Faecal Immunochemistry Test - qFIT Dr Rob Palmer GPwSI Gastro CCG Cancer and Gastro lead

Colorectal Cancer (CRC)- Epidemiology 4th most common malignancy in the UK 2nd commonest cause of cancer death >20% of new cases in London are in people under 60 years old (i.e. below the screening age)

Bowel Cancer (C18-C20): 2002-2006 Five-Year Relative Survival (%) by Stage, Adults Aged 15-99, Former Anglia Cancer Network

Bowel Cancer (C18-C20) Proportion of Cases Diagnosed at Each Stage, All Ages

Colorectal cancer survival Over half of all cases in England and almost 60% of cases in London are diagnosed at Stages 3 and 4. People under 60 years are less likely to be diagnosed with early stage CRC (37%) compared to those over 60 years (44%). In London: 28% diagnosed via an emergency route – 33% 5yr survival 49.7% diagnosed via 2ww referral - 69% 5yr survival In NEL, 6 out of 7 CCGs have a one year survival for colorectal cancer below the England average

Local data

HOW AND WHEN BOWEL CANCER PATIENTS ARE DIAGNOSED Though bowel screening is an important part of cancer control, the majority of bowel cancer patients are diagnosed symptomatically. This infographic is based on the latest Routes to Diagnosis information, illustrates both the route of referral to diagnosis – screening, 2WW, Routine GP etc., and also the recorded stage at the point of diagnosis. In colorectal cancer, only 44% of cancers are diagnosed at an early stage I & II).

What is FIT and how can it help? FIT (Faecal Immunochemical Test) - uses antibodies that specifically recognise human haemoglobin TO TEST FOR OCCULT BLOOD Comparison of FIT vs g-FOBT FIT g-FOBT High sensitivity and specificity Low sensitivity -only detects up to 50% of CRC in asymptomatic patients Easier to give samples - Leading to higher uptake by patients Harder to give samples Only detects human blood Not specific to human haemoglobin: - high number of false positives - requirement for dietary restrictions

NICE Cancer Recognition and Referral guidelines – NG12 June 2015 NG12 released, giving new recommendations for recognition and referral of suspected cancer in primary care Patients with higher risk symptoms recommended for urgent suspected cancer referral (2WW) Faecal occult blood testing recommended for patients with ‘low risk but not no risk’ signs/symptoms but NOT adopted in London. Instead low risk London patients sent on 2WW pathway July 2017 Diagnostic guideline (DG) 30 released recommending use of Faecal Immunochemical Test (FIT), a type of faecal occult blood test, in low risk but not no risk patients NICE DG30 replaced recommended 1.3.4 in NG12 In NG12 there were major changes to the suspected cancer pathway for colorectal cancer. The 6 week time period for change in bowel habit was removed along with the levels of haemoglobin for IDA and abdominal pain included. This was due to evidence from primary care studies that reflect the importance of mild anaemia and abdominal pain as important presenting symptoms. The biggest change was the inclusion of a positive faecal occult blood test as a criteria for placing a patient on a suspected cancer pathway. Willie Hamilton, who was involved in the development of the guidance, still believes that inclusion of a positive FIT will save the most lives.

Lower GI Suspected Cancer Pathway (2WW) - NICE NG12 Refer on 2WW if: ≥40y with unexplained weight loss and abdominal pain ≥50y with unexplained rectal bleeding ≥60y with iron deficiency anaemia (IDA) or change in bowel habit Positive faecal occult blood test Consider referral on a 2WW if: Rectal or abdominal mass <50y and rectal bleeding + any of: abdominal pain, change in bowel habit, weight loss or IDA In NG12 there were major changes to the suspected cancer pathway for colorectal cancer. The 6 week time period for change in bowel habit was removed along with the levels of haemoglobin for IDA and abdominal pain included. This was due to evidence from primary care studies that reflect the importance of mild anaemia and abdominal pain as important presenting symptoms. The biggest change was the inclusion of a positive faecal occult blood test as a criteria for placing a patient on a suspected cancer pathway. Willie Hamilton, who was involved in the development of the guidance, still believes that inclusion of a positive FIT will save the most lives.

Offer a FIT test if: Offer FIT to assess for colorectal cancer in adults without rectal bleeding who: Are aged 50 years and over with unexplained: Abdominal pain or Weight loss or Are aged under 60 with: Changes in their bowel habit or Iron deficiency anaemia or Are aged 60 and over and have anaemia even in the absence of iron deficiency. NICE DG30 Guidelines

New Pan London Suspected Lower GI Cancer Referral Form

Broad Principles of how FIT will work locally GP offers test to eligible patient and issue s FIT test kit Patient completes test and returns the kit to the lab for processing Safety-netting Result to GP – communication with patient Negative FIT This is an example slide – Facilitators can remove this one and replace it with a diagram showing local pathways. Positive FIT ie [FHb] ≥10µg/g Safety-netting Symptoms persist Symptoms resolve Safety-netting 2WW pathway Safety-netting NFA Further investigations or referral

How good is FIT? Godber et al Clin Chem Lab Med 2016; 54(4): 595-602 Scottish Study using FIT at 10mcg/g threshol Sensitivity for colorectal cancer 100%, Specificity 80.2% PPV 26.3% NPV 100% Widlak et al Aliment Pharmacol Ther 2017: 45: 354-363 English study Sensitivity 84%, Specificity 93% NPV 99%

If FIT result negative… The risk of cancer would be very low… but not zero and it doesn’t rule out other non-cancer diagnoses If ongoing clinical concerns  refer

What is the difference between FIT and calprotectin? FIT: measures human haemoglobin; i.e. bleeding Calprotectin: released from neutrophils & macrophages at sites of inflammation Recommend to use FIT when suspect cancer and F.calp when suspect IBD. In younger patients, it may be appropriate to request both. FIT has quite good sensitivity/spec for IBD, but less good for SB disease FCP reasonable figures for cancer

Projected benefits of implementation of FIT Proportion of CRC diagnosed at Stage 1-2 to increase from 39.9% (2015) to 43.1% (NEL STPs) Proportion of CRC diagnosed through emergency A&E visit to drop from 28.4% to 20% Reduction in the need for colonoscopy in 75-80% of cases Overall reduction of colonoscopy/CTC by 15% Significant savings to NHS (middle projection figure £6.5million for London) Cost of test = £15-20 (kit + testing)

FIT in Bowel Cancer Screening Programme (BCSP) Due to replace g-FOBT during 2019 Improved sensitivity over FOBt Higher thresholds for qFIT used in screening programme (120mcg/g vs 10mcg/g for symptomatic patients) i.e. patients who have a negative screening result may still have bowel cancer and should be offered a symptomatic FIT test if appropriate Projected improved uptake by patients (approx 7%)

The Future … Use in high-risk (2ww) patients Surveillance (previous polyps, strong FH CRC)

Patient resources What is FIT and how to deliver samples: Leaflet Video https://gps.cityandhackneyccg.nhs.uk/topic/cancer