Effect of More vs Less Frequent Follow-up Testing on Overall and Colorectal Cancer–Specific Mortality in Patients With Stage II or III Colorectal Cancer
- Study type
- Clinical trial
- Study name
- COLOFOL
- Design
- Unblinded, randomised, multicentre trial (24 centres in Sweden, Denmark and Uruguay)
- Sample size
- 2509 patients in the intention-to-treat analysis (of 2555 randomised)
- Source
- JAMA · 2018
- Trial registration
- NCT00225641
In plain words
In this large study, patients with stage 2 or 3 bowel (colorectal) cancer were followed after surgery with CT scans and a CEA blood test either five times (at 6, 12, 18, 24 and 36 months) or twice (at 12 and 36 months). After 5 years, the number of deaths did not differ significantly between the two groups. So in this study, doing these tests more often did not save more lives. Decisions about your follow-up schedule should be made with your treating doctor.
Key results
Treatment arms and regimens
No drugs (follow-up strategy). CT of the chest and abdomen and serum carcinoembryonic antigen (CEA) measurement at 6, 12, 18, 24 and 36 months after surgery (1253 patients). In the registered protocol: CEA, multislice CT of the liver and chest radiograph. If recurrence was detected, the best available treatment (curative-intent reoperation or palliative oncological treatment) was offered.
No drugs (follow-up strategy). CT of the chest and abdomen and serum CEA measurement at 12 and 36 months after surgery (1256 patients); treatment of recurrence as in the other group.
Source of the regimen details: No drugs (follow-up strategy); test schedule from the abstract of the paper (PMC6583244) and ClinicalTrials.gov NCT00225641
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
Patients with stage II or III colorectal cancer randomised after curative-intent surgery. Patients were enrolled at 24 centres in Sweden, Denmark and Uruguay from January 2006 to December 2010 and followed for 5 years; follow-up ended on 31 December 2015. Mean age was 63.5 years and 1128 (45%) were women.
Inclusion criteria (ClinicalTrials.gov): radical (R0) resection of colorectal adenocarcinoma with or without adjuvant therapy, age below 75 years, a "clean colon" confirmed by colonoscopy or barium enema during surgery or within 3 months afterwards, stage II or III (Tany N1-2 M0 or T3-4 Nany M0). Exclusion criteria: HNPCC or FAP, local excision (such as TEM), life expectancy below 2 years because of comorbidity, and previous malignancy (except non-melanoma skin cancer).
Endpoints
Primary endpoints: 5-year overall mortality and colorectal cancer-specific mortality. Secondary endpoint: colorectal cancer-specific recurrence rate. Both intention-to-treat and per-protocol analyses were performed.
Safety and side effects
Drug-free diagnostic intervention; no data on complications of the tests are reported in the abstract or the trial registration.
Clinical significance and place in guidelines
The results of this trial show that more frequent follow-up with CT and CEA in stage 2 and 3 patients after curative surgery did not significantly reduce overall or colorectal cancer-specific mortality. This finding supports a less frequent follow-up approach. The status of this finding in current clinical guidelines should be checked separately.
Limitations
The trial was unblinded. The abstract does not address other limitations; see the full text of the paper for further details.
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.