Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.

How reliable is restaging MRI after neoadjuvant therapy in rectal cancer?

BACKGROUND: Despite the pivotal role of magnetic resonance imaging (MRI) in rectal cancer staging and evaluation, the reliability of restaging MRI after neoadjuvant therapy is still debatable. This study aimed to assess the accuracy of restaging MRI by comparing post-neoadjuvant MRI findings with those of the final pathology. METHODS: This study was a retrospective review of the medical records of adult rectal cancer patients who had restaging MRI following neoadjuvant therapy and prior to rectal cancer resection in a NAPRC-certified rectal cancer centre between 2016 and 2021. The study compared findings of preoperative, post-neoadjuvant MRI with final pathology relative to T stage, N stage, tumour size, and circumferential resection margin (CRM) status. RESULTS: A total of 126 patients were included in the study. We found fair concordance (kappa -0.316) for T stage between restaging MRI and pathology report, and slight concordance for N stage and CRM status (kappa -0.11, kappa = 0.089, respectively). Concordance rates were lower for patients following total neoadjuvant treatment (TNT) or with a low rectal tumour. In total, 73% of patients with positive N pathology status had negative N status in the restaging MRI. Sensitivity and specificity regarding positive CRM in post-neoadjuvant treatment MRI were 45.45% and 70.4%, respectively. CONCLUSION: We found low concordance levels between restaging MRI and pathology regarding TN stage and CRM status. Concordance levels were even lower for patients after TNT regimen and with a low rectal tumour. In the era of TNT and watch-and-wait approach, we should not rely solely on restaging MRI to make post-neoadjuvant treatment decisions.

Distal Tumor Spread in Rectal Cancer-How Low Should We Go?

BACKGROUND: Distal tumor spread (DTS) is an adverse prognostic factor in rectal cancer correlating with advanced stage disease. We aimed to assess prevalence and location of distal tumor spread and impact of neoadjuvant chemoradiotherapy (NACRT) in patients who underwent proctectomy for rectal cancer. METHODS: The pathology database at our institution was queried for all patients who underwent proctectomy with curative intent for rectal cancer from 1/2008 to 12/2016. Specimen slides were re-evaluated by a single expert rectal cancer pathologist to verify diagnosis and measure the distance to the distal resection margin. Main outcome measures were 3-year overall and disease-free survival. RESULTS: 275 consecutive patients were identified. 109/111 patients with clinical stage 3 disease received preoperative neoadjuvant chemoradiotherapy. DTS was found in 13 (4.7%) specimens, 6 with intra-mural and 7 with extra-mural distal tumor spread. DTS was found only in patients with clinical stage 3 disease. Length of DTS from the distal end of the tumor ranged from 0 to 30 mm; in only 4 specimens DTS was >10 mm. A positive distal resection margin was found in 5/275 (1.8%) specimens. CONCLUSION: A macroscopically tumor-free margin may suffice in patients with pre-treatment stage 1 or 2 disease. Furthermore, a 1 cm margin is adequate in most patients with stage 3 disease.

Medullary carcinoma of the colon: A comprehensive analysis of the National Cancer Database.

PURPOSE: Medullary carcinomas (MC) of the colon are uncommon tumors. In this study, we analyzed demographic and disease characteristics as well as survival outcomes of MC versus undifferentiated (UDA) and poorly differentiated (PDA) adenocarcinomas (AC) of the colon. MATERIALS AND METHODS: The National Cancer Database (2004-2018) was utilized to identify patients with colon cancer. Patient demographics (including age, gender, race), disease characteristics (including grade, TNM stage, carcinoembryonic levels, perineural and lymphovascular invasion, lymph node status, microsatellite stability, KRAS mutation, and primary tumor site), and facility type and location were evaluated. Chi-square tests were used to compare descriptive data. Cox Regression and Kaplan Meier analyses were used to analyze survival characteristics. RESULTS: 1,041,753 patients with colon cancer were identified of whom 2709 patients had MC and 897,902 had AC (136,597 PDA and 18,042 UDA). MC was seen in older patients (mean age 74 ± 13 years) and women (72.5% vs. 27.5% males). Most MCs were poorly differentiated (63.3%), and 82.4% of patients with MC had microsatellite instability. Fewer patients with MC had perineural invasion (15.6% vs. 22.0% in PDA and 22.4% in UDA, p < 0.001) and positive lymph nodes (38.4% versus 59.9% with PDA and 59.7% with UDA, p < 0.0001). MC diagnosis increased by year (Cochran-Armitage trend test, p < 0.0001). Kaplan Meir analysis revealed a better prognosis for patients with MC when compared to PDA or UDA (p < 0.001). CONCLUSION: Given the rarity, pathologists should maintain a high suspicion for MC when encountering poorly differentiated or undifferentiated right-sided colon cancer with associated MSI-H.

