Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study

Background: The strategy of watch and wait (W&W) in patients with rectal cancer who achieve a complete clinical response (cCR) after neoadjuvant therapy is new and offers an opportunity for patients to avoid major resection surgery. However, evidence is based on small-to-moderate sized series from specialist centres. The International Watch & Wait Database (IWWD) aims to describe the outcome of the W&W strategy in a large-scale registry of pooled individual patient data. We report the results of a descriptive analysis after inclusion of more than 1000 patients in the registry. Methods: Participating centres entered data in the registry through an online, highly secured, and encrypted research data server. Data included baseline characteristics, neoadjuvant therapy, imaging protocols, incidence of local regrowth and distant metastasis, and survival status. All patients with rectal cancer in whom the standard of care (total mesorectal excision surgery) was omitted after neoadjuvant therapy were eligible to be included in the IWWD. For the present analysis, we only selected patients with no signs of residual tumour at reassessment (a cCR). We analysed the proportion of patients with local regrowth, proportion of patients with distant metastases, 5-year overall survival, and 5-year disease-specific survival. Findings: Between April 14, 2015, and June 30, 2017, we identified 1009 patients who received neoadjuvant treatment and were managed by W&W in the database from 47 participating institutes (15 countries). We included 880 (87%) patients with a cCR. Median follow-up time was 3·3 years (95% CI 3·1–3·6). The 2-year cumulative incidence of local regrowth was 25·2% (95% CI 22·2–28·5%), 88% of all local regrowth was diagnosed in the first 2 years, and 97% of local regrowth was located in the bowel wall. Distant metastasis were diagnosed in 71 (8%) of 880 patients. 5-year overall survival was 85% (95% CI 80·9–87·7%), and 5-year disease-specific survival was 94% (91–96%). Interpretation: This dataset has the largest series of patients with rectal cancer treated with a W&W approach, consisting of approximately 50% data from previous cohort series and 50% unpublished data. Local regrowth occurs mostly in the first 2 years and in the bowel wall, emphasising the importance of endoscopic surveillance to ensure the option of deferred curative surgery. Local unsalvageable disease after W&W was rare. Funding: European Registration of Cancer Care financed by European Society of Surgical Oncology, Champalimaud Foundation Lisbon, Bas Mulder Award granted by the Alpe d'Huzes Foundation and Dutch Cancer Society, and European Research Council Advanced Grant

Risk factors for anastomotic failure after total mesorectal excision of rectal cancer

Background: Anastomotic leakage is a major complication of rectal cancer surgery. The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision (TME).Methods: Between 1996 and 1999, patients with operable rectal cancer were randomized to receive short-term radiotherapy followed by TME or to undergo TME alone. Eligible Dutch patients who underwent an anterior resection (924 patients) were studied retrospectively.Results: Symptomatic anastomotic leakage occurred in 107 patients (11.6 per cent). Pelvic drainage and the use of a defunctioning stoma were significantly associated with a lower anastomotic failure rate. A significant correlation between the absence of a stoma and anastomotic dehiscence was observed in both men and women, for both distal and proximal rectal tumours. In patients with anastomotic failure, the presence of pelvic drains and a covering stoma were both related to a lower requirement for surgical reintervention.Conclusion: Placement of one or more pelvic drains after TME may limit the consequences of anastomotic failure. The clinical decision to construct a defunctioning stoma is supported by this study.</p

Risk factors for anastomotic failure after total mesorectal excision of rectal cancer

Background: Anastomotic leakage is a major complication of rectal cancer surgery. The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision (TME). Methods: Between 1996 and 1999, patients with operable rectal cancer were randomized to receive short-term radiotherapy followed by TME or to undergo TME alone. Eligible Dutch patients who underwent an anterior resection (924 patients) were studied retrospectively. Results: Symptomatic anastomotic leakage occurred in 107 patients (11.6 per cent). Pelvic drainage and the use of a defunctioning stoma were significantly associated with a lower anastomotic failure rate. A significant correlation between the absence of a stoma and anastomotic dehiscence was observed in both men and women, for both distal and proximal rectal tumours. In patients with anastomotic failure, the presence of pelvic drains and a covering stoma were both related to a lower requirement for surgical reintervention. Conclusion: Placement of one or more pelvic drains after TME may limit the consequences of anastomotic failure. The clinical decision to construct a defunctioning stoma is supported by this study