome results inColorectal, Breast, Lung andLymphoma modules.

In 2009, Roger Williams became thefirst Cancer Center in Rhode Island toprovide k-ras molecular testing forpatients with colorectal cancer. TheHematology/Oncology Division andPathology Department jointly initiatedthis molecular testing, which accuratelypredicts which patients will benefit fromvery expensive targeted chemotherapydrugs.

Satellite Offices: An office at theSpecialty Clinic in Cranston startedfunctioning with Dr. Ritesh Rathoreserving patients and practices in thatarea.

Academics: In 2009, the divisionfaculty had multiple clinical trial andreview article publications as well aspresented abstracts at major oncologymeetings as listed below:

Rathore R, Safran H, Soares G,Dubel G, McNulty B, Ahn S, IannittiD, Kennedy T. Hepatic arterial infusion

(HAI) of oxaliplatin in advancedhepatocellular cancer (HCC): a PhaseI Brown University Oncology Group(BrUOG) study. Am J Clin Oncol(early release article).

Birnbaum A, DiPetrillo T, Rathore R,Anderson E, Wanebo H, Puthwala H,Joyce D, Safran H, Henderson D,Kennedy T, Ready N, Sio TT.Cetuximab, paclitaxel, carboplatin andradiation for head and neck cancer: Atoxicity analysis. Am J Clin Oncol (earlyrelease article). Berz D, Colvin GA, McCormack

EM, Winer ES, Karwan P, Colvin L,Rathore R, Lum LG, Elfenbein GJ,Quesenberry PJ. Triple MEL100Therapy in Multiple Myeloma.Transplant Proc. 2009;41(9):3863-7. Kurniali PC, Luo LG, Weitberg AB.

Role of calcium/ magnesium infusion inoxaliplatin-based chemotherapy forcolorectal cancer patients. Oncology(Williston Park). (early release).

Hematology/Oncology FellowshipThe ACGME-accreditated fellowshiptraining program is led by Dr. FrancisCummings (Program Director) and hasa full complement of six fellows for the3-year training program. Dr. Naveed Rana and Dr. Zeina el-

Amil joined as the new first year Fellows. Graduating Fellows Dr. E. J.

Anderson & Dr. Lisa Manera joinedpractices in Boston and New Bedford,respectively. Hematology/Oncology Fellows

presented these abstracts at NationalMeetings in 2009:1.‘HIV-associated peripheral T-celllymphoma.” (Dr. Canon Milani, ASCO2009)2. A phase II Brown UniversityOncology Group study of docetaxel,oxaliplatin, and capecitabine formetastatic esophagogastric cancer. (Dr.E.J.Anderson, ASCO 2009)3. ‘Transient iron resistance in severeiron deficiency anemia.’ (Dr. CanonMilani, ASH 2009)4. ‘The association between red bloodcell transfusions and development ofNon-Hodgkins Lymphoma.’ (Dr. ShielaPascual, ASH 2009)5. Thromboembolic complications of

HEMATOLOGY/ONCOLOGY

Division MembersAttending physicians: RiteshRathore, MD (Director); Francis J.Cummings, MD; Bharti Rathore,MD; Alan B.Weitberg, MD

Fellows: Canon Milani (3rd year),Sheila Pascual (3rd year), Kevin Jain(2nd year), Melham Jabour (2nd

year), Naveed Rana (1st year), ZenaEl Amil (1st year).

Administrative staff: Mary Cordo(administrative associate); CynthiaBoutin (Fellowship coordinator)

intravenous immunoglobulin (IVIG)in Hypo-gammaglobulinemic patientswith Chronic LymphocyticLeukemia. (Dr. Canon Milani ASH2009)6. Neutrophil platelet satellitismrevisited: sidedness and domain ofneutrophil associated plateletaggregates. (Dr. Canon Milani ASH2009)

In parallel with our laboratory research,we presently have clinical trials openfor patients with metastatic cancer thatinvolves treatment with reprogrammedT cells. In brief, patient T cells areharvested through an IV, programmedto attacked cancer cells, and then givenback to patients. We are opening anexciting new trial in the coming monthsto test the administration of these Tcells directly into the livers of patientswith metastatic colon cancer. Moreinformation about our clinical trials canbe found at www.rwmc.org andwww.rhodeislandcancer.org.

