Curative Treatment Of Rectal Cancer Research Articles

Combined Pubic Arch and Ischial Bone Resection for Metachronous and Frequent Local Recurrences of Rectal Cancer.

Complete surgical resection with negative margins remains the cornerstone for curative treatment of rectal cancer; however, local recurrence can pose a significant challenge. Herein, we aimed to introduce a novel surgical technique for combined resection of the pubic arch and ischial bone in the context of treating recurrent rectal cancer. We present a case of a patient with a fourth local recurrence of rectal cancer, with no evidence of distant metastasis. The tumor directly invaded the posterior wall of the pubic arch. To achieve complete tumor resection, an osteotomy was performed using a thread wire saw at the bilateral pubic rami and ischial bones. Intraoperative frozen section analysis (rapid tissue examination) was conducted on tissue samples from the lateral margins of the planned osteotomy line. Samples were negative for adenocarcinoma (cancerous cells). The combined resection of the pubic arch and ischial bone was successfully performed with negative margins for adenocarcinoma, as confirmed by frozen section analysis. Mastery of the surgical technique for combined resection of the pubic arch and ischial bone may be clinically significant for achieving complete resection in cases of multiple resections for locally recurrent rectal cancer.

Role of body mass index in anastomotic leakage after curative treatment for rectal cancer.

Anastomotic leakage (AL) represents a severe complication after rectal surgery, leading to significant morbidity, mortality, and increased healthcare costs. Despite improvements in surgical methods and perioperative care, the challenge of AL persists. Explore the impact of body mass index (BMI) on the risk of AL following curative treatment for rectal cancer, providing insight into its predictive value. Retrospective review. Data were collected from a single tertiary center, emphasizing the specialized postoperative outcomes in a high-care setting. The study population was comprised patients who underwent sphincter-saving surgery combined with neoadjuvant chemoradiation for rectal cancer from 2001 to 2011. Patients with anastomotic stenosis were excluded. The primary outcome investigated was the occurrence of AL post-surgery. Secondary outcomes included the assessment of local cancer recurrence rates within the AL group. 224; 13 excluded. Of 237 patients who underwent surgery, 13 with anastomotic stenosis were excluded from this study. Of the remaining 224, 15 individuals (6.3%) developed AL. A potential association between higher BMI and increased AL risk was identified. Additionally, the study noted a higher incidence of local rectal cancer recurrence in the group that developed leakage. The findings suggest BMI as a significant predictive factor for AL after curative rectal cancer treatment. This emphasizes the need for heightened awareness and possible preoperative counseling for obese patients regarding their increased risk of postoperative leakage. The study was retrospective with all the inherit biases of such studies. The sample size was small and this may have introduced a type 2 statistical error.

Robotic Rectal Resection for Rectal Cancer in Elderly Patients: A Systematic Review and Meta-Analysis.

Rectal cancer is estimated to increase due to an expanding aging population, thus affecting elderly patients more frequently. The optimal surgical treatment for this type of patient remains controversial because they are often excluded from or underrepresented in trials. This meta-analysis aimed to evaluate the feasibility and the safety of robotic surgery in elderly patients (>70 years old) undergoing curative treatment for rectal cancer. Studies comparing elderly (E) and young (Y) patients submitted to robotic rectal resection were searched on PubMed, Embase, and the Cochrane Library. Data regarding surgical oncologic quality, post-operative, and survival outcomes were extracted. Overall, 322 patients underwent robotic resection (81 in the E group and 241 in the Y group) for rectal cancer. No differences between the two groups were found regarding distal margins and the number of nodes yielded (12.70 in the E group vs. 14.02 in the Y group, p = 0.16). No differences were found in conversion rate, postoperative morbidity, mortality, and length of stay. Survival outcomes were only reported in one study. The results of this study suggest that elderly patients can be submitted to robotic resection for rectal cancer with the same oncologic surgical quality offered to young patients, without increasing postoperative mortality and morbidity.

