Comparative short- and long-term outcomes of three techniques of natural orifice specimen extraction surgery for rectal cancer

BackgroundThe aim of this study was to evaluate the safety of natural orifice specimen extraction surgery (NOSES) and to compare the short- and long-term outcomes of three techniques of NOSES for rectal cancer (RC).Materials and methodsA consecutive series of RC patients in stage I-III who underwent laparoscopic NOSES were enrolled. Three main techniques of NOSES included specimen eversion and extra-abdominal resection (EVER), specimen extraction and extra-abdominal resection (EXER) and intra-abdominal resection and specimen extraction (IREX). The postoperative complications, 5-year disease free survival (DFS), 5-year local recurrence rate (LRR) and 5-year distant metastasis rate (DMR) were compared in three techniques.Results268 RC patients met inclusion criteria, including 83 patients treated with EVER, 75 patients treated with EXER and 110 patients treated with IREX. Tumor location was the most critical factor associated with technique selection, with P < 0.001. Postoperative complication rate was 12.3% for all patients, and it was 18.1% for EVER, 13.3% for EXER and 7.3% for IREX. There were no significant differences for anastomotic leakage, anastomotic bleeding and intraabdominal abscess among three technique groups, with P > 0.05. For long-term outcomes, the 5-year DFS, 5-year LRR and 5-year DMR were 85.03%, 4.22% and 11.00% for all patients. Patients in advanced tumor stage have worse long-term survival compared with patients in early stage, but no significant survival differences were observed among three technique groups.ConclusionThree techniques of NOSES for RC had acceptable short- and long-term outcomes, and tumor location was a determinant of technique selection.     

Systematic review and meta-analysis determining the effect of implemented COVID-19 guidelines on surgical oncology volumes and clinical outcomes

BackgroundTo provide for Coronavirus Disease 2019 (COVID-19) healthcare capacity, (surgical oncology) guidelines were established, forcing to alter the timing of performing surgical procedures. It is essential to determine whether these guidelines have led to disease progression. This study aims to give an insight into the number of surgical oncology procedures performed during the pandemic and provide information on short-term clinical outcomes.Materials and methodsA systematic literature search was performed on all COVID-19 articles including operated patients, published before March 21, 2022. Meta-analysis was performed to visualize the number of performed surgical oncology procedures during the pandemic compared to the pre-pandemic period. Random effects models were used for evaluating short-term clinical outcomes.ResultsTwenty-four studies containing 6762 patients who underwent a surgical oncology procedure during the pandemic were included. The number of performed surgical procedures for an oncological pathology decreased (−26.4%) during the pandemic. The number of performed surgical procedures for breast cancer remained stable (+0.3%). Moreover, no difference was identified in the number of ≥T2 (OR 1.00, P = 0.989), ≥T3 (OR 0.95, P = 0.778), ≥N1 (OR 1.01, P = 0.964) and major postoperative complications (OR 1.55, P = 0.134) during the pandemic.ConclusionThe number of performed surgical oncology procedures during the COVID-19 pandemic decreased. In addition, the number of performed surgical breast cancer procedures remained stable. Oncological staging and major postoperative complications showed no significant difference compared to pre-pandemic practice. During future pandemics, the performed surgical oncology practice during the first wave of the COVID-19 pandemic seems appropriate for short-term results.     

Metabolic Syndrome,Obesity, and Radical Cystectomy Complications: A Clavien Classification System-Based Analysis

Introduction/BackgroundThe objective of this study was to evaluate the effect of MetS and its components on the early complications observed in patients treated with RC and urinary diversion.Patients and MethodsWe retrospectively analyzed 346 patients with bladder cancer undergoing RC with standard lymphadenectomy, according to the procedure suggested by the International Consultation on Bladder Cancer, and urinary diversion. All early complications within 90 days of surgery were recorded and collected according to the 10 Martin criteria and classified according to the established 5 grades of the modified Clavien classification system (CCS). MetS was defined according to the National Cholesterol Educational Program's Third Adult Treatment Panel. A binary logistic regression analysis was used to analyze MetS and, separately, its single components, as possible independent risk factors for high-grade complications.ResultsA total of 323 complications occurred in 231 of 346 patients (66.8%). The rates for low-grade (CCS I-II) and high-grade complications (CCS III-V), and mortality within 90 days (CCS V), were 80.8% (261 of 323), 19.2% (62 of 323), and 1.7% (6 of 346), respectively. At univariate analysis, MetS patients showed a higher rate of high-grade complications compared with patients without MetS (P < .001). At binary logistic regression analysis, MetS (OR, 1.3; P = .010), waist circumference (OR, 1.9; P = .022) and, only in single model, urinary diversion (OR, 1.3; P = .024) were independent risk factors for high-grade complications.ConclusionRC is a major surgical procedure with a significant early complications rate, nevertheless, most are low-grade complications. MetS and, separately, waist circumference are associated with high-grade complications.     

