Total Number Of Lesions Research Articles

Understanding eligibility creep in psoriasis assessments: a survey study.

Psoriasis severity assessments for clinical trial entry may be unintentionally overestimated, especially if trial eligibility is chiefly dependent on rating of disease severity. When this results in patients with less severe phenotypes joining clinical trials it is referred to as eligibility creep. We investigated the potential impact of psychosocial incentives on psoriasis lesion severity grading. A survey was constructed and disseminated through Amazon Mechanical Turk. Participants completed two vignette-style questions prompted with a randomly allocated psychosocial incentive. Questions required participants to grade and select psoriasis lesion pictures for a fictional trial. Participants also decided whether or not to schedule re-evaluation of patients deemed ineligible at initial visit. There were 646 participants. There was no significant difference in number of total lesions selected for study inclusion between incentive groups (Kruskal-Wallis, P=0.30). In general, participants completing empathy and professional uncertainty incentives selected the most and least number of lesion pictures for trial inclusion, respectively. Participants prompted with empathy incentives had significantly greater rates of choosing to schedule a follow-up visit for ineligible patients compared to participants prompted with other incentives (69.7% versus 59.1%, Chi square P=0.046). Situations evoking empathy may contribute to eligibility creep.

18F-PSMA-11 Versus 68Ga-PSMA-11 Positron Emission Tomography/Computed Tomography for Staging and Biochemical Recurrence of Prostate Cancer: A Prospective Double-blind Randomised Cross-over Trial

BackgroundFluorine-18 (18F)-labelled prostate-specific membrane antigen (PSMA) offers several advantages over gallium-68 (68Ga) in terms of costs, yield, transport/distribution, and image resolution. ObjectiveThis trial investigates the new radiotracer 18F-PSMA-11 via a prospective, intraindividual crossover design. The trial was powered for noninferiority of 18F-PSMA-11 over 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) in terms of the number of positive PET scans. Secondary endpoints were as follows: (1) superiority of 18F-PSMA-11 over 68Ga-PSMA-11 with respect to the number of positive PET scans, the total number of suspicious prostate cancer lesions, and the miPSMA expression score of corresponding lesions; (2) correlation of the PET/CT images with available follow-up data for 18F-PSMA-11 and 68Ga-PSMA-11; and (3) assessment of the interobserver variability. Design, setting, and participantsProstate cancer patients (primary or biochemical recurrence) were randomised in a double-blind crossover design whereby each patient received both 18F-PSMA-11 and 68Ga-PSMA-11 PET/CT. Outcome measurements and statistical analysisAll scans were reviewed and scored by three independent experienced nuclear physicians following the proposed guideline for the interpretation of PSMA-ligand PET/CT, as described by Eiber et al. Results and limitationsIn total, 82 patients were included for scan analyses. The primary endpoint was met: per patient, the proportions of positive scans rated by the three readers were 67%/67%, 65%/65%, and 73%/70% for 18F-PSMA-11/68Ga-PSMA-11 PET/CT. The miPSMA expression score was higher for 18F-PSMA-11 than for 68Ga-PSMA-11 for the reference reader. Follow-up data showed identical estimated sensitivity for both the 18F-PSMA-11 and the 68Ga-PSMA-11 scan (0.92, 0.83, and 0.92 for the three readers). A fair to good agreement among readers (at patient level) was obtained, which was demonstrated by a Light’s kappa value of 0.59 for both tracers. ConclusionsThe tracer 18F-PSMA-11 is noninferior to68Ga-PSMA-11. Superiority of 18F-PSMA-11 was limited to the miPSMA expression score, given by the reference reader. Inter-rater agreement was fair to good, and equal for both radiotracers. Patient summaryIn this study, we compared two radiotracers: 18F-PSMA-11 and 68Ga-PSMA-11. We proved that 18F-PSMA-11 is not inferior to 68Ga-PSMA-11 for detecting prostate cancer and thus can be used as an alternative. Possible superiority of this tracer should be further investigated in specific subpopulations.