Stoma versus anastomosis after sphincter-sparing rectal cancer resection; the impact on health-related quality of life

BackgroundSurgical resection is the mainstay of curative treatment for rectal cancer. Post-operative complications, low anterior resection syndrome (LARS), and the presence of a stoma may influence the quality of life after surgery. This study aimed to gain more insights into the long-term trade-off between stoma and anastomosis.MethodsAll patients who underwent sphincter-sparing surgical resection for rectal cancer in the Leiden University Medical Center and the Reinier de Graaf Gasthuis between January 2012 and January 2016 were included. Patients received the following questionnaires: EORTC-QLQ-CR29, EORTC-QLQ-C30, EQ-5D-5L, and the LARS score. A comparison was made between patients with a stoma and without a stoma after follow-up.ResultsSome 210 patients were included of which 149 returned the questionnaires (70.9%), after a mean follow-up of 3.69 years. Overall quality of life was not significantly different in patients with and without stoma after follow-up using the EORTC-QLQ-C30 (p = 0.15) or EQ-5D-5L (p = 0.28). However, after multivariate analysis, a significant difference was found for the presence of a stoma on global health status (p = 0.01) and physical functioning (p < 0.01). Additionally, there was no difference detected in the quality of life between patients with major LARS or a stoma.ConclusionThis study shows that after correction for possible confounders, a stoma is associated with lower global health status and physical functioning. However, no differences were found in health-related quality of life between patients with major LARS and patients with a stoma. This suggests that the choice between stoma and anastomosis is mainly preferential and that shared decision-making is required.

Efficacy of endoscopic surveillance in the detection of local recurrence after radical rectal cancer surgery is limited? A retrospective study

BackgroundRectal cancer, one of most common neoplasms, is characterized by an overall survival rate exceeding 60%. Nonetheless, local recurrence (LR) following surgery for rectal cancer remains a formidable clinical problem. The aim of this study was to assess the value of postoperative endoscopic surveillance (PES) for the early detection of LR in rectal cancer after radical anterior resection with sigmoid-rectal anastomosis.MethodsWe performed an anterior resection in 228 patients with stages I‑III rectal cancer who had undergone surgery from 2001 to 2008 in the Oncology Center in Bydgoszcz, Poland. Of these patients, 169 had perioperative radiotherapy or radiochemotherapy. All patients underwent PES with abdominal and pelvic imaging (abdominal ultrasound, computed tomography, magnetic resonance) and clinical examination. Sensitivities, specificities, positive likelihood ratios, negative likelihood ratios, and receiver operating characteristic curves were calculated to compare the value of colonoscopy versus imaging techniques for the diagnosis of LR.ResultsDuring the 5-year follow-up, recurrences occurred in 49 (21%) patients; of these, 15 (6%) had LR, which was most often located outside the intestinal lumen (n = 10, 4%). Anastomotic LR occurred in 5 (2%) patients. The mean time to anastomotic LR was 30 months after initial surgery, similar to that of other locations (29 months). Both imaging and endoscopy were shown to be efficient techniques for the diagnosis of LR in anastomotic sites. In the study group, endoscopy did not provide any additional benefit in patients who were receiving radiation therapy.ConclusionsThe benefit of PES for the detection of LR after curative treatment of rectal cancer is limited and not superior to imaging techniques. It remains a useful method, however, for the histopathological confirmation of suspected or confirmed recurrence.

Rectal dysfunction and QoL in patients after curative treatment for rectal cancer

Rectal dysfunction and QoL in patients after curative treatment for rectal cancer

Endorectal Ultrasound in Local Recurrence of Rectal Cancer: A Systematic Review.