Prognostic impact of infectious complications after curative gastric cancer surgery

IntroductionThere have been few studies about the effect of infectious complications on recurrence or long-term survival outcome after curative gastric cancer surgery in large populations. This study was conducted to investigate the impact of infectious complications on long-term survival after curative gastrectomy in high volume center.MethodFrom January 2002 to December 2012, patients who underwent curative gastrectomy were enrolled. Infectious complications were defined as wound infection, intra-abdominal infection or postoperative pneumonia. Five-year overall survival was compared between two groups and followed by multivariable analysis using a Cox proportional hazards model.ResultOf 6585 patients who underwent curative gastrectomy, 413 (6.2%) had infectious complications after curative gastrectomy. The five-year overall survival rate was 86.0% in non-complication patients and 74.1% in infectious complications patients (P < 0.001). In univariate analysis, Age over 70 years, male sex, higher ASA score, total or proximal gastrectomy, advanced stage and infectious complication had statistically worse survival. A Cox proportional hazards model indicated that the infectious complication was independent prognostic factor (HR = 1.478, CI 95% 1.242–1.757 p < 0.001) as well as age over 70 years (HR = 2.434, CI 95% 2.168–2.734 p < 0.001), male sex (HR = 1.153, CI 95% 1.022–1.302 p = 0.014), higher ASA score (p < 0.001) and advanced Stage (p < 0.001). Local recurrence (P = 0.044), LN recurrence (P = 0.038) and hematologic recurrence (P = 0.033) were significantly associated with infectious complications.ConclusionPostoperative infectious complication was an independent prognostic factor for five-year overall survival after curative gastrectomy as well as known factors. A significant association between infectious complications and recurrence were also noted. The surgeon should try to prevent the infectious complications in gastric cancer surgery to improve the long term survival.     

The comprehensive complication index is associated with a significant increase in complication severity between 30 and 90 days after radical cystectomy for bladder cancer

ObjectiveTo assess the true cumulative morbidity after RC by implementing the Comprehensive Complication Index (CCI) over a 90-day period, since recent evidence suggests underreporting of the cumulative morbidity after radical cystectomy (RC) with inconsistent complication rates when reported with conventional reporting systems.Patients and methodsMedical records of 433 patients with bladder cancer who underwent RC were retrospectively reviewed over a 90-day period. Clinical variables were assessed and complications were graded by the Clavien-Dindo Classification (CDC). The resulting 30- and 90-day CCI-scores were calculated and compared for each patient. Multivariable regression models for developing at least one severe (≥CDC IIIb) complication were designed.ResultsOverall, 848 complications were recorded in 371 patients (85.7%). Severe complications occurred in 130 patients (30%) and the cumulative morbidity corresponded to the level of a severe complication in 159 patients (36.7%), meaning an upgrade in 6.7% of patients compared to the CDC. The 90-day CCI (24.2 (median, IQR 20.9–39.7)) was higher than the 30-day CCI (22.6 (median, IQR 8.7–39.7)), (p < 0.001). Comorbidity indices (ASA, ACE 27), BMI, and incontinent urinary diversions were independent risk factors for suffering a severe complication within 90 days post-surgery.ConclusionThe cumulative morbidity (CCI) after RC seems to be higher than previously reported with CDC, especially over a 90-day period. The CCI is an appropriate assessment-tool with an upgrade in morbidity in a significant proportion of patients when compared to the CDC. BMI, several comorbidity indices, and incontinent urinary diversions are independent risk factors for suffering a severe complication after RC.     

