Recurrence-free Rates Research Articles

Effect of Combined Pulmonary Vein and Superior Vena Cava Isolation on the Outcome of Second Catheter Ablation for Paroxysmal Atrial Fibrillation

Recurrence of paroxysmal atrial fibrillation (AF) is partly due to pulmonary vein (PV) reconnection and non-PV foci, especially superior vena cava (SVC). We aimed to investigate the efficacy and safety of empiric SVC isolation plus PV isolation after first failed radiofrequency ablation involving only PV isolation for paroxysmal AF. Procedural and follow-up outcomes of ablation for 144 consecutive paroxysmal AF patients after first failed radiofrequency ablation involving only PV isolation were retrospectively compared between patients undergoing either conventional SVC isolation (additional SVC isolation if SVC-triggered AF or rapid SVC activity was observed; n = 72) or empiric SVC isolation after PV isolation (n = 72). In conventional SVC isolation versus empiric SVC isolation groups: baseline characteristics and proportion of recorded PV electrical potentials were similarly distributed and all pulmonary veins were successfully reisolated; SVC isolation was performed less often (6 [8.3%] vs 70 [97.2%]; p <0.001, respectively); and during 19 ± 10 months follow-up, atrial tachyarrhythmias recurrence-free rate after a second procedure was lower (58.3% vs 77.8%, log rank; p = 0.037). Multivariate regression analysis revealed LA diameter ≥45 mm (odds ratio [OR] = 2.5; 95% confidence interval [CI], 1.4 to 4.6; p = 0.002) as the independent risk factor of atrial tachyarrhythmias recurrence and empiric SVC isolation (OR = 0.47; 95% CI, 0.25 to 0.87; p = 0.016) as the independent protector against atrial tachyarrhythmias recurrence after a second ablation procedure. Empiric SVC isolation plus PV isolation did not increase significantly procedural time or complications. In conclusion, the strategy of empiric SVC isolation plus PV isolation during a second procedure for paroxysmal AF improved atrial tachyarrhythmias recurrence-free rate without increasing procedural time or complications.

MP60-12 MID-TERM RESULTS OF ANTERIOR URETHROPLASTY WITH TISSUE-ENGINEERED ORAL MUCOSA GRAFT MUKOCELL®

INTRODUCTION AND OBJECTIVE: Anterior urethroplasty with buccal mucosa grafting is the standard procedure for recurrent urethral strictures of ≥2 cm length. Trying to avoid oral complications through harvesting buccal mucosa, a tissue-engineered oral mucosa graft (MukoCell®) was manufactured. Current multicenter retrospective studies report success rates of 67-84%. The objective of our institutional retrospective analysis is the assessment of the mid-term efficacy and complications of this method. METHODS: Between 05/2016 and 06/2019 a total of 77 patients with anterior urethral strictures underwent a urethroplasty with MukoCell®. Our cohort consisted of 45 patients with bulbar strictures (78,9%), 15 with penobulbar (19,5%), 11 with penile (14,3%), 4 with membranous (5,2%) and 2 with simultaneous bulbar and penile strictures (2,6%) respectively. Mean patient age was 59 years (range 16 to 87) with mean 2,5 previous endoscopic or anastomotic procedures (range 0 to 8). 4 different surgeons performed in 61 cases ventral/dorsal onlay techniques (79,2%), in 5 cases inlay-ASOPA technique (6,5%) and in 11 cases combined (Palminteri et al.) technique (14,3%). Mean stricture length was 5,3 cm (range 2 to 16). 8 (10,4%) strictures were traumatic, 39 (50,6%) iatrogenic, 21 (27,3%) idiopathic, 1 (1,3%) radiogenic, 1 (1,3%) associated with Lichen sclerosus, 2 (2,6%) former hypospadias and 2 (2,6%) had other causes. IPSS-Score, Uroflowmetry and post void residual measurement were recorded pre- and postoperatively twice a year. Retrograde urethrography was performed pre- and 3 weeks postoperatively and repeated by suspicion of recurrence. RESULTS: Mean follow up was 24 months (range 8 to 43). 24 patients (31,2%) developed a recurrence of the stricture (14 with bulbar, 4 penobulbar, 3 penile, 2 membranous and 1 simultaneous bulbar and penile localization and mean 2,3 previous endoscopic operations (range 1-6) after mean 6,5 months (range 1,5 to 17). None perioperative hemorrhage occurred in all patients. We reported 5 cases of perineal wound dehiscence, 5 UTIs, 7 contrast leaks in the postoperative urethrography and 1 urethrocutaneous fistula requiring surgical intervention (Clavien-dindo 3b). No local (oral-urethral) or general adverse events related to the use of MukoCell® were observed. CONCLUSIONS: The recurrence-free rate of anterior urethroplasty using MukoCell® in our hands was 68,8% after a two-year follow-up. A prospective multicenter study comparing „head-to-head“ the efficiency of this graft with the native oral mucosa will be initiated in Germany in 2020. Source of Funding: none

Prognostic values of immune scores and immune microenvironment-related genes for hepatocellular carcinoma.

