Anal Cancers in Previously Screened Versus Unscreened Patients: Tumor Stage and Treatment Outcomes.

BACKGROUND: Targeted screening programs for patients at high risk for anal squamous-cell carcinoma have been proposed; however, the evidence in support of screening remains unclear. OBJECTIVE: This study aimed to determine whether screening high-risk patients (predominantly those living with HIV) detected squamous-cell carcinoma at an earlier stage compared to the routine practice of not screening. DESIGN: This is a cohort study. SETTINGS: This study was conducted at a quaternary care center in Canada. PATIENTS: Included patients were at least 18 years old with a pathologic diagnosis of invasive anal squamous-cell carcinoma between 2002 and 2022. INTERVENTIONS: Patients diagnosed through a high-risk screening program were compared to those who did not undergo screening. MAIN OUTCOME MEASURES: The primary outcome was clinical stage at presentation, categorized as T1N0M0 vs other. Secondary outcomes included treatments received, treatment failure, and overall survival. RESULTS: A total of 612 patients with anal squamous-cell carcinoma were included, with 26 of those patients diagnosed through a screening program. Patients with screen-detected cancers had greater odds of presenting with T1N0M0 tumors compared to unscreened patients (18 [69.2%] vs 84 [14.3%]; adjusted OR 9.95; 95% CI, 3.95-25.08). A propensity score-matched sensitivity analysis found similar results (OR 11.13; 95% CI, 4.67-26.52). Screened patients had greater odds of treatment with wide local excision alone, as opposed to any combination of chemotherapy, radiation therapy, and surgery (3 [12.5%] vs 18 [3.2%]; OR 4.38; 95% CI, 1.20-16.04). There were no statistically significant differences in treatment failure or overall survival between groups. LIMITATIONS: The small number of screened patients limits the power of the analysis. CONCLUSIONS: Screening for anal squamous-cell carcinoma among high-risk populations detects cancers at an earlier stage. Patients with screen-detected cancers also had a greater likelihood of being candidates for wide local excision alone, which may have spared them the morbidity associated with chemoradiotherapy or abdominoperineal resection. See Video Abstract. CNCERES DE ANO EN PACIENTES PREVIAMENTE DETECTADOS POR CRIBADO VERSUS NO DETECTADOS ESTADIO DEL TUMOR Y RESULTADOS DEL TRATAMIENTO: ANTECEDENTES:Se han propuesto programas de cribado dirigidos a pacientes con alto riesgo de carcinoma anal de células escamosas; sin embargo, la evidencia a favor de la detección sigue sin estar clara.OBJETIVO:Este estudio tuvo como objetivo determinar si el cribado de pacientes de alto riesgo (predominantemente aquellos que viven con el VIH) detectó el carcinoma de células escamosas en una etapa más temprana en comparación con la práctica habitual de no cribado.DISEÑO:Este es un estudio de cohortes.CONFIGURACIÓN:Este estudio se realizó en un centro de atención cuaternaria en Canadá.PACIENTES:Los pacientes incluidos tenían al menos 18 años con un diagnóstico patológico de carcinoma de células escamosas anal invasivo entre 2002 y 2022.INTERVENCIONES:Los pacientes diagnosticados mediante un programa de cribado de alto riesgo se compararon con aquellos que no se sometieron a cribado.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el estadio clínico en la presentación, categorizado como T1N0M0 versus otro. Los resultados secundarios incluyeron los tratamientos recibidos, el fracaso del tratamiento y la supervivencia general.RESULTADOS:Se incluyeron un total de 612 pacientes con carcinoma anal de células escamosas, con 26 de esos pacientes diagnosticados a través de un programa de cribado. Los pacientes con cánceres detectados mediante cribado tenían mayores probabilidades de presentar tumores T1N0M0 en comparación con los pacientes no cribados (18 [69.2%] frente a 84 [14.3%]; razón de probabilidad ajustada 9.95; intervalo de confianza del 95 % 3.95 -25.08). Un análisis de sensibilidad emparejado por puntaje de propensión encontró resultados similares (odds ratio 11.13; intervalo de confianza del 95% 4.67 -26.52; p < 0.001). Los pacientes examinados tenían mayores probabilidades de recibir tratamiento con escisión local amplia sola, en comparación con cualquier combinación de quimioterapia, radiación y cirugía (3 [12.5%] frente a 18 [3.2%]; razón de probabilidad 4.38; intervalo de confianza del 95 % 1.20 -16.04). No hubo diferencias estadísticamente significativas en el fracaso del tratamiento o la supervivencia global entre los grupos.LIMITACIONES:El pequeño número de pacientes evaluados limita el poder del análisis.CONCLUSIONES:La detección del carcinoma anal de células escamosas entre las poblaciones de alto riesgo detecta los cánceres en una etapa más temprana. Los pacientes con cánceres detectados mediante cribado también tenían una mayor probabilidad de ser candidatos para una escisión local amplia sola, lo que puede haberles evitado la morbilidad asociada con la quimiorradioterapia o la resección abdominoperineal. (Traducción --Dr. Aurian Garcia Gonzalez ).

