Background
Methods
Outcomes
Ethics
Inclusion and exclusion criteria
Examination/test | Surveillance cycle (postoperative months) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 30 | 36 | 42 | 48 | 54 | 60 | |
Chest x-ray | X | X | X | X | X | X | X | ||||||||
Liver ultrasonography | X | X | X | X | X | X | X | ||||||||
Colonoscopy | X | X | |||||||||||||
CEA measurement | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Clinical examination | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Description of the surveillance program
Hospitals, primary and secondary care professionals
Serious clinical events
Data collection
Statistics
Results
Variable | Surgeon-surveillance n = 55 (%) | GP-surveillance n = 55 (%) | Total n = 110 (%) | p value |
---|---|---|---|---|
Mean age (SD) | 66.7 (7.3) | 64.0 (8.7) | 65.4 (8.1) | ns |
Male | 32 (58.2) | 33 (60.0) | 65 (59.1) | ns |
Female | 23 (41.8) | 22 (40.0) | 45 (40.9) | ns |
Tumour location
| ||||
Coecum | 13 (23.6) | 13 (23.6) | 26 (23.6) | ns |
Ascendens | 9 (16.3) | 5 (9.1) | 14 (12.7) | ns |
Transversum | 4 (7.2) | 5 (9.1) | 9 (8.1) | ns |
Decendens | 1 (1.8) | 4 (1.8) | 5 (4.5) | ns |
Sigmoid | 28 (50.9) | 28 (50.9) | 56 (50.9) | ns |
Type of surgery
| ||||
Laparoscopic | 14 (25.5) | 11 (20.0) | 25 (22.7) | ns |
Open | 41 (74.5) | 44 (80.0) | 85 (77.3) | ns |
Tumour stage
| ||||
Dukes A | 12 (21.8) | 11 (20.0) | 24 (21.8) | ns |
Dukes B | 25 (45.5) | 30 (54.5) | 55 (50.0) | ns |
Dukes C | 18 (32.7) | 14 (25.5) | 32 (29.0) | ns |
Total surveillance months | 942 | 942 | 1884 | ns |
Median surveillance (months) | 17 | 17 | 17 | NA |
Surveillance tests n
| 513 | 592 | 1105 | ns |
Carcinoembryonic antigen CEA (%) | 203 (39) | 300 (51) | 503 | <0.001 |
Chest X-ray (%) | 150 (29) | 128 (21) | 278 | 0.003 |
Liver ultrasound (%) | 110 (21) | 99 (17) | 209 | 0.03 |
Colonoscopy (%) | 50 (9) | 65 (11) | 115 | ns |
Consultations n | 508 | 678 | 1186 | ns |
Serious clinical events and false positive tests
Serious clinical event characteristics | Surgeon-surveillance | GP-surveillance | Total | p value |
---|---|---|---|---|
Surveillance (months) | 942 | 942 | 1884 | ns |
Interval SCE | 12 | 13 | 25 | ns |
Routine SCE | 11 | 12 | 23 | ns |
Total SCE | 22 | 26 | 48 | ns |
Symptom initiated SCE
| ||||
Abdominal pain (n) | 3 | 11 | 14 | 0.05 |
Blood in stool (n) | 6 | 4 | 10 | ns |
Anaemia (n) | 0 | 1 | 1 | ns |
Weight loss (n) | 1 | 1 | 2 | ns |
Lymphadenopathy (n) | 2 | 0 | 2 | ns |
Other findings (n) | 1 | 1 | 2 | ns |
Total | 13 | 18 | 31 | ns |
True cancer recurrence | 4 | 3 | 7 | ns |
Test initiated SCE
| ||||
Elevated CEA | 2 | 4 | 6 | ns |
Radiology | 6 | 3 | 9 | ns |
Colonoscopy | 1 | 1 | 2 | ns |
Total | 9 | 8 | 17 | ns |
True cancer recurrence | 4 | 3 | 7 | ns |
False positive tests and symptoms (%) | 14 (25%) | 20 (36%) | 34 (31%) | ns |
Program positive predictive value | 0.36 | 0.23 | 0.29 | ns |
Diagnostics for potential recurrent cancer
| ||||
CEA (repeated) | 2 | 4 | 7 | ns |
Chest x-ray | 4 | 3 | 6 | ns |
CEUS | 2 | 6 | 6 | ns |
Colonoscopy | 3 | 12 | 15 | 0.05 |
CT thorax/abdomen/liver | 13 | 8 | 21 | ns |
PET | 0 | 2 | 2 | ns |