Local recurrence (LR) of rectal cancer (RC) has a disease-free survival rate of up to 50% if diagnosed early. Endorectal ultrasound (ERUS) is an outpatient procedure that can be used together with rectal digital examination for patient follow-up. This is the first study to determine the diagnostic test accuracy of ERUS in the detection of LR after RC and whether it is a good follow-up method. Three authors independently searched MEDLINE and ClinicalTrials.gov databases and included relevant original studies based on strict inclusion/ exclusion criteria. 3220 articles were identified. After reading the abstracts, 50 articles were selected, out of which 22 were deemed suitable for study inclusion, comprising 3737 patients, which were followed for 59,72 -16,4 months. Based on the available data, sensitivity of ERUS was 88,3% (CI 84,6 - 91,3%), specificity was 94,3 % (CI 92,7 - 95,5%) and diagnostic odds ratio of ERUS was 271,88 (CI 76,998 - 960,04), with ERUS being the only diagnosis method to detect LR in 40 - 12%. Area under the curve for ERUS was 0,9723 - 0,0131. LR after curative treatment of RC in our study was 15 - 2,99%. Concluding, ERUS seems to be a good and efficient follow-up method for diagnosing RC LR.

Radiotherapy management of rectal cancer in the backdrop of the COVID pandemic.

BackgroundCOVID‐19 outbreak was declared as a pandemic by the World Health Organization in March 2020. Over the last 3 months, the pandemic has challenged the diagnosis and treatment of all cancer, including rectal cancer. Constraints in resources call for a change in the treatment strategy without compromising efficacy.Recent FindingsDelivery of shorter treatment schedules for radiotherapy offers advantages like short overall treatment time, improved throughput on the machine, improved compliance and reduced risk of transmission of COVID 19. Other strategies include delaying surgery, reducing the intensity of chemotherapy and adoption of organ preservation approach.ConclusionThe curative treatment of rectal cancer should not be hindered during the COVID pandemic, and modifications in the multi‐modality treatment will help achieve quality care.

Functional outcomes after laparoscopic versus robotic-assisted rectal resection: a systematic review and meta-analysis

Surgical resection is crucial for curative treatment of rectal cancer. Through multidisciplinary treatment, including radiochemotherapy and total mesorectal excision, survival has improved substantially. Consequently, more patients have to deal with side effects of treatment. The most recently introduced surgical technique is robotic-assisted surgery (RAS) which seems equally effective in terms of oncological control compared to laparoscopy. However, RAS enables further advantages which maximize the precision of surgery, thus providing better functional outcomes such as sexual function or contience without compromising oncological results. This review was done according to the PRISMA and AMSTAR-II guidelines and registered with PROSPERO (CRD42018104519). The search was planned with PICO criteria and conducted on Medline, Web of Science and CENTRAL. All screening steps were performed by two independent reviewers. Inclusion criteria were original, comparative studies for laparoscopy vs. RAS for rectal cancer and reporting of functional outcomes. Quality was assessed with the Newcastle–Ottawa scale. The search retrieved 9703 hits, of which 51 studies with 24,319 patients were included. There was a lower rate of urinary retention (non-RCTs: Odds ratio (OR) [95% Confidence Interval (CI)] 0.65 [0.46, 0.92]; RCTs: OR[CI] 1.29[0.08, 21.47]), ileus (non-RCTs: OR[CI] 0.86[0.75, 0.98]; RCTs: OR[CI] 0.80[0.33, 1.93]), less urinary symptoms (non-RCTs mean difference (MD) [CI] − 0.60 [− 1.17, − 0.03]; RCTs: − 1.37 [− 4.18, 1.44]), and higher quality of life for RAS (only non-RCTs: MD[CI]: 2.99 [2.02, 3.95]). No significant differences were found for sexual function (non-RCTs: standardized MD[CI]: 0.46[− 0.13, 1.04]; RCTs: SMD[CI]: 0.09[− 0.14, 0.31]). The current meta-analysis suggests potential benefits for RAS over laparoscopy in terms of functional outcomes after rectal cancer resection. The current evidence is limited due to non-randomized controlled trials and reporting of functional outcomes as secondary endpoints.

