Recurrence-free Survival Curves Research Articles

Laparoscopic Versus Open Hernia Repair for Indirect Inguinal Hernia in Adolescents: A Retrospective Cohort Study

Background and Purpose The optimal surgical approach for inguinal hernia (IH) repair in adolescents has not been established. This study aimed to analyze and compare the perioperative results and long-term outcomes of adolescent patients with IH treated with laparoscopic (LHR) versus open hernia repair (OHR). Methods This study retrospectively reviewed the clinicopathological data of adolescent patients with IH who underwent LHR or OHR as initial treatment from March 2012 to February 2018 at Xinxiang Central Hospital. Clinicopathological factors associated with the prognosis of patients were identified using univariate and multivariate Cox regression analysis. Recurrence-free survival (RFS) curves between different cohorts of patients were generated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching (PSM) analysis was used to match patients of the LHR and OHR groups in a 1:1 ratio. Results Adolescent patients with IH were enrolled, including 243 patients in the LHR group and 252 patients in the OHR group. After PSM, 189 patients were matched in each of the study group. Compared with the OHR group, the LHR group had a shorter hospitalization, less blood loss, fewer overall postoperative complications and lower rates of recurrence and chronic pain. The LHR group had a significantly better RFS than the OHR group before and after PSM. Conclusions Laparoscopic inguinal hernia repair for adolescent patients with IH can be safely performed with favorable perioperative and long-term outcomes.

Immunohistochemistry as a reliable predictor of remission in patients with endometrial cancer: Establishment and validation of a machine learning model.

Endometrial cancer (EC) is the most common gynecologic cancer. Unfortunately, its prognosis remains poor due to limited screening and treatment options. To address this issue, the present study evaluated the predictive value of four immunohistochemical (IHC) indicators for overall survival (OS) and recurrence-free survival (RFS) in patients with EC. A total of 834 patients diagnosed with EC were included at Peking University People's Hospital between January 2006 and December 2020. These patients were randomly divided into training and validation cohorts at a 2:1 ratio, collecting data on clinicopathological information and IHC indicators. A total of 92 combinations of algorithms were assessed using the Leave-One-Out Cross-Validation framework to identify the one with the highest C-index. To estimate the accuracy of the factors and four IHC indicators for predicting both OS and RFS, survival curves and receiver operating characteristic (ROC) curves were used. Independent predictors included estrogen receptor, progesterone receptor, body mass index, P53, FIGO stage, histology, grade, Ki67, ascites and lymph node metastasis. Both the training and validation cohorts exhibited excellent predictive performance for OS and RFS, as demonstrated by ROC curves at 1-year, 3-year and 5-year follow-ups. By introducing a model based solely on clinicopathological information as model 1 and adding four IHC indicators in model 2, a significant improvement was observed in the area under the curve (AUC) values across the entire sample. The AUC value for OS curves increased from 0.765 to 0.872, and the AUC for RFS curves rose from 0.791 to 0.882. Thus, the present study's model effectively predicts patients' probability of OS and RFS using these factors. This prediction capability can guide postoperative treatment plans and follow-up intervals, potentially enhancing long-term survival for patients with EC.

A preliminary study of developing an MRI-based model for postoperative recurrence prediction and treatment direction of intrahepatic cholangiocarcinoma.

To establish an MRI-based predictive model for postoperative recurrence in intrahepatic cholangiocarcinoma (iCCA) and further to evaluate the model utility in treatment direction for neoadjuvant and adjuvant therapies. Totally 114 iCCA patients with curative surgery were retrospectively included, including 38 patients in the neoadjuvant treatment, traditional surgery, and adjuvant treatment groups for each. Predictive variables associated with postoperative recurrence were identified using univariate and multivariate Cox regression analyses, and a prognostic model was formulated. Recurrence-free survival (RFS) curves were compared using log-rank test between MRI-predicted high-risk and low-risk iCCAs stratified by the optimal threshold. Tumor multiplicity (hazard ratio (HR) = 1.671 [95%CI 1.036, 2.695], P = 0.035), hemorrhage (HR = 2.391 [95%CI 1.189, 4.810], P = 0.015), peri-tumor diffusion-weighted hyperintensity (HR = 1.723 [95%CI 1.085, 2.734], P = 0.021), and positive regional lymph node (HR = 2.175 [95%CI 1.295, 3.653], P = 0.003) were independently associated with postoperative recurrence; treatment group was not significantly related to recurrence (P > 0.05). Independent variables above were incorporated for the recurrence prediction model, the 1-year and 2-year time-dependent area under the curve values were 0.723 (95%CI 0.631, 0.815) and 0.725 (95%CI 0.634, 0.816), respectively. After risk stratification, the MRI-predicted high-risk iCCA patients had higher cumulative incidences of recurrence and worse RFS than the low-risk patients (P < 0.001 for both). In the MRI-predicted high-risk patients, neoadjuvant therapy was associated with improved all-stage RFS (P = 0.034), and adjuvant therapy was associated with improved RFS after 4months (P = 0.014). The MRI-based iCCA recurrence predictive model may serve as a decision-making tool for both personalized prognostication and therapy selection.