It is crucial to grasp the characteristics of tumour immune microenvironment to improve effects of immunotherapy. In this study, the immune and stromal scores of 371 cases were calculated for quantitative analysis of immune and stromal cell infiltration in the tumour microenvironment of hepatocellular carcinoma (HCC). The weighted gene co-expression network analysis and protein–protein interaction network were analysed to identify immune microenvironment-related genes. The results showed that patients with high immune scores had a higher 4-year recurrence-free rate. TP53, CTNNB1, and AXIN1 mutations significantly varied with immune scores. In immune score-related modules analysis, Kyoto encyclopaedia of genes and genomes pathways and gene ontology terms were closely related to immune processes, tumorigenesis, and metastasis. Twelve new immune microenvironment-related genes were identified and had significantly positive correlations with seven immune checkpoint genes. In prognostic analysis, eleven immune microenvironment-related genes exhibited high expression, nine of which were validated in the GSE62232 dataset and were significantly associated with a good prognosis. Our findings suggest that calculating immune score and stromal score could help to determine tumour purity and immune cell infiltration in the tumour microenvironment. Nine immune microenvironment-related genes identified in this study had potential as prognostic markers for HCC.

Systematic Review of the Therapeutic Efficacy of Bladder-preserving Treatments for Non–muscle-invasive Bladder Cancer Following Intravesical Bacillus Calmette-Guérin

ContextThere is a critical need for effective bladder-sparing therapies for bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC). Owing to the current lack of effective agents that can be used as a control, the US Food and Drug Administration began to accept single-arm trials for patients with carcinoma in situ (CIS), using complete response rate (CRR) and duration of response as the primary endpoints to support marketing applications. Despite the ensuing growth of clinical trials in this space, no consensus exists on a clinically relevant benchmark for CRR. ObjectiveTo elucidate the CRR and recurrence-free rate (RFR) using bladder-sparing agents after BCG failure in order to provide a frame of reference for future clinical trial results. Evidence acquisitionWe performed a systematic review of clinical trials utilizing bladder-sparing therapeutics for NMIBC recurring after intravesical BCG (PROSPERO CRD42019130553). The search was performed in MEDLINE, EMBASE, and Cochrane Library. Relevant studies identified from bibliography search and conference abstracts were searched to complement the systematic review. A total of 42 studies utilizing 24 treatment options and consisting of 2254 patients were included for final analysis. Evidence synthesisMedian CRRs in the treatment of CIS-containing tumors were 26% at 6 mo, 17% at 12 mo, and 8% at 24 mo after treatment. In comparison, median RFRs in the papillary-only studies were 67% at 6 mo, 44% at 12 mo, and 10% at 24 mo. Specifically in the BCG-unresponsive population, 6- and 12-mo CRRs in CIS-containing patients treated with Mycobacterium phlei cell wall–nucleic acid complex were 45% and 27%, respectively, and the median 6-, 12-, and 24-mo disease-free rates in the other studies were 43%, 35%, and 18%, respectively. The median progression-free rate was 91%: 95% in the CIS-containing studies and 89% in studies restricted to papillary-only recurrences. Toxicities of intravesical agents were generally mild, with very few dose limiting toxicities. ConclusionsWe demonstrate that, to date, bladder-sparing therapies achieved modest efficacy in patients with NMIBC after BCG. Results from the current study will serve as a frame of reference for emerging trial results in the BCG-unresponsive space. Patient summaryIn this study, we found that bladder-sparing therapies achieved modest efficacy in patients with non–muscle-invasive bladder cancer after bacillus Calmette-Guérin (BCG). These results will serve to inform future clinical trial results for salvage agents used to treat BCG-unresponsive bladder cancer.

Management and Outcome of Local Regrowths in a Watch-and-wait Prospective Cohort for Complete Responses in Rectal Cancer.