Educational ProgramsThe Society of Surgical OncologyFellowship represents one of onlyeighteen of its kind in entire NorthAmerica. For the past three years, wehave been able to match our first choiceapplicant. Based upon our clinicalvolume, our Fellowship offers a richexperience with complex malignancies.Fellows also have ample opportunityto present research at national meetingsand conduct independent studies in thelaboratory. In July 2011, our firstSurgical Oncology Research Fellowwill join the team.

The Surgical Oncology ResearchFellowship represents an importantaddition, as it will offer general surgeryresidents the opportunity to developscientific backgrounds necessary forobtaining competitive clinical fellowshipspots and for pursuing careers asacademic surgical oncologists. We havealso forged agreements with St.Raphael Hospital in New Haven, CTand the Berkshires Medical Center toallow their general surgery residents torotate on our service. To accommodatethe expanded education needs withinour Division, we have instituted a 3hours CME accredited conferenceeach week.

During our weekly conference, wereview indications, complications,research projects, and pertinent journalarticles. We are certainly pleased tohave a large number of fellows,residents, and medical studentsspending time with our team andbenefiting from our robust clinical anddidactic experience.

Our team has also become a regionalreferral center for soft tissue sarcomas.Sarcomas are tumors arising frommuscle or fat cells, and often affectyoung adults in the primes of their lives.Management of these rare neoplasmsrequires particular expertise and oursurgical oncologists have a wealth ofexperience in caring for sarcomapatients. It is therefore not surprisingthat we have received referrals fromoutside of our state and region. Werecently received a prestigious grant todevelop novel immunotherapies forsarcoma and are holding a largesarcoma symposium in the spring of2011.

Roger Williams is one of the fewcenters offering hyperthermic intra-operative peritoneal chemotherapy(HIPEC), a sophisticated treatment forcancer that has spread throughout theabdomen. This therapy is offered foradvanced appendiceal cancers,metastatic colorectal cancer, metastaticovarian cancer and other cancerswhich are localized to the peritonealcavity. HIPEC represents anothercomplex therapeutic interventionoffered by the Division of SurgicalOncology, positioning us to help leadongoing growth of the Roger WilliamsCancer Center.

Research ProgramsThe surgical oncology researchlaboratory currently has severalprojects designed to develop newimmunotherapies for difficult to treatcancers. We reprogram patient immunecells or T cells to recgonize and destroycancer cells. The immune system is apowerful weapon that we believe canbe harnessed to destroy tumors.Presently, we have experimentalmodels for the treatment of metastaticcolon cancer and gastrointestinalstromal tumor, a type of sarcoma. Eachof our research projects is designed toprovide important information that wecan apply to our patients within theclinical trials offered through our cancercenter. We have received three grantswithin the first year of full operation andanticipate ongoing success withpending and future applications.

Dr. Steven Katz, Director of SurgicalImmunotherapy at Roger Williams,was the first author on a paper en-titled “T cell infiltrate predicts long-term survival following resection ofcolorectal cancer liver metastases,”published in the September issue ofAnnals of Surgical Oncology. His pa-per will be featured in an upcomingissue of Nature Reviews Clinical On-cology.

Dr. Katz was senior author on a pa-per entitled “Abdominal CysticLymphangiomatosis” that was ac-cepted for publication in The Ameri-can Surgeon.

The following were published in thethe official journal of the Hepato-Pancreato- Biliary Association:

Evaluation of a bipolarradiofrequency device forlaparoscopic hepatic resection: tech-nique and clinical experience in 18patients. HPB. Volume 11, Issue 2,Date: March 2009, Pages: 145-149.Ponnandai Somasundar, CherifBoutros, W. Scott Helton, N. JosephEspat.