The clinical impact of intraoperative bleeding on peritoneal recurrence after surgery for stage II to III colorectal cancer

BackgroundThis study aimed to investigate the risk factors for peritoneal recurrence (PR) in patients with stage II to III colorectal cancer who underwent colorectal surgery. MethodsA retrospective study was conducted on 232 patients who underwent colorectal surgery for stage II to III colorectal cancer. Univariate and multivariate analyses were performed to determine risk factors for PR. ResultsThe overall incidence of PR was 8.2 % (19/232). A univariate Cox regression analysis showed that a higher level of carcinoembryonic antigen (CEA) (P = 0.039), higher levels of carbohydrate antigen 19–9 (CA19-9) (P < 0.001), preoperative bowel obstruction (P = 0.011), tumor invasion of T4 category (P = 0.019), lymph node metastasis (P = 0.016), poorly differentiated, mucinous or signet-ring histological type (P = 0.010), larger amount of intraoperative bleeding (P = 0.002), R1 resection (P = 0.003), anastomotic leakage Clavien-Dindo classification (CD) ≥2 (P = 0.018), longer postoperative stay (P = 0.002), and recurrence of other organs preceding disseminated recurrence (P = 0.004) were observed significantly more frequently in patients with PR than in patients without PR. A multivariate Cox regression analysis revealed that poorly differentiated, mucinous, or signet-ring histological type (HR: 5.067, 95 % CI: 1.192–21.534, P = 0.028) and intraoperative bleeding (HR: 1.003, 95 % CI: 1.000–1.005, P = 0.017) were independent risk factors for PR. Peritoneal recurrence-free survival curves generated using the Kaplan-Meier method gradually worsened with increasing intraoperative bleeding (P < 0.001). In addition, the sub-analyses between stage II and stage III and between ≤ cT3 and cT4 also demonstrated that peritoneal recurrence-free survival worsened with increasing intraoperative bleeding. ConclusionsOur findings suggest that histological type, and intraoperative bleeding are risk factors for PR in patients who undergo colorectal surgery for stage II to III colorectal cancer. In particular, peritoneal recurrence is associated with increased intraoperative bleeding.

Thulium laser en bloc resection reduces recurrence rates in NMIBC patients with tumor diameters ≥3cm compared to transurethral resection: a non-randomized controlled study

PurposeThe advantages of en bloc resection of bladder tumors (ERBT) over transurethral resection of bladder tumors (TURBT) in terms of patient prognosis are not yet clear, and there are some technical limitations. We aimed to compare the tumor recurrence in non-muscle invasive bladder cancer (NMIBC) patients with tumor diameter ≥ 3 cm undergoing either TURBT or thulium laser ERBT.MethodsThe patients included were those diagnosed with NMIBC based on pathological confirmation and underwent TURBT or modified thulium laser ERBT in the Department of Urology at Tongji Hospital from 2019 to 2024. The patients’ medical records were meticulously collected and postoperative follow-up was diligently conducted by trained personnel. Recurrence-free survival curves were generated utilizing the Kaplan–Meier method, and group comparisons were performed using the log-rank trend test. To minimize biases, we employed stratified survival analysis, alongside univariate and multivariate Cox regression analysis.ResultsThis study included a total of 396 patients with NMIBC, with 214 undergoing TURBT and 182 undergoing ERBT. For all patients, there was no significant difference (P = 0.180) in RFS between the TURBT and ERBT groups. For patients with tumor diameter ≥ 3 cm, stratified analysis revealed that the RFS of the ERBT group was significantly better than that of the TURBT group (P = 0.033). However, in patients with tumor diameter < 3 cm, there was no significant difference (P = 0.150) between the two groups. Univariate (HR: 0.52, 95% CI 0.28–0.96, P = 0.036) and multivariate (HR: 0.49, 95% CI 0.25–0.93, P = 0.031) Cox analyses revealed that ERBT was an independent protective factor for recurrence in NMIBC patients with tumor diameter ≥3cm.ConclusionThis study found that thulium laser ERBT may offer advantages in managing NMIBC patients with tumor diameters ≥ 3 cm. This could potentially drive the clinical application of thulium laser ERBT.Trial registrationProtocol was registered at Chinese Clinical Trial Register (ChiCTR) with number ChiCTR2000035407 on 12 August 2020.

Recurrence risk analysis for stage II and III colorectal cancer, and the implications of diabetes mellitus as a risk factor for the recurrence of stage III colorectal cancer.