Efficacy and the safety of endoscopic ultrasound guided radiofrequency ablation of pancreatic cancer: A systematic review and meta-analysis.

e16276 Background: Endoscopic ultrasound-guided RFA (EUS-RFA) is a minimally invasive emerging modality that may be an alternative to surgical resection for the management of unresectable pancreatic cancer (UPC). In this review, we highlighted the efficacy, clinical and technical success of the EUS-RFA for UPC. Methods: Studies were selected with a comprehensive search strategy for EUS-RFA and pancreatic cancer on PubMed, Google Scholar, and Embase databases as of October 2021. The primary outcomes were the technical (TS) and clinical success rate (CS) of the EUS-RFA procedure, while the secondary outcome was the adverse events (AEs) rate. Results: Twelve studies including 114 patients with 50% (57) females were included. Common pancreatic tumors were locally advanced pancreatic ductal adenocarcinoma (LAPDAC) 38.3% (49), followed by nonfunctional neuroendocrine tumor (NNET) 32% (41), pancreatic cystic neoplastic lesions 14.8% (19), insulinoma 12.5% (16) and others 2.3% (3). The most common site of the tumor was pancreatic head 45.7% (59) followed by body, neck, and tail 47.6% (61). The average number of ablation sessions per patient was 1.4 based on the total of 115 EUS-RFA sessions performed in 84 neoplastic lesions. The pooled TS rate of EUS-RFA calculated from the total number of procedures was 99.2% [95% CI = 0.90-0.98, I2 = 0%]. The pooled CS rate calculated from the total number of pancreatic lesions was 91.9% [95% CI = 0.77-0.92, I2 = 0%]. Clinical improvement in symptoms was reported in five studies whereas complete resolution or decrease in tumor size was reported in all studies. The pooled AEs rate was 24.6% [95% CI = 0.17-0.39, I2 = 30%]. Common AEs were abdominal pain 10.5% (12), and pancreatitis 3.5% (4). Conclusions: EUS-RFA is a promising and safe modality that can be used for the management of UPC in selected patients with a high TS (99.2%) and CS rates (91.9%). Large clinical trials are needed to identify safety, clinical outcomes, and overall survival benefits of EUS-RFA.[Table: see text]

Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial

Background & AimsColonoscopy for colorectal cancer screening is endoscopist dependent, and colonoscopy quality improvement programs aim to improve efficacy. This study evaluated the clinical benefit and safety of using a computer-aided detection (CADe) device in colonoscopy procedures. MethodsThis randomized study prospectively evaluated the use of a CADe device at 5 academic and community centers by US board-certified gastroenterologists (n = 22). Participants aged ≥40 scheduled for screening or surveillance (≥3 years) colonoscopy were included; exclusion criteria included incomplete procedure, diagnostic indication, inflammatory bowel disease, and familial adenomatous polyposis. Patients were randomized by endoscopist to the standard or CADe colonoscopy arm using computer-generated, random-block method. The 2 primary endpoints were adenomas per colonoscopy (APC), the total number of adenomas resected divided by the total number of colonoscopies; and true histology rate (THR), the proportion of resections with clinically significant histology divided by the total number of polyp resections. The primary analysis used a modified intention-to-treat approach. ResultsBetween January and September 2021, 1440 participants were enrolled to be randomized. After exclusion of participants who did not meet the eligibility criteria, 677 in the standard arm and 682 in the CADe arm were included in a modified intention-to-treat analysis. APC increased significantly with use of the CADe device (standard vs CADe: 0.83 vs 1.05, P = .002; total number of adenomas, 562 vs 719). There was no decrease in THR with use of the CADe device (standard vs CADe: 71.7% vs 67.4%, P for noninferiority < .001; total number of non-neoplastic lesions, 284 vs 375). Adenoma detection rate was 43.9% and 47.8% in the standard and CADe arms, respectively (P = .065). ConclusionsFor experienced endoscopists performing screening and surveillance colonoscopies in the United States, the CADe device statistically improved overall adenoma detection (APC) without a concomitant increase in resection of non-neoplastic lesions (THR).ClinicalTrials.gov registration: NCT04754347.

