Introduction In patients with rectal cancer, management by ‘watch and wait’ (W&W), with potential avoidance of surgical resection (SR), has emerged as a management option following a clinical complete response (cCR) after pre-operative chemoradiotherapy (CRT). However, precise quantification of oncological outcomes after this treatment pathway is unclear.

Method Between 2010 and 2013, we followed a consecutive series of 259 patients with non-metastatic rectal cancer who completed pre-operative CRT (majority: 45 Gy in 25 daily fractions with concurrent fluoropyrimidine-based chemotherapy). Post-CRT, 31 patients (12%) were considered at a multi-disciplinary meeting to have cCR and offered W&W on a protocolised pathway. We supplemented these cases with a registry of 89 patients managed across four cancer treatment centres in the North West of England and North Wales (total cCRs: 120). Primary endpoint was actuarial rate of intraluminal re-growth. Secondary endpoints were non-intraluminal disease-free survival (niDFS) and colostomy-free survival (CFS). Comparisons with standard care (SR) were performed using propensity score matched-treatment analysis and using time-dependent survival analyses to account for differences in times to W&W decision and salvage SR.

Results With a mean follow-up from W&W decision of 23 months, there were 36 (30%) intraluminal re-growths (3-year actuarial rate: 35%). Of the 32 intraluminal re-growths without concomitant distant metastases, 25 (78%) underwent subsequent salvage surgery (R0: 24, R1: 1); and 3 underwent Papillon local radiotherapy. After propensity score matching, there were no deleterious effect on niDFS for patients treated by W&W versus SR (hazard ratio, 95% confidence intervals: 0.562; 0.269 to 1.174). However, there was a significant improvement in 3-year CFS rates for patients treated by W&W versus SR: 83% and 54% (log rank, p < 0.001).

Conclusion Approximately two-thirds of patients with rectal cancer managed by W&W after cCR avoided surgical resection with improvement in colostomy-free survival, without loss of oncological safety. The outcomes from this multi-centred clinical cohort will assist the rectal cancer patient and oncologist with decision making at the outset of long-course CRT.

This study was generously supported by the BDRF.

Disclosure of interest None Declared.