Follow up The way ahead John Griffith
Key Emerging Principles Risk stratified pathways of care Personalised care plan and treatment summary with a hand held record Information and education Remote monitoring Care coordination with open access
One Size Fits All established follow-up No metastases picked up by the 5 year CT in 79 patients The one year colonoscopy detected 1 cancer (ba enema pre-op) 13 patients with polyps 8 known incomplete or not removed pre-op 5 new (one adenoma)
CRC Recurrence Retrospective study Included colorectal cancer AND surgical resection Excluded those who had de-functioning stomas only Period between 2002-2006 Ensures a full 5 year follow-up cycle completed 1000 Case-notes 600 Bradford (60%) 250 Calderdale and Huddersfield (25%) 150 York (15%) Data collected: Patient Demographic Tumour Features Recurred? If so, where, when and how was it detected?
Final Analysis: 1001 Cases 877 adenocarcinomas undergoing curative resection Location 71.0% Colon 29.0% Rectum Dukes Stage Dukes A = 15.6% Dukes B = 45.1% Dukes C = 39.0% Dukes C1 = 34.9% Dukes C 2 = 4.1% Location % Caecum/Right/Ascending 22.92 Hepatic flexure 2.39 Transverse/Splenic flexure 6.73 Left/Descending 4.33 Sigmoid/RSJ 34.66 Rectum (High >12cm) 6.61 Rectum (Mid 6-12cm) 11.74 Rectum (Low <6cm) 10.38 Anal 0.23
Mortality and Recurrences Mortality 40.9% Mortality Rate Cancer Related Deaths (51.3%) Recurrence Rate 232 recurrences (26.5%) No significant difference between centres Recurrence YES Recurrence NO Total Cases % age Recurrence Bradford 120 364 484 24.79 C&H 69 150 219 31.51 York 43 131 174 24.71 Total 232 645 877 26.45
Recurrence Location Most common site of recurrence is multiple followed closely by: Liver Anastamosis/Pelvis Lung Location of Recurrences Bones Brain Lymph node Other Lung Anastomosis/Pelvis Liver Multiple
Location of Recurrence: Colon vs. Rectal Primary 35 30 25 20 15 10 5 0 %'age Rectum %'age Colon Colonic primary - Isolated liver metastasis (28.9%) Significantly greater likelihood of recurring in liver p-value = 0.09 Rectal primary - Isolated lung metastasis (30.0%) Significantly greater likelihood of recurring in lung p-value = 0.0004
Recurrence Mode of Detection Mode of Detection vs. Location of Recurrence 45 40 35 30 25 20 15 10 5 0 CEA Endoscopy CT USS Other Eg. MRI/PET CT Isolated Anastomosis/Pelvis Recurrences: Endoscopy detected 37.4% CT detected 46.5% Isolated Liver Recurrences: CT detected: 69.4%
Management of Recurrence 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Lung Anastomosis/Pelvis Liver Multiple Proceed to Intervention 82.93% 81.40% 71.18% 50.82% Proceed to Resection 53.66% 44.18% 47.46% 9.84%
Impact of Resected Recurrence Of those who had their recurrence resected (n=81): 49.3% Completed 5 year follow-up 2.5% Died of non-cancer related causes eg. MI However, 46.9% had a cancer related death Count Percentage Not died during follow-up 40 49.38% Death not cancer related 2 2.47% Cancer related death 38 46.91% Unknown Cause 1 1.23%
Tumour Features if Recurred Dukes Stage Significant difference in recurrence rate depending on Dukes Stage (p<0.001) Dukes Stage of Primary No recurrence Recurrence Recurrence Rate (%) A 129 8 5.84 B 309 87 21.97 C1 195 111 36.27 C2 12 24 66.67 D 0 2 100.00
EMVI Status EMVI Status of Primary No recurrence Recurrence Recurrence Rate (%) EMVI Present 139 111 44.40 No EMVI 506 121 19.30 Significantly increased risk of recurrence if EMVI from primary: P-value = <0.001 Location of recurrence if EMVI present: EMVI & Recurrence Percentage (%) Liver 22 19.82 Anastomosis/Pelvis 17 15.32 Lung 18 16.22 Multiple 37 33.33 Lymph Node/Other 14 12.60
CRM Status Increased risk of recurrence if primary was CRM positive (p<0.001) 51.4% CRM positive vs. 25.3% not CRM positive Location of recurrence if CRM positive: Anastamosis/Pelvis recurrences most likely p = 0.04 CRM Positive & Recurrence % Liver 5 13.89 Anastomosis/Pelvis 11 30.56 Lung 6 16.67 Multiple 8 22.22 Lymph Node/Other 5 13.89
0.00 0.25 0.50 0.75 1.00 Survival Curve vs. Dukes Stage Kaplan-Meier survival estimates, by dukes 0 500 1000 1500 2000 analysis time dukes = A dukes = C1 dukes = D dukes = B dukes = C2
Time to Recurrence Time to Recurrence (Days) Percentage of Total Recurrences (%) Cumulative Total of Recurrences (%) 0-180 11.64 11.64 181-365 (1 year) 18.96 30.60 366-546 20.69 51.30 547-730 (2 years) 15.95 67.25 731-910 12.50 79.75 911-1095 (3 years) 4.73 84.48 1096-1275 2.59 87.08 1276-1460 (4 years) 3.45 90.53 1461-1640 2.59 93.12 1641-1825 (5 years) 3.02 96.14 Greater than 5 years 3.88 100.00 By 3 years, we have 84.5% of our recurrences.