Association of Mild Valvular Lesions With Long-term Cardiovascular Outcomes Among Black Adults

Little is known about the long-term outcomes of mild valvular lesions. To examine the associations of 3 major types of valvular lesions (aortic stenosis, trace or mild aortic regurgitation, and trace or mild mitral regurgitation) with risk of cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, and atrial fibrillation. This cohort study analyzed data from the ongoing Atherosclerosis Risk in Communities study and focused on Black participants in the Jackson, Mississippi, site who underwent echocardiography at visit 3 from 1993 to 1995. Data analysis was conducted between April 2021 and February 2022. Three valvular lesions were analyzed: aortic sclerosis, aortic regurgitation (trace or mild), and mitral regurgitation (trace or mild). The outcomes were cardiovascular mortality, coronary heart disease, heart failure, stroke, and atrial fibrillation. Multivariable Cox proportional hazards regression models were used to examine the independent associations between the 3 valvular lesions and these outcomes. A total of 2106 Black participants were included, with a mean (SD) age of 59.1 (5.6) years and 1354 women (64.3%). The baseline prevalence was 7.7% for aortic sclerosis, 15.1% for aortic regurgitation (6.1% with trace, and 9.0% with mild), and 43.0% for mitral regurgitation (29.4% with trace, and 13.6% with mild). During a median (interquartile interval) follow-up of 22.5 (15.6-23.5) years, 890 participants developed at least 1 cardiovascular outcome. Each valvular lesion was significantly associated with at least 1 cardiovascular outcome: aortic sclerosis was associated with cardiovascular mortality (adjusted hazard ratio [HR], 1.54; 95% CI, 1.06-2.22), mild mitral regurgitation was associated with atrial fibrillation (HR, 1.47; 95% CI, 1.09-1.99), and trace or mild aortic regurgitation was associated with all outcomes (HRs ranging from 1.45 [95% CI, 1.17-1.81] to 1.75 [95% CI, 1.29-2.37]) except stroke. The total number of valvular lesions had graded associations with all cardiovascular outcomes except stroke: the HR of cardiovascular mortality was 1.77 (95% CI, 1.18-2.65) for those with 2 to 3 lesions and was 1.44 (95% CI, 1.05-1.96) for those with 1 lesion vs no lesions. Results of this study indicate an association between valvular lesions, even at mild stage, and a long-term risk of cardiovascular events, suggesting the importance of recognizing and monitoring these valvular conditions.

Endoscopic resection for colorectal laterally spreading tumors in East Asian countries: a systematic review.

BackgroundTo assess the efficacy and safety of different endoscopic resection methods for colorectal laterally spreading tumors (LSTs) in East Asian countries.MethodsA literature search was performed in PubMed, Embase, Cochrane Library and Web of Science databases. Colorectal LSTs of the included studies were resected with endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD). The main outcomes involved rates of en bloc resection, R0 resection, adverse events and recurrence.ResultsA total of 20 studies were finally included in the present study. The total number of lesions were 3,903 (EMR: 1,230, ESD: 2,673). EMR-en bloc resection was obtained in 395/591 (66.8%), with ESD-en bloc resection reported in 2,020/2,265 (89.2%) [odds ratio (OR) 0.244, P<0.0001, 95% confidence interval (CI): 0.197–0.304]. EMR-R0 resection was achieved in 409/547 (74.8%), which was lower than that of ESD (1,895/2,241, 84.6%) (OR 0.541, P<0.0001, 95% CI: 0.432–0.677). Bleedings occurred more frequently in EMR than in ESD group (10.4% vs. 3.1%, OR 3.559, P<0.0001, 95% CI: 2.618–4.836). Rates of perforations in EMR and ESD were 0.4% and 4.1% (OR 0.099, P<0.0001, 95% CI: 0.036–0.27). Recurrence of EMR was higher than ESD group (6.3% vs. 1.0%, OR 6.732, P<0.0001, 95% CI: 3.751–12.082).DiscussionEndoscopic resections of colorectal LSTs are safe and effective. ESD leads to higher rates of en bloc and R0 resection, as well as lower rates of bleeding and recurrence, but it has a high risk of perforation, compared with EMR.