The present study investigated the risk factors for recurrence in patients with stage II-III colorectal cancer (CRC) who underwent colorectal surgery. Data from 232 patients with stage II and III CRC who underwent primary tumor resection were retrospectively analyzed. Univariate and multivariate analyses were performed to determine the risk factors for recurrence. The overall recurrence rate was 21.6% (n=50/232). Univariate Cox regression analysis identified diabetes mellitus (DM) (P=0.032) as a risk factor for recurrence. In addition, multivariate Cox regression analysis showed that DM was an independent risk factor for recurrence-free survival (RFS) (hazard ratio 2.40, P=0.016). The RFS curve obtained using the Kaplan-Meier method indicated that in patients with stage III colon cancer, the non-DM group demonstrated a significantly longer RFS than the DM group (P=0.012). In conclusion, the present study demonstrated that DM may be an independent risk factor for recurrence in patients undergoing curative resection for stage III CRC. Consequently, better postoperative therapy and careful monitoring might be required, especially in patients with stage III CRC and preoperative DM.

765. PATTERNS, TIMING, AND SURVIVAL OF RECURRENCE FOLLOWING SURGERY FOR ESOPHAGEAL ADENOCARCINOMA IN THE EUROPEAN MULTICENTRE ENSURE STUDY

Abstract Background After surgery for esophageal cancer approximately half of patients will develop disease recurrence. A more accurate and detailed understanding of the pattern, timing, treatment and prognosis of initial recurrence sites can guide improvements in surveillance and therapy. Therefore, the aim of this study was to accurately describe the pattern and timing of esophageal cancer recurrence, and to assess the distinct survival patterns of these recurrence locations. Methods This study included all patients who underwent surgical resection for esophageal and junctional adenocarcinoma registered in the ENSURE study. ENSURE was an international multicenter study of consecutive patients undergoing surgery for esophageal and esophagogastric junction cancers between 2009 and 2015 across 20 centers in Europe and Canada (NCT03461341). The first recurrence site was recorded and recurrence-free survival (RFS) was estimated using Kaplan-Meier curves. Sites of first recurrence were stratified into different groups and survival outcomes post recurrence detection were estimated using Kaplan-Meier curves. Results Of 3397 eligible patients, 1310 patients had disease recurrence with comprehensive follow-up data available (median RFS of 12.1 months). First recurrence was detected at multiple distant sites (n=469; 37.3%) or at a single distant site (n=463; 33.7%), while isolated local recurrence occurred in 189 (14.4%) patients. Liver-only recurrence occurred significantly earlier (median 9.0 months), while lung-only (15.2 months) and local-only occurred later (17.8 months). Patients with multiple-sites and liver-only recurrence had significant worse median post recurrence survival (7.4 and 8.3 months, respectively) when compared with lung- or local-only recurrence (10.4 and 15.9 months, respectively). Conclusion This study demonstrates that specific recurrence locations of esophageal cancer possess distinct RFS curves. Furthermore, specific recurrence locations result in different post recurrence survival outcomes. This information can help guide improvements in surveillance after esophageal cancer surgery and decisions regarding treatment of esophageal cancer recurrence.

Chitinase-3 like-protein-1, a prognostic biomarker in patients with hepatocellular carcinoma and concomitant myosteatosis

BackgroundChitinase-3 like-protein-1 (CHI3L1) is a member of the mammalian chitinase-like proteins and elevated serum CHI3L1 level has been proved to be associated with poor prognosis in hepatocellular carcinoma (HCC). This study aimed to investigate the relationship between serum CHI3L1 levels and body composition parameters in patients with HCC after liver transplantation (LT).MethodsThis retrospective study enrolled 200 patients after LT for HCC. Blood samples were collected and serum concentrations of CHI3L1 were measured by enzyme-linked immunosorbent assay. Computer tomography (CT) were used to estimate skeletal muscle and adipose tissue mass. Spearman’s rank correlation test was performed to assess associations between serum CHI3L1 levels and these body composition parameters. A Cox proportional-hazards regression model was performed to identify independent prognostic factors. Overall survival (OS) and recurrence-free survival (RFS) curves were constructed using the Kaplan-Meier method and compared by the log-rank test.ResultsTotal 71 patients (35.5%) were diagnosed with myosteatosis according to skeletal muscle radiation attenuation (SMRA). The 5-year OS rates were 66.9% in non-myosteatosis group, significantly higher than 49.5% in myosteatosis group (p = 0.025), while the RFS of myosteatosis group (5-year RFS: 52.6%) or non-myosteatosis group (5-year RFS: 42.0%) shown no significant difference (p = 0.068). The serum CHI3L1 level were significantly negative correlated with SMRA (r = -0.3, p < 0.001). Interestingly, in patients with myosteatosis, Kaplan-Meier analysis revealed that elevated serum CHI3L1 levels were associated with worse OS (p < 0.001) and RFS (p = 0.047). However, in patients without myosteatosis, Kaplan-Meier analysis found elevated serum CHI3L1 levels were not associated with OS (p = 0.070) or RFS (p = 0.104).ConclusionsElevated CHI3L1 was negatively correlated with SMRA, and predicted poorer prognosis in Chinese population after LT for HCC, especially in those patients with concomitant myosteatosis. Monitoring serum CHI3L1 can predict prognosis and effectively guide individual nutrition intervention.