0.0002.0004.0006 Time to Recurrences vs. Primary Tumour Site Smoothed hazard estimates, by primary_tumour_site 0 500 1000 1500 2000 analysis time primary_tumour_site = Caecum/Rightprimary_tumour_site = Hepatic flexure to Left primary_tumour_site = Sigmoid primary_tumour_site = Rectum
Building Our Model of Recurrence Level of Significance p = Age 0.69 Primary Tumour Site Rectum = 0.024 Hepatic Flex to Desc = 0.943 Sigmoid = 0.501 Duke s Stage <0.001 Grade 0.004 0.42* EMVI <0.001 CRM <0.001 Mucinous 0.64 0.59** Sex 0.67 Ethnicity NS * When controlled for Duke s Stage ** When controlled for Duke s Stage, EMVI and CRM
The next steps Risk stratified follow up Remote follow up Survivorship programmes Late effects of treatment Life with recurrence
Success!
Where can we deliver this? Increasing number of survivors Increasing number of new referrals Reduction in staff Primary care budgets! NHS Improvement Remote monitoring tool
Criteria for CRC risk stratification Disease Treatment or effects of treatment Individual Supported Self Management pathway (green) Dukes A, B, C T1-3 N0-2 Curative intent After closure of temporary stoma After completion of adjuvant therapy Good understanding of care pathway Good general fitness Willingness to self manage Clinically Supervised Pathway (amber) Unstable CEA T4 Trial Patients N1N2 Palliative Intent Post op bowel or urological dysfunction Temporary stoma in place Poor symptom control High anxiety scores (>5 on DT score) Poor compliance Social isolation Significant comorbidity Complex Care pathway (red) Dukes D M1 Liver metastases High score EMVI patients Post hepatic surgery Severe side effects of treatment On active treatment Multiagency support FOR TESTING January to December 2011(V.3 revised December 2011)
% patients stratified to each pathway % 96 55 38 72 20 7 0 4 7 Salford NBT Guys Red complex pathway Amber shared pathway Green Self Management Pathway Red Amber Green Number % Number % Number % Salford 10 7 75 55 52 38 Bristol 0 0 4 4 108 96 Guys 7 8 17 20 60 72
No:patients Time since treatment combined data Combined - Time since end of treatment 70 60 50 40 30 20 10 0 64 45 29 23 15 18 20 7 3 months 6months 12 months 18 months 2 years 3 years 4 years 5 years Of these 45 (20%) suitable at 12 months or before Question: Where does it leave the 18 month suggested time point before risk stratification occurs
Annual Saving Estimates (based on data submitted by sites) Bristol Guys Salford Average slots/month Projected slots saved /annum Projected savings*/ annum 39 65 91 468 780 1,092 37,440 62,400 87,360 *Outpatients slots calculated at 80 per appointment Estimated savings across all three sites in year 1 = 187K NB longer term savings will be less as backlog is cleared
Outcome measures Laparoscopic surgery CRM involvement? Personalised care pathways Survivorship events PROMS data Survival!
Suvivorship and Education Programmes Symptoms Benefits and finance Group care and well being Dietetics Exercise (local councils) Follow-up regime
What are the late effects? Low anterior resection syndrome Sexual dysfunction Urinary symptoms Chemotherapy toxicity
Main findings from Ipsos Mori baseline survey Information deficit about providing information on symptoms & signs of recurrence. 45% did not feel they had enough. 45% of patients with ED since treatment continue to have problems. 53% noticed a change of interest in sex and 35% say they have not had any advice relating to this 20% currently have a care plan
Questions we must answer What is the unmet need of our patients? What services do we need to provide for them and when? What is life like living with recurrence: duration, treatment, side effects, visits.
Low risk Medium risk Risk stratification Tumour Dukes A & B (-ve EMV & CRM) Dukes B (Either +ve EMV OR +ve CRM) Dukes C1 (-ve EMV & CRM) High risk Dukes B (+ve EMV & + ve CRM) Dukes C1 (Either +ve EMV OR +ve CRM) Dukes C2 Patients receiving neoadjuvant treatments
Diagnosis CT, MRI, Colonoscopy Low risk 6 weeks post op CEA 4 months CEA, Colonoscopy (if not performed preop) 8 months CEA 30 25 Low risk time of recurrence patients (cumulative) 12 months CEA 16 months CEA number of patients 20 15 Op Chemo/Radio Palliative 18 months CT 10 20 months CEA 5 24 months CEA 30 months CEA, CT 0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 years 36 months CEA, Colonoscopy Follow-up to 5 years 6 monthly CEA
Diagnosis CT, MRI, Colonoscopy Medium risk 6 weeks post op CEA 4 months CEA, Colonoscopy (if not performed preop) 8 months CEA 12 months CEA 25 20 Medium risk time of recurrence (cumulative) 16 months CEA 18 months CT 20 months CEA 15 number of patients 10 5 OP Chemo/Radi o 24 months CEA 30 months CEA, CT 0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 years 36 months CEA, Colonoscopy Follow-up to 5 years 6 monthly CEA
Diagnosis CT, MRI, Colonoscopy High risk 6 weeks post-op CEA 4 months CEA, Colonoscopy (if not performed preop) 8 months CEA 60 50 High risk time of recurrence (cumulative) 12 months CEA, CT, Flexible sigmoidoscopy 40 16 months CEA 20 months CEA number of patients 30 20 OP Chemo/Radio Palliative 24 months CEA, CT 10 30 months CEA 36 months CEA, CT & Colonoscopy 0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 years Follow-up to 5 years 6 monthly CEA, 5 year CT
What follow-up & When? Low and medium risk: Regular CEA, CT at 18 & 36 months, Colon 3yrs High risk: Regular CEA, CT 12, 24 & 36 months, Colon 3yrs
Conclusion There is currently a lot of interest in the overall package of the care our patients receive. Many of the indices which care will be assessed by are currently not being measured, and we probably have no idea as to the services we need for many of the problems. Follow up regimes should be patient specific.