Interactive Training Program Improves Surgeon and Pathologist Comfort Level With Total Mesorectal Excision Grading for Rectal Cancer.

BACKGROUND: Total mesorectal excision for rectal cancer has been shown to decrease local recurrence and improve survival, and specimen grading is recommended as a best practice. However, specimen grading remains underutilized in the United States potentially because of the lack of surgeon and pathologist training in the technique. OBJECTIVE: This study aimed to determine whether an interactive webinar improves physician comfort with mesorectal grading. DESIGN: To test the effect of the program, participants completed a survey before and after participating. SETTINGS: Twelve Michigan Surgical Quality Collaborative hospitals volunteered to participate in a Total Mesorectal Excision Project. PARTICIPANTS: Total mesorectal excision grading training program participants were surgeons, surgery residents, pathologists, and pathology assistants from 12 hospitals. MAIN OUTCOME MEASURES: Comfort with grading total mesorectal excision specimens was our main outcome measure. Prewebinar surveys also measured familiarity, previous experience, and training in grade assignment, as well as interest in the training program. Postwebinar surveys measured webinar relevance and effectiveness as well as participant intention to use content in practice. RESULTS: A total of 34 participants completed the prewebinar survey and 28 participants completed the postwebinar survey. The postwebinar overall median comfort level with specimen grading of 3.64 was significantly higher than the prewebinar overall median comfort level of 2.94 (95% CI, 3.32-3.96 versus 95% CI 2.56-3.32; p = 0.007). When evaluated separately, both surgeons and pathologists reported significantly higher comfort levels with total mesorectal excision grading after the webinar. LIMITATIONS: Six participants did not complete the postwebinar survey. Surgery residents and pathology assistants were analyzed with practicing surgeons and pathologists. The pre- and postwebinar surveys were deidentified, so paired analysis was not possible. CONCLUSIONS: Our total mesorectal excision grading training program improved the comfort level of both surgeons and pathologists with specimen grading. Survey results also demonstrate that providers are interested in receiving training in rectal cancer specimen grading. See Video Abstract at http://links.lww.com/DCR/B766.PROGRAMA DE ENTRENAMIENTO INTERACTIVO MEJORA EL NIVEL DE COMODIDAD DEL CIRUJANO Y DEL PATÓLOGO CON LA CLASIFICACIÓN DE LA ESCISIÓN TOTAL DEL MESORRECTO PARA EL CÁNCER DE RECTO. ANTECEDENTES: Se ha demostrado que la escisión total del mesorrecto para el cáncer de recto disminuye la recurrencia local y mejora la supervivencia, y se recomienda la clasificación de la muestra como buena práctica de rutina. Sin embargo, sigue siendo poco utilizado en los Estados Unidos debido principalmente a la falta de formación en la técnica de cirujanos y patólogos. OBJETIVO: Determinar si un seminario interactivo en línea mejora la comodidad del médico con la clasificación mesorrectal. DISEO: Para probar el efecto del programa, los participantes completaron una encuesta antes y después de haber participado de la misma. MARCO: Doce hospitales en cooperación sobre la calidad quirúrgica de Michigan se ofrecieron como voluntarios para participar en el proyecto de Escisión Total de Mesorrecto. PARTICIPANTES: Los participantes del programa de entrenamiento en la clasificación de escisión total de mesorrecto fueron cirujanos, residentes de cirugía, patólogos y asistentes de patología de doce hospitales. PRINCIPALES RESULTADOS MEDIDOS: La comodidad con la clasificación de las muestras de escisión total de mesorrecto fue nuestro principal resultado de medición. Las encuestas previas al seminario en línea también midieron la familiaridad, la experiencia y entrenamiento previo en la clasificación, así como el interés en el programa de entrenamiento. Las encuestas posteriores midieron la relevancia y la eficacia del seminario web, así como la intención de los participantes de utilizar en la practica el contenido. RESULTADOS: Un total de 34 participantes completaron la encuesta previa, y 28 de ellos la completaron con posterioridad al seminario en línea.La mediana del nivel de comodidad general, posterior al seminario en línea, con respecto a la clasificación de la pieza de 3,64 fue significativamente mayor con respecto al valor de 2,94 previo al seminario (IC del 95%: 3,32 - 3,96 versus IC 2,56 - 3,32, respectivamente; valor de p = 0,007).Cuando fueron evaluados de manera separada, tanto los cirujanos como los patólogos reportaron niveles de comodidad significativamente más altos con la clasificación de escisión total de mesorrecto (TME) después del seminario en línea. LIMITACIONES: Seis participantes no completaron la encuesta posterior al seminario en línea. Los residentes de cirugía y los asistentes de patología fueron analizados conjuntamente con los cirujanos y patólogos en ejercicio, respectivamente. Las encuestas previas y posteriores al seminario en línea fueron anónimas, anulándose la identificación, por lo que no fue posible realizar un análisis por pares. CONCLUSIONES: Nuestro programa de entrenamiento en la clasificación de escisión total de mesorrecto mejoró el nivel de comodidad tanto de los cirujanos como de los patólogos con la clasificación de las muestras. Los resultados de la encuesta también demuestran que el personal involucrado está interesado en recibir capacitación en la clasificación de muestras de cáncer de recto. Consulte Video Resumen en http://links.lww.com/DCR/B766. (Traducción-Dr Osvaldo Gauto).