To evaluate the management and oncological outcomes of rectal cancer patients with local regrowth in a watch-and-wait (W&W) program. Approximately 15%-30% of patients with a clinical complete response after (chemo) radiotherapy who undergo a W&W policy will experience a local regrowth. The risks of these local regrowths have not yet been fully established and main concerns include high postoperative morbidity, requirement of advanced surgery, and pelvic recurrence after regrowth treatment. All patients with a local regrowth after an initial W&W approach between January 2005 and March 2018 were retrospectively identified from 2 cohorts of rectal cancer patients with a clinical complete response after (chemo) radiotherapy. Type and outcome of regrowth treatment were assessed. Oncological outcome was assessed using Kaplan-Meier estimates. Eighty-nine out of 385 patients developed a local regrowth after a median of 9 (interquartile range 7-14) months. Median follow-up time was 28 (interquartile range 19-41) months. Eighty-four (94%) patients underwent surgical treatment of the local regrowth: total mesorectal excision was performed in 58 out of 84 (69%) patients and local excision was performed in 26 (31%) patients. The 2-year local recurrence-free rate, distant metastasis-free rate, disease-free survival, and overall survival in the patients undergoing surgical treatment were 97.8%, 91.8%, 90.3%, and 98.4%, respectively. The vast majority (97%) of patients with regrowth after a W&W policy were able to undergo treatment with curative intent for local regrowth. Uncontrolled pelvic disease was very rare.

Relationship between platelet-based models and the prognosis of patients with malignant hepatic tumors.

Platelets (PLTs) are involved in tumor growth, metabolism and vascular activation. PLT-based models have been reported to have significant value on the recurrence of malignant hepatic tumors. The present study aimed to investigate the effect of PLT count and 18 PLT-based models on the prognosis of patients with malignant hepatic tumors. The clinical data from 189 patients with malignant hepatic tumors were retrospectively analyzed and used to calculate the scores of the 18 PLT-based models. Receiver operating characteristic curve was used to determine the suitable cut-off values of mortality and recurrence in patients with malignant hepatic tumors. The overall survival and cumulative recurrence rates of patients were calculated using Kaplan-Meier survival curves and the difference was analyzed using log-rank test. Multivariate analysis was performed to determine the independent risk factors of recurrence-free survival and overall survival. In the present study, 11 models were considered as predictors of mortality (P<0.05) and six models were considered as predictors of recurrence (P<0.05). The results from multivariate analysis demonstrated that vascular cancer embolus, uric acid >231 µmol/l, hemoglobin >144 g/l and the Lok index model >0.695 were considered as independent risk factors of mortality (P<0.05). Furthermore, vascular cancer embolus, PLT to lymphocyte ratio (PLR) >175 and fibrosis-4 (FIB-4) >4.82 were independent factors of recurrence (P<0.05). In addition, the results from this study indicated that the Lok-index could be considered as a predictor of the overall survival rate. In conclusion, the FIB-4 and PLR model may be valuable for predicting the recurrence-free rate of patients with malignant hepatic tumors.

Learning curve of various type of male urethroplasty.

PurposeTo determine the number of cases required to achieve a specified recurrence-free rate (>80%) among urethroplasty types.Materials and MethodsA retrospective analysis of consecutive patients, who underwent urethroplasty performed by a single surgeon between April 2013 and January 2019, was conducted. Urethroplasty subtypes were divided according to stricture location: penile, bulbar, and posterior. If there was no recurrence for >6 months after surgery, the surgery was considered to be a success. The average success rates among quintile groups were compared to determine the learning curve for each type.ResultsOf 150 patients who underwent urethroplasty, 112 were included in this study. The overall success rate was 89.7% in penile, 97.8% in bulbar, and 74.1% in posterior urethroplasty. Bulbar urethroplasty reached the target success rate in the first quintile group (1–9 cases). Penile urethroplasty also achieved the target success rate in the first quintile group (1–8 cases), and the success rate gradually increased until the fifth quintile group (32–39 cases). In posterior urethroplasty, the target success rate was achieved in the fifth quintile group (20–27 cases).ConclusionsBulbar urethroplasty had the fastest learning curve, and posterior urethroplasty the slowest.

Characteristics and clinical outcome of pT1a-b node-negative breast cancer.

OBJECTIVE:Tumor size, along with other clinicopathological characteristics, has a prognostic role in breast cancer. Recurrence risk tends to rise as tumor size increases. Early T-stage portends a good prognosis. We aimed to investigate the recurrence-free interval rates of T1abN0 group of early breast cancer.METHODS:Patients diagnosed with pT1a and T1b, lymph node metastasis-negative breast cancer were included in the study. Clinicopathologic characteristics including recurrence, distant metastasis, and final status of the patients were obtained retrospectively from the patient files.RESULTS:A total of 84 patients included. Twenty-six patients (31%) had T1a and 58 patients (69%) had T1b tumors. The 5-year distant relapse-free survival (DRFS) rate of T1ab tumors was 95.2%. The DRFS rate of T1a tumors was 96.2%, while the rate of T1b tumors was 94.8% (p=0.555). The 5-year RFS rate of T1ab tumors was 90.5%. The RFS rate of T1a tumors was 84.6%, whereas the rate of T1b tumors was 93.1% (p=0.359). The 5-year DRFS rate of hormone receptor positive group was 97%, Her-2 positive group was 81.8%, and triple negative group was 100% (p=0.041). The 5-year RFS rate of the hormone receptor positive group was 97%, Her-2 positive group was 72.7%, and triple negative group was 57.1% (p=0.001).CONCLUSION:The results of the study provided that both T1a and T1b tumors have a good and similar prognosis.

