Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer (Dutch TME trial)
N = 1,861
- Population
- Patients with resectable rectal cancer without evidence of distant disease
- Design
- Multicentre randomised trial of preoperative radiotherapy (5 Gy on each of five days) followed by total mesorectal excision versus total mesorectal excision alone; 1861 patients were randomly assigned between January 1996 and December 1999, with standardisation and quality control of radiotherapy, surgery and pathology. No chemotherapy was allowed. The trial tested radiotherapy added to standardised TME, not TME itself.
- Primary endpoint
- Local recurrence
- Arms
- TME alone (control, n = 937): Standardised total mesorectal excision without radiotherapy
- Radiotherapy plus TME (experimental, n = 924): 5 Gy on each of five days, then standardised total mesorectal excision
- People
- Kapiteijn E, Dutch Colorectal Cancer Group
Δ 24-month OS+0.2 pointsΔ 24-month Local recurrence−5.8 pointsΔ 60-month Local recurrence−5.3 pointsΔ 60-month OS+0.7 pointsΔ 120-month Local recurrence−6 pointsΔ 120-month OS+10 points
Show the numbers
| Endpoint | Analysis | Radiotherapy plus TME | TME alone | Effect |
|---|---|---|---|---|
| OSEligible patients (1805 of the 1861 randomised)Overall survival rate at two years | primaryKapiteijn 2001 | 82% at 2 y | 81.8% at 2 y | P=0.84 |
| Local recurrencePatients who underwent a macroscopically complete local resection (1748 patients)Rate of local recurrence at two years | primaryKapiteijn 2001 | 2.4% at 2 y | 8.2% at 2 y | P<0.001The two-year local recurrence rate across both groups was 5.3% (abstract). |
| Local recurrencePatients undergoing a macroscopically complete local resectionFive-year local recurrence risk | long term-updatemedian follow-up 6.1 yearsPeeters 2007 | 5.6% at 5 y | 10.9% at 5 y | P<0.001Median follow-up of surviving patients. |
| OSAnalysis population not stated in the abstractOverall survival at five years | long term-updatemedian follow-up 6.1 yearsPeeters 2007 | 64.2% at 5 y | 63.5% at 5 y | P=0.902 |
| Local recurrenceEligible patients who underwent a macroscopically complete local resectionTen-year cumulative incidence of local recurrence | long term-updatemedian follow-up 12 yearsvan 2011 | 5% at 10 y | 11% at 10 y | P<0.0001The abstract states that overall survival did not differ between groups. |
| OSSubgroup: TNM stage III with a negative circumferential resection marginTen-year survival | exploratorymedian follow-up 12 yearsvan 2011 | 50% at 10 y | 40% at 10 y | P=0.032Subgroup result; the abstract reports no overall survival difference for all patients. |
| Endpoint | Analysis | Radiotherapy plus TME | TME alone | Effect |
|---|---|---|---|---|
| OSEligible patients (1805 of the 1861 randomised)Overall survival rate at two years | primaryKapiteijn 2001 | 82% at 2 y | 81.8% at 2 y | P=0.84 |
| Local recurrencePatients who underwent a macroscopically complete local resection (1748 patients)Rate of local recurrence at two years | primaryKapiteijn 2001 | 2.4% at 2 y | 8.2% at 2 y | P<0.001The two-year local recurrence rate across both groups was 5.3% (abstract). |
| Local recurrencePatients undergoing a macroscopically complete local resectionFive-year local recurrence risk | long term-updatemedian follow-up 6.1 yearsPeeters 2007 | 5.6% at 5 y | 10.9% at 5 y | P<0.001Median follow-up of surviving patients. |
| OSAnalysis population not stated in the abstractOverall survival at five years | long term-updatemedian follow-up 6.1 yearsPeeters 2007 | 64.2% at 5 y | 63.5% at 5 y | P=0.902 |
| Local recurrenceEligible patients who underwent a macroscopically complete local resectionTen-year cumulative incidence of local recurrence | long term-updatemedian follow-up 12 yearsvan 2011 | 5% at 10 y | 11% at 10 y | P<0.0001The abstract states that overall survival did not differ between groups. |
| OSSubgroup: TNM stage III with a negative circumferential resection marginTen-year survival | exploratorymedian follow-up 12 yearsvan 2011 | 50% at 10 y | 40% at 10 y | P=0.032Subgroup result; the abstract reports no overall survival difference for all patients. |
Appears in
Sources
Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001;345(9):638-46.
Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, et al. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007;246(5):693-701.
van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011;12(6):575-82.