Differences in short-term outcomes between open versus robot-assisted radical cystectomy in frail malnourished patients

IntroductionWe tested whether frail patients may benefit from robot-assisted (RARC) relative to open radical cystectomy (ORC).Materials and methodsFrail patients treated with RC were identified within the National Inpatient Sample database (2008–2015). The effect of RARC vs. ORC was tested in five separate multivariable models predicting: complications, failure to rescue (FTR), in-hospital mortality, length of stay (LOS) and total hospital charges (THCs). As internal validity measure, analyses were repeated among non-frail patients. All models were weighted and adjusted for clustering, as well as all available patient and hospital characteristics.ResultsOf 11,578 RC patients, 3477 (30.0%) were frail. RARC was performed in 488 (14.0%) frail patients and 1386 (17.1%) non-frail patients. Among frail, RARC was only independently associated with shorter LOS (median 8 vs. 9 days, relative ratio [RR] 0.79, p < 0.001). Conversely, among non-frail, RARC was independently associated with lower complications (57.3 vs. 59.1%, odds ratio [OR] 0.82, p = 0.004) and shorter LOS (median 6 vs. 7 days, RR 0.88, p < 0.001), but also predicted higher THCs (+2850.3 US dollars, p = 0.001).ConclusionsIn frail patients, the use of RARC did not result in better short-term outcomes except for one-day advantage in LOS. Conversely, in non-frail patients, the use of RARC resulted in lower complication rates and shorter LOS at the cost of higher THCs. In consequence, the benefit of RARC appears relatively marginal in frail patients and our data do not suggest a clear and clinically-meaningful benefit of RARC over ORC in frail radical cystectomy population.     

Pathological downstaging and survival after induction chemotherapy and radical cystectomy for clinically node-positive bladder cancer—Results of a nationwide population-based study

BackgroundInduction chemotherapy (IC) for clinically node-positive bladder cancer is applied without clinical evidence of improved outcome. Our objective was to compare complete pathological downstaging (pCD) and overall survival (OS) for IC versus upfront radical cystectomy (RC) in cT1-4aN1-3M0 urothelial carcinoma (UC).MethodsThis population-based study included 659 cN+ patients treated with RC between 1995 and 2013. IC was applied in 212 (32%) patients. We defined pCD as ≤(y)pT1N0 at RC. Multivariable analyses were preformed to identify independent predictors of pCD and OS.ResultsIn cN1 and cN2–3 patients, 31% and 19% of patients proved to be pN0 at upfront RC. In cN1, pCD was achieved in 39% following IC versus 5% for upfront RC (P < 0.001). In cN2–3 UC, rates were 27% versus 3% (P < 0.001). Three-year OS for pCD and ypCD were 81% and 84%, respectively. Three-year OS rates were 66% versus 37% (cN1) and 43% versus 22% (cN2-3), again in favour of IC (P < 0.001). In multivariable analyses, IC was associated with pCD (Odds ratio, 14; 95% confidence interval [CI], 7.4–25) and a 53% decreased risk of death (Hazard ratio [HR], 0.47; 95% CI, 0.36–0.61). Indication bias and unequal distributions of factors associated with OS (e.g. patients proceeding to RC) limit interpretation of our results.ConclusionsPatients with clinical nodal involvement should not be neglected. Up to 1/4 of patients with cN+ disease had pN0 at upfront RC. Moreover, IC followed by RC for clinically node-positive UC was associated with improved pathological downstaging compared with RC alone. A potential OS benefit for IC needs to be validated in a randomised trial.Take home messageIC followed by RC for clinically node-positive UC is associated with improved pathological downstaging compared with RC alone. A potential OS benefit for IC needs to be validated in a randomised trial.     

Short-term and long-term effects of recurrent laryngeal nerve injury after robotic esophagectomy

BackgroundRobot-assisted minimally invasive esophagectomy (RAMIE) was reported to have superiority in upper mediastinal lymph nodes dissection than traditional approach, but related injuries to recurrent laryngeal nerve (RLNI) cannot be avoided. Considering that there is no study centering on RLNI during robotic manipulation, this study aimed to investigate the impact of RLNI on the short-term and long-term outcomes after RAMIE.MethodsPatients with esophageal cancer (EC) who underwent RAMIE from June 2015 to July 2019 were collated from a prospectively maintained database. Short-term and long-term outcomes of RLNI were analyzed.ResultsA total of 409 patients were included with the incidence of RLNI being 18.6% (76/409). A higher rate of postoperative pulmonary complications including pneumonia (P < 0.001) and acute respiratory distress syndrome (ARDS) (P = 0.041) was associated with RLNI, requiring more interventions for bronchoscopy airway suction (P < 0.001), tracheal reintubation (P = 0.013) and tracheostomy (P < 0.001). Patients with RLNI had a prolonged length of hospitalization and intensive care unit (ICU) stay (P < 0.001). With the median follow-up time of 48.7 (interquartile range [IQR]:27.6–60.9) months, recurrence in regional lymph nodes at mediastinum did not differ between groups (P = 0.351). Similarly, the Kaplan-Meier curves revealed no significant divergency for overall survival after RLNI (P = 0.452).ConclusionsRLNI after robotic esophagectomy is a serious morbidity associated with an increased rate of pulmonary complications, prolonged length of hospitalization with limited influence on long-term prognosis.     