A narrative celebrating the recent contributions of women to colorectal surgery.

BACKGROUND: To interview extraordinary women who have made recent significant contributions to the field of colorectal surgery. DESIGN: The authors asked some of the many extraordinary women who have made significant contributions to the field of colorectal surgery to answer several questions. These women were selected from many potential candidates based upon their extraordinary recent contributions to the field of colorectal surgery. These thought leaders were asked about their contributions to colorectal surgery, their mentors, whether they had any women as role models, and, lastly, what they would tell their younger selves. The study was structured to recognize these women for their remarkable recent contributions to colorectal surgery, and we wished to encourage women to pursue leadership in colorectal surgery including the allied fields of colorectal pathology and colorectal imaging. Furthermore, the authors hoped to inspire male colorectal surgeons to actively mentor and help the career development of women colorectal surgeons. The potential limitations of the study include the fact that there are many more well-deserving women who could have been included in the sample survey but, because of space constraints, were not invited. CONCLUSION: Women in colorectal surgery and in the allied specialties of colorectal pathology and colorectal radiology have made many recent major significant contributions to colorectal surgery. The expectation is that the volume and frequency of such contributions as well as the number of women making these contributions should further significantly increase with time.

The multidisciplinary management of rectal cancer.

Rectal cancer treatment has evolved during the past 40 years with the use of a standardized surgical technique for tumour resection: total mesorectal excision. A dramatic reduction in local recurrence rates and improved survival outcomes have been achieved as consequences of a better understanding of the surgical oncology of rectal cancer, and the advent of adjuvant and neoadjuvant treatments to compliment surgery have paved the way for a multidisciplinary approach to disease management. Further improvements in imaging techniques and the ability to identify prognostic factors such as tumour regression, extramural venous invasion and threatened margins have introduced the concept of decision-making based on preoperative staging information. Modern treatment strategies are underpinned by accurate high-resolution imaging guiding both neoadjuvant therapy and precision surgery, followed by meticulous pathological scrutiny identifying the important prognostic factors for adjuvant chemotherapy. Included in these strategies are organ-sparing approaches and watch-and-wait strategies in selected patients. These pathways rely on the close working of interlinked disciplines within a multidisciplinary team. Such multidisciplinary forums are becoming standard in the treatment of rectal cancer across the UK, Europe and, more recently, the USA. This Review examines the essential components of modern-day management of rectal cancer through a multidisciplinary team approach, providing information that is essential for any practising colorectal surgeon to guide the best patient care.

How Reliable Is CT Scan in Staging Right Colon Cancer?

