Preoperative Radiotherapy Combined with Total Mesorectal Excision for Resectable Rectal Cancer
Open accessAbstract
BACKGROUND: Short-term preoperative radiotherapy and total mesorectal excision have each been shown to improve local control of disease in patients with resectable rectal cancer. We conducted a multicenter, randomized trial to determine whether the addition of preoperative radiotherapy increases the benefit of total mesorectal excision. METHODS: We randomly assigned 1861 patients with resectable rectal cancer either to preoperative radiotherapy (5 Gy on each of five days) followed by total mesorectal excision (924 patients) or to total mesorectal excision alone (937 patients). The trial was conducted with the use of standardization and quality-control measures to ensure the consistency of the radiotherapy, surgery, and pathological techniques. RESULTS: Of the 1861 patients randomly assigned to one of the two treatment groups, 1805 were eligible to participate. The overall rate of survival at two years among the eligible patients was 82.0 percent in the group assigned to both radiotherapy and surgery and 81.8 percent in the group assigned to surgery alone (P=0.84). Among the 1748 patients who underwent a macroscopically complete local resection, the rate of local recurrence at two years was 5.3 percent. The rate of local recurrence at two years was 2.4 percent in the radiotherapy-plus-surgery group and 8.2 percent in the surgery-only group (P<0.001). CONCLUSIONS: Short-term preoperative radiotherapy reduces the risk of local recurrence in patients with rectal cancer who undergo a standardized total mesorectal excision.
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In the Dutch CKVO 95-04 trial, 5- and 10-year local control rates were significantly higher in the preoperative radiotherapy plus TME group than in the TME alone group.
“the 5- and 10-year local control rates were significantly higher in the combination therapy group”
From Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer (2018) · cites this paper as [110]
The Local Recurrence section reports significantly less local recurrence with preoperative radiotherapy plus TME than with TME alone, but only at two years (2.4% versus 8.2%; P<0.001). The Follow-up section says recurrence rates are presented at two years; this paper does not establish the claimed 5- or 10-year local-control rates. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the Dutch CKVO 95-04 trial, there was no significant difference between preoperative radiotherapy plus TME and TME alone in 5- and 10-year survival rates.
“but there was no significant difference between the two groups in the 5- and 10-year survival rates [110–112].”
From Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer (2018) · cites this paper as [110]
The Overall Survival section reports no significant difference between the groups at two years (P=0.84). The Discussion gives a median follow-up of 24.9 months, so this paper does not support the attributed finding about five- and ten-year survival. (LLM, conf=0.84)
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- Authors
- Kapiteijn, E., Marijnen, C. A. M., Nagtegaal, I. D., Putter, H., Steup, W. H., Wiggers, T., Rutten, H. J. T., Pahlman, L., Glimelius, B., van Krieken, J. H. J. M., Leer, J. W. H., & van de Velde, C. J. H.
- Affiliations
- Leiden University Medical Center (NL)
- University Medical Center Groningen (NL)
- Catharina Ziekenhuis (NL)
- Uppsala University Hospital (SE)
- Radboud University Medical Center (NL)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2001-08-30
- Volume
- 345
- Issue
- 9
- Pages
- 638-646
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2132565869
- Cited by
- 4,205
- References
- 28
- Citations by year
- 2026: 70 · 2025: 119 · 2024: 109 · 2023: 170 · 2022: 174 · 2021: 170 · 2020: 190 · 2019: 168 · 2018: 152 · 2017: 154 · 2016: 168 · 2015: 206 · 2014: 207 · 2013: 193 · 2012: 188
- FWCI
- 58.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Surgery › Colorectal and Anal Carcinomas
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Keywords
- rectal cancer, preoperative radiotherapy, total mesorectal excision, local recurrence, resectable rectal cancer, survival, local control
- MeSH terms
- Adenocarcinoma, Adult, Aged, Aged, 80 and over, Analysis of Variance, Colorectal Surgery, Female, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Preoperative Care, Prospective Studies, Rectal Neoplasms, Rectum, Survival Rate, Proportional Hazards Models, Radiotherapy, Adjuvant
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