Clinical tools to assess functional capacity before elective non-cardiac surgery: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to map the evidence on clinical tools to assess functional capacity prior to elective non-cardiac surgery. INTRODUCTION: Functional capacity is a strong prognostic indicator before surgery, which can be used to identify patients at elevated risk of postoperative complications, yet, there is no consensus on which clinical tools should be used to assess functional capacity in patients prior to non-cardiac surgery. INCLUSION CRITERIA: This review will consider any randomized or non-randomized studies that evaluate the performance of a functional capacity assessment tool in adults (≥18 years) prior to non-cardiac surgery. For studies to be included, the tool must be used clinically for risk stratification. We will exclude studies on lung and liver transplant surgery, as well as ambulatory procedures performed under local anesthesia. METHODS: The review will be conducted in line with the JBI methodology for scoping reviews. A peer-reviewed search strategy will be used to query relevant databases (ie, MEDLINE, Embase, EBM Reviews). Additional sources of evidence will include databases of non-peer-reviewed literature and the reference lists of included studies. Two independent reviewers will identify eligible studies in 2 stages: stage 1, based on titles and abstracts; and stage 2, based on full texts. Information on study details, measurement properties, pragmatic qualities, and/or clinical utility metrics will be charted in duplicate onto standardized data collection forms. The results will be presented using descriptive summaries, frequency tables, and visual plots that highlight the extent of evidence and remaining gaps in the validation process of each tool. REVIEW REGISTRATION: Open Science Framework https://osf.io/6nfht.

The impact of unexpected intensive care unit admission after cancer surgery on long-term symptom burden among older adults: a population-based longitudinal analysis.

BACKGROUND: Older adults are at high-risk for a post-operative intensive care unit (ICU) admission, yet little is known about the impact of these admissions on quality of life. The objective of this study was to evaluate the impact of an unexpected post-operative ICU admission on the burden of cancer symptoms among older adults who underwent high-intensity cancer surgery and survived to hospital discharge. METHODS: We performed a population-based cohort study of older adults (age ≥ 70) who underwent high-intensity cancer surgery and survived to hospital discharge in Ontario, Canada (2007-2017). Using the Edmonton Symptom Assessment System (ESAS), a standardized tool that quantifies patient-reported physical, mental, and emotional symptoms, we described the burden of cancer symptoms during the year after surgery. Total symptom scores ≥ 40 indicated a moderate-to-severe symptom burden. Modified log-Poisson analysis was used to estimate the impact of an unexpected post-operative ICU admission (admission not related to routine monitoring) on the likelihood of experiencing a moderate-to-severe symptom burden during the year after surgery, accounting for potential confounders. We then used multivariable generalized linear mixed models to model symptom trajectories among patients with two or more ESAS assessments. A 10-point difference in total symptom scores was considered clinically significant. RESULTS: Among 16,560 patients (mean age 76.5 years; 43.4% female), 1,503 (9.1%) had an unexpected ICU admission. After accounting for baseline characteristics, patients with an unexcepted ICU admission were more likely to experience a moderate-to-severe symptom burden relative to those without an unexpected ICU admission (RR 1.64, 95% CI 1.31-2.05). Specifically, among patients with an unexcepted ICU admission the average probability of experiencing moderate-to-severe symptoms ranged from 6.9% (95 CI 5.8-8.3%) during the first month after surgery to 3.2% (95% CI 0.9-11.7%) at the end of the year. Among the 11,229 (67.8%) patients with multiple ESAS assessments, adjusted differences in total scores between patients with and without an unexpected ICU admission ranged from 2.0 to 5.7-points throughout the year (p < 0.001). CONCLUSION: While unexpected ICU admissions are associated with a small increase in the likelihood of experiencing a moderate-to-severe symptom burden, most patients do not experience a high overall symptom burden during the year after surgery. These findings support the role of aggressive therapy among older adults after major surgery.