Periocular basal cell carcinoma: recurrence risk factors/when to reoperate?

IntroductionThe aim of periocular basal cell carcinoma (BCC) surgery is radical excision of the tumour while maintaining eyelid functionality and facial aesthetics. Differences in management of the patients after excision of eyelid BCC with a narrow margin are described in the literature.AimThis study concerns the correlation between the recurrence rate in the periorbital area and the narrow safety margin of excision in the histopathological report with respect to various clinical and histopathological features.Material and methodsA retrospective non-randomized analysis was conducted on 158 patients with BCC of the periorbital area. These patients were operated on between January 2002 and December 2016. A database was created, comprised of patient age, sex, location of the lesion, TNM, method of reconstruction, result of the histopathological examination, date and location of the recurrence.ResultsIn 66 (41.77%) patients BCC was radically removed. In 50 (31.65%) patients BCC was removed with a narrow margin and in 42 (26.58%) cases, radical excision was not achieved. The recurrence rate was significantly higher in the aggressive BCC group compared to those with non-aggressive BCC (p = 0.004). The recurrence-free rate for non-aggressive subtypes was 98.11% in both the first and fifth years, but in aggressive subtypes it was 89.06% in the first year but fell to 80.16% in the fifth year.ConclusionsAn aggressive subtype of BCC significantly influences the risk of non-radical excision of the lesion. Aggressive BCC subtypes should have more frequent check-ups. There is no need to reoperate patients with a narrow margin of BCC excision.

Therapeutic Endoscopic Treatment Plus Maintenance Dimethyl Sulfoxide Therapy Prolongs Recurrence-Free Time in Patients With Hunner Type Interstitial Cystitis: A Pilot Study.

PurposeTo evaluate whether hydrodistention with fulguration of Hunner lesions (HD/FUL) plus maintenance dimethyl sulfoxide (DMSO) therapy prolongs the recurrence-free time in patients with Hunner type interstitial cystitis (IC).MethodsThe study enrolled patients with Hunner type IC who required repeat HD/FUL due to recurrence of IC symptoms after the first HD/FUL at our institution. All patients received a second HD/FUL plus maintenance DMSO therapy. The maintenance DMSO therapy was performed every 2 weeks for a total of 8 instillations, and then once every 4 weeks thereafter. The recurrencefree time from HD/FUL to therapeutic failure was estimated using the Kaplan-Meier method. The recurrence-free time between the first HD/FUL and second HD/FUL plus maintenance DMSO therapy was statistically compared using the log-rank test.ResultsA total of 21 patients (mean age, 66.3±10.8 years) with Hunner type IC were evaluated. The recurrence-free time for the second HD/FUL plus maintenance DMSO therapy was significantly longer than that for the first HD/FUL (P<0.0001). The median recurrence-free time for the first HD/FUL was 10.1 months, while that for the second HD/FUL plus maintenance DMSO therapy has yet to be reached. The recurrence-free rate for the first HD/FUL was 81.0% at 6 months, 38.1% at 1 year, 9.5% at 2 years, and 4.8% at 3 years. In contrast, the rate for the second HD/FUL plus maintenance DMSO therapy was 100% at 6 months, 94.7% at 1 year, 82.6% at 2 years, and 82.6% at 3 years. There were no significant differences in efficacy between the first and second HD/FUL.ConclusionsHD/FUL plus maintenance DMSO therapy clearly prolongs the recurrence-free time compared with HD/FUL alone in Hunner type IC.

Effects of pelvic bone fracture on recurrence-free rate after bulbomembranous anastomotic urethroplasty in men with posterior urethral injuries.

PurposeTo determine the impact of pelvic bone fracture on the recurrence of urethral stenosis after bulbomembranous anastomotic urethroplasty.Materials and MethodsA total of 197 patients with complete posterior urethral injuries underwent bulbomembranous anastomotic urethroplasty. These patients were divided into two groups according to the presence of pelvic bone fracture. Recurrence of urethral stenosis was defined as the need for any postoperative surgical intervention. The surgical outcomes and postoperative recurrence rate of urethral stenosis were compared between the two groups, and significant predictors for posterior urethral restenosis, including pelvic bone fracture, were analyzed via multivariate analysis.ResultsOf the patients, 92 had pelvic bone fractures and the other 105 patients did not. The patients with pelvic bone fracture had increased involvement of the prostatic urethra compared to the group without pelvic bone fracture (3.8% vs. 17.4%, p=0.002). Recurrence of urethral stenosis was more common in the pelvic bone fracture group (42/92, 45.7%) than the group without pelvic fracture (27/105, 25.7%). In a Kaplan—Meier analysis, the recurrence rate at 5 years was significantly lower in the pelvic bone fracture group (59.1% vs. 72.6%, p=0.003). A Cox proportional hazard analysis showed that the presence of pelvic bone injury was a significant predictor of posterior urethral re-stenosis.ConclusionsPatients with posterior urethral injuries associated with pelvic bone fracture had a higher recurrence rate of urethral stenosis after bulbomembranous anastomotic urethroplasty than those without pelvic bone fracture.