Bladder preservation or complete cystectomy during pelvic exenteration of patients with locally advanced or recurrent rectal cancer,what should we do?

IntroductionIn patients with locally advanced (LARC) or locally recurrent (LRRC) rectal cancer and bladder involvement, pelvic exenteration (PE) with partial (PC) or radical (RC) cystectomy can potentially offer a cure. The study aim was to compare PC and RC in PE patients in terms of oncological outcome, post-operative complications and quality-of-life (QoL).Materials & methodsThis was a retrospective cohort analysis of a prospectively maintained surgical database. Patients who underwent PE for LARC or LRRC cancer with bladder involvement between 1998 and 2021 were included. Post-operative complications and overall survival were compared between patients with PC and RC.Results60 PC patients and 269 RC patients were included. Overall R0 resection was 84.3%. Patients with LRRC and PC had poorest oncological outcome with 69% R0 resection; patients with LARC and PC demonstrated highest R0 rate of 96.3% (P = 0.008). Overall, 1-, 3- and 5-year OS was 90.8%, 68.1% and 58.6% after PC, and 88.7%, 62.2% and 49.5% after RC. Rates of urinary sepsis or urological leaks did not differ between groups, however, RC patients experienced significantly higher rates of perineal wound- and flap-related complications (39.8% vs 25.0%, P = 0.032).ConclusionPC as part of PE can be performed safely with good oncological outcome in patients with LARC. In patients with LRRC, PC results in poor oncological outcome and a more aggressive surgical approach with RC seems justified. The main benefit of PC is a reduction in wound related complications compared to RC, although more urological re-interventions are observed in this group.     

Comparison of Immediate Breast Reconstruction Outcomes in Patients With and Without Prior Cosmetic Breast Surgery

BackgroundSkin-sparing (SSM) and nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) have significantly increased. There is limited information on complications of IBR in patients with prior cosmetic breast surgery (CBS). We compare IBR outcomes in patients undergoing SSM and/or NSM with and without prior CBS.Materials and MethodsPatients undergoing mastectomy from January 1, 2017 to December 31, 2019 were selected. Patient characteristics, surgical approach, and complications were compared between mastectomy and IBR cases for breasts with and without prior CBS. Binary logistic regression analysis was performed to identify predictors of complications and reconstruction loss.Results956 mastectomies were performed in 697 patients, with IBR performed for 545 mastectomies in 356 patients. Median age was 51 (range 19-83), 45.8% of patients were age < 50, 62.6% of mastectomies were performed for breast cancer. 95 mastectomies (17.4%) were performed in breasts with prior CBS and 450 (82.6%) without. NSM was more frequently utilized for breasts with prior CBS (P < .001). Complications occurred in 80 mastectomies (14.7%); reconstruction loss in 30 (5.5%). On multivariable analysis, age ≥ 50 (OR 1.76, 95%CI 1.01-3.09, P = .047) and NSM (OR 2.11, 95%CI 1.17-3.79, P = .013) were associated with an increased risk of any complication. Prior CBS was not associated with an increased risk of complications (OR 1.11, 95%CI 0.58-2.14, P = .743) or reconstruction loss (OR 1.32, 95%CI 0.51-3.38, P = .567).ConclusionIn this analysis of mastectomy and IBR, prior CBS was not associated with an increased risk of complications or reconstruction loss. In patients with prior CBS undergoing mastectomy, IBR may be safely performed.     

