Critical appraisal of the 'wait and see' approach in rectal cancer for clinical complete responders after chemoradiation

Background: Some 1020 per cent of patients with locally advanced rectal cancer achieve a pathological complete response (pCR) at surgery following preoperative chemoradiation (CRT). Some demonstrate a sustained clinical complete response (cCR), defined as absence of clinically detectable residual tumour after CRT, and do not undergo resection. The aim of this review was to evaluate non-operative treatment of rectal cancer after CRT, and the outcome of patients observed without radical surgery. Methods: A systematic computerized search identified 30 publications (9 series, 650 patients) evaluating a non-operative approach after CRT. Original data were extracted and tabulated, and study quality evaluated. The primary outcome measure was cCR. Secondary outcome measures included locoregional failure rate, disease-free survival and overall survival. Results: The most recent Habr-Gama series reported a low locoregional failure rate of 4.6 per cent, with 5-year overall and disease-free survival rates of 96 and 72 per cent respectively. These findings were supported by a small prospective Dutch study. However, other retrospective series have described higher recurrence rates. All studies were heterogeneous in staging, inclusion criteria, study design and rigour of follow-up after CRT, which might explain the different outcomes. The definition of cCR was inconsistent, with only partial concordance with pCR. The results suggested that patients who are observed, but subsequently fail to sustain a cCR, may fare worse than those who undergo immediate tumour resection. Conclusion: The rationale of a wait and see policy relies mainly on retrospective observations from a single series. Proof of principle in small low rectal cancers, where clinical assessment is easy, should not be extrapolated uncritically to more advanced cancers where nodal involvement is common. Long-term prospective observational studies with more uniform inclusion criteria are required to evaluate the risk versus benefit. Copyright (C) 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.