Geriatric assessment and treatment decision-making in surgical oncology.

PURPOSE OF REVIEW: Present an approach for surgical decision-making in cancer that incorporates geriatric assessment by building upon the common categories of tumor, technical, and patient factors to enable dual assessment of disease and geriatric factors. RECENT FINDINGS: Conventional preoperative assessment is insufficient for older adults missing important modifiable deficits, and inaccurately estimating treatment intolerance, complications, functional impairment and disability, and death. Including geriatric-focused assessment into routine perioperative care facilitates improved communications between clinicians and patients and among interdisciplinary teams. In addition, it facilitates the detection of geriatric-specific deficits that are amenable to treatment. We propose a framework for embedding geriatric assessment into surgical oncology practice to allow more accurate risk stratification, identify and manage geriatric deficits, support decision-making, and plan proactively for both cancer-directed and non-cancer-directed therapies. This patient-centered approach can reduce adverse outcomes such as functional decline, delirium, prolonged hospitalization, discharge to long-term care, immediate postoperative complications, and death. SUMMARY: Geriatric assessment and management has substantial benefits over conventional preoperative assessment alone. This article highlights these advantages and outlines a feasible strategy to incorporate both disease-based and geriatric-specific assessment and treatment when caring for older surgical patients with cancer.

Minimally Invasive Compared to Open Colorectal Cancer Resection for Older Adults: A Population-based Analysis of Long-term Functional Outcomes.

OBJECTIVE: We sought to compare long-term healthcare dependency and time-at-home between older adults undergoing minimally invasive surgery (MIS) for colorectal cancer (CRC) and those undergoing open resection. BACKGROUND: Although the benefits of MIS for CRC resection are established, data specific to older adults are lacking. Long-term functional outcomes, central to decision-making in the care for older adults, are unknown. METHODS: We performed a population-based analysis of patients ≥70years old undergoing CRC resection between 2007 to 2017 using administrative datasets. Outcomes were receipt of homecare and "high" time-at-home, which we defined as years with ≤14 institution-days, in the 5years after surgery. Homecare was analyzed using time-to-event analyses as a recurrent dichotomous outcome with Andersen-Gill multivariable models. High timeat-home was assessed using Cox multivariable models. RESULTS: Of 16,479 included patients with median follow-up of 4.3 (interquartile range 2.1-7.1) years, 7822 had MIS (47.5%). The MIS group had lower homecare use than the open group with 22.3% versus 31.6% at 6 months and 14.8% versus 19.4% at 1 year [hazard ratio 0.87,95% confidence interval (CI) 0.83-0.92]. The MIS group had higher probability ofhigh time-at-home than open surgery with 54.9% (95% CI 53.6%-56.1%) versus 41.2% (95% CI 40.1%-42.3%) at 5years (hazard ratio 0.71, 95% CI 0.68-0.75). CONCLUSIONS: Compared to open surgery, MIS for CRC resection was associated with lower homecare needs and higher probability of high time-at-home in the 5 years after surgery, indicating reduced long-term functional dependence. These are important patient-centered endpoints reflecting the overall long-term treatment burden to be taken into consideration in decision-making.

Patient-Reported Symptom Burden After Cancer Surgery in Older Adults: A Population-Level Analysis.

BACKGROUND: Older adults have unique needs for supportive care after surgery. We examined symptom trajectories and factors associated with high symptom burden after cancer surgery in older adults. PATIENTS AND METHODS: We conducted a population-level study of patients ≥ 70 years old undergoing cancer surgery (2007-2018) using prospectively collected Edmonton Symptom Assessment System (ESAS) scores. The monthly prevalence of moderate to severe symptoms (ESAS ≥ 4) for anxiety, depression, drowsiness, lack of appetite, nausea, pain, shortness of breath, tiredness, and poor wellbeing was computed over 12 months after surgery. RESULTS: Among 48,748 patients, 234,420 ESAS scores were recorded over 12 months after surgery. Moderate to severe tiredness (57.8%), poor wellbeing (51.9%), and lack of appetite (39.3%) were most common. The proportion of patients with moderate to severe symptoms was stable over the 1 month prior to and 12 months after surgery (< 5% variation for each symptom). There was no clinically significant change (< 5%) in symptom trajectory with the initiation of adjuvant therapy. CONCLUSIONS: Patient-reported symptom burden was stable for up to 1 year after cancer surgery among older adults. Neither surgery nor adjuvant therapy coincided with a worsening in symptom burden. However, the persistence of symptoms at 1 year may suggest gaps in supportive care for older adults. This information on symptom trajectory and predictors of high symptom burden is important to set appropriate expectations and improve patient counseling, recovery care pathways, and proactive symptom management for older adults after cancer surgery.