Novel laparoscopic bipolarradiofrequency energy technology forexpedited hepatic tumour ablation.HPB. Volume 11, Issue 2, Date:March 2009, Pages: 135-139. BingYi, Ponnandai Somasundar, N. JosephEspat

Dr. C. Boutros. Dr. PonnandaiSomasundar, and Dr. N. JosephEspat had a publication entitled“Extrahepatic cholangiocarcinoma:Current Surgical Strategy” included inthe Surgical Oncology Clinics NorthAmerica 2009, April 18.

Dr. N. Joseph Espat was a co-hostand Faculty member at the Univer-sity of Cincinati/Ethicon laparoscopichepatic resection formal trainingcourse for HPB surgeons.

Publications andPresentations

CAT scan based planning and advancesin radiation delivery technology todirect dose to the tumor with littlespillage of radiation into normalstructures. IGRT or image guidedradiotherapy, involves the use ofimaging, such as a CAT scan, to verifypatient positioning immediately beforeradiation delivery.

Our department has a state of the artlinear accelerator which is capable ofboth IMRT and IGRT. Ultimately,IMRT and IGRT allow the safeescalation of radiation dose to the tumorwhile lowering the dose to nearbynormal organs - improving the chancesof cancer cure with fewer and lessintense side effects.

In June of 2009, the RadiosurgeryCenter of Rhode Island (RCRI)opened with the first and onlyCyberknife Radiosurgery machine inRhode Island. Radiosurgery involvesthe delivery of high doses of radiationtherapy in one to five treatments.Historically, it was used in the treatmentof static tumors, such as those in thebrain. The Cyberknife RadiosurgerySystem is a unique tool because it canaccurately deliver radiation to bothstatic and dynamic tumors, such asthose in the lung or abdomen, whichmove with respiration. Recently,radiosurgery has been found to be asafe and effective alternative to surgeryfor patients with tumors in the lung orliver who may not be candidates forsurgery.

Currently, we are developing aRadiosurgery Center of Excellencewhere patients will be evaluated by ateam of radiation oncologists, surgicaloncologists, neurosurgeons andmedical oncologists at Roger WilliamsMedical Center. Patients who benefitfrom this exciting new technology willthen be treated by our team at RCRI.

Soon, our department will be able tooffer high dose rate brachytherapy orHDR as a treatment option for patientswith breast, prostate, sarcoma andgynecologic cancers. For select womenwith breast cancer, HDR

RADIATION ONCOLOGY

Dr. N. Joseph Espat was the invitedvisiting professor to The Ohio StateUniversity on April 15-16th. He wasthe keynote speaker at the GammaChapter of AOA Medical HonorSociety and lectured on the topic“Personal Responsibility in PatientCare.” He also presented to thecombined Department of Medicineand Surgery Grand Rounds on“Achieving Balance in an AcademicMedical Career.”

Dr. N. Joseph Espat was an invitedspeaker and panelist at the Associa-tion Academic Medical Centers “TheGeneralist Society” on the topic of“Celebrating Professionalism inMedical Education.”

Dr. Steven Katz’s paper entitled“Randomized Clinical Trials in SoftTissue Sarcoma” was published inSurgical Oncology Clinics NorthAmerica.

Dr. Bing Yi, Dr. N. Joseph Espatand Dr. Ponnandi Somasundar pre-sented their abstract,” LaroscopicResection of Rectal Cancer - An Ap-propriate Procedure?” at the Soci-ety of Surgical Oncology conference.

Dr. N. Joseph Espat was the invitedProfessor at the InternationalHepatopancreatobiliary Association,Brazil Chapter November 11-14. Hiskeynote lectures were: Liver Di-rected Therapies for Metastatic Co-lon Cancer; Surgical Treatment forNon-Colorectal Liver Metastases;Performing Safe and Oncologic Ap-propriate Laparoscopic Hepatic Re-section and Technique for OncologicAppropriate Laparoscopic SubtotalDistal Pancreatectomy.