Short-term Outcome of RPVBT Combined with Chemotherapy for Patients with Single, < 3 cm, T2 Stage Bladder cancer

BackgroundTo investigate the survival outcome of “radical” GreenLight photoselective vaporization of bladder tumor (RPVBT) in conjunction with postoperative chemotherapy for patients with single, < 3 cm in diameter, T2 stage muscle invasive bladder cancer (MIBC).MethodsThirty-eight patients with single, < 3 cm, T2 stage bladder cancer were treated with RPVBT combined with chemotherapy and were included in the RPVBT group. To compare the differences in survival outcome, 80 patients with Ta/T1 bladder cancer and 30 patients with T2 bladder cancer were included as controls. The 80 patients with Ta/T1 bladder cancer underwent GreenLight photoselective vaporization of bladder tumors(PVBT), while 30 patients with T2 bladder cancer underwent radical cystectomy (RC) combined with pelvic lymph node dissection (PLND). Tumor recurrence and death were recorded, and recurrence-free survival (RFS) and overall survival (OS) curves were plotted to compare the survival difference between the RPVBT and control groups.ResultsNo significant differences were observed in comorbidities or living habits between the RPVBT and control groups. Blood loss [RPVBT: 20 (IQR10, 20) vs. RC: 100 (IQR90, 150) mL] and postoperative hospital stay [RPVBT: 5.5 (IQR5, 6), vs. RC: 10 (IQR8, 12) days] in the RPVBT group were significantly lower than that in the RC group. Urinary tract infection [RPVBT: 6 (15.8%) vs. PVBT: 14 (17.5%)] and bladder irritation sign [RPVBT: 11 (28.9%) vs. PVBT: 23 (28.8%) ] were the most common short-term complications in the RPVBT group, with no statistical difference between the RPVBT and PVBT group. The median follow-up time for survival endpoints was 22 (16, 27) months for the included patients after surgery. The outcomes of tumor recurrence at 12, 24, and 36 months were 2 (5.3%), 3 (7.9%), and 5 (13.2%) patients in the RPVBT groups, 13 (16.3%) and 3 (10%) patients experienced recurrence in the PVBT and RC groups at 36 months. No significant differences were noted among the three groups (P = 0.778). Additionally, Kaplan–Meier survival analysis revealed no statistically significant differences in RFS (P = 0.791) and OS (P = 0.689) among the three groups.ConclusionsOur findings indicate that RPVBT combined with chemotherapy is a simple and feasible treatment option with fewer complications and satisfactory survival outcomes in patients with single, < 3 cm, T2 stage bladder cancer.

Long-term outcomes and risk factors for recurrence after lung segmentectomy.

The long-term oncological outcomes and risk factors for recurrence after lung segmentectomy are unclear. The aims of this study were to investigate the long-term prognosis and to evaluate risk factors for recurrence after segmentectomy. Between January 2008 and December 2012, a total of 177 patients underwent segmentectomy for clinical stage I non-small cell lung cancer. The median follow-up period was 120.1 months. The overall survival (OS) and recurrence-free survival curves were analysed using the Kaplan-Meier method with a log-rank test. Univariable and multivariable analyses were used to identify significant factors that predicted recurrence. The study included 177 patients with a median age of 67 years. The median operative time was 155 min. No 30-day deaths were observed. Nine patients (5.1%) had recurrences: loco-regional in 3, distant in 3 and both in 3. The 5-year and 10-year recurrence-free survival rates were 89.7% and 79.8%, and the OS rates were 90.9% and 80.4%, respectively. On multivariable analysis, the risk factor associated with recurrence was a pure solid tumour [hazard ratio, 23.151; 95% confidence interval 2.575-208.178; P = 0.005]. The non-pure solid tumour group had a significantly better probability of survival (5-year OS: 95.4% vs 77.2%; 10-year OS: 86.5% vs 61.8%; P < 0.0001). A total of 113 patients received preoperative positron emission tomography/computed tomography. Patients with a higher maximum standardized uptake value had a significantly higher recurrence rate. Segmentectomy for clinical stage I non-small cell lung cancer produced acceptable long-term outcomes. Pure solid radiographic appearance was associated with recurrence and decreased survival.

Recurrence-free survival curve for pulmonary metastasectomy in colorectal cancer plateaus at 3years.