Long-term Dependency in Older Adults After Surgery or Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer.

OBJECTIVE: To examine long-term healthcare dependency outcomes of stereotactic body radiation therapy (SBRT) to surgery for older adults with stage I non-small cell lung cancer (NSCLC). BACKGROUND: SBRT is an emerging alternative to surgery in patients with early-stage lung cancer. There remains a paucity of prospective studies comparing these modalities, especially with respect to long-term dependency outcomes in older adults with lung cancer. METHODS: Adults 70 years old and above with stage I NSCLC treated with surgery or SBRT from January 2010 to December 2017 were analyzed using 1:1 propensity score matching. Homecare use, days at home, and time spent alive and at home were compared. E-value methods assessed residual confounding. RESULTS: A total of 1129 and 2570 patients underwent SBRT and surgery, respectively. In all, 1016 per group were matched. SBRT was associated with a higher overall risk of homecare utilization [hazard ratio (HR)=1.75, 95% confidence interval (CI): 1.37-2.23] than surgery up to 5 years following treatment. While the hazards of death or nursing home admission were lower in the first 3 months after SBRT (HR=0.55, 95% CI: 0.36-0.85), they became consistently higher beyond this period and remained high up to 5 years compared with surgery (HR=2.13; 95% CI: 1.85-2.45). The above findings persisted in stratified analyses for frail patients and those with no pretreatment homecare. E-values indicated it was unlikely that the observed estimates could be explained by unmeasured confounders. CONCLUSIONS: Surgery offers robust long-term dependency outcomes compared with SBRT. These are important patient-centered endpoints which may be used for counseling and shared decision-making in older adults with stage I NSCLC.

Association Between Frailty and Time Alive and At Home After Cancer Surgery Among Older Adults: A Population-Based Analysis.

BACKGROUND: Although frailty is known to impact short-term postoperative outcomes, its long-term impact is unknown. This study examined the association between frailty and remaining alive and at home after cancer surgery among older adults. METHODS: Adults aged ≥70 years undergoing cancer resection were included in this population-based retrospective cohort study using linked administrative datasets in Ontario, Canada. The probability of remaining alive and at home in the 5 years after cancer resection was evaluated using Kaplan-Meier methods. Extended Cox regression with time-varying effects examined the association between frailty and remaining alive and at home. RESULTS: Of 82,037 patients, 6,443 (7.9%) had preoperative frailty. With median follow-up of 47 months (interquartile range, 23-81 months), patients with frailty had a significantly lower probability of remaining alive and at home 5 years after cancer surgery compared with those without frailty (39.1% [95% CI, 37.8%-40.4%] vs 62.5% [95% CI, 62.1%-63.9%]). After adjusting for age, sex, rural living, material deprivation, immigration status, cancer type, surgical procedure intensity, year of surgery, and receipt of perioperative therapy, frailty remained associated with increased hazards of not remaining alive and at home. This increase was highest 31 to 90 days after surgery (hazard ratio [HR], 2.00 [95% CI, 1.78-2.24]) and remained significantly elevated beyond 1 year after surgery (HR, 1.56 [95% CI, 1.48-1.64]). This pattern was observed across cancer sites, including those requiring low-intensity surgery (breast and melanoma). CONCLUSIONS: Preoperative frailty was independently associated with a decreased probability of remaining alive and at home after cancer surgery among older adults. This relationship persisted over time for all cancer types beyond short-term mortality and the initial postoperative period. Frailty assessment may be useful for all candidates for cancer surgery, and these data can be used when counseling, selecting, and preparing patients for surgery.

Frailty assessment tools for use by surgeons when evaluating older adults prior to surgery: a scoping review protocol.