Dr. Espat was co-author of a paperthat was published in Annals of Sur-gery, the highest impact factor surgi-cal journal in the United States. Thepaper is entitled: The InternationalPosition on Laparoscopic Liver Sur-gery: The Louisville Statement, 2008.

Dr. Joseph Espat was an invited inter-national expert to the recent 17th an-nual National Congress of AdvancedLaparoscopic Surgery of the MexicanSurgical Society in Acapulco, MexicoAugust 6-9, 2009. He lectured on train-ing residents to perform totalextraperitoneal hernia repair,Laparoscopic techniques for abdomi-nal wall reconstruction using biomaterialsand Laparoscopic myocutaneous flapin the repair of abdominal wall defects.

Dr. N. Joseph Espat presented favor-able results of biologic materials for thetreatment of abdominal wall woundscomplicated from chemotherapy, at theAbdominal Wall Reconstruction Con-ference at the Georgetown UniversityHospital in Washington, D.C.

Dr. N. Joseph Espat was the invitedgrand rounds speaker on January 29 atTufts Medical Center, where he spokeon “Indication for hepaticmetastasectomy and the role of non-resectional hepatic therpaies in multi-disciplinary management.”

Dr. Espat was one of nine keynotespeakers to present their work at theretimrement symposiums in honor of Dr.Stanley Dudrick hosted by theDepartment of Surgery at YaleUniversity. Dr. Espat presented on:Omega-3 Fatty Acids: MacrophageInhibition to Pancreatic CancerRestoration of Apoptosis.

The Radiation Oncology Department atRoger Williams is dedicated toproviding patients with expert cancercare in an environment that iscompassionate and hopeful.

Radiation therapy is an essentialcomponent in the curative and palliativetreatment of cancer. Recent advancesin treatment technology, known asIMRT and IGRT, have dramaticallyimproved our ability to accurately targetand treat a tumor while sparing nearbynormal organs. IMRT or intensitymodulated radiotherapy, relies on careful

brachytherapy is an attractivealternative to conventional radiationtherapy. HDR offers similar rates ofcancer control and toxicity comparedwith conventional therapy over a timeframe of 1-2 weeks instead of aconventional seven week treatmentcourse.

The Diagnostic Imaging Departmentprovides Cancer Center patientsaccess to the most advanceddiagnostic and treatment optionsavailable today. We offer a full rangeof imaging services including CT,MRI, interventional radiology,ultrasound, mammography, nuclearmedicine, PET and general radiology.All of these services are available inone location, making it convenient forcancer patients and provides thereferring physician with accessibility toimages and reports in an integratedelectronic medical record.

In January, we established a processfor uploading of patient’s core imagingdata sets into our PACS system withprovision for consultative overreads.

In July, we acquired our new state-of–the-art MRI unit, offering fasterscanning times, higher resolution, andgreater versatility than any othermagnet in the region. Breast MRI isnow available, as well as advancedapplications in abdominal and brainimaging.

Also in July, both a fellowship trainedand board certified neuro and amusculoskeletal radiologist joined ourprofessional staff.

The division of InterventionalRadiology is active with local andregional tumor therapy, providingpercutaneous radiofrequency ablationof lung, renal, and liver tumors as wellas the most advanced array oftransarterial therapies includingconventional chemoembolization,drug eluting beads, and transarterialbrachytherapy. In addition to these

DIAGNOSTIC IMAGING

services, Interventional Radiologyoffers the full array of venous accessservices, pain and palliative proceduressuch as cementoplasty for the treatmentof painful pathologic fractures.

As dedicated members of the cancercare team at RWMC, we are availablefor consultation providing our patientsthe best in integrated comprehensivecancer care.

