Effect of 3 to 5 Years of Scheduled CEA and CT Follow-up to Detect Recurrence of Colorectal Cancer
- Study type
- Clinical trial
- Study name
- FACS
- Design
- Randomised, multicentre clinical trial at 39 UK National Health Service (NHS) hospitals, with four groups
- Sample size
- 1202 patients
- Source
- JAMA · 2014
In plain words
After surgery for bowel cancer, doctors usually follow patients up with a blood test (CEA) and CT scans to find the cancer early if it comes back. In this study, follow-up with either the CEA test or CT scans meant that more patients could have surgery aimed at curing a recurrence, but doing both together gave no extra benefit. There was no meaningful difference in the number of deaths between the groups, and if intensive follow-up does help survival, the benefit is probably small.
Key results
Treatment arms and regimens
No drug (follow-up strategy). 300 patients. Blood CEA measurement in primary care every 3 months for 2 years, then every 6 months for 3 years. All groups had a booklet on symptoms suggestive of recurrence and a colonoscopy at the end of the trial (year 5), and contact with a colorectal specialist nurse could continue.
No drug (follow-up strategy). 299 patients. CT of the chest, abdomen and pelvis in hospital every 6 months for 2 years, then annually for 3 years, plus colonoscopy at year 2. All groups had a booklet on symptoms suggestive of recurrence and a colonoscopy at the end of the trial (year 5), and contact with a colorectal specialist nurse could continue.
No drug (follow-up strategy). 302 patients. Both the CEA and CT follow-up schedules, plus colonoscopy at year 2. All groups had a booklet on symptoms suggestive of recurrence and a colonoscopy at the end of the trial (year 5), and contact with a colorectal specialist nurse could continue.
No drug (follow-up strategy). 301 patients. Symptom-driven follow-up in primary care (only if symptoms occur). All groups had a booklet on symptoms suggestive of recurrence and a colonoscopy at the end of the trial (year 5), and contact with a colorectal specialist nurse could continue.
Source of the regimen details: No drug (follow-up strategy); abstract of the paper and registration ISRCTN41458548 (where tests were done, patient booklet and colonoscopies)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Eligible participants enrolled between January 2003 and August 2009. These patients had undergone surgery with curative intent for primary colorectal cancer (with adjuvant therapy if indicated) and had no evidence of residual disease on investigation.
Endpoints
Primary endpoint: surgical treatment of recurrence with curative intent. Secondary endpoints: mortality (overall and from colorectal cancer), time to detection of recurrence and survival after treatment of recurrence with curative intent.
Safety and side effects
Diagnostic intervention without drugs; no data on test-related adverse events were reported in the abstract or the trial registration.
Clinical significance and place in guidelines
This trial showed that scheduled follow-up with CEA or CT increases the proportion of patients whose recurrence can be treated with curative-intent surgery; however, combining the two methods gave no added advantage, and a survival benefit was not shown. The place of these findings in current colorectal cancer follow-up guidelines should be checked separately.
Limitations
According to the abstract, there was no significant difference in mortality between the intensive monitoring and minimum follow-up groups, and results on survival and other secondary endpoints can be assessed only as far as the abstract summary allows. Further details should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.