Rectal Cancer: The CCF perspective Meagan Costedio, MD, FACS, FASCRS Medical Director Colorectal Surgery University Hospitals Ahuja Medical Center Associate Professor - Division of Colorectal Surgery Rectal Cancer 38,220 new cases estimated in 2016 1 Multidisciplinary disease Surgery Medical and Radiation Oncology Pathology Radiology Complex treatment decisions Neoadjuvant/adjuvant therapies Surgical approach Quality of surgery largely determines outcome 1 NCI 2016 Rectal Cancer PDQ 2 1
University of Minnesota Study 2007 Nationwide Inpatient Sample 20% stratified random sample of U.S. inpatients 1988-2003 41,631 pts with radical proctectomy 16,510 (39.7%) sphincter sparing 25,121 (60.3%) colostomy Increase in sphincter-preservation rate from 26.9% in 1988 to 48.3% in 2003 Rate flat after 1999 Elderly, male, black, Medicaid, low-income zip code predicted colostomy most radical resections for rectal cancer in U.S. hospitals result in a colostomy Dis Colon Rectum 2007; 50:1119-1127 Hospital discharge data from 21 states with county-level place of residence information (2002-04) 20,000 proctectomies 50% of cases non-restorative (APR) Only 20% of counties with colostomy rate <40% Agency for Healthcare Research and Quality Office of Statewide Health Planning and Development Calif. Dis Colon Rectum 2010; 53:874-880 2
Colostomy Rates Source Year(s) n Country Tumor distance from anal verge Norwegian Rectal 1993 1999 2136 Norway <12 cm 38% Cancer Project Dutch Trial 1996 1999 1805 Netherlands/Sweden <15 cm 32% MRC CRO 7 1998 2005 1350 UK/Canada/NZ/SAF <15 cm 35% German Trial 1994 2002 799 Germany <16 cm 25% Trans Tasman 2001 2006 323 Australia/New <12 cm 33% Zealand AHRQ and OSHPD (CA) 2002 2004 19,912 USA rectum 50% Colostomy Rate Same dataset as prior study plus tumor characteristics from SEER, screening rates from Medicare, hospital characteristics from AHA, and surgeon specialty from ASCRS and SSO rosters data support concept that surgeon specialization and familiarity with rectal cancer treatment are important determinants of rectal cancer care High Stoma Counties (26% of all counties) Defined as >60% colostomy rate (mean 71%) Less likely to have MRI or PET scanner Less likely to have teaching hospital Significantly fewer specialty surgeons Dis Colon Rectum 2011; 54:207-13 3
72% of hospitals low volume Only 30% patients treated in high volume hospitals Hospital Volume Outcome Low Medium High p value Yearly case volume (avg) 1-5 6-10 11-24 Number of hospitals 232 65 24 Number of patients 2364 2686 2137 Mortality (%) 2.1 1.1 0.9 <0.001 Complications (%) 22 24 20 0.709 Sphincter preservation (%) 51 55 64 <0.001 Length of stay (mean # days) 9.7 9.2 8.8 <0.001 California Office of Statewide Health Planning and Development database (2000 2005) Mortality, colostomy rate, and length of stay higher in low volume hospitals Do We Have a Problem with Rectal Cancer Care in the U.S.? 4
OSTRiCh Consortium for Optimizing Surgical Treatment of Rectal Cancer Founded 2011 by 17 institutions during meeting in Cleveland, Ohio Mission: to improve the quality of rectal cancer care in the U.S. through advocacy, education, and research Today: 350+ hospitals and institutions representing all facets of U.S. healthcare delivery system and with all major rectal cancer stakeholders involved Making the Case: The National Cancer Database (NCDB) Hospital-based cancer registry sponsored by the CoC and ACS >1 million case reports yearly from ~1500 CoC-member institutions Collects data on 70% of all new invasive cancer diagnoses in the U.S. each year 5
NCDB Rectal Cancer Patients 2013 N=21,393 Approximately 50% of annual U.S. rectal cancer cases Number of hospitals=1327 Approximately 90% of all CoC-accredited hospitals Range of rectal cancer patients treated: 1 to 286 Median number of patients per hospital: 27 How Experienced is the Typical U.S. Rectal Cancer Hospital? Percentage of CoC hospitals (n=1327) Answer: Not very! 70% of hospitals treat fewer than 20 patients/year Only 30% of hospitals are high volume by common definition Only 6% of hospitals treat more 50 patients/year 12 6
Are U.S. Rectal Cancer Patients Being Shifted to High Volume Centers? Percentage of CoC rectal pts (n=21,393) Answer: No More than half of patients treated in hospitals that see fewer than 30 cases/year Only 25% of patients treated in the highest volume centers 13 Is Treatment Evidence Based? NCDB data 2006-2011 Clinical stage II/III rectal cancer patients (n=30,994) Examined adherence to evidence-based guidelines for neoadjuvant chemoradiation therapy (NCRT) use based on center type, volume, and geographic location Academic, Community, Comprehensive Volume: Low ( 10/year), Medium (11-30/year), High ( 31/year) Monson, et al. Ann Surg 2014; 260:625-632 7