BACKGROUND: The observation of inferior oncologic outcomes after surgery for proximal colon cancers has led to the investigation of alternative treatment strategies, including surgical procedures and neoadjuvant systemic chemotherapy in selected patients. OBJECTIVE: The purpose of this study was to determine the accuracy of CT staging in proximal colon cancer in detecting unfavorable pathologic features that may aid in the selection of ideal candidates alternative treatment strategies, including extended lymph node dissection and/or neoadjuvant chemotherapy. DESIGN: This was a retrospective consecutive series. SETTINGS: Trained abdominal radiologists from 2 centers performed a blinded review of CT scans obtained to locally stage proximal colon cancer according to previously defined prognostic groups, including T1/2, T3/4, N+, and extramural venous invasion. CT findings were compared with histopathologic results as a reference standard. Unfavorable pathologic findings included pT3/4, pN+, or extramural venous invasion. PATIENTS: Consecutive patients undergoing right colectomy in 2 institutions between 2011 and 2016 were retrospectively reviewed from a prospectively collected database. MAIN OUTCOME MEASURES: T status, nodal status, and extramural venous invasion status comparing CT with final histologic findings were measured. RESULTS: Of 150 CT scans reviewed, CT failed to identify primary cancer in 18%. Overall accuracy of CT to identify unfavorable pathologic features was 63% with sensitivity, specificity, positive predictive value, and negative predictive value of 63% (95% CI, 54%-71%), 63% (95% CI, 46%-81%), 87% (95% CI, 80%-94%) and 30% (95% CI, 18%-41%). Only cT3/4 (55% vs 45%; p = 0.001) and cN+ (42% vs 58%; p = 0.02) were significantly associated with correct identification of unfavorable features at final pathology. CT scans overstaged and understaged cT in 23.7% and 48.3% and cN in 28.7% and 53.0% of cases. LIMITATIONS: The study was limited by its retrospective design, relatively small sample size, and heterogeneity of CT images performed in different institutions with variable equipment and technical details. CONCLUSIONS: Accuracy of CT scan for identification of pT3/4, pN+, or extramural venous invasion was insufficient to allow for proper identification of patients at high risk for local recurrence and/or in whom to consider alternative treatment strategies. Locoregional overstaging and understaging resulted in inappropriate treatment strategies in <48%. See Video Abstract at http://links.lww.com/DCR/A935.

Personalized management of elderly patients with rectal cancer: Expert recommendations of the European Society of Surgical Oncology, European Society of Coloproctology, International Society of Geriatric Oncology, and American College of Surgeons Commission on Cancer.

With an expanding elderly population and median rectal cancer detection age of 70 years, the prevalence of rectal cancer in elderly patients is increasing. Management is based on evidence from younger patients, resulting in substandard treatments and poor outcomes. Modern management of rectal cancer in the elderly demands patient-centered treatment, assessing frailty rather than chronological age. The heterogeneity of this group, combined with the limited available data, impedes drafting evidence-based guidelines. Therefore, a multidisciplinary task force convened experts from the European Society of Surgical Oncology, European Society of Coloproctology, International Society of Geriatric Oncology and the American College Surgeons Commission on Cancer, with the goal of identifying the best practice to promote personalized rectal cancer care in older patients. A crucial element for personalized care was recognized as the routine screening for frailty and geriatrician involvement and personalized care for frail patients. Careful patient selection and improved surgical and perioperative techniques are responsible for a substantial improvement in rectal cancer outcomes. Therefore, properly selected patients should be considered for surgical resection. Local excision can be utilized when balancing oncologic outcomes, frailty and life expectancy. Watch and wait protocols, in expert hands, are valuable for selected patients and adjuncts can be added to improve complete response rates. Functional recovery and patient-reported outcomes are as important as oncologic-specific outcomes in this age group. The above recommendations and others were made based on the best-available evidence to guide the personalized treatment of elderly patients with rectal cancer.

Novel biomarkers for patient stratification in colorectal cancer: A review of definitions, emerging concepts, and data.