Standard (8\u2009weeks) vs long (12\u2009weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR)

BackgroundThe optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing.MethodsThe trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks.DiscussionTo date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23–30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer.Trial registrationClinicalTrials.gov NCT3465982.

The management of rectal cancer in older patients in England - a retrospective population based study a patients diagnosed between April 2009 and December 2014

Background This study sought to examine the use of radical treatment for rectal cancer (neoadjuvant radiotherapy and major surgical resection) and the associated outcomes across the English National Health Service (NHS) in relation to age. Materials and Methods Data for all patients diagnosed with a first primary rectal cancer between 1st April 2009 and 31st December 2014 were included. Data from multiple sources including cancer registration data and Hospital Episode Statistics (HES) data, which were compiled as part of the Bowel Cancer Intelligence UK (BCI UK) hub, were used to obtain information about patient and tumour characteristics, treatments and outcomes. Patients were divided into three groups in relation to their age at the time of diagnosis; <70, 70-79 and ≥80. Descriptive analyses were undertaken to assess the variation in treatment and outcomes. Multilevel binary logistic regression models were used to assess the factors associated with the receipt of a major surgical resection, with patients clustered within NHS trusts. Results In total, 52,922 people were diagnosed with a first primary rectal cancer in England over the study period. Of these, 11,924 (22.4%) were aged 80 or over at the time of diagnosis. The proportion undergoing a major resection decreased with age, falling from 66.5% amongst those aged under 70 to 31.7% amongst those aged 80 and over. The use of neoadjuvant radiotherapy decreased with age, with 48.3% of those aged under 70 receiving pre-operative radiotherapy compared to 26.5% of those aged 80 and over. Stoma creation rates were similar across all age groups. However the proportion of patients having their stoma closed within 18 months fell with age, from 66.3% amongst those aged <70 to 32.4% amongst those aged ≥80. Deaths within 30 days of a major surgical resection increased with age, from 1.0% to 5.5%. The rate of returns to theatre were consistent between age groups (11.0%, 11.6% and 10.2% respectively). The rate of 30-day post-operative mortality was lower amongst those who received neoadjuvant radiotherapy than those who did not across all age groups (1.6% versus 2.6%). After adjustment for case-mix factors significant variation in operative rates for the oldest patients between NHS trusts in England remained. Results from adjusted logistic regression models showed no significant difference in 30-day post-operative mortality, length of stay or emergency readmission amongst those aged 80 and over between trusts with high and low operative rates. Conclusions This study demonstrates that older patients with rectal cancer were less likely than younger patients to receive potentially curative treatment. However those who did receive potentially curative treatment for rectal cancer demonstrated outcomes comparable to those of their younger counterparts, suggesting that they have been well selected.

Functional Outcomes and Health-Related Quality of Life After Curative Treatment for Rectal Cancer: A Population-Level Study in England