Comparison of laparoscopic versus open gastrectomy for gastric cancer

BackgroundThis study aimed to compare the short-term and long-term outcomes of laparoscopic gastrectomy (LG) and open gastrectomy (OG) for gastric cancer in a tertiary referral center in Hong Kong.MethodsTwo hundred and ninety-four consecutive patients with gastric cancer who underwent radical gastrectomy with curative intent between January 2008 and December 2015 were analyzed. Data was prospectively collected and reviewed. Propensity score matching was applied at a ratio of 1:1 to compare the OG and LG groups.ResultsAfter propensity score matching, operation duration (294.7 vs 231.8min, P < 0.01) was significantly longer while estimated blood loss (191.6 vs 351.0 ml, P = 0.01) was significantly less in LG group compared with OG. There were no significant differences in postoperative complications and mortality between LG and OG groups (postoperative complication rate, 35.2% vs 40.7%, P = 0.69; 90-day mortality rate, 1.9% vs 3.7%, P = 1.00). Three-year OS and 3-yr DFS of patients who underwent LG was not inferior to that of patients who had OG (P = 0.34; P = 0.51). However, there were significantly more peritoneal recurrences among the OG group than LG group (P < 0.01).ConclusionsLG has comparable outcomes for gastric cancer, even in advanced tumors. We could appropriately increase the proportion of laparoscopic gastrectomy for gastric cancer.     

Complications in the Early Recovery Period After Radical Cystectomy—Real Data From Impartial Inpatient Rehabilitation

PurposeTo examine postoperative complications after radical cystectomy (RC) and creation of an ileum conduit (IC) or a neobladder (NB), and to identify preoperative risk factors in a contemporary series of bladder cancer patients.Patients and MethodsThe study relied on prospectively collected data for 842 patients, who underwent inpatient rehabilitation (IR) after RC and urinary diversion (IC n = 447, NB n = 395) between April 2018 and December 2019. Postoperative complications until the end of IR were assessed according to the Clavien-Dindo classification. Uni- and multivariate analyses were performed to identify predictors for complications.ResultsA total of 2689 complications occurred in 813 patients (96.6%). High-grade complications occurred more frequently before IR onset (25.5% vs. 5.7%; P < .001), whereas a higher percentage of low-grade complications occurred during IR (89.0% vs. 77.8%; P < .001). The most common complication categories were genitourinary (60.9%), infectious (54.0%) and gastrointestinal (49.2%). Rates of high-grade complications do not differ between IC and NB patients (26.8% vs. 31.6%, P = .126). Independent predictors for overall complications were NB (odds ratio [OR] 21.520; P < .001), age ≥70 years (OR 2.522; P = .027) and higher body mass index (OR 1.153, P = .008). Risk factors for high-grade complications were NB (OR 1.448; P = .039) and Charlson Comorbidity Index ≥2 (OR 1.999; P = .001). Hospital readmission rate was 9.4%.ConclusionOur study revealed significantly higher overall and high-grade complication rates after RC with IC or NB creation than previously published. A high percentage of low-grade complications occur after hospital discharge. The hospital readmission rate was lower compared to historical data.     

Partial nephrectomy in frail patients: Benefits of robot-assisted surgery

BackgroundTo compare the effect of robot-assisted (RAPN) vs. open (OPN) partial nephrectomy on short-term postoperative outcomes and total hospital charges in frail patients with non-metastatic renal cell carcinoma (RCC).MethodsWithin the National Inpatient Sample database we identified 2745 RCC patients treated with either RAPN or OPN between 2008 and 2015, who met the Johns Hopkins Adjusted Clinical Groups frailty-defining indicator criteria. We examined the rates of RAPN vs. OPN over time. Moreover, we compared the effect of RAPN vs. OPN on short-term postoperative outcomes and total hospital charges. Time trends and multivariable logistic, Poisson and linear regression models were applied.ResultsOverall, 1109 (40.4%) frail patients were treated with RAPN. Rates of RAPN increased over time, from 16.3% to 54.7% (p < 0.001). Frail RAPN patients exhibited lower rates (all p < 0.001) of overall complications (35.3 vs. 48.3%), major complications (12.4 vs. 20.4%), blood transfusions (8.0 vs. 13.5%), non-home-based discharge (9.6 vs. 15.2%), shorter length of stay (3 vs. 4 days), but higher total hospital charges ($50,060 vs. $45,699). Moreover, RAPN independently predicted (all p < 0.001) lower risk of overall complications (OR: 0.58), major complications (OR: 0.55), blood transfusions (OR: 0.60) and non-home-based discharge (OR: 0.51), as well as shorter LOS (RR: 0.77) but also higher total hospital charges (RR: +$7682), relative to OPN.ConclusionsIn frail patients, RAPN is associated with lower rates of short-term postoperative complications, blood transfusions and non-home-based discharge, as well as with shorter LOS than OPN. However, RAPN use also results in higher total hospital charges.     