INTRODUCTION: Despite growing evidence, uncertainty persists about which frailty assessment tools are best suited for routine perioperative care. We aim to understand which frailty assessment tools perform well and are feasible to implement. METHODS AND ANALYSIS: Using a registered protocol following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA), we will conduct a scoping review informed by the Joanna Briggs Institute Guide for Scoping Reviews and reported using PRISMA extension for Scoping Reviews recommendations. We will develop a comprehensive search strategy with information specialists using the Peer Review of Electronic Search Strategies checklist, and implement this across relevant databases from 2005 to 13 October 2021 and updated prior to final review publication. We will include all studies evaluating a frailty assessment tool preoperatively in patients 65 years or older undergoing intracavitary, non-cardiac surgery. We will exclude tools not assessed in clinical practice, or using laboratory or radiologic values alone. After pilot testing, two reviewers will independently assess information sources for eligibility first by titles and abstracts, then by full-text review. Two reviewers will independently chart data from included full texts using a piloted standardised electronic data charting. In this scoping review process, we will (1) index frailty assessment tools evaluated in the preoperative clinical setting; (2) describe the level of investigation supporting each tool; (3) describe useability of each tool and (4) describe direct comparisons between tools. The results will inform ready application of frailty assessment tools in routine clinical practice by surgeons and other perioperative clinicians. ETHICS AND DISSEMINATION: Ethic approval is not required for this secondary data analysis. This scoping review will be published in a peer-review journal. Results will be used to inform an ongoing implementation study focused on geriatric surgery to overcome the current lack of uptake of older adult-oriented care recommendations and ensure broad impact of research findings.

Functional Improvement Trajectories After Surgery (FIT After Surgery) study: protocol for a multicentre prospective cohort study to evaluate significant new disability after major surgery in older adults.

INTRODUCTION: Older adults prioritise surviving surgery, but also preservation of their functional status and quality of life. Current approaches to measure postoperative recovery, which focus on death, complications and length of hospitalisation, may miss key relevant domains. We propose that postoperative disability is an important patient-centred outcome to measure intermediate-to-long recovery after major surgery in older adults. METHODS AND ANALYSIS: The Functional Improvement Trajectories After Surgery (FIT After Surgery) study is a multicentre cohort study of 2000 older adults (≥65 years) having major non-cardiac surgery. Its objectives are to characterise the incidence, trajectories, risk factors and impact of new significant disability after non-cardiac surgery. Disability is assessed using WHO Disability Assessment Schedule (WHODAS) 2.0 instrument and participants' level-of-care needs. Disability assessments occur before surgery, and at 1, 3, 6, 9 and 12 months after surgery. The primary outcome is significantly worse WHODAS score or death at 6 months after surgery. Secondary outcomes are (1) significantly worse WHODAS score or death at 1 year after surgery, (2) increased care needs or death at 6 months after surgery and (3) increased care needs or death at 1 year after surgery. We will use multivariable logistic regression models to determine the association of preoperative characteristics and surgery type with outcomes, joint modelling to characterise longitudinal time trends in WHODAS scores over 12 months after surgery, and longitudinal latent class mixture models to identify clusters following similar trajectories of disability. ETHICS AND DISSEMINATION: The FIT After Surgery study has received research ethics board approval at all sites. Recruitment began in December 2019 but was placed on hold in March 2020 because of the COVID-19 pandemic. Recruitment was gradually restarted in October 2020, with 1-year follow-up expected to finish in 2023. Publication of the primary results is anticipated to occur in 2024.

Long-term Dependency Outcomes in Older Adults Following Hepato-Pancreato-Biliary Surgery for Cancer: A Population-based Analysis.