Different Mechanisms of DNA Radiosensitization by 8-Bromoadenosine and 2'-Deoxy-2'-fluorocytidine Observed on DNA Origami Nanoframe Supports.

DNA origami nanoframes with two parallel DNA sequences are used to evaluate the effect of nucleoside substituents on radiation-induced DNA damage. Double strand breaks (DSB) of DNA are counted using atomic force microscopy (AFM), and total number of lesions is evaluated using real-time polymerase chain reaction (RT-PCR). Enhanced AT or GC content does not increase the number of DNA strand breaks. Incorporation of 8-bromoadenosine results in the highest enhancement in total number of lesions; however, the highest enhancement in DSB is observed for 2'-deoxy-2'-fluorocytidine, indicating different mechanisms of radiosensitization by nucleoside analogues with the halogen substituent on base or sugar moieties, respectively. "Bystander" effects are observed, when the number of DSB in a sequence is enhanced by a substituent in the parallel DNA sequence. The present approach eliminates limitations of previously developed methods and motivates detailed studies of poorly understood conformation or bystander effects in radiation induced damage to DNA.

Clinical presentation of verruca vulgaris in HIV

Immunocompromised patients, including those with human immunodeficiency virus (HIV), have been observed to have verrucae that are more extensive and treatment-resistant compared to those in immunocompetent patients. However, there is a critical lack of data in the current literature on the characteristics of verruca vulgaris in individuals with HIV. This retrospective chart review included a cohort of HIV-positive individuals and a control group of immunocompetent individuals presenting to an outpatient, county hospital-based dermatology clinic for evaluation of verruca vulgaris between the years of 2016 and 2018. Clinical characteristics, including gender, age, last CD4 count, viral load, antiretroviral therapy adherence, and total number and location of lesions were recorded. A total of 66 patients (33 HIV-positive, 33 immunocompetent) were included in the study. HIV-positive status was significantly associated with a higher total number of lesions (42% of immunocompromised patients versus 21% of immunocompetent patients presented with four or more lesions, P=0.04) as well as location of lesions on the face, scalp, and neck (51.5% versus 9.1%, P&lt;0.001). HIV-positive status may be associated not only with a higher burden of verruca vulgaris lesions but also a higher number of lesions in locations at or above the neck.

Edoxaban Versus Dual Antiplatelet Therapy for Leaflet Thrombosis and Cerebral Thromboembolism After TAVR: The ADAPT-TAVR Randomized Clinical Trial.

It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. URL: https://www. gov. Unique identifier: NCT03284827.

ACCURACY OF FINE NEEDLE ASPIRATION CYTOLOGY IN COMPARISON WITH BIOPSY, IN DIAGNOSIS OF PAROTID GLAND NEOPLASM

Objectives: To evaluate the accuracy of Fine needle aspiration cytology (FNAC)to be used as a standalone diagnostic tool in parotid gland tumors.Materials and Methods: This prospective study was performed at Rehman Medical Institute, Peshawar. About 49 patients with swellings of the salivary glands were included in the study. FNAC was performed on each of the patient followed by biopsy and the results were compared. Results:Total numbers of benign and malignant lesions were 37 and 12 respectively. In this study the sensitivity of FNAC was 91.7% and specifi city was 100%. Positive predictive value was 100% whereas negative predictive value was 97.4%.Conclusion: FNAC was found to be highly accurate in diagnosing the tumors of parotid gland and in diff erentiating benign and malignant lesions and treatment planning.

Cavotricuspid isthmus ablation guided by force-time integral - A randomized study.