Since 1994, hundreds of cancer patientsfrom throughout the region have cometo Roger Williams, home to RhodeIsland’s only Blood and MarrowTransplantation Program. In thiscomprehensive transplant center,autologous, allogeneic (related andunrelated) and cord bloodtransplantation services are offered.In 2009, the Blood and Marrow Unitperrmed a total of 35 transplants (19autologous, 16 allogeneic). Two werecordblood, six were unrelated donors,and 8 were related.

The 100-day survival rate forautologous tranplants was100%; forallogeneic transplants, the100-daysurvival rate was 88%.One-year survival for autologoustransplants was 93%; for allogeneictranplants, the one-year survival ratewas 57%.

Other highlights:

In 2009, the Blood and MarrowTransplant Program receiveddesignation as a full transplantationcenter from the National MarrowDonor Program. A. Samer Al-Homsi, MD, Chief of

the Division of HematologicalMalignancies and Blood and MarrowTransplantion, was appointed for 3years to the editorial board inExperimental Hematology, the officialjournal for the International Society ofExperimental Hematology.

Dr. Hande H. Tuncer was namedAssociate Director of the Blood andMarrow Transplantation program atRoger Williams Medical Center. Shecompleted her fellowship training inhematology-oncology at Tufts-NewEngland Medical Center and inTransfusion Medicine and BloodBanking at the University of Alabamaat Birmingham.

An abstract co-authored byCannon Milani, MD, 3rd yearHematology & Medical Oncologyfellow, was accepted for presentationat the Annual American Society ofBlood and Marrow TransplantationMeeting in Florida. The abstract,entitled “Isolated Epstein-Barr Virus-Induced Central Nervous SystemP o s t - T r a n s p l a n t a t i o nLymphoproliferative DisorderDespite Negative Serum PCR” wasco-authored by Tara Roy, NP, JennaPojani, NP, Paula Welch, NP, HandeTuncer, MD and A. Samer Al-Homsi,MD.

SURGICAL RESEARCHResearchers at Roger WilliamsMedical Center were awarded $5.9million to research how breastcancer patients’ own cells can bemodified to fight their disease. TheImpact Award, from the Departmentof Defense Breast Cancer ResearchProgram, is believed to be the largestbreast cancer research grant everreceived in Rhode Island. Underthis DOD award, clinical trials arepresently enrolling patients withmetastatic breast cancer.

On April 19, Dr. Richard Junghans,Director of Surgical Research,presented at the annual meeting ofthe American Association of CancerResearch in Colorado. Hispresentation, “Phase I Trial Of Anti-Psma Designer T Cells In ProstateCancer,” showed data on the firstprostate cancer patients treated withdesigner T cells that have beenmodified by retroviral gene therapy.

BLOOD AND MARROWTRANSPLANTATION

The Roger Williams Protocol Officehas had an active and productive year.The office moved to accommodate anincrease in staffing, which now includesan RN manager, a clinical researchcoordinator, both at full time, and a parttime administrative assistant.

This increase in staffing has resulted inexpanded screening efforts. During2009, the office screened 500 patientsfor potential entry into open clinical trials.These potential subjects were generatedfrom lists of patients provided by theDepartment of Surgery, and representpatients being seen at the CancerCenter.

The Protocol Office has approximately20-25 trials open for accrual andapproximately 10-15 closed trialsrequiring long term subject survivalfollow up, at any given time. During thepast year, the newly created ProtocolReview Committee (PRC) focused onmore rapid turnaround of trials in orderto prevent wasting labor resources onnon accruing trials.

New trials must also undergo PRCreview to determine feasibility, inparticular a stringent review of ourpopulation and ability to providesponsors with the enrollment theyrequire.