The Diagnostic Accuracy and Postoperative Outcomes of Cervical Cancer Patients for MR-invisible or MR-visible Diagnosis of Combined T2- and Diffusion-weighted 3T MRI Using the External Phased-array Receiver.

This study aimed to determine the diagnostic accuracy and postoperative outcomes of early-stage cervical cancer patients [2009 FIGO stages IA2-IB1 (<2 cm)] diagnosed with magnetic resonance (MR)-invisible disease or MR-visible disease using the external phased-array receiver. Between 2007 and 2014, 110 patients with a FIGO clinical stage IA2-IB1 (<2 cm) cervical cancer underwent primary surgical treatment after external array coil T2W and DW MR imaging following the diagnostic biopsy procedure. The median histological size of MR-invisible vs. MR-visible diagnosis was 3±6.4 mm and 16±5.2 mm. Eighty-five of the 110 patients had histologically residual tumor. The sensitivity, specificity, PPV, and NPV of tumor diagnosis were 63.5%, 92.0%, 96.4%, and 42.6%, respectively. Histological estimates of 54 (49.1%) MR-invisible vs. 56 (50.9%) MR-visible diagnoses were identified as 23 true-negative (TN) and 31 false-negative (FN) vs. 54 true-positive (TP) and 2 false-positive (FP). The recurrence-free rate was 98.1% in the MR-invisible group and 91.1% in the MR-visible group. The overall survival rates were 100% and 92.9%, respectively. A preoperative MR-invisible diagnosis in early-stage cervical cancer patients led to a high probability of FN and was associated with underdiagnosis.

IJU this issue

In this issue, seven Original Articles with four Editorial Comments, two Review Articles and three Urological Notes were published in the International Journal of Urology. Urinary tract infection or perioperative infection control is one of the important clinical issues for urologists. A rapid increase of carbapenem-resistant Enterobacteriaceae and its outbreak is a grave worldwide problem. Kitano et al. (Hiroshima, Japan) reviewed mechanisms behind antimicrobial resistance, and new antimicrobials to treat resistant microbes. This article concisely describes the current state of resistant microbes associated with urinary tract infections and countermeasures for antimicrobial resistance, including new antimicrobials. As the author denotes in Table 3 of that article, the World Health Organization priority list for antibiotic-resistant bacteria should be recognized by urologists. As different treatment modalities for localized prostate cancer yield similar patient outcomes, the focus in determining appropriate treatment has shifted toward health-related quality of life. Murakami et al. (Kanagawa, Japan) reviewed the impact of brachytherapy and other modalities on health-related quality of life. Except for the inferior outcome regarding urinary obstruction and irritation, brachytherapy is likely to yield similar or better health-related quality of life than other treatment modalities, such as operation, active surveillance or external beam radiation therapy. Due to scant data on prospective direct comparison among modalities and recent replacement by sophisticated technologies, such as intensity-modulated radiation therapy or robot-assisted radical prostatectomy, it seems hardly difficult to draw a convincing conclusion. Sazuka et al. (Chiba, Japan) retrospectively examined the impact of post-void residual urine volume on the risk of postoperative intravesical recurrence in 81 patients with upper urinary tract urothelial carcinoma undergoing nephroureterectomy. The authors found the presence of pyuria and a residual urine volume (defined as ≥30 mL) were associated with bladder recurrence in the multivariate analysis, and the 2-year postoperative recurrence-free rates of patients with and without a residual urine volume were 32% and 82%, respectively. Although the number of the cohort for a propensity-score match study is limited, the authors’ hypothesis is unique and is worthwhile for a large-scale prospective analysis. Choo et al. (Suwon, Korea) carried out to a web-based questionnaire survey regarding the individual treatment trend and adherence to international guidelines on non-muscle-invasive bladder cancer. Out of 2334 urologists who were active members of the Japanese Society of Urological Oncology, the Korean Urological Oncology Society and the Taiwan Urological Association, 701 (30%) responded to the survey from June 2016 to February 2017. The authors found significant differences in the management of intermediate- to high-risk non-muscle-invasive bladder cancer between Japan, Korea and Taiwan. As the authors described, East Asian countries are geographically close together, and share ethnic and sociocultural similarities, such that the survey can serve as the basis for joint efforts among East Asian urologists to develop common clinical guidelines for the management of non-muscle-invasive bladder cancer. Nephrostomy tube after percutaneous intrarenal surgeries, such as percutaneous nephrolithotomy (PCNL), sometimes prevents a short hospital stay and adversely affects patients’ quality of life. A tubeless procedure would be ideal after PCNL. Takeda et al. (Miyazaki, Japan) compared the efficacy and safety among patients who received trans-tract electrocoagulation at the end of endoscopic combined intrarenal surgery (225 patients) with that of those who did not (72 patients). Although stone number or size was in favor of the trans-tract electrocoagulation group, the nephrostomy tube-free rate and other postoperative clinical parameters were significantly higher in the trans-tract electrocoagulation group. As Kakinoki (Saga, Japan) indicated in the Editorial Comment, all patients do not always require such procedure, particularly when miniaturized PCNL is used. To clarify the necessity of hemostasis, a prospective randomized study comparing miniaturized PCNL is warranted. None declared.