Pulmonary metastasectomy in colorectal cancer (CRC) has encouraging results; however, specific criteria for lung resection and the timing of resection remain undetermined. Therefore, in this study, we aimed to examine the long-term prognosis and 10-year survival rates and analyze poor prognostic factors in patients who underwent resection of pulmonary metastases from CRC. This retrospective, single-institution study included 156 patients with controlled primary CRC and metastases confined to the lungs or liver who underwent pulmonary metastasectomy between 2005 and 2022. Statistical analyses were conducted using the X2 and two-tailed Student's t test to compare variables. The receiver operating characteristic (ROC) curve was used to determine the appropriate cut-off point for tumor size as a predictive factor of survival. Recurrence-free survival (RFS) and overall survival (OS) were estimated using the Kaplan-Meier method, and non-parametric group comparisons were performed using log-rank tests. The 5- and 10-year OS rates were 67% and 59%, respectively. Further, there was no recurrence 38months post-surgery, and the RFS curve plateaued. Moreover, by 88months post-surgery, no deaths occurred, and the OS curve plateaued. Multivariate analysis revealed that a pulmonary metastatic tumor >14mm and disease-free interval <2years indicated poor prognosis. The RFS curve for pulmonary metastasectomy may plateau approximately 3years after surgery. Pulmonary metastasectomy can achieve long-term survival in selected patients with CRC. Furthermore, surgical resection of recurrence after pulmonary metastasectomy may lead to better results. Thus, tumor size and disease-free interval may be independent prognostic factors.

Establishment of artificial intelligence model for precise histological subtyping of lung adenocarcinoma and its application to quantitative and spatial analysis.

The histological subtype of lung adenocarcinoma is a major prognostic factor. We developed a new artificial intelligence model to classify lung adenocarcinoma images into seven histological subtypes and adopted the model for whole-slide images to investigate the relationship between the distribution of histological subtypes and clinicopathological factors. Using histological subtype images, which are typical for pathologists, we trained and validated an artificial intelligence model. Then, the model was applied to whole-slide images of resected lung adenocarcinoma specimens from 147 cases. The model achieved an accuracy of 99.7% in training sets and 90.4% in validation sets consisting of typical tiles of histological subtyping for pathologists. When the model was applied to whole-slide images, the predominant subtype according to the artificial intelligence model classification matched that determined by pathologists in 75.5% of cases. The predominant subtype and tumor grade (using the WHO fourth and fifth classifications) determined by the artificial intelligence model resulted in similar recurrence-free survival curves to those determined by pathologists. Furthermore, we stratified the recurrence-free survival curves for patients with different proportions of high-grade components (solid, micropapillary and cribriform) according to the physical distribution of the high-grade component. The results suggested that tumors with centrally located high-grade components had a higher malignant potential (P<0.001 for 5-20% high-grade component). The new artificial intelligence model for histological subtyping of lung adenocarcinoma achieved high accuracy, and subtype quantification and subtype distribution analyses could be achieved. Artificial intelligence model therefore has potential for clinical application for both quantification and spatial analysis.

Elevated postoperative carcinoembryonic antigen guides adjuvant chemotherapy for stage II colon cancer: a multicentre cohort retrospective study

Most clinical doctors rely on high-risk factors recommended by guidelines to decide whether to undergo adjuvant chemotherapy for stage II colon cancer. However, these high-risk factors do not include postoperative carcinoembryonic antigen (CEA). This study aims to explore the elevation of postoperative CEA as a risk factor, in addition to other high-risk factors, to guide adjuvant chemotherapy for patients with stage II colon cancer. A retrospective analysis was conducted on stage II colon cancer patients who underwent curative surgery at Yunnan Cancer Hospital and The Sixth Affiliated Hospital of Sun Yat-Sen University from April 2008 to January 2019. Patients were classified into three groups based on high-risk factors recommended by guidelines and postoperative CEA levels: low-risk with normal postoperative CEA, low-risk with elevated postoperative CEA and high-risk. COX regression analysis was used to identify independent prognostic factors affecting patients’ recurrence free survival (RFS). The Kaplan–Meier method was used to create the patients’ RFS curve. The restricted cubic spline (RCS) curve was used to assess the correlation between postoperative CEA and RFS on a continuous scale. Among 761 patients, there were 444 males (62.01%), with a median [IQR] age of 58.0 (18.0–88.0) years. A group of 425 high-risk patients had a 3-year RFS of 82.2% (95% CI 78.5–86.1%), while a group of 291 low-risk patients had a 3-year RFS of 89.7% (95% CI 86.1–93.5%). There was a statistically significant difference between the two groups (HR 1.83; 95% CI 1.22–2.74; P = 0.0067). Among them, the 3-year RFS of 261 low-risk patients with normal postoperative CEA was 93.6% (95% CI 90.5–96.8%), while the 3-year RFS of 30 low-risk patients with elevated postoperative CEA was 57.3% (95% CI 41.8–71.4%). There was a significant difference compared to the 3-year RFS of 425 high-risk patients (overall log-rank P < 0.0001). The multivariate analysis adjusted by the COX proportional hazards model showed that low-risk patients with elevated postoperative CEA patients (HR 14.95, 95% CI 4.51–49.63, P < 0.0001) was independently associated with a 3-year RFS. The restricted cubic spline model showed that in stage II colon cancer patients with tumor diameter > 1.955 ng/mL, the risk of postoperative recurrence increased with increasing postoperative CEA levels. Patients with elevated postoperative CEA levels have a significantly increased risk of recurrence. They should be included as high-risk factors to guide adjuvant chemotherapy for stage II colon cancer.