Robot-assisted versus thoracolaparoscopic oesophagectomy for locally advanced oesophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy

IntroductionRobot-assisted oesophagectomy (RAE) and thoracolaparoscopic oesophagectomy (TLE) are surgical techniques for the treatment of oesophageal cancer. This study aimed to compare the perioperative and mid-term outcomes of RAE versus TLE for patients with locally advanced oesophageal squamous cell carcinoma (ESCC) undergoing neoadjuvant chemoradiotherapy (nCRT).MethodsConsecutive patients receiving nCRT plus RAE or TLE were retrospectively included in this single-institution study from January 2016 to January 2021. Perioperative outcomes were compared and survival analysis was performed.ResultsThis study enrolled 251 patients, 80 (31.9%) in RAE and 171 (68.1%) in TLE. The conversion rate was equivalent in RAE versus TLE (3.8% vs 2.9%, P = 1). Median operative time in RAE was significantly shorter than that in TLE (254 vs 289 min, P < 0.001). Compared to TLE, RAE harvested more lymph nodes along the recurrent laryngeal nerve [4 (3–6) vs 3 (1–5), P < 0.001]. Overall complications were similar in RAE compared to TLE (38.8% vs 38.0%, P = 0.911). No statistically significant difference in disease-free survival (log-rank P = 0.721) or overall survival (log-rank P = 0.325) was found between groups.ConclusionsCompared to TLE, RAE could achieve shorter operative duration and better lymph nodes dissection along the bilateral RLN for locally advanced ESCC after nCRT, with comparable short-term outcomes. A long-term survival remains to be verified.     

The relevance of primary tumour location in patients with metastatic colorectal cancer: A meta-analysis of first-line clinical trials

BackgroundRetrospective subgroup analyses suggest that primary tumour location (PTL) has a prognostic importance and relates to response to targeted therapy.MethodsWe conducted a meta-analysis of first-line clinical trials available up to October 2016, which assessed the relevance of PTL in patients with metastatic colorectal cancer (mCRC). Right- and left-sided colorectal cancers were differentiated (RC and LC).ResultsIn 13 first-line randomised controlled trials and one prospective pharmacogenetic study, RC was associated with a significantly worse prognosis compared with LC (hazard ratio [HR] for overall survival: 1.56; 95% confidence interval [CI]: 1.43–1.70; P < 0.0001). A meta-analysis of PRIME and CRYSTAL study suggests that PTL was predictive of survival benefit from addition of anti-EGFR antibody to standard chemotherapy in patients with RAS wild-type tumour (overall survival, HR for LC: 0.69; 95% CI: 0.58–0.83; P < 0.0001 and HR for RC: 0.96; 95% CI: 0.68–1.35; P = 0.802). A meta-analysis of FIRE-3/AIO KRK0306, CALGB/SWOG 80405 and PEAK study indicates that patients with RAS wild-type LC had a significantly greater survival benefit from anti-EGFR treatment compared with anti-VEGF treatment when added to standard chemotherapy (HR 0.71; 95% CI: 0.58–0.85; P = 0.0003). By contrast, in patients with RC, benefit from standard therapy was poor and bevacizumab-based treatment was numerically associated with longer survival (HR 1.3; 95% CI: 0.97–1.74; P = 0.081).ConclusionsThe present meta-analysis demonstrates that PTL is prognostic in mCRC. Further, it supports the conclusion that patients with left-sided RAS wild-type mCRC should be preferentially treated with an anti-EGFR antibody. In right-sided mCRC, chemotherapy plus bevacizumab is a treatment option, but optimal treatment has yet to be defined.     

Can we predict trial failure among older adult-specific clinical trials using trial-level factors?