Colorectal cancer (CRC) treatment has become more personalised, incorporating a combination of the individual patient risk assessment, gene testing, and chemotherapy with surgery for optimal care. The improvement of staging with high-resolution imaging has allowed more selective treatments, optimising survival outcomes. The next step is to identify biomarkers that can inform clinicians of expected prognosis and offer the most beneficial treatment, while reducing unnecessary morbidity for the patient. The search for biomarkers in CRC has been of significant interest, with questions remaining on their impact and applicability. The study of biomarkers can be broadly divided into metabolic, molecular, microRNA, epithelial-to-mesenchymal-transition (EMT), and imaging classes. Although numerous molecules have claimed to impact prognosis and treatment, their clinical application has been limited. Furthermore, routine testing of prognostic markers with no demonstrable influence on response to treatment is a questionable practice, as it increases cost and can adversely affect expectations of treatment. In this review we focus on recent developments and emerging biomarkers with potential utility for clinical translation in CRC. We examine and critically appraise novel imaging and molecular-based approaches; evaluate the promising array of microRNAs, analyze metabolic profiles, and highlight key findings for biomarker potential in the EMT pathway.

The Future of Rectal Cancer Surgery: A Narrative Review of an International Symposium.

Surgery remains the mainstay of curative treatment for primary rectal cancer. For mid and low rectal tumors, optimal oncologic surgery requires total mesorectal excision (TME) to ensure the tumor and locoregional lymph nodes are removed. Adequacy of surgery is directly linked to survival outcomes and, in particular, local recurrence. From a technical perspective, the more distal the tumor, the more challenging the surgery and consequently, the risk for oncologically incomplete surgery is higher. TME can be performed by an open, laparoscopic, robotic or transanal approach. There is a lack of consensus on the "gold standard" approach with each of these options offering specific advantages. The International Symposium on the Future of Rectal Cancer Surgery was convened to discuss the current challenges and future pathways of the 4 approaches for TME. This article reviews the findings and discussion from an expert, international panel.

Association Between Adjuvant Chemotherapy and Overall Survival in Patients With Rectal Cancer and Pathological Complete Response After Neoadjuvant Chemotherapy and Resection.

Importance: Although American guidelines recommend use of adjuvant chemotherapy in patients with locally advanced rectal cancer, individuals who achieve a pathological complete response (pCR) following neoadjuvant chemoradiotherapy are less likely to receive adjuvant treatment than incomplete responders. The association and resection of adjuvant chemotherapy with survival in patients with pCR is unclear. Objective: To determine whether patients with locally advanced rectal cancer who achieve pCR after neoadjuvant chemoradiation therapy and resection benefit from the administration of adjuvant chemotherapy. Design, Setting, and Participants: This retrospective propensity score-matched cohort study identified patients with locally advanced rectal cancer from the National Cancer Database from 2006 through 2012. We selected patients with nonmetastatic invasive rectal cancer who achieved pCR after neoadjuvant chemoradiation therapy and resection. Exposures: We matched patients who received adjuvant chemotherapy to patients who did not receive adjuvant treatment in a 1:1 ratio. We separately matched subgroups of patients with node-positive disease before treatment and node-negative disease before treatment to investigate for effect modification by pretreatment nodal status. Main Outcome and Measures: We compared overall survival between groups using Kaplan-Meier survival methods and Cox proportional hazards models. Results: We identified 2455 patients (mean age, 59.5 years; 59.8% men) with rectal cancer with pCR after neoadjuvant chemoradiation therapy and resection. We matched 667 patients with pCR who received adjuvant chemotherapy and at least 8 weeks of follow-up after surgery to patients with pCR who did not receive adjuvant treatment. Over a median follow-up of 3.1 years (interquartile range, 1.94-4.40 years), patients treated with adjuvant chemotherapy demonstrated better overall survival than those who did not receive adjuvant treatment (hazard ratio, 0.44; 95% CI, 0.28-0.70). When stratified by pretreatment nodal status, only those patients with pretreatment node-positive disease exhibited improved overall survival with administration of adjuvant chemotherapy (hazard ratio, 0.24; 95% CI, 0.10-0.58). Conclusions and Relevance: The administration of adjuvant chemotherapy in patients with rectal cancer with pCR is associated with improved overall survival, particularly in patients with pretreatment node-positive disease. Although this study suggests a beneficial effect of adjuvant treatment on survival in patients with pCR, these results are limited by the presence of potential unmeasured confounding in this nonrandomized study.

Rectal cancer and the pathologist.