There is a growing population of cancer survivors at risk of treatment-related morbidity. This study investigated how potentially curative rectal cancer treatment influences subsequent function and health-related quality of life using data from a large-scale survey of patient-reported outcomes. All individuals 12 to 36months after receiving a diagnosis of colorectal cancer in England were sent a survey in January 2013. The survey responses were linked with cancer registration, hospital admissions, and radiation therapy data through the National Cancer Registration and Analysis Service. Outcome measures were cancer specific (Functional Assessment of Cancer Therapy and Social Difficulties Inventory items related to fecal incontinence, urinary incontinence, and sexual difficulties) and generic (EuroQol EQ-5D). Surveys were returned by 6713 (64.2%) of 10,452 patients with rectal cancer. Of these, 3998 patients were in remission after a major resection and formed the final analysis sample. Compared with those who had surgery alone, patients who received preoperative radiation therapy had higher odds of reporting poor bowel control (43.6% vs 33.0%; odds ratio [OR]=1.55; 95% confidence interval [CI], 1.26-1.91), severe urinary leakage (7.2% vs 3.5%; OR=1.69; 95% CI, 1.18-2.43), and severe sexual difficulties (34.4% vs 18.3%; OR=1.73; 95% CI, 1.43-2.11). Patients who received long-course chemoradiotherapy reported significantly better bowel control than those who had short-course radiation therapy, with no difference for other outcomes. Respondents with a stoma present reported significantly higher levels of severe sexual difficulties and worse health-related quality of life than those who had never had a stoma or had undergone stoma reversal. This study demonstrated the feasibility of a large-scale assessment of patient-reported outcomes and provided "real-world" data regarding the effect of rectal cancer treatment. The results show that patients who receive preoperative radiation therapy reported poorer outcomes, particularly for bowel and sexual function, and highlighted the negative impact of a stoma. We hope that our experiencewillencourage researchers to perform similar studies in other healthcare systems.

Local recurrence rate in a national Danish patient cohort after curative treatment for rectal cancer

Aim: Several trials have shown that preoperative (chemo)radiotherapy (CRT) reduces local recurrence rates (LRRs) in rectal cancer (RC). The use of CRT varies greatly between countries. It is unknown whether the restrictive use of CRT in Denmark results in a higher LRR relative to other countries. The aim was to evaluate the LRR in a national Danish consecutive cohort of patients with RC.Methods: All data from patients with RC in Denmark in 2009–2010 who were operated on with curative intent were retrieved from the Danish Colorectal Cancer Group database. Patients with metastases at the time of diagnosis, patients with synchronous colon cancer, and patients, in whom only local surgical procedures were performed, were excluded. In total, 1633 patients met the inclusion criteria. Clinical follow-up was at least five years with a cut-off date of 31 December 2015.Results: Clinical follow-up was 5.4 years (median) with an interquartile range of 4.5–6.1 years. Of all included patients, 479 (29%) were treated with preoperative long-course CRT. Local recurrence was found in 68 patients, resulting in an LRR of 4.2%, and 182 (11%) patients developed distant metastases. Five-year overall survival was 74% (95% CI: 71.64–75.91).Conclusions: Five-year follow-up of curatively treated patients with RC in Denmark revealed a low LRR. This figure is identical to those reported in other Nordic countries, despite Denmark’s considerably stricter guidelines for CRT. The obtained results justify the currently adopted restrictive use of preoperative CRT in Denmark.

Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection

BackgroundCommonly in surgical randomised controlled trials (RCT) the experimental treatment is a relatively new technique which the surgeons may still be learning, while the control is a well-established standard. This can lead to biased comparisons between treatments. In this paper we discuss the implementation of approaches for addressing this issue in the ROLARR trial, and points of consideration for future surgical trials.MethodsROLARR was an international, randomised, parallel-group trial comparing robotic vs. laparoscopic surgery for the curative treatment of rectal cancer. The primary endpoint was conversion to open surgery (binary). A surgeon inclusion criterion mandating a minimum level of experience in each technique was incorporated. Additionally, surgeon self-reported data were collected periodically throughout the trial to capture the level of experience of every participating surgeon.Multi-level logistic regression adjusting for operating surgeon as a random effect is used to estimate the odds ratio for conversion to open surgery between the treatment groups. We present and contrast the results from the primary analysis, which did not account for learning effects, and a sensitivity analysis which did.ResultsThe primary analysis yields an estimated odds ratio (robotic/laparoscopic) of 0.614 (95% CI 0.311, 1.211; p = 0.16), providing insufficient evidence to conclude superiority of robotic surgery compared to laparoscopic in terms of the risk of conversion to open.The sensitivity analysis reveals that while participating surgeons in ROLARR were expert at laparoscopic surgery, some, if not all, were still learning robotic surgery. The treatment-effect odds ratio decreases by a factor of 0.341 (95% CI 0.121, 0.960; p = 0.042) per unit increase in log-number of previous robotic operations performed by the operating surgeon. The odds ratio for a patient whose operating surgeon has the mean experience level in ROLARR – 152.46 previous laparoscopic, 67.93 previous robotic operations – is 0.40 (95% CI 0.168, 0.953; p = 0.039).ConclusionsIn this paper we have demonstrated the implementation of approaches for accounting for learning in a practical example of a surgery RCT analysis. The results demonstrate the value of implementing such approaches, since we have shown that without them the ROLARR analysis would indeed have been confounded by the learning effects.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) registry, ID: ISRCTN80500123. Registered on 27 May 2010.