IntroductionConducting older adult-specific clinical trials can help overcome the lack of clinical evidence for older adults due to their underrepresentation in clinical trials. Understanding factors contributing to the successful completion of such trials can help trial sponsors and researchers prioritize studies and optimize study design. We aimed to develop a model that predicts trial failure among older adult-specific cancer clinical trials using trial-level factors.Materials and methodsWe identified phase 2–4 interventional cancer clinical trials that ended between 2008 and 2019 and had the minimum age limit of 60 years old or older using Aggregate Analysis of ClinicalTrials.gov data. We defined trial failure as closed early for reasons other than interim results or toxicity or completed with a sample of <85% of the targeted size. Candidate trial-level predictors were identified from a literature review. We evaluated eight types of machine learning algorithms to find the best model. Model fitting and testing were performed using 5-fold nested cross-validation. We evaluated the model performance using the area under receiver operating characteristic curve (AUROC).ResultsOf 209 older adult-specific clinical trials, 87 were failed trials per the definition of trial failure. The model with the highest AUROC in the validation set was the least absolute shrinkage and selection operator (AUROC in the test set = 0.70; 95% confidence interval [CI]: 0.53, 0.86). Trial-level factors included in the best model were the study sponsor, the number of participating centers, the number of modalities, the level of restriction on performance score, study location, the number of arms, life expectancy restriction, and the number of target size. Among these factors, the number of centers (odds ratio [OR] = 0.83, 95% CI: 0.71, 0.94), study being in non-US only vs. US only (OR = 0.32, 95% CI: 0.12, 0.82), and life expectancy restriction (OR = 2.17, 95% CI: 1.04, 4.73) were significantly associated with the trial failure.DiscussionWe identified trial-level factors predictive of trial failure among older adult-specific clinical trials and developed a prediction model that can help estimate the risk of failure before a study is conducted. The study findings could aid in the design and prioritization of future older adult-specific clinical trials.     

Development and validation of an XGBoost model to predict 5-year survival in elderly patients with intrahepatic cholangiocarcinoma after surgery: a SEER-based study

BackgroundNomograms have been established to predict survival in postoperative or elderly intrahepatic cholangiocarcinoma (ICC) patients. There are no models to predict postoperative survival in elderly ICC patients. Extreme gradient boosting (XGBoost) can adjust the errors generated by existing models. This retrospective cohort study aimed to develop and validate an XGBoost model to predict postoperative 5-year survival in elderly ICC patients.MethodsThe Surveillance, Epidemiology, and End Results (SEER) program provided data on elderly ICC patients aged 60 years or older and undergoing surgery. The median follow-up time was 20 months. Totally 1,055 patients were classified as training (n=738) and testing (n=317) sets at a ratio of 7:3. The outcome was postoperative 5-year survival. Demographic, tumor-related and treatment-related variables were collected. Variables were screened using the XGBoost model. The predictive performance of the model was assessed by the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Kaplan-Meier curve. Cox regression analysis was conducted to estimate the risk of death in the predicted populations. The predictive abilities of the XGBoost model and the American Joint Commission on Cancer (AJCC) system (7th edition) were compared.ResultsThe XGBoost model achieved an AUC of 0.811, a sensitivity of 0.573, a specificity of 0.890, and a PPV of 0.849 in the training set. In the testing set, the model had an AUC of 0.713, a sensitivity of 0.478, a specificity of 0.814, and a PPV of 0.726. The 5-year mortality risk of patients predicted to die was 2.91 times that of patients predicted to survive [hazard ratio (HR) =2.91, 95% confidence interval (CI): 2.42–3.50]. The XGBoost model showed a better predictive performance than the AJCC staging system both in the training and testing sets. AJCC stage, multiple (satellite) tumors/nodules, tumor-node-metastasis (TNM) stage, more than one lobe invaded, direct invasion of adjacent organs, tumor size, and radiotherapy were relatively important features in survival prediction.ConclusionsThe XGBoost model exhibited some predictive capacity, which may be applied to predict postoperative 5-year survival for elderly ICC patients.     

Comparison of surgical and oncological outcomes between oncoplastic breast-conserving surgery versus conventional breast-conserving surgery for treatment of breast cancer: A systematic review and meta-analysis of 31 studies

AimsTo evaluate comparative outcomes of oncoplastic breast conserving surgery (OBCS) versus conventional breast conserving surgery (BCS) for breast cancer treatment.MethodsA systematic search of multiple electronic data sources was conducted, and all eligible studies comparing OBCS and BCS were included. Characteristics of the tumour includes preoperative size of tumour on imaging and the weight of the specimen after resection. While positive margins rate, re-excision rate, completion mastectomy rate and loco-regional recurrence were considered as oncological outcome parameters. Post-operative complications include surgical site infection (SSI), seroma, haematoma and skin/nipple necrosis.ResultsThirty-one studies reporting a total number of 115011 patients who underwent OBCS (n = 11978) or BCS (n = 103033) were included. OBCS group showed lower risk of positive margins rate [OR 0.76, P = 0.05], re-excision rate [OR 0.72, P = 0.02], and loco-regional recurrence [OR 0.62, P = 0.03] compared to BCS group. There was no significant difference between the two groups regarding post-operative complications.ConclusionAlthough there is a lack of level 1 evidence, the available studies clearly demonstrate superior or at least equivalent outcomes when comparing OBCS with conventional BCS. The benefits of OBCS include dealing with larger tumours, wider surgical margins and better aesthetic results for patients.     