OBJECTIVE: To evaluate healthcare dependency following hepatopancreato-biliary cancer surgery in older adults (OA). SUMMARY BACKGROUND DATA: Functional outcomes are central to decisionmaking by OA, but long-term risks of dependency have not been described beyond 1 year in this population. METHODS: All patients over age 70 undergoing hepatectomy or pancreatec-tomy for cancer between 2007 and 2017 in Ontario were analyzed. Outcomes were 1) receipt of homecare and 2) time at home. Homecare was analyzed with cumulative incidence functions, and time at home with Kaplan-Meier and Cox multivariate models. RESULTS: A total of 902 and 1283 patients underwent hepatectomy and pancreatectomy, respectively. Homecare use was highest (72.3%) in postoperative month-1, decreasing to stabilize between year-1 (25.5%) and year-5 (18.3%). Repeated receipt of homecare was associated with female sex (HR 1.18, 95% CI 1.05-1.32), receipt of adjuvant therapy (HR 1.56, 1.37-1.78), and more recent year of surgery (HR 3.80, 3.05-4.72). The ratio of home nursing care versus personal support services reversed from 68%/26% in year-1, to 29/64% in year-5. High time at home (>350 days) at 1 and 5 years were 40.6% (95% CI 38.5%-42.6%) and 28.1% (25.9%-30.3%), respectively. The ratio of institution-days in acute care versus nursing homes went from 77%/14% in year-1 to 23%/70% in year-5. Low time at home was associated with duodenal (HR 1.45, 1.15-1.70) and pancreas cancer (HR 1.20, 1.02-1.42), and with rural residence (HR 1.24, 1.04-1.48). High time at home was associated with more recent year of surgery (HR 0.84, 0.76-0.93) and perioperative cancer therapy (HR 0.88, 0.78-0.99). Increasing age was neither associated with homecare receipt nor time at home. CONCLUSIONS: Following hepatopancreatobiliary cancer surgery, there is a high rate of long-term healthcare dependency for OA. There is an immediate high need for homecare that reaches a new baseline after 6 months, and the majority of OA will have at least 1 year with low time at home, most commonly the first year. These findings can aid in preoperative preparation and transitional care planning.

Self-management interventions for issues identified in a geriatric assessment: A systematic review.

BACKGROUND: With the development of electronic geriatric assessment (GA), recommendations for self-management can be provided to patients without the presence of health care providers. Our research question was to identify what self-management interventions can be used by patients to address issues identified in GA and to determine their effect on patient-centered outcomes such as quality of life, health, mood, cognition, and functional status. METHODS: Searches were conducted on July 13, 2021, by a health sciences librarian in Medline, Embase, CINAHL, PsycInfo, and the Cochrane Library. A combination of database-specific subject headings and text word searches was used such as self-management, a key word for each of the geriatric assessment domains and older adults. Two independent reviewers reviewed abstracts and full texts for inclusion and abstracted data. Narrative synthesis was used to summarize findings. RESULTS: Among 28,520 abstracts reviewed, 34 randomized controlled trials were included. The most frequently studied geriatric domains were mood (n = 13 studies), mobility/falls (n = 12), quality of life (n = 11), and functional status (n = 7). The majority of studies demonstrated positive effects on mobility/falls (9 of 12), pain (3 of 5), comorbidity (4 of 4), and medication management (4 of 4). Most studies were of low to moderate quality. All geriatric domains were targeted in at least one study. CONCLUSIONS: Low- to moderate-quality studies show a variety of effective self-efficacy-targeted interventions exist for older adults to improve several important geriatric domains and related outcomes. However, long-term effects, validation, and scalability of these interventions remain largely unknown.

Neoadjuvant therapy versus direct to surgery for T4 colon cancer: meta-analysis.

BACKGROUND: Despite persistently poor oncological outcomes, approaches to the management of T4 colonic cancer remain variable, with the role of neoadjuvant therapy unclear. The aim of this review was to compare oncological outcomes between direct-to-surgery and neoadjuvant therapy approaches to T4 colon cancer. METHODS: A librarian-led systematic search of MEDLINE, Embase, the Cochrane Library, Web of Science, and CINAHL up to 11 February 2020 was performed. Inclusion criteria were primary research articles comparing oncological outcomes between neoadjuvant therapies or direct to surgery for primary T4 colonic cancer. Based on PRISMA guidelines, screening and data abstraction were undertaken in duplicate. Quality assessment was carried out using Cochrane risk-of-bias tools. Random-effects models were used to pool effect estimates. This study compared pathological resection margins, postoperative morbidity, and oncological outcomes of cancer recurrence and overall survival. RESULTS: Four studies with a total of 43 063 patients met the inclusion criteria. Compared with direct to surgery, neoadjuvant therapy was associated with increased rates of margin-negative resection (odds ratio (OR) 2.60, 95 per cent c.i. 1.12 to 6.02; n = 15 487) and 5-year overall survival (pooled hazard ratio 1.42, 1.10 to 1.82, I2 = 0 per cent; n = 15 338). No difference was observed in rates of cancer recurrence (OR 0.42, 0.15 to 1.22; n = 131), 30-day minor (OR 1.12, 0.68 to 1.84; n = 15 488) or major (OR 0.62, 0.27 to 1.44; n = 15 488) morbidity, or rates of treatment-related adverse effects. CONCLUSION: Compared with direct to surgery, neoadjuvant therapy improves margin-negative resection rates and overall survival.