Is Treatment Evidence Based? Adherence to guidelines for NCRT use suboptimal and variable Only 74% of stage II/III rectal cancer patients received NCRT (and no improvement over time) Significant variation by hospital volume High 78.1% vs. Low 69.4% (p<0.001) 28% of hospitals treated >30 pts/yr Significant variation by geography Midwest 76.1% vs. South 70.6% (p<0.001) No variation by hospital type Monson, et al. Ann Surg 2014; 260:625-632 Quality of Surgery/Pathology: Lymph Node Yield Minimum of 12 lymph nodes is an internationally-accepted marker for quality of surgery and pathology assessment in rectal cancer* NCDB data 2008-2012 53,911/59,653 (90.4%) patients with lymph node yield documented Rate of suboptimal lymph node yield (<12) was 35.5% Rate in patients receiving NCRT was 41% Rate in patients treated with surgery alone was 30% *Lykke, et al. Int J Colorectal Dis 2015:30:347-351 8
Accuracy of Clinical Staging Rate and impact of understaging (c<pstage) NCDB 2006-2013 (n=178,755) cstage I-III, no ncrt, complete data (n=12,684) Outcomes +CRM ( 1mm) Receipt of adjuvant chemotherapy 5-year OS Becerra, et al. Accuracy of Clinical Staging 24% all patients understaged Wide variation among hospitals (1%-70%) Understaging associated with Increased +CRM rate No adjuvant chemotherapy Worse survival Becerra, et al. 9
NCDB 2010-2011 NCDB +CRM data Clinical stage I-III N=16,619 patients 17.2% with +CRM Variation by clinical stage and operation type No variation by facility type, volume, or NCRT Rickles, et al. Ann Surg, in press US Rectal Cancer Care Low volume hospitals Inexperienced providers High colostomy rates 10
US Rectal Cancer Care (cont ) Suboptimal adherence to evidence-based guidelines for use of neoadjuvant therapy High rate of clinical understaging leading to adverse consequences Suboptimal surgery High rates of +CRM, a surrogate marker for poor oncologic outcomes in rectal cancer patients U.S. outcomes are likely inferior to countries that that have instituted national programs to improve quality of rectal cancer care Fixing the Problem 11
Rectal Cancer A Multidisciplinary Disease OSTRiCh Consortium for Optimizing Surgical Treatment of Rectal Cancer Rectal Cancer Multidisciplinary Team (MDT) Radiology Specialist Rad Oncology Specialist Surgeon Specialist Med Oncology Specialist Pathology Specialist 12
Evidence for MDT Management Abundant evidence supports the effectiveness of MDT management in other cancers Improved outcomes in breast, head and neck, esophagus, lung cancers Gabel, et al. Cancer 1997; Chang, et al. Cancer 2001; Stephens, et al. Dis Esophagus 2006; Birchall, et al. Br J Cancer 2004; Coorey, et al. Lung Cancer 2008 MDTs and Circumferential Resection Margin (CRM) Status MRI-directed MDT discussion significantly reduced rates of involved CRM N=298 pts 76% discussed at MDT, 24% not discussed Discussed (-) CRM 97% (+) CRM 1% Not Discussed (-) CRM 74% (+) CRM 26% Burton et al, Br J Cancer 2006 13
The Challenge The Lone Provider The Multidisciplinary Team (MDT) Norway Strategy: nationwide TME education Outcomes Increased proportion of patients undergoing TME (78% to 92%) Reduced local recurrence and improved survival in the TME group Risk of local recurrence Risk of overall mortality Wibe et al. Dis Colon Rectum 2002 14
Sweden Strategy: TME education + neoadjuvant xrt Outcomes Centralization of 4 hospitals into 1 CoE Local recurrence decreased from 8% to 3.5% (p=0.04) 5 year survival increased from 38% to 62% (p=0.003) Multivariate analysis: new colorectal unit independent predictor of long-term survival Khani & Smedh. Colorectal Dis 2010 Rectal Cancer Centers of Excellence: Danish Experience 1994: Danish National Rectal Cancer Registry National implementation of standards: Total mesorectal excision Improved staging Centralization of care Increased 5-year survival from 37% to 51% after new standards Bulow et al. Colorectal Dis 2010 15
Quality Rectal Cancer Care (The 4 Key Principles) Total Mesorectal Excision (TME) Evaluation of surgical quality by standardized pathology assessment and reporting Identifying high risk tumors through use of specialized MRI (rectal cancer protocol) MDT discussion to identify, coordinate, and deliver individualized treatment 31 How Well are the Expert U.S. Centers Performing? Cleveland Clinic Colorectal Cancer MDT Conference 16