Multicenter Analysis of Postoperative Complications in Octogenarians After Radical Cystectomy and Ureterocutaneostomy: The Role of the Frailty Index

BackgroundThe purpose of this study was to assess patient frailty as a risk factor for radical cystectomy (RC) complications.Materials and MethodsWe performed an analysis of prospectively collected data of consecutive patients 80 years of age or older who underwent RC and ureterocutaneostomy in 6 primary care European urology centers. Frailty was measured using a simplified frailty index (sFI) with a 5-item score including: (1) diabetes mellitus; (2) functional status; (3) chronic obstructive pulmonary disease; (4) congestive cardiac failure; and (5) hypertension, with a maximum 5-item score meaning high level of frailty. Within 90 days surgical complications were scored according to the Clavien Classification System (CCS). sFI ≥3 was considered as poor frailty status. Clinical and pathological variables were analyzed as predictors of severe complications (CCS ≥3).ResultsOne hundred seventeen patients were enrolled. Most patients reported an sFI score of 2 and 3, respectively, 31/117 (26.5%) and 45/117 patients (38.5%). CCS ≥3 occurred in 17/117 patients (14.5%). Patients with sFI ≥3 were significantly older than patients with sFI <3 (median age, 85 years [interquartile range (IQR), 82-86] versus 82 years [IQR, 80-84]; P = .001). Most CCS ≥3 scores occurred in patients with sFI ≥3: 13 (11.1%) versus 4 (3.4%; P = .02). No significative differences were detected in terms of length of hospital stay, pathological stage, and postoperative bowel canalization when related to sFI. sFI ≥3 was an independent risk factor of CCS ≥3 in univariate and multivariate analysis (respectively, odds ratio [OR], 3.81 [95% confidence interval (CI), 1.16-12.5; P = .02] and OR, 3.1 [95% CI, 0.7-13.7; P = .01]). Body mass index, age, American Society of Anesthesiologists score ≥3, and pathological stage were not related to CCS ≥3.ConclusionRC appears feasible in elderly patients with an sFI <3. In cases of sFI ≥3, this choice should be carefully valued, discussed, and possibly avoided because of a higher risk of complications.     

Second-Line Conservative Device-Assisted Intravesical Treatment in Selected Patients With Recurrent High-Risk Non–Muscle-Invasive Bladder Cancer

IntroductionIn cases of recurrent high-risk non–muscle-invasive bladder cancer, radical cystectomy (RC) is recommended. We compared oncologic and treatment-related outcomes of second-line conservative device-assisted therapy to RC.Patients and MethodsIn a retrospective cohort study, we analyzed 209 consecutive patients with recurrent bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer; 107 subjects refused RC and were offered electromotive drug administration (n = 44) or chemohyperthermia (n = 63) (group A), and 102 patients underwent RC (group B). In group A, patients who did not benefit from device-assisted treatment underwent RC. The endpoints were high-grade disease-free survival, progression-free survival, cancer-specific survival, overall survival, and treatment-related complications. Follow-up was based on international guideline recommendations. Analyses were performed with log-rank and Fisher exact tests.ResultsThe median follow-up was 59 months (SD ± 5.3). When comparing group A to B, overall survival rates were 91.6% and 90.2%, respectively (P > .05); cancer-specific survival was 94.4% and 96.1%, respectively (P > .05); high-grade disease-free survival was 43% and 74.5%, respectively (P < .05); and progression-free survival was 59.8% and 75.5%, respectively (P < .05). Patients with carcinoma-in-situ had worse oncologic outcomes compared to patients with papillary disease. In the multivariate analysis, multifocality, disease recurrence, and progression risk group were independently associated with device treatment failure. The 90-day RC-related overall complications rates were 63.9% in group A and 66.6% in group B (P = .63); grade 3 to 5 complications were 9.8% in group A and 9.8% in group B(P = .99). Complications within group A were comparable (P > .05).ConclusionDevice-assisted treatment may a represent a valid second-line conservative tool in selected patients with recurrent high-risk non–muscle-invasive bladder cancer.