Elevated CEA is associated with worse survival in recurrent rectal cancer

This study investigated the prognostic impact of serum carcinoembryonic antigen (CEA) level in recurrent rectal cancer. We reviewed 745 patients who developed recurrence after curative treatment for rectal cancer between January 2000 and December 2012. Multivariate analyses for survival revealed that age > 60 years (p = 0.005), r-CEA ≥ 5 ng/ml (p < 0.001), disease free interval (DFI) < 12 months (p < 0.001), and palliative or conservative treatment (p < 0.001) were unfavorable factors.

The Impact of Obesity on the Perioperative, Clinicopathologic, and Oncologic Outcomes of Robot Assisted Total Mesorectal Excision for Rectal Cancer

To analyze the feasibility and outcomes of robotic rectal cancer surgery in obese patients. From 2005 to 2012, 101 consecutive rectal cancers operated robotically were enrolled in a prospective database. Patients were stratified into obese (BMI ≥ 30 kg/m2) and non-obese (BMI &lt; 30 kg/m2) groups. Operative, perioperative parameters, and pathologic outcomes were compared. Data were analyzed using SPSS 22.0, while statistical significance was defined as a p value ≤ .05. There were 33 obese patients (mean BMI 33.8 kg/m2). Patients were comparable regarding gender, T stage, and type of operation. Operative time and blood loss were higher in the obese group; only operative time was statistically significant. The conversion rate, length of stay, and anastomotic leak rates were similar. Circumferential margin positivity and lymph node yield were comparable. Disease free and overall survivals at 3 years were 75.8% versus 80.9% and 84.8% versus 92.6%, respectively for obese and non-obese subgroups. Robotic surgery for curative treatment of rectal cancer in the obese is safe and feasible. BMI does not influence conversion rates, length of stay, postoperative complications, and quality of the specimen or survival when the robotic platform is used.

Innovation or disparity? National trends in nonoperative management of rectal adenocarcinoma.

688 Background: While surgical resection has always been the cornerstone of curative treatment for rectal cancer, preoperative chemoradiation for stage II/III rectal cancer results in up to 49% of patients with a clinical complete response. As a result, many have questioned whether surgery can be omitted for this group of patients. Currently, there is insufficient evidence on the safety and efficacy of chemoradiation-only, or non-operative management (NOM), to support the wholesale adoption of this treatment paradigm. Despite this, anecdotal evidence suggests there is a trend for increased use of NOM. Our objective was to examine trends in the use of NOM for rectal cancer over time as well as patient- and facility-level factors associated with its use. Methods: We included all incident cases of invasive, non-metastatic, rectal adenocarcinoma reported to the National Cancer Data Base (NCDB) from 1998–2010. We performed univariate and multivariate analyses to assess NOM use over time as well as patient- and facility-level predictors of NOM. Results: 146,135 patients met inclusion criteria: 5,741 had NOM and 140,394 had surgery +/- additional therapy. From 1998-2010, the use of NOM doubled from 2.4% to 5% of all cases annually. Patients who were Black (AOR=1.71, 95%CI=1.57-1.86), uninsured (AOR=2.35, 95%CI=2.08-2.65), Medicaid-enrolled (AOR=2.10, 95%CI=1.90-2.33), and those treated at low-volume facilities (AOR=1.53, 95%CI=1.42-1.64) were more likely to receive NOM than White, privately insured, and high-volume facility patients, respectively. Additionally, NOM was more common in the South (AOR=1.53, 95%CI=1.32-1.76) and Pacific (AOR=1.82, 95%CI=1.57-2.12) as compared with the Northeast. Conclusions: NOM is an innovative approach that demonstrate promise in the treatment of rectal cancer. Pursing this approach in the context of a clinical trial and with well-informed patients would be appropriate. We observed evidence of increasing NOM utilization; however, this increase is occurring more frequently in Black and uninsured/Medicaid patients, raising concern that increased NOM use may actually represent increasing disparities in rectal cancer care rather than innovation.