Examination of the rectum by pathologists is instrumental in the management of patients affected by rectal carcinoma. That role includes evaluation of multiple gross and microscopic features that convey prognostic implications. The analysis is based on the authors' experience handling rectal specimens along with review of the pertinent literature in these areas: margins of excision, quality of the mesorectum, diligence and techniques to sample lymph nodes, tumor budding, grading of residual amount of carcinoma after preoperative therapy, vascular/perineural invasion, and staging the tumor. Pathologists must communicate the findings in a clear manner. Evaluation of margins and completeness of mesorectum are markers of the quality of surgical excision. The number of lymph nodes obtained and examined is dependent in great part on the diligence of the pathologist finding them in the mesenteric adipose tissue. There are grades for budding and response to prior chemoradiation therapy. The location of vascular invasion (extramural vs. intramural) may predict aggressive behavior. Pathologists proactively are to choose sections of tumor for molecular testing. Meticulous macro- and microscopic evaluation of specimens for rectal carcinoma by pathologist is needed to determine an accurate assessment of staging and other prognostic factors. The modern pathologists play a pivotal part in the care and management of patients suffering from rectal adenocarcinoma. That role goes from the initial histological diagnosis to the gross and microscopic examination of the excised specimens. Based on that examination pathologists issue statements that not only evaluate the quality of the surgical procedure, but also through the application of molecular tests they give light on prognostic factors and information for therapeutic purposes.

The Rationale for and Reality of the New National Accreditation Program for Rectal Cancer.

BACKGROUND: The treatment of rectal cancer has greatly evolved because of numerous diagnostic and therapeutic advances. More accurate staging by MRI has allowed more appropriate use of neoadjuvant therapy as well as more standardized high-quality total mesorectal excision. Lower rates of perioperative morbidity, permanent colostomy creation, and improved rates of oncologically acceptable rectal excision have led to lower recurrence and greater disease-free survival rates. The recognition of the need for pathologic assessment of the quality of total mesorectal excision, the status of the circumferential resection margins, and the finding of a minimum of 12 lymph nodes as well as identification of extramural vascular invasion has improved staging. These evolutions in imaging, surgical management, and pathologic specimen assessment are interdependent and have been repeatedly shown on national levels to be best operationalized in a multidisciplinary team environment. OBJECTIVE: The aim of this article is to evaluate the evidence leading to these important changes, including the imminent launch of the National Accreditation Program for Rectal Cancer. DESIGN AND SETTING: Based on the myriad confirmatory experiences in Europe and in the United Kingdom, a multidisciplinary team rectal cancer program was designed by the Consortium for Optimizing Surgical Treatment of Rectal Cancer and subsequently endorsed and accepted by the American College of Surgeons Commission on Cancer. MAIN OUTCOME MEASURES: The primary outcome measured is the adherence to the new program standards. RESULTS: Surgical treatment of rectal cancer consortium membership rapidly increased from 14 centers in August 2011 to more than 350 centers in April 2017. LIMITATIONS: The multidisciplinary team rectal cancer program has not yet launched; thus, its impact cannot yet be assessed. CONCLUSIONS: It is our hope and expectation that the outstanding improvement in quality outcomes repeatedly demonstrated within Europe, and extensively shown as much needed in the United States, will be rapidly achieved.

Surgeon-, pathologist-, and hospital-level variation in suboptimal lymph node examination after colectomy: Compartmentalizing quality improvement strategies.

BACKGROUND: The goals of this study were to characterize the variation in suboptimal lymph node examination for patients with colon cancer across individual surgeons, pathologists, and hospitals and to examine if this variation affects 5-year, disease-specific survival. METHODS: A retrospective cohort study was conducted by merging the New York State Cancer Registry with the Statewide Planning & Research Cooperative System, Medicaid, and Medicare claims to identify resections for stages I-III colon cancer from 2004-2011. Multilevel logistic regression models characterized variation in suboptimal lymph node examination (<12 lymph nodes). Multilevel competing-risks Cox models were used for survival analyses. RESULTS: The overall rate of suboptimal lymph node examination was 32% in 12,332 patients treated by 1,503 surgeons and 814 pathologists at 187 hospitals. Patient-level predictors of suboptimal lymph node examination were older age, male sex, nonscheduled admission, lesser stage, and left colectomy procedure. Hospital-level predictors of suboptimal lymph node examination were a nonacademic status, a rural setting, and a low annual number of resections for colon cancer. The percent of the total clustering variance attributed to surgeons, pathologists, and hospitals was 8%, 23%, and 70%, respectively. Increasing the pathologist and hospital-specific rates of suboptimal lymph node examination were associated with worse 5-year, disease-specific survival. CONCLUSION: There was a large variation in suboptimal lymph node examination between surgeons, pathologists, and hospitals. Collaborative efforts that promote optimal examination of lymph nodes may improve prognosis for colon cancer patients. Given that 93% of the variation was attributable to pathologists and hospitals, endeavors in quality improvement should focus on these 2 settings.

