Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial
By D. Sebag‐Montefiore, R. Stephens, R. Steele, J. Monson, R. Grieve, S. Khanna, P. Quirke, J. Couture, C. de Metz, A. Myint and 4 more. The Lancet, 2009
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Summary Background Preoperative or postoperative radiotherapy reduces the risk of local recurrence in patients with operable rectal cancer. However, improvements in surgery and histopathological assessment mean that the role of radiotherapy needs to be reassessed. We compared short-course preoperative radiotherapy versus initial surgery with selective postoperative chemoradiotherapy. Methods We undertook a randomised trial in 80 centres in four countries. 1350 patients with operable adenocarcinoma of the rectum were randomly assigned, by a minimisation procedure, to short-course preoperative radiotherapy (25 Gy in five fractions; n=674) or to initial surgery with selective postoperative chemoradiotherapy (45 Gy in 25 fractions with concurrent 5-fluorouracil) restricted to patients with involvement of the circumferential resection margin (n=676). The primary outcome measure was local recurrence. Analysis was by intention to treat. This study is registered, number ISRCTN 28785842. Findings At the time of analysis, which included all participants, 330 patients had died (157 preoperative radiotherapy group vs 173 selective postoperative chemoradiotherapy), and median follow-up of surviving patients was 4 years. 99 patients had developed local recurrence (27 preoperative radiotherapy vs 72 selective postoperative chemoradiotherapy). We noted a reduction of 61% in the relative risk of local recurrence for patients receiving preoperative radiotherapy (hazard ratio [HR] 0·39, 95% CI 0·27–0·58, p<0·0001), and an absolute difference at 3 years of 6·2% (95% CI 5·3–7·1) (4·4% preoperative radiotherapy vs 10·6% selective postoperative chemoradiotherapy). We recorded a relative improvement in disease-free survival of 24% for patients receiving preoperative radiotherapy (HR 0·76, 95% CI 0·62–0·94, p=0·013), and an absolute difference at 3 years of 6·0% (95% CI 5·3–6·8) (77·5% vs 71·5%). Overall survival did not differ between the groups (HR 0·91, 95% CI 0·73–1·13, p=0·40). Interpretation Taken with results from other randomised trials, our findings provide convincing and consistent evidence that short-course preoperative radiotherapy is an effective treatment for patients with operable rectal cancer. Funding Medical Research Council (UK) and the National Cancer Institute of Canada.
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- F. Taylor
- L. Blomqvist
- G. Brown
- P. Quirke
- D. Sebag‐Montefiore
- R. Heald
- B. Moran
- P. Tekkis
Citations in the corpus
- Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2017, neutral): “0 Gy/fraction) or SCPRT has better outcomes than postoperative CRT [87, 88].”
- Preoperative High-resolution Magnetic Resonance Imaging Can Identify Good Prognosis Stage I, II, and III Rectal Cancer Best Managed by Surgery Alone: A Prospective, Multicenter, European Study (2011, background): “The CR07 and Dutch TME results suggest that LR rates in mobile cancers are substantially reduced if patients with rectal cancer are treated with preoperative short-course radiotherapy.(8,9,32) In both CR07 and the Dutch TME trial, preoperative staging using MRI was not used to determine which patien”