Combination chemotherapy versus single-agent chemotherapy during preoperative chemoradiation for resectable rectal cancer.

Colorectal cancer represents 10% of all cancers and is the third most common cause of death in women and men. Almost two-thirds of all bowel cancers are cancers of the colon and over one-third (34%) are cancers of the rectum, including the anus. Surgery is the cornerstone for curative treatment of rectal cancer. Mesorectal excision decreases the rate of local recurrences; however, it does not improve the overall survival of people with locally advanced rectal cancer. There have been significant research efforts since the mid-1990s to optimise the treatment of rectal cancer. Based on the findings of clinical trials, people with T3/T4 or N+ rectal tumours are now being treated preoperatively with radiation and chemotherapy, mainly fluoropyrimidine. However, the incidence of distant metastases remains as high as 30%. Combination chemotherapy regimens, similar to those used in metastatic disease with the addition of oxaliplatin and irinotecan, have been tested to improve the prognosis of people with rectal cancer. To compare outcomes (including overall survival, disease-free survival and toxicity) between two 5-fluorouracil-containing chemotherapy regimens in people with stage II and III rectal cancer who are receiving preoperative chemoradiation. We searched the Cochrane Colorectal Cancer Group Specialised Register (January 2015), the Cochrane Central Register of Controlled Trials (2015, Issue 1), Ovid MEDLINE (1950 to January 2015), Ovid EMBASE (1974 to January 2015) and LILACS (1982 to January 2015). We reviewed the reference lists of included studies, checked clinical trials registers and handsearched relevant journal proceedings. We applied no language or publication restrictions. Randomised controlled trials (RCTs) comparing single-agent chemotherapy (fluoropyrimidine) versus combination chemotherapy (fluoropyrimidine plus another agent including, but not limited to, oxaliplatin) during preoperative radiochemotherapy in people with resectable rectal cancer. Two review authors (HMR, EMKS) independently extracted data and assessed trial quality. When necessary, we requested additional information and clarification of published data from the authors of individual trials. We included four RCTs involving 3875 people with resectable rectal cancer. In the preoperative period, the participants of these studies were randomised to receive chemoradiation either with a single fluoropyrimidine agent (capecitabine or 5-fluorouracil) or with a combination of drugs (fluoropyrimidine plus oxaliplatin). The only study that reported overall survival and disease-free survival found no significant differences between the intervention and control groups; we considered this evidence very low quality. For pathological complete response after preoperative treatment (ypCR) there was high quality evidence favouring the intervention group (odds ratio (OR) 1.23, 95% confidence interval (CI) 1.04 to 1.46), but there was also moderate quality evidence suggesting a higher risk for early toxicity in the intervention group (OR 2.07, 95% CI 1.31 to 3.27). Moderate to high quality evidence suggested that the control group had better compliance to radiotherapy (OR 0.32, 95% CI 0.14 to 0.75). There were no significant differences between groups in postoperative mortality within 60 days, postoperative morbidity, resection margins, abdominoperineal resection and Hartmann procedures. There was very low quality evidence that people with resectable rectal cancer who receive combination preoperative chemotherapy have no improvements in overall survival or disease-free survival. There was high quality evidence that suggested that combination chemotherapy with oxaliplatin may improve local tumour control in people with resectable rectal cancer, but this regimen also caused more toxicity. The review included four RCTs but only one reported survival; therefore, we cannot make robust conclusions or useful clinical recommendations. The publication of more survival data from these studies will contribute to future analyses.