Apical lymphadenectomy during low ligation of the IMA during rectosigmoid resection for cancer.

BACKGROUND: Low ligation of the inferior mesenteric artery with preservation of the left colic artery may decrease the risk of colorectal anastomotic ischemia compared to high ligation at its origin. Low ligation leaves apical nodes in situ and is therefore paired with apical lymphadenectomy. We sought to compare relevant oncologic outcomes between high ligation and low ligation plus apical lymphadenectomy in rectosigmoid resection for colorectal cancer. METHODS: We conducted a retrospective cohort study. Patients receiving a rectosigmoid resection for cancer between January 2012 and July 2018 were included. Patients with metastatic disease and those who underwent low ligation without apical lymphadenectomy were excluded. Our primary outcome was nodal yield/metastasis. Secondary outcomes included perioperative complications, local recurrence, and overall survival. RESULTS: Eighty-four patients underwent high ligation and 89 low ligation plus apical lymphadenectomy (median follow-up 20 months). In the low-ligation group, a median of 2 (interquartile range = 1-3) apical nodes was resected; 4.1% were malignant, increasing pathologic stage in 25% of these patients. There were no differences in nodal yield, complications, anastomotic leak, local recurrence, or overall survival. CONCLUSION: No differences were identified between high ligation and low ligation plus apical lymphadenectomy with respect to relevant clinical outcomes. Prospective trial data are needed to robustly establish the oncologic benefit and safety of the low ligation plus apical lymphadenectomy technique.

A Population-Based Analysis of Long-Term Outcomes Among Older Adults Requiring Unexpected Intensive Care Unit Admission After Cancer Surgery.

BACKGROUND: High-intensity cancer surgery is increasingly common among older adults. However, these patients are at high-risk for unexpected intensive care unit (ICU) admissions after surgery. How these admissions impact older adults' long-term outcomes is unknown. METHODS: We performed a population-based, cohort study of older adults (age ≥ 70 years) who underwent high-intensity cancer surgery from 2007 to 2017. Analyses were performed to examine time alive and at home following surgery, defined as time from surgery to nursing home admission or death. Patients were followed for up to 5 years. Extended Cox proportional hazards models examined the independent association between unexpected ICU admission (ICU admissions excluding routine postoperative monitoring) and remaining alive and at home. Subgroup analysis stratified patients by duration of mechanical ventilation (MV). RESULTS: Of 47,367 identified older adults, 7372 (15.6%) had an unexpected ICU admission. Patients with an unexpected ICU admission had a significantly lower probability of being alive and at home at 5 years (26.2%; 95% confidence interval [CI] 25.1-27.2%) compared with those without an unexpected admission (56.8%; 95% CI 56.3-57.4%). After adjusting for baseline characteristics, unexpected ICU admission remained associated with less time alive and at home. The elevated risk of death or nursing home admission persisted for 5 years after surgery (years 2-5: hazard ratio [HR] 1.58, 95% CI 1.50-1.66). Duration of MV was inversely associated with time alive and at home. CONCLUSIONS: Older adults with an unexpected ICU admission after high-intensity cancer surgery are at increased risk for death or admission to a nursing home for at least 5 years.

Improving the reporting of non-inferiority trials by incorporating non-efficacy benefits: not all non-inferiority trials are created equal.

Non-inferiority trials are used to test if a novel intervention is not worse than a standard treatment by more than a prespecified amount, the non-inferiority margin (ΔNI). The ΔNI indicates the amount of efficacy loss in the primary outcome that is acceptable in exchange for non-efficacy benefits in other outcomes. However, non-inferiority designs are sometimes used when non-efficacy benefits are absent. Without non-efficacy benefits, loss in efficacy cannot be easily justified. Further, non-efficacy benefits are scarcely defined or considered by trialists when determining the magnitude of and providing justification for the non-inferiority margin. This is problematic as the importance of a treatment's non-efficacy benefits are critical to understanding the results of a non-inferiority study. Here we propose the routine reporting in non-inferiority trial protocols and publications of non-efficacy benefits of the novel intervention along with the reporting of non-inferiority margins and their justification. The justification should include the specific trade-off between the accepted loss in efficacy (ΔNI) and the non-efficacy benefits of the novel treatment and should describe whether patients and other relevant stakeholders were involved in the definition of the ΔNI.