Effect of bronchial artery embolisation on the management of tuberculosis-related haemoptysis.

OBJECTIVE: To identify risk factors influencing outcomes of bronchial arterial embolisation (BAE) in tuberculosis (TB) related haemoptysis.METHODS: A cohort of 207 patients underwent BAE for TB-related haemoptysis between March 2014 and March 2018. The clinical data were reviewed. Follow-up ranged from 24 to 1749 days.RESULTS: Immediate haemostasis rate was 94.2%; aggressive pleural thickening (PT) was found to be a risk factor for haemoptysis (P = 0.000, OR 22.52). Cumulative recurrence-free rates were respectively 98.5%, 94.8%, 88.7%, 79.9%, 68.5%, 65.7% and 62.7% for 1, 3, 6, 12, 24, 36 and 48 months. Respectively 8 and 15 patients recovered from pneumonectomy and re-BAE. However, five patients required a third BAE. The Cox regression analysis indicated that aggressive PT (P = 0.000), diabetes mellitus (DM) (P = 0.018) and pulmonary fungal infection (PFI) (P = 0.001) were independent risk factors for recurrence. The death rate following BAE was 9.2%; aggressive PT was a risk factor (P = 0.000, OR 8.14).CONCLUSION: BAE is effective for TB-related haemoptysis in most cases. Aggressive PT, DM and PFI are independent risk factors influencing the prognosis following BAE. PFI and DM should be well managed, while proper surgery should be considered for aggressive PT.

RARE-47. CHARACTERIZATION OF ADULT MEDULLOBLASTOMA; A RETROSPECTIVE REVIEW OF 200 PATIENTS AT MD ANDERSON CANCER CENTER

Abstract INTRODUCTION Prospective studies for adult medulloblastoma (MB) are scarce and management guidelines are largely derived from pediatric experience and retrospective data. However, adult MB is a distinct disease for which limited data exist regarding clinical characteristic, prognostic factors, outcome based on upfront treatment, or patterns of recurrence. METHODS 200 patients (≥18 years at diagnosis) were identified from 1978 to 2017. Survival analysis was performed using the Kaplan-Meier method. RESULTS Median age at diagnosis 29 (18–63); 111 (55.5%) standard-risk (SR), 59 (29.5%) high-risk (HR), 30 (15%) unknown. 188 (94%) and 97 (48.5%) underwent radiotherapy and upfront chemotherapy, respectively. Median PFS: 6.28 years (4.9–11.2); median OS: 8.8 (7.8–12.4) years. Median time to first recurrence: 8.2 (5.1-not reached); 5-year recurrence-free rate: 71% in SR and 45% in HR patients. Survival after first recurrence: 2 years (1.64–2.4). Documented recurrence and risk group were associated with survival (HR 30.4, p&lt; 0.0001 and 2.33, p&lt; 0.001), but metastatic status and local vs. distant recurrence were not. The effect of upfront chemotherapy on survival did not reach statistical significance in SR patients. The use of chemotherapy regimens with or without vincristine or containing cisplatin vs. carboplatin, did not alter the survival outcome. In a subgroup of 57 SR patients who were seen at initial diagnosis and for whom complete staging and treatment information were available 3 and 5-year PFS were 94% (88%, 100%) and 76% (66%, 86%); OS at 5 years, 94% (87%, 100%). CONCLUSION No statistically significant difference was noted in outcome of patients treated without vincristine or with carboplatin instead of cisplatin, suggesting attenuated upfront regimens could be considered to reduce toxicity. Adult MB patients recur late and have a poor post-recurrence survival, therefore long-term follow-up, development of molecular risk-adjusted upfront treatment, and optimization of rescue treatments are needed.