Practice Patterns at OSTRiCh Hospitals >2000 patients undergoing surgery for rectal cancer at 16 centers in 2010 ~ 130 patients/center Range 39-350 Good News All surgeons either ASCRS/SSO/SSAT/SAGES members All surgeons performed TME All centers with MDT 94% held regular MDT conferences 33 OSTRiCh Practice Patterns Bad News Frequency of MDT meetings varied All cases discussed at only 20% of centers Majority of centers discussed < 50% cases Little standardized pathology reporting MRI validated in only one-fourth of centers and standardized reports in less than half 34 17
Can we duplicate the European System in the U.S.? Challenges Culture Geography Politics Lack of singlepayer model Training Considerable! 18
The UK Rectal Cancer Model 1 2 3 Regional MDTs of trained Specialist Providers: Surgeon External Audit to confirm adherence to protocols Radiologist Pathologist Radiation and Medical Oncologists Evidence Based Protocols for patient care Rectal Cancer CoEs: Cost Savings Full U.S. Implementation 41,000 patients/year Projected reduction in Total Cost of Care $528,000,000 (16.2%)* 6000 lives saved yearly *(2009 2011 URMC inpatient sampling with rectal cancer diagnosis (ICD 9 code 154.10)) Origin: Center for Medicare and Medicaid Innovation CMS 1C1 12 001 Application for Funding, January 2012 19
OSTRiCh Proposal Create a national rectal cancer program in US based on already-successful international models: Train and accredit MDT s at motivated hospitals Establish standards pertaining to defined protocols of patient care and process Prospective data collection to track compliance, quality of care, and outcomes Administered by American College of Surgeons Commission on Cancer (CoC) Proposed Standards Set of 18 Standards pertaining to program structure and the process of patient care Accreditation Structure Standards (5) Creation and Training of Multidisciplinary Team Re accreditation Process Standards (13) MDT discussions, timing of treatment, imaging, pathology assessment, communication, data submission Set of 10 Performance Indicators Quality Improvement American College of Surgeons 2014 Content cannot be reproduced or repurposed without written permission of the American College of Surgeons 20
Education Program NRCAP Training Course (NRCAP TC) Group Training Specialty specific Training Program Administration and Teamwork Surgery Training Module (ASCRS) Pathology Training Module (CAP) Radiology Training Module (ACR) MDT Patient Coordinator Training Module Assemble Your MDT members from each specialty All surgeons wishing to do rectal cancer surgery Understand attendance requirement (50% or better) Buy-In extremely important 42 21
Rectal Cancer Program (RCP) Leadership RCP Leader Physician member of MDT Oversees MDT Liaison to CoC cancer committee RCP Coordinator Provides administrative support to the MDT Organizes MDT meetings Gathers information Ensures pathways but not a patient navigator Works with cancer registrars funding 43 Organize MDT Meetings 2x/month (minimum) Record attendance Standard format for case presentations Patients discussed twice Pre-Treatment Post-Surgery 22
Systemic Staging CT chest, abdomen, and pelvis (95%) CEA Local Rectal cancer-protocol MRI (90%) Surgery MDT-member surgeons only Synoptic operative report OSTRiCh Synoptic Op Report Committee Approved by ACS and NAPRC Electronic medical record smartphrases Pilot study underway 23
Pathology Primary tumor resection specimen Read by MDT-member pathologist in at least 90% of cases Synoptic report College of American Pathologists Specimen photographed (65%) 95% of reports within 2 weeks of surgery Outside diagnostic biopsies obtain/file path report (>95%) review slides at MDT (>80%) 47 Radiology Staging 95% of patients staged before treatment Systemic: CT chest/abdomen/pelvis Tumor: rectal cancer-protocol MRI Read by MDT-member radiologist (90%) Synoptic report (95%) OSTRiCh Synoptic Rectal Cancer Operative Report 48 24
Treatment Timing Start definitive treatment within 60 days of initial evaluation at the accredited center Adjuvant therapy begins within 8 weeks of surgical resection in eligible/agreeable patients 49 CCF <7d <14d Rectal Cancer Diagnosed Pathologically Surgeon Consult CEA CT C/A/P Pelvic MRI 25
MDT Board Colonoscopy, Pathology, CEA, Imaging N any T3 or 4 T1/2 N0 ncrt 8 12 wks Short course XRT 7 d Surgery Surgery Surgery NOT Surgical Invades S2 or higher Invades External iliacs Central lymphadenopathy Surgery is based on PREOPERATIVE imaging Do not routinely performing internal iliac lymph node dissection 26
Stage 4 Resectable Liver Metastases Unresectable Liver Metastases Small tumor CRM: Combined surgery Symptomatic 1 LAR followed by liver surgery in 6 8 wks followed by 6mo chemo Liver resection followed by LAR +/ neoadjchemo/xrt Chemo Liver Disease Progressed: No surgery Change Chemo Liver Disease Regressed: Ablation/Combined resection More chemo 27