Protocol Office staff have worked tostreamline the enrollment and datacollection processes by working closelywith clinical staff in the Cancer Center,and with the Principal Investigators, toassure timely evaluations and overallprotocol compliance. Bone MarrowUnit and Tumor Board conferences areattended weekly by PO staff to maintainclose working relationships with clinicalstaff and screen for eligible subjects. POstaff has worked closely withDepartment of Surgery PrincipalInvestigators this year to accomplish theopening of the first tissue bankingprotocol at this facility. These tissuesamples will be used to learn moreabout cancer, its causes and treatments.

PROTOCOL OFFICE The efforts on behalf of the ProtocolOffice to distribute researchinformation within and outside of thefacility were commended by ACOSon their most recent PerformanceReport in 2009. The Protocol Officecreates and distributes the “ClinicalTrial Watch” (CTW) to over 200 careproviders every month. The CTWhighlights various trials on a monthlybasis. The CTW and a current list ofopen trials is provided to outsidecare providers, is posted and updatedon the RWMC Internet, and isdistributed to the Cancer Center forstaff and patients, as well as at TumorBoard Conferences in flyer format,on a monthly basis.

The Protocol Office has beeninstrumental in the recent nationalcommendation received by theAmerican Society of ClinicalOncology. Twice a year the ProtocolOffice organizes this effort andcollaborates with the Cancer Centerstaff to complete an in depth chartreview of 60-100 charts in order toparticipate in this national initiative toimprove our standards of cancercare.

This year RWMC was one of only35 practices to receive this qualitycare award. PO staff recentlyattended the annual conference heldin Miami, Florida by the EasternCooperative Oncology Group tomaintain our ParticipatingMembership status, and to updatestaff on new data collection andregulatory requirements.

ONCOLOGY NURSINGAs a center of excellence, theComprehensive Cancer Programprovides a professional environmentfor nurses to focus on both thehealing art and science of the nursingprofession. Nurses are intimatelyinvolved in the comprehensive cancercare we provide to our patientsacross the continuum of healthcare.Our exceptional and skillful staff

touches patients through diagnosis andtreatment plans, research, palliativecare and survivorship programs.

The Hematology/Oncology, BoneMarrow Day Program and SurgicalOncology staff provides high qualitycare in the Infusion Center and theclinic. They receive recognition andpraise for their exceptional patientsatisfaction feedback.

The specialized team in RadiationOncology creatively meets the needsof patients receiving innovative newtechnologies including stereotacticcranial and extracranial, radiotherapyand brachytherapy. They identified theirunique role in meeting the challengesof cutting-edge technology whilesupporting the special and emotionalneeds of their patients. Nursingleadership continues to promotecertification in Cancer Nursing. Ournurses’ dedication and unwaveringcommitment to patients and familiescontinues to be the common bondamongst these specialized teams.

Eight nurses from throughout thecancer programs at Roger Williamswere certified in 2009 as ONSChemotherapy Biotherapy Providers.

The nurses who were certified areKaren Bissonnette, RN, BSN, PattyCafaro, RN, Piroshka Forster-Price,RN, BSN, Jessie Grove, RN JodiLamontagne, RN, BSN, Mary Small,RN, MBA, Lynn Valentine, RN, BSN,and Kate Watier, RN.

This brings the total number of ONS-certified chemotherapy providers to12. In 2009, the nurses on the SurgicalOncology unit provided inpatientschemotherapy to more than 40 cancerpatients.

Roger Williams’s employs two full-timemasters prepared LICSW (LicensedIndependent Clinical Social Workers).Four hours of Social Work time is spentdaily at the Outpatient Cancer Center.Patients are visited, needs assessedand resources matched with patient/family need. Patients and familiesreceive psychosocial support,counseling and are referred to RogerWilliams Blood Cancer Support Groupaffiliated with the Leukemia/LymphomaSociety and other community supportgroups. Social Workers are employedin the Case Management Department.A representative from the CaseManagement Department attends theCancer Center Committee Meetings.

Representatives from casemanagement assess the needs of thepatient/family unit, plan and implementinterventions and evaluateeffectiveness, efficiency, timeliness, andappropriateness of the interventions.The goal is to ensure that patients/families receive appropriate and timelypsychosocial support.