A novel approach with holmium laser ablation for endoscopic management of intrahepatic biliary stricture

BackgroundHepatolithiasis, featuring high incidence, severe symptoms, and common recurrence, poses a heavy disease burden. Endoscopic management provides an opportunity to cure hepatolithiasis, but fails to properly resolve biliary stricture without additional interventional techniques. An innovative approach towards endoscopic management of biliary stricture is required.MethodsHolmium laser ablation was applied to biliary strictures via endoscopic access. Patients’ demographic, operative, and follow-up data after receiving holmium laser ablation were retrospectively collected for analysis.ResultsA total of 15 patients (4 males and 11 females) underwent stricture ablation by holmium laser via cholangioscopy. All the patients successfully received holmium laser ablation, indicating a technical success rate of 100%. No postoperative mortality or no major perioperative complication was observed. During the follow-up period, the recurrence-free rate was 73% at 2 years and 67% at 5 years.ConclusionsWe successfully developed a novel technique of biliary stricture removal by cholangioscopic holmium laser ablation with satisfying clinical outcomes.

LB5. A Long-Time Coming: Final 2-year Analysis of Efficacy, Durability, and Microbiome Changes in a Controlled Open-Label Trial of Investigational Microbiota-Based Drug RBX2660 for Recurrent Clostridioides difficile Infections

BackgroundRecurrent Clostridioides difficile infection (rCDI) is an urgent public health threat associated with significant mortality and medical cost. Microbiota therapy is gaining acceptance as a strategy to reduce rCDI recurrence. We present the final 24-month analysis of clinical safety, efficacy, and microbiome restoration from a Phase 2 open-label trial of RBX2660 for prevention of CDI recurrence.MethodsParticipants with multi-recurrent CDI received <2 doses of RBX2660 delivered via enema 7 days apart in this multicenter, open-label Phase 2 study. Efficacy was defined as the absence of CDI recurrence through 56 days after the last dose and was compared with 8-week recurrence-free rates for a historical control cohort that received standard-of-care antibiotic therapy. Fisher exact test compared the proportion of treatment participants who were CDI-free by age and sex. Durability was defined as continued absence of CDI episodes beyond 8 weeks. Safety and durability assessments occurred at 3, 6, 12, and 24 months. Participant stool samples were collected prior to and for up to 720 days after treatment, and microbiome changes were assessed by shallow shotgun sequencing.ResultsThe efficacy of RBX2660 to prevent rCDI at 8 weeks (78.9%; 112/142) was higher than the CDI-free rate in the historical control group (30.7%, 23/75; P < 0.0001). Age and sex did not impact efficacy. Among participants who achieved treatment success at 8 weeks and were evaluable for long-term durability (n = 95), 8 experienced a new CDI episode by the 24-month follow-up for an overall durability of 91.6%. The safety profile was consistent with previous reports for RBX2660. In total, 503 stool samples from 110 treatment responders were analyzed. Within 7 days of treatment, the relative abundance of Bacteroidia and Clostridia remained shifted higher than pre-treatment levels while Gammaproteobacteria and Bacilli declined sharply after treatment, and these changes persisted to at least 24 months.ConclusionRBX2660, a microbiota-based drug, was safe and efficacious for preventing rCDI with clinical durability to 24 months after treatment, independent of age or sex, and RBX2660 durability associated with durable microbiome shifts from pre-treatment to a healthier composition. DisclosuresRobert Orenstein, DO, Rebiotix Inc. (Advisor or Review Panel member), Sarah Mische, PhD, Rebiotix Inc. (Employee), Ken Blount, PhD, Rebiotix Inc. (Employee), Lindy Bancke, PharmD, Rebiotix Inc. (Employee), Xin Su, MD, MSci, Rebiotix Inc. (Employee), Dana Walsh, PhD, Rebiotix Inc. (Employee), Adam Harvey, PhD, Rebiotix Inc. (Employee), Carlos Gonzalez, MS, Rebiotix Inc. (Consultant), Dale N. Gerding, MD, Rebiotix Inc. (Board Member).

The 1973 WHO and 2004 WHO grading systems are not equal in prediction of survival among stage T1 bladder cancer patients

Introduction and ObjectivesThe aim of this study was to analyse prognostic impact of tumour histological grade on survival differences between primary G2 and G3 WHO1973 stage T1 tumours which were graded as HG according to WHO2004 grading system. Patients or Materials and MethodsData from 481 patients with primary T1HG bladder cancer who were treated between 1986 and 2016 in two university centres were retrospectively reviewed. Log-rank test and Cox regression analysis was performed to compare the groups. Results95 (19,8%) tumours were classified as G2 and 386 (80,2%) were G3. Median follow-up was 68 months. The recurrence was observed in 228 (47,5%), and progression in 109 patients (22,7%). Radical cystectomy was performed in 114 pts (23,7%) and there were 64 (13,3%) cancer specific deaths. Recurrence-free rates at 5-years follow-up for G2, G3 and all patients were 68,7%, 51,2% and 56,3% and progression-free rates were 89,3%, 73,2% and 78,1% respectively. For total observation period patients with G3 tumours presented also worse recurrence-free, and progression-free survival levels than patients with G2 tumours. In multivariate analysis, after adjustment for clinical features, the risk of recurrence and progression for G3 tumours was 1,65 and 2,42 fold higher than for G2 tumours. ConclusionsIt was shown that G3 T1 tumours are characterized by worse recurrence free and progression free survivals when compared to G2 cancers.