C-reactive protein flare predicts response to checkpoint inhibitor treatment in melanoma.

The treatment of melanoma has been revolutionized by the use of immune checkpoint inhibition (ICI), but many patients do not benefit. Furthermore, immune-related adverse events may occur during therapy. A predictive biomarker is needed to reliably identify patients benefitting. In lung, renal cell and bladder cancer early C-reactive protein (CRP) kinetics were shown to be a predictive biomarker for ICI. Here, we investigate early CRP kinetics as predictive biomarker for ICI in melanoma patients. Two independent prospectively collected cohorts were analysed: Cohort 1 (n = 87) with advanced and Cohort 2 (n = 99) with completely resected melanoma. Patients were stratified by in the dynamics of CRP after ICI initiation: A doubling of baseline CRP within 30 days followed by at least a 30% drop within 3 months was classified as a CRP flare. If no doubling of CRP was reported, but a 30% drop within 3 months, patients were classified as CRP responders and all others as CRP non-responders. Analysed factors included clinical characteristics like S100B and LDH. Median follow-up was 1.5 and 1.7 years for Cohorts 1 and 2. In Cohort 1 CRP flare (n = 12), CRP responders (n = 43) and CRP non-responders (n = 32) with a progression-free survival (PFS) of 0.7, 0.6 and 0.2 years (p = 0.017) and an overall survival (OS) of 2.2, 1.5 and 1.0 years (p = 0.014), respectively. Multivariable Cox analysis showed an independent risk reduction of progression for CRP responders by 62% compared to CRP non-responders (p = 0.001). In Cohort 2 CRP flare (n = 13), CRP responders (n = 70) and CRP non-responders (n = 16) the log-rank analysis showed a significant difference between OS and recurrence-free survival (RFS) curves (p = 0.046 and p = 0.049). Early CRP kinetics could indicate a response to ICI with improved OS and RFS/PFS. CRP flare and CRP response indicating significantly improved outcomes compared to CRP non-responders.

P857 Effectiveness and safety of subcutaneous infliximab in perianal Crohn's disease: a multicentre cohort study

Abstract Background Infliximab (IFX) demonstrated its effectiveness in perianal CD (pCD) and represents the first-line medical treatment. A subcutaneous (SC) formulation has recently been developed, however so far it has not been specifically investigated in pCD. The aim of our study was to evaluate the effectiveness and safety of SC IFX in pCD. Methods We conducted a multicentre retrospective cohort study in the French GETAID, in patients with either active (group 1) or inactive (group 2) pCD who received SC IFX. Inclusion criteria were, for group 1: active pCD in the 6 months prior to initiation of SC IFX; and for group 2: inactive pCD for &amp;gt; 6 months at the time of IV to SC switch, but with a history of seton drainage. The primary endpoint in group 1 was clinical remission at 6 months (absence of anal ulcers, and absence of draining fistula). Univariate and multivariable logistic regression analyses were performed to identify predictors of clinical remission. In group 2, the primary endpoint was perianal clinical recurrence during follow-up. Results A total of 192 patients were included in 24 centres. Mean age was 38.9 years, 43.2% were women, 25.1% were smokers. 66 patients were included in group 1, 117 in group 2. In 9 patients, pCD had a &amp;gt; 6 months persistent activity on IV IFX when switched to SC. In group 1, median follow-up was 46 (26.6-64.6) weeks, 51/66(77.3%) patients received combination therapy, surgical drainage was performed in 40(60.6%) patients. One(1.5%), 1(1.5%), 32(48.5%), 20(30.3%) and 12(18.2%) patients received 0, 1, 2, 3 and ≥ 4 IV perfusions respectively before SC switch. At M6, 27/61(44.3%) patients were in clinical remission and 53/61(86.9%) in clinical response. MRI remission or response was achieved in 19/28(68%) patients. In univariate analysis, factors inversely associated with remission were BMI, previous pCD surgery, initial seton drainage, and SC dose optimization. In multivariable analysis, prior exposure to ≥1 biologic (OR 0.248;CI95% [0.071-0.861]p= 0.0243) was predictive of clinical remission. In group 2, median follow-up was 53.6(36.7-67) weeks. The pCD recurrence rate at 6 months was 3.1%. The recurrence-free survival curve is shown in Figure1. Overall, SC IFX was discontinued in 20(10.4%) patients, 8 switched back to IV. Two cases of immunization were observed. Median IFX serum concentration was &amp;gt; 20(17.1- &amp;gt; 20) µg/l. There were 16(8.3%) cases of adverse events related to pain/injection-site reaction: 4 switched back to IV, 1 stopped IFX. There were 5 cases of infection, no case of cancer. Conclusion Our results are in line with those reported in the literature on the effectiveness of IV IFX in pCD. The SC formulation appears to be effective and safe for active pCD, and for maintaining remission in inactive pCD