Consultations | 14 | 23 | 37 | ns |
Diagnostic work-up days (SD) | 45 (45) | 35 (28) | 39 (35) | ns |
Clinical presentation of colon cancer recurrence
Case no | Gender | Presenting problem | Routine vs. interval | Diagnostic tests | Metastatic site | Time to diagnosis (days) | Metastasis surgery | Time to surgery (days) |
---|---|---|---|---|---|---|---|---|
GP-surveillance
| ||||||||
1 | F | Elevated CEA | Routine | CEUS | Disseminated | 27 | No | Inoperable |
PET CT | ||||||||
2 | M | Abdominal pain | Interval | CEUS | Liver | 21 | No | Inoperable |
3 | M | Elevated CEA | Routine | CEA | Disseminated | 71 | No | Inoperable |
CT thorax | ||||||||
CT abdomen | ||||||||
4 | M | Metastatic lesion detected at CEUS | Routine | CEUS | Liver | 4 | Yes | 38 |
CT thorax | ||||||||
CT abdomen | ||||||||
5 | F | Abdominal pain, normal CEA, CT and CEUS, disseminated cancer detected at laparotomy | Interval | CEUS | Disseminated | 270 | Yes | 270 |
CT thorax | ||||||||
CT abdomen | ||||||||
6 | M | Abdominal tenderness | Interval | Anorectoscopy | Local recurrence | 2 | Yes | 30 |
CT thorax | ||||||||
CT abdomen | ||||||||
Surgeon-Surveillance
| ||||||||
7 | M | Metastatic lesion detected chest x-ray | Routine | CT thorax | Lung | 45 | Yes | 62 |
CT abdomen | ||||||||
8 | M | Stoma bleeding | Interval | Colonoscopy | Local and lymph node recurrence | 10 | No | Inoperable |
CT thorax | ||||||||
CT abdomen | ||||||||
9 | M | Weight loss | Routine | CT Thorax | Lung | 45 | No | Inoperable |
Night sweating | CT abdomen | |||||||
10 | M | Metastatic lesion detected at chest-x ray | Routine | CT Thorax | Lung | 4 | Yes | 42 |
CT abdomen | ||||||||
11 | M | Metastatic lesion detected on CEUS | Routine | MR liver | Liver | 3 | Yes | 43 |
CT thorax | ||||||||
CT abdomen | ||||||||
12 | F | Abdominal pain | Interval | CT abdomen | Disseminated | 16 | No | Inoperable |
CT thorax | ||||||||
13 | M | Elevated CEA | Routine | CT thorax | Liver | 30 | No | Inoperable |
CT abdomen | Lung | |||||||
CT liver | ||||||||
14 | F | Occult blood in faeces | Interval | CT thorax | Liver | 31 | Yes | 35 |
CT abdomen | ||||||||
CEUS |
Harms and benefits of cancer surveillance
Variable | Surveillance effects |
---|---|
Resource use
| |
Analysed surveillance months | 110 patients for 1884 months |
Cost per successful R0 resection (£) | 103207 |
Screening tests per R0 metastases resection
| |
Carcinoembryonic antigen CEA (n) | 125 |
Chest x-ray (n) | 70 |
Liver ultrasound (n) | 52 |
Colonoscopies (n) | 30 |
Total screening tests (n) | 276 |
Total health care consultations (n) | 296 |
Benefits
| |
Number of cancer recurrences detected (n) | 14 |
Probability of R0 metastasis surgery (%)* | 57% (4 of 7 metastasis surgeries) |
Side effects
| |
False positive events (n) | 34 (31%) |
Probability of recurrent cancer when diagnostic check up i.e. surveillance positive predictive value | 29% |
a
Mean days to SCE diagnosis (SD) | 39 (35) |
Asymptomatic but incurable metastases recurrences | 3 of 14 recurrences (21%) |
Quality of life
| |
aMean EQ-5D VAS score (CI) | 75.9 (74.5-77.3) |
aMean EQ-5D Index score (CI) | 0.862 (0.84-0.87) |