Lymph node yield is an independent predictor of survival in rectal cancer regardless of receipt of neoadjuvant therapy.

AIMS: Lymph node yield (LNY) is used as a marker of adequate oncological resection. The American Joint Committee on Cancer (AJCC) currently recommends that at least 12 nodes are necessary to confirm node-negative disease for rectal cancer. A LNY of 12 is not always achieved, particularly in patients who have undergone neoadjuvant treatment. This study attempts to examine factors associated with LNY and its prognostic impact following neoadjuvant chemoradiation in rectal cancer. METHODS: The 2006-2011 National Cancer Data Base was queried for patients with clinical stage I-III rectal cancer who underwent a proctectomy. Suboptimal LNY was defined as <12 lymph nodes examined. A mixed-effects multinomial logistic regression model was used to identify independent factors associated with LNY. Mixed-effects Cox proportional hazards models were used to estimate the adjusted effect of LNY on 5-year overall survival. RESULTS: 25 447 patients met inclusion criteria. Overall, 62% of the cohort received neoadjuvant chemoradiation and 32% had suboptimal LNY. The median LNY for patients who received neoadjuvant therapy was 13 (IQR: 9-18) and for patients who did not receive neoadjuvant therapy was 15 (IQR: 12-21). After risk adjustment, there was a 3.5-fold difference in the rate of suboptimal LNY among individual hospitals (27%-95%). Suboptimal LNY was independently associated with an 18% increased hazard of death among patients who did not receive neoadjuvant treatment and a 20% increased hazard of death among those who did receive neoadjuvant treatment when controlled for adjuvant treatment, staging, proximal/distal margins and other patient factors. CONCLUSIONS: Suboptimal LNY is independently associated with worse overall survival regardless of neoadjuvant therapy, pathological staging and patient factors in rectal cancer. This finding underlies the importance and challenge of an optimal lymph node evaluation for prognostication, especially for patients receiving neoadjuvant therapy.

Variation in Hospital-Specific Rates of Suboptimal Lymphadenectomy and Survival in Colon Cancer: Evidence from the National Cancer Data Base.

BACKGROUND: Little is known about between-hospital differences in the rate of suboptimal lymphadenectomy. This study characterizes variation in hospital-specific rates of suboptimal lymphadenectomy and its effect on overall survival in a national hospital-based registry. METHODS: Stage I-III colon cancer patients were identified from the 2003-2012 National Cancer Data Base. Bayesian multilevel logistic regression models were used to assess the impact of patient- and hospital-level factors on hospital-specific rates of suboptimal lymphadenectomy (<12 lymph nodes), and multilevel Cox models were used to estimate the effect of suboptimal lymphadenectomy at the patient (yes vs. no) and hospital level (quartiles of hospital-specific rates) on overall survival. RESULTS: A total of 360,846 patients across 1345 hospitals in the US met the inclusion criteria, of which 25 % had a suboptimal lymphadenectomy. Wide variation was observed in hospital-specific rates of suboptimal lymphadenectomy (range 0-82 %, median 44 %). Older age, male sex, comorbidity score, no insurance, positive margins, lower tumor grade, lower T and N stage, and sigmoid and left colectomy were associated with higher odds of suboptimal lymphadenectomy. Patients treated at lower-volume and non-academic hospitals had higher odds of suboptimal lymphadenectomy. Patient- and hospital-level factors explained 5 % of the between-hospital variability in suboptimal lymphadenectomy, leaving 95 % unexplained. Higher suboptimal lymphadenectomy rates were associated with worse survival (quartile 4 vs. quartile 1: hazard ratio 1.19, 95 % confidence interval 1.16-1.22). CONCLUSION: Large differences in hospital-specific rates of suboptimal lymphadenectomy were observed, and this variation was associated with survival. Quality improvement initiatives targeting hospital-level adherence to the national standard may improve overall survival among resected colon cancer patients.