The application of 4S atrial fibrillation scheme in predicting atrial arrhythmia recurrence after catheter ablation

Abstract Background Atrial fibrillation (AF) is the most common chronic cardiac arrhythmia. Recently, there is a new scoring system - 4S (Stroke Risk; Symptoms; Severity of Burden; Substrate), proposed in 2020 European Society of Cardiology AF guideline to identify the characteristics of AF patients in details and provide precise guidance for the AF management. Purpose We aimed to report the disease severity of AF patients who received first time catheter ablation (CA) using 4S-AF scoring system, and further discover the value of 4S-AF scheme in the prediction of atrial arrhythmia recurrence after CA. Methods We conducted a retrospective study of 350 AF patients between 2015 and 2017 referred for first time CA. The components of 4S-AF scheme including the following: (1) ischemic stroke risk (score 0 or 1), (2) symptoms (score 0 to 2), (3) severity of AF burden (score 0 to 2), (4) substrate (cardiovascular risk factors-score 0 to 2; left atrial enlargement-score 0 to 2). The 4S-AF score ranges from 0 to 9, and the study population was stratified into three groups as mild (score 0 to 2), moderate (score 3 to 4) and severe (score 5 to 9) disease. The 3-year risk of recurrence of atrial arrhythmias was studied using the Cox regression analysis. Atrial arrhythmias at follow-up were reported with a time-to-event analysis, and survival curves were created utilizing the Kaplan–Meier method with differences between groups compared with the log-rank test. Results The mean age of patients was 56 ± 11 years, 260 (74%) were men, and 82 (23%) had non-paroxysmal AF. Over the 3-year follow-up, 168 (47%) patients experienced recurrence. The recurrence rates were 32%, 47% and 62% for mild, moderate, and severe disease groups, respectively (Figure A). Non-paroxysmal AF (hazard ratios [HR]: 2.1, 95% confidence interval [CI]:1.5-2.9, p&amp;lt;0.001), larger left atrial dimensions (HR: 1.0, 95% CI:1.0-1.1, p=0.03) and a higher 4S-AF score (HR: 1.2, 95% CI:1.1-1.3, p=0.001) were significantly associated with a higher risk of recurrence of atrial arrhythmia. After the multivariate adjustment, a higher 4S-AF score (HR: 1.1, 95% CI:1.0-1.2, p=0.006) remained as the independent predictor of recurrence. The recurrence-free survival curves after CA are shown in Figure B. The severe disease group was associated with a 1.9-fold higher risk of atrial arrhythmia recurrence compared to mild disease group (HR 1.9, 95% CI:1.3-2.9, p =0.002). Conclusions The disease severity of AF patients characterized using 4S-AF scheme could predict the risk of atrial arrhythmia recurrence after CA.

Long-term follow-up of a consecutive cohort validating an epidermal growth factor receptor mutation as an independent risk factor for postoperative recurrence in lung adenocarcinoma.

Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors were recently reported to be effective as adjuvant therapy for resected lung adenocarcinoma (ADC) harbouring common EGFR mutations. However, whether the EGFR mutation is a direct risk factor for postoperative recurrence remains unknown. Therefore, we conducted a multi-institutional observational study to compare postoperative survival according to EGFR mutation status. We collected the medical records of consecutive patients who underwent surgical resection for ADC between 2005 and 2012 at 4 participating institutions. Recurrence-free survival (RFS) and overall survival (OS) associated with EGFR mutation status were evaluated. We further analysed survival after pair-matching patients' clinicopathological characteristics. EGFR mutations were harboured by 401 of 840 (48%) enrolled patients. The number of patients with an EGFR mutation (M group) differed from that with the EGFR wild-type sequence (W group) in terms of sex, smoking history and pathological stage. The median follow-up period was 85 months. The five-year RFS/OS rates of the M and W groups were 70%/85% and 61%/75%, respectively (P < 0.001 for both groups). However, multivariable analysis revealed that EGFR mutation status was not independently related with both RFS and OS. In pair-matched analysis, the RFS and OS curves of the patients with an EGFR mutation and wild-type sequence were not statistically different, either. Long-term follow-up of consecutive patients did not show that a common EGFR mutation was an independent risk factor of recurrence or prognostic factor for completely resected lung ADC.

