Assessment of the 2020 NICE criteria for preoperative radiotherapy in patients with rectal cancer treated by surgery alone in comparison with proven MRI prognostic factors: a retrospective cohort study.

BACKGROUND: Selection of patients for preoperative treatment in rectal cancer is controversial. The new 2020 National Institute for Health and Care Excellence (NICE) guidelines, consistent with the National Comprehensive Cancer Network guidelines, recommend preoperative radiotherapy for all patients except for those with radiologically staged T1-T2, N0 tumours. We aimed to assess outcomes in non-irradiated patients with rectal cancer and to stratify results on the basis of NICE criteria, compared with known MRI prognostic factors now omitted by NICE. METHODS: For this retrospective cohort study, we identified patients undergoing primary resectional surgery for rectal cancer, without preoperative radiotherapy, at Basingstoke Hospital (Basingstoke, UK) between Jan 1, 2011, and Dec 31, 2016, and at St Marks Hospital (London, UK) between Jan 1, 2007, and Dec 31, 2017. Patients with MRI-detected extramural venous invasion, MRI-detected tumour deposits, and MRI-detected circumferential resection margin involvement were categorised as MRI high-risk for recurrence (local or distant), and their outcomes (disease-free survival, overall survival, and recurrence) were compared with patients defined as high-risk according to NICE criteria (MRI-detected T3+ or MRI-detected N+ status). Kaplan-Meier and Cox proportional hazards analyses were used to compare the groups. FINDINGS: 378 patients were evaluated, with a median of 66 months (IQR 44-95) of follow up. 22 (6%) of 378 patients had local recurrence and 68 (18%) of 378 patients had distant recurrence. 248 (66%) of 378 were classified as high-risk according to NICE criteria, compared with 121 (32%) of 378 according to MRI criteria. On Kaplan-Meier analysis, NICE high-risk patients had poorer 5-year disease-free survival compared with NICE low-risk patients (76% [95% CI 70-81] vs 87% [80-92]; hazard ratio [HR] 1·91 [95% CI 1·20-3·03]; p=0·0051) but not 5-year overall survival (80% [74-84] vs 88% [81-92]; 1·55 [0·94-2·53]; p=0·077). MRI criteria separated patients into high-risk versus low-risk groups that predicted 5-year disease-free survival (66% [95% CI 57-74] vs 88% [83-91]; HR 3·01 [95% CI 2·02-4·47]; p<0·0001) and 5-year overall survival (71% [62-78] vs 89% [84-92]; 2·59 [1·62-3·88]; p<0·0001). On multivariable analysis, NICE risk assessment was not associated with either disease-free survival or overall survival, whereas MRI criteria predicted disease-free survival (HR 2·74 [95% CI 1·80-4·17]; p<0·0001) and overall survival (HR 2·44 [95% CI 1·51-3·95]; p=0·00027). 139 NICE high-risk patients who were defined as low-risk based on MRI criteria had similar disease-free survival as 118 NICE low-risk patients; therefore, 37% (139 of 378) of patients in this study cohort would have been overtreated with NICE 2020 guidelines. Of the 130 patients defined as low-risk by NICE guidelines, 12 were defined as high-risk on MRI risk stratification and would have potentially been missed for treatment. INTERPRETATION: Compared to previous guidelines, implementation of the 2020 NICE guidelines will result in significantly more patients receiving preoperative radiotherapy. High-quality MRI selects patients with good outcomes (particularly low local recurrence) without radiotherapy, with little margin for improvement. Overuse of radiotherapy could occur with this unselective approach. The high-risk group, with the most chance of benefiting from preoperative radiotherapy, is not well selected on the basis of NICE 2020 criteria and is better identified with proven MRI prognostic factors (extramural venous invasion, tumour deposits, and circumferential resection margin). FUNDING: None.

Assessment of a Staging System for Sigmoid Colon Cancer Based on Tumor Deposits and Extramural Venous Invasion on Computed Tomography.

Importance: Preoperative TNM stratification of colon cancer on computed tomography (CT) does not identify patients who are at high risk of recurrence that could be selected for preoperative treatment. Objective: To evaluate the utility of CT findings for prognosis of sigmoid colon cancer. Design, Setting, and Participants: This prognostic study used retrospective data from patients who underwent bowel resection for sigmoid colon cancer between January 1, 2006, and January 1, 2015, at a tertiary care center receiving international and national referrals for colorectal cancer. Statistical analysis was performed in April 2019. Main Outcomes and Measures: Cox proportional hazards regression analysis was performed to investigate CT findings associated with disease recurrence. Kaplan-Meier survival plots were calculated for disease-free survival using CT staging systems. Results: Of the 414 patients who had sigmoid colon cancer (248 [60.0%] men; mean [SD] age, 66.1 [12.7] years), with median follow-up of 61 months (interquartile range, 40-87 months), 122 patients (29.5%) developed disease recurrence. On multivariate analysis, nodal disease was not associated with disease recurrence; only tumor deposits (hazard ratio [HR], 1.90; 95% CI, 1.21-2.98; P = .006) and extramural venous invasion (HR, 1.97; 95% CI, 1.26-3.06; P = .003) on CT were associated with disease recurrence. Significant differences in disease-free survival were found using CT-T3 substage classification (HR, 1.88; 95% CI, 1.32-2.68) but not CT-TNM (HR, 1.55; 95% CI, 0.94-2.55). The presence of tumor deposits or extramural venous invasion on CT (HR, 2.45; 95% CI, 1.68-3.56) had the strongest association with poor outcome. Conclusions and Relevance: In this study, T3 substaging and detection of tumor deposits or extramural venous invasion on preoperative CT scans of sigmoid colon cancer were prognostic factors for disease-free survival, whereas TNM and nodal staging on CT had no prognostic value. T3 substaging and detection of tumor deposits or extramural venous invasion of sigmoid colon cancer was superior to TNM on CT and could be used to preoperatively identify patients at high risk of recurrence.

Consumer demand for surgical innovation: a systematic review of public perception of NOTES.

BACKGROUND: The full scope of benefits offered by NOTES over traditional laparoscopy, if any, is not yet fully clear. Perceived patient demand for truly "scarless surgery" is often referenced one of the driving factors in the continued development of this relatively new technique. The true scale of patient preference and demand for NOTES as a surgical technique is unknown. This review aims to summarise currently available literature on the topic of patient perceptions of NOTES to guide future development of the technique. METHODS: A comprehensive search of PubMed and Web of Science electronic databases was performed on 1st Jan 2014. To be considered for inclusion, articles were required to assess and report the perception of NOTES in a sample of laypersons (patients or general public). The primary endpoint assessed was acceptance or preference rates expressed by patients for NOTES procedures. Reasons given for preference or rejection of NOTES were recorded, as well as preferred access routes and any predicting factors of NOTES acceptance. RESULTS: Initial search returned 1,334 results, resulting in 15 articles included in final data synthesis. These polled a total of 4,420 subjects. Acceptance of NOTES ranged between 41 and 84 %. Compared to a laparoscopic approach, preference rates for NOTES ranged from 0 to 78 %. Reasons for preferring NOTES were largely centred on potentially reduced recovery time, complications (particularly with reference to hernias) and postoperative pain. Improved cosmesis also played a role, but was secondary to the above issues. Overall, study quality was poor. CONCLUSIONS: This review suggests significant public interest in NOTES and scarless surgery in general. Further research and consideration of differences in public perceptions across regions, countries and cultures are required.