Induction of a clinical complete response with chemoradiotherapy, followed by observation via a watch-and-wait approach, has emerged as a management option for patients with rectal cancer. We aimed to address the shortage of evidence regarding the safety of the watchand- wait approach by comparing oncological outcomes between patients managed by watch-and-wait who achieved a clinical complete response and those who had surgical resection (standard care). The study “Oncological outcomes after clinical complete response in patients with rectal cancer” (OnCoRe) was a propensity-score matched cohort analysis study, that included patients of all ages diagnosed with rectal adenocarcinoma without distant metastases who had received preoperative chemoradiotherapy (45 Gy in 25 daily fractions with concurrent fluoropyrimidine-based chemotherapy) at a tertiary cancer centre in Manchester, UK, between January 14, 2011, and April 15, 2013. Patients who had a clinical complete response were offered management with the watch-and-wait approach, and patients who did not have a complete clinical response were offered surgical resection if eligible. We also included patients with a clinical complete response managed by watch-and-wait between March 10, 2005, and January 21, 2015, across three neighbouring UK regional cancer centres, whose details were obtained through a registry. For comparative analyses, we derived one-to-one paired cohorts of watch-and-wait versus surgical resection using propensity-score matching (including T stage, age and performance status). The primary endpoint was nonregrowth disease-free survival from the date that chemoradiotherapy was started, and secondary endpoints were overall survival, and colostomy-free survival. We used a conservative p value of less than 0.01 to indicate statistical significance in the comparative analyses. 259 patients were included in our Manchester tertiary cancer centre cohort, 228 of whom underwent surgical resection at referring hospitals and 31 of whom had a clinical complete response, managed by watch-and-wait. A further 98 patients were added to the watch-and-wait group via the registry. Of the 129 patients managed by watch-and-wait (median follow-up 33 months [IQR 19–43]), 44 (34%) had local regrowths (3-year actuarial rate 38% [95% CI 30–48]); 36 (88%) of 41 patients with non-metastatic local regrowths were salvaged. In the matched analyses (109 patients in each treatment group), no differences in 3-year non-regrowth disease-free survival were noted between watch-and-wait and surgical resection (88% [95% CI 75–94] with watchand- wait vs 78% [63–87] with surgical resection; timevarying p=0·043). Similarly, no difference in 3-year overall survival was noted (96% [88–98] vs 87% [77–93]; timevarying p=0.024). By contrast, patients managed by watchand- wait had significantly better 3-year colostomy-free survival than did those who had surgical resection (74% [95% CI 64–82] vs 47% [37–57]; hazard ratio 0·445 [95% CI 0.31–0.63; p<0.0001), with a 26% (95% CI 13–39) absolute difference in patients who avoided permanent colostomy at 3 years between treatment groups. A substantial proportion of patients with rectal cancer managed by watch-and-wait avoided major surgery and averted permanent colostomy without loss of oncological safety at 3 years. These findings should inform decision making at the outset of chemoradiotherapy.
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Thomas Aparicio (2016) studied this question.
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