Outcomes of the distal rectal cancer treatment depending on the type of sphincter-sparing surgery

Introduction: The increase in mid-ampullary and lower ampullary rectal cancer with disappointing treatment results requires ongoing discussion, research, and improvement of the complex treatment. Materials and methods: We analyzed the results of complex treatment in 442 patients with stages II–III mid-ampullary and lower ampullary rectal cancer that underwent three types of sphincter-sparing surgeries, including low anterior resection (LAR), intersphincteric resection (ISR), and abdomino-anal resection of the rectum (AAR) at the second stage of complex treatment. Results: There was a significant difference between groups in terms of surgery type selection based on the distance from the tumor to the dentate line. When the tumor was located at a distance of 30 mm or less from the dentate line, LAR was performed in 16.4% of cases, whereas ISR and AAR were used in 96.58 and 58.09% of cases, respectively, which is statistically significant (P&lt;0.001). Preventive stoma was used in 78.87% of LAR, 5.9% of ISR, and 6.62% of AAR, which had a significant difference (P&lt;0.001). In the structure of postoperative complications, a group of typical complications (ІІІ–IV) was identified for the types of operations performed. Their frequency when performing LAR was 18.2%, ISR – 7.7%, and AAR – 8.1%, which was statistically significant (P=0.003). The frequency of local recurrences, depending on the type of surgery was not statistically significant (P&gt;0.05), but had a direct correlation with the recurrence-free survival curves. Relapse-free and overall (3 years and 5 years) survival depending on the type of sphincter-preserving surgery did not have a significant difference according to the log-rank test. Conclusion: The more types of surgical intervention surgeons have at their disposal, the more rational it is to select the one that will ensure the best treatment results.

Prognostic impact of tumor ureteral invasion on recurrence after radical cystectomy.

Several preoperative factors have been suggested to be risk factors of disease recurrence after radical cystectomy. There is no study focusing on the impact on prognosis of bladder tumor ureteral invasion in preoperative imaging. The study population consisted of 136 patients, all of whom underwent radical cystectomy during the period between 2007-2019. We excluded patients with concurrent or a history of upper tract urothelial carcinoma and who underwent radical cystectomy for other cancers or nononcologic reasons. The starting point of this study was the timing of neoadjuvant chemotherapy or radical cystectomy and the endpoint was the timing of disease recurrence. To identify the factors influencing recurrence, univariate and multivariate analyses were performed using the Cox proportional hazard model. Recurrence-free survival curves were constructed using the Kaplan-Meier method. Ureteral invasion was observed in 20 (14.7%) patients. Disease recurrence was observed in 11 (55.0%) of 20 ureteral invasion positive patients and 35 (30.2%) of 116 ureteral invasion negative patients, respectively. In the ureteral invasion positive group, clinical T and N stage were higher and hydronephrosis were more common than in the ureteral invasion negative group. According to the multivariate analysis, ureteral invasion (hazard ratio: 2.307, p = 0.016) and clinical N stage ≥ 1 (hazard ratio: 2.140, p = 0.028) were independent risk factors for postoperative recurrence. In the ureteral invasion positive group, more local recurrences were observed. This study suggested that ureteral invasion in preoperative imaging is a significant risk factor for postoperative recurrence.

Tumor volume doubling time as a potential predictor of prognosis in clinical stage I lung squamous cell carcinoma.

Tumor volume doubling time (VDT) has been shown to predict prognosis in various non-small cell lung carcinoma with scant evidence for lung squamous cell carcinoma (SCC). The purpose of this study was to investigate the prognostic value of tumor VDT in resected lung SCCs. In this study, subjects were 51 patients who underwent lobectomy for clinical stage I SCC of the peripheral lung at our institution between January 2006 and April 2020. Univariable and multivariable analyses of overall survival (OS) and recurrence-free survival (RFS) were performed using the Cox proportional hazards model. The Kaplan-Meier method was used to create OS and RFS curves and to determine statistical significance. The cut-off value of VDT was defined by receiver operating characteristic (ROC) curve analysis on survival. Multivariable analysis found only VDT (HR, 0.990; 95% CI: 0.979-0.997) to be an independent predictor of OS. Also, only VDT (HR, 0.989; 95% CI: 0.978-0.995) was an independent predictor of RFS. The 5-year OS rates were 88.4% and 30.4% in the long (≥150 days) and short (<150 days) VDT groups, respectively (P=0.002). The 5-year RFS rates were 88.8% and 26.5% in the long (≥150 days) and short (<150 days) VDT groups, respectively (P<0.001). Tumor VDT was found to be a useful prognostic predictor in clinical stage I lung SCC in this study.