Hospice: General Inpatient HospiceProgram is available at Roger Williamsand with contract Hospice Agenciesthroughout the state. Support takes theform of a multi-disciplinary teamapproach to ensure coordinatedcontinuity of care, and respect for theautonomous prerogative of the patientand family to make decisions andchoices regarding care, to help ensurequality of life, and to respect the patient/family worth, dignity and comfort.

The focus is on the palliation ofdistressing physical, psychological,emotional and spiritual symptomsencountered by the patient and familyduring a terminal illness.

The team includes: Physicians, StaffNurses, Hospice nurses, SocialWorkers, Nursing Aides, HospiceNursing Aides, Chaplin, Dietitian,Pharmacists, RN Case Managers andTherapists.

Staff: Tom Habershaw, RPh, HeleneDelisle, RPh, and Robin Ferra,CRPhTII

Created with the opening of the CancerCenter in January 2009, the CancerCenter Pharmacy is staffed Mondaythrough Friday, 7am – 7pm.With therelocation of the Day Chemo unit to theCancer Center Infusion room, thePharmacy department created aPharmacy Satellite, with “clean room”preparation areas in compliance withUSP 797 guidelines, dedicated solely toservicing the needs of the Cancer Center.

In addition to the compounding of allout-patient chemotherapy and ancillarymedications, Pharmacist work with thephysicians and nurses reviewing andprocessing chemotherapy orders.

The Cancer Center Pharmacy, inaddition, has committed to the educationof Cancer Center patients. Each patient,who is either new to chemotherapy oris receiving a new treatment regimen, isprovided with information on theirmedication(s) from a pharmacist.

In addition, each patient receives acontact card with the telephonenumbers of the Cancer CenterPharmacy and the Hospital Pharmacy,which is in operation 24 hours a day, 7-days a week, for any follow-upquestions they may have.

During the first year of operation,Pharmacy provided education to 223patients and provided follow-upinformation to 85 patients in responseto telephone calls.

In 2009, the Cancer Center Pharmacyreceived an Honorable Mention forHealthcare Innovation in the annualawards presented by Quality Partnersof Rhode Island.

CASE MANAGEMENT CANCER CENTERPHARMACY In 2009, the Food and Nutrition

Department at Roger Williams staffedthree full-time, inpatient RD’s thatwere available by consult to seepatients in the Cancer Center.

The staff included: Sheri L. Rego,MS, RD, LDN, CNSD; DonnaCastricone, RD, LDN; AmaryllisMcKeag, MS, RD, LDN, CDOE

Donna Castricone was located on-site and dedicated from 8-12 hoursper week to consults and follow-upwith cancer patients. Dietitians onstaff see 90% of new Hem/Oncpatients either in chemo infusion orin clinic.

The staff also delivered a publiclecture on reducing cancer riskthrough nutrition.

NUTRITION

OUTREACHRoger Williams partnered with otherhospitals in Rhode Island and theAmerican Cancer Society to hostRhode Island’s first-ever statewideCancer Survivors Day. The eventwas attended by 400 survivors andfriends.

In September, Roger Williamshosted its annual Prostate cancerscreening for more than 75 men.

Free community education wasprovided by a number of physiciansincluding Dr. A. Samer Al-Homsiand Dr. Hande Tuncer (BMT Unit)and Dr. Steven Katz and Dr.Ponnandai Somasundar (SurgicalOncology).

The Roger Williams annual golftournament raised more than$75,000 for the Cancer Center.

Kenneth H. Belcher, President andCEO of Roger Williams, chaired theLeukemia & Lymphoma Society’s“Light The Night” walk in RhodeIsland. More than 40 teams fromRoger Williams participated in thefundraiser.

Adele R. Decof Cancer Centerat Roger Williams Medical Center

50 Maude Street Providence, Rhode Island www.rwmc.org 1-401-456-2077