P1032Efficacy and safety of radiofrequency catheter ablation for atrial fibrillation in patients undergoing hemodaialysis

Abstract Introduction Although radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) has become a standard therapy, the ablation outcomes in patients undergoing hemodialysis (HD) has not been fully elucidated. The present study aimed to evaluate the clinical outcomes of RFCA for AF in patients undergoing HD. Methods Twenty-three patients undergoing HD (17 men, age 65±8 years, 19 paroxysmal AF) who underwent RFCA for drug-refractory AF in two institutes were enrolled in the study and defined as HD group. The clinical parameters, recurrence free rate and frequency of periprocedural complications were compared to 46 randomly selected age, gender and left atrial diameter matched controls not requiring HD defined as non-HD group (34men, age 67±7 years, 38 paroxysmal AF). Results The patients in HD group had a significantly lower body mass index (21±3 vs. 25±3 P&lt;0.01), higher prevalence of coronary artery disease (30% vs. 10% P=0.04), and higher prevalence of congestive heart failure (52% vs. 10% P&lt;0.01) compared to patients in non-HD group. Echocardiography indicated lower left ventricular ejection fraction (57±17% vs. 65±9% P=0.02), higher E/e' (20±8 vs. 12±4 P&lt;0.01), higher tricuspid regurgitation pressure gradient (30mmHg vs. 24mmHg P&lt;0.01) and more impaired left ventricular diastolic function in HD group. All the subjects underwent bilateral pulmonary vein isolation plus additional linear lesion. The number of ablation procedure was similar between the two groups (1.43±0.5 vs. 1.46±0.6 P=0.88). During the follow-up period of 37±25 months after the last procedure, the arrhythmia free rate was similar between the two groups (86% vs. 84% log-rank P=0.82). Vascular access complication occurred in two patients in HD group, and pericardial effusion occurred in one patient in non-HD group, while no life-threatening complications were observed in either group. Cardiogenic cerebral infarction occurred in one patient in non-HD group. Discontinuation of oral anticoagulation after the ablation was more often seen in the HD group compared to non-HD group (91% vs. 60% P&lt;0.01). Conclusions Although patients undergoing HD had more impaired left ventricular systolic and diastolic function, RFCA for AF in patients with HD was shown to be as effective and safe as in non-HD patients. RFCA may be an efficient approach to manage AF in patients undergoing HD.

Tumor regression during radiotherapy for non-small cell lung cancer patients using cone-beam computed tomography images

PurposePrevious literature has reported contradicting results regarding the relationship between tumor volume changes during radiotherapy treatment for non-small cell lung cancer (NSCLC) patients and locoregional recurrence-free rate or overall survival. The aim of this study is to validate the results from a previous study by using a different volume extraction procedure and evaluating an external validation dataset.MethodsFor two datasets of 94 and 141 NSCLC patients, gross tumor volumes were determined manually to investigate the relationship between tumor volume regression and locoregional control using Kaplan–Meier curves. For both datasets, different subgroups of patients based on histology and chemotherapy regimens were also investigated. For the first dataset (n = 94), automatically determined tumor volumes were available from a previously published study to further compare their correlation with updated clinical data.ResultsA total of 70 out of 94 patients were classified into the same group as in the previous publication, splitting the dataset based on median tumor regression calculated by the two volume extraction methods. Non-adenocarcinoma patients receiving concurrent chemotherapy with large tumor regression show reduced locoregional recurrence-free rates in both datasets (p < 0.05 in dataset 2). For dataset 2, the opposite behavior is observed for patients not receiving chemotherapy, which was significant for overall survival (p = 0.01) but non-significant for locoregional recurrence-free rate (p = 0.13).ConclusionThe tumor regression pattern observed during radiotherapy is not only influenced by irradiation but depends largely on the delivered chemotherapy schedule, so it follows that the relationship between patient outcome and the degree of tumor regression is also largely determined by the chemotherapy schedule. This analysis shows that the relationship between tumor regression and outcome is complex, and indicates factors that could explain previously reported contradicting findings. This, in turn, will help guide future studies to fully understand the relationship between tumor regression and outcome.