Quality Assurance in Rectal Cancer Treatment

Colorectal cancer is the cancer with the second highest cancer incidence in Europe. Roughly, 1 out of 3 patients with a colorectal malignancy has a rectal carcinoma. Surgery is the cornerstone in the curative treatment of rectal cancer. In the 1980s with conventional surgery, the 5-year local recurrence rate was over 20% and the 5-year overall survival rate around 50%. In the Swedish Rectal Cancer trial, in which 1,168 patients were included, preoperative radiotherapy in addition to conventional surgery resulted in a reduction of more than 50% in the 5-year local recurrence rate in comparison to conventional surgery alone (11 vs. 27%; p < 0.001). In addition, the 5-year overall survival rate improved from 48 to 58% if patients were treated with preoperative radiotherapy in addition to conventional surgery (p = 0.004). With total mesorectal excision (TME), by which the rectum with its mesorectum and visceral fascia are dissected sharply and under direct vision, local recurrence rates dropped and overall survival improved. In the Dutch TME trial, 5 × 5 Gy preoperative radiotherapy in combination with TME surgery was compared to TME surgery alone (1,861 patients). In this trial, the 5-year local recurrence rate for patients treated with TME surgery alone was similar to patients treated in the Swedish Rectal Cancer trial with blunt dissection in combination with preoperative 5 × 5 Gy radiotherapy (11%). If preoperative radiotherapy was added to TME surgery, the 5-year local recurrence rate was reduced to 5.6%. The overall survival rate at 5 years was 64% for both patients treated with TME surgery alone and patients treated with preoperative radiotherapy followed by TME surgery, compared to 48% for patients treated with blunt dissection alone in the previously mentioned Swedish trial. TME surgery is now considered the standard surgical procedure for rectal cancer. However, even if TME surgery is performed, surgical quality varies. First, these results indicate that improvements in the surgical procedure itself can result in major progress regarding long-term oncological outcome, such as decreased local recurrence rates and improved overall survival. Second, it illustrates that variation in surgical quality could lead to large differences in outcome. Recently, it was shown that surgical variation is not only important for patients with rectal cancer, but also plays an important role for the outcome of patients with colon cancer.

An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer

There is growing enthusiasm for robotic-assisted laparoscopic operations across many surgical specialities, including colorectal surgery, often not supported by robust clinical or cost-effectiveness data. A proper assessment of this new technology is required, prior to widespread recommendation or implementation. The ROLARR trial is a pan-world, prospective, randomised, controlled, unblinded, superiority trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer. It will investigate differences in terms of the rate of conversion to open operation, rate of pathological involvement of circumferential resection margin, 3-year local recurrence, disease-free and overall survival rates and also operative morbidity and mortality, quality of life and cost-effectiveness. The primary outcome measure is the rate of conversion to open operation. For 80% power at the 5% (two-sided) significance level, to identify a relative 50% reduction in open conversion rate (25% to 12.5%), 336 patients will be required. The target recruitment is 400 patients overall to allow loss to follow-up. Patients will be followed up at 30 days and 6 months post-operatively and then annually until 3 years after the last patient has been randomised. In many centres, robotic-assisted surgery is being implemented on the basis of theoretical advantages, which have yet to be confirmed in practice. Robotic surgery is an expensive health care provision and merits robust evaluation. The ROLARR trial is a pragmatic trial aiming to provide a comprehensive evaluation of both robotic-assisted and standard laparoscopic surgery for the curative resection of rectal cancer.