BackgroundForce‐time integral (FTI) is an ablation marker of lesion quality and transmurality. A target FTI of 400 gram‐seconds (gs) has been shown to improve durability of pulmonary vein isolation, following atrial fibrillation ablation. However, relevant targets for cavotricuspid isthmus (CTI) ablation are lacking.HypothesisWe sought to investigate whether CTI ablation with 600 gs FTI lesions is associated with reduced rate of transisthmus conduction recovery compared to 400 gs lesions.MethodsFifty patients with CTI‐dependent flutter were randomized to ablation using 400 gs (FTI400 group, n = 26) or 600 gs FTI lesions (FTI600 group, n = 24). The study endpoint was spontaneous or adenosine‐mediated recovery of transisthmus conduction, after a 20‐min waiting period.ResultsThe study endpoint occurred in five patients (19.2%) in group FTI400 and in four patients (16.7%) in group FTI600, p = .81. First‐pass CTI block was similar in both groups (50% in FTI400 vs. 54.2% in FTI600, p = .77). There were no differences in the total number of lesions, total ablation time, procedure time and fluoroscopy duration between the two groups. There were no major complications in any group. In the total population, patients not achieving first‐pass CTI block had significantly higher rate of acute CTI conduction recovery, compared to those with first‐pass block (29.2% vs. 7.7% respectively, p = .048).ConclusionsCTI ablation using 600 gs FTI lesions is not associated with reduced spontaneous or adenosine‐mediated recurrence of transisthmus conduction, compared to 400 gs lesions.

Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia

Background & AimsArtificial intelligence (AI) may detect colorectal polyps that have been missed due to perceptual pitfalls. By reducing such miss rate, AI may increase the detection of colorectal neoplasia leading to a higher degree of colorectal cancer (CRC) prevention. MethodsPatients undergoing CRC screening or surveillance were enrolled in 8 centers (Italy, UK, US), and randomized (1:1) to undergo 2 same-day, back-to-back colonoscopies with or without AI (deep learning computer aided diagnosis endoscopy) in 2 different arms, namely AI followed by colonoscopy without AI or vice-versa. Adenoma miss rate (AMR) was calculated as the number of histologically verified lesions detected at second colonoscopy divided by the total number of lesions detected at first and second colonoscopy. Mean number of lesions detected in the second colonoscopy and proportion of false negative subjects (no lesion at first colonoscopy and at least 1 at second) were calculated. Odds ratios (ORs) and 95% confidence intervals (CIs) were adjusted by endoscopist, age, sex, and indication for colonoscopy. Adverse events were also measured. ResultsA total of 230 subjects (116 AI first, 114 standard colonoscopy first) were included in the study analysis. AMR was 15.5% (38 of 246) and 32.4% (80 of 247) in the arm with AI and non-AI colonoscopy first, respectively (adjusted OR, 0.38; 95% CI, 0.23–0.62). In detail, AMR was lower for AI first for the ≤5 mm (15.9% vs 35.8%; OR, 0.34; 95% CI, 0.21–0.55) and nonpolypoid lesions (16.8% vs 45.8%; OR, 0.24; 95% CI, 0.13–0.43), and it was lower both in the proximal (18.3% vs 32.5%; OR, 0.46; 95% CI, 0.26–0.78) and distal colon (10.8% vs 32.1%; OR, 0.25; 95% CI, 0.11–0.57). Mean number of adenomas at second colonoscopy was lower in the AI-first group as compared with non-AI colonoscopy first (0.33 ± 0.63 vs 0.70 ± 0.97, P < .001). False negative rates were 6.8% (3 of 44 patients) and 29.6% (13 of 44) in the AI and non-AI first arms, respectively (OR, 0.17; 95% CI, 0.05–0.67). No difference in the rate of adverse events was found between the 2 groups. ConclusionsAI resulted in an approximately 2-fold reduction in miss rate of colorectal neoplasia, supporting AI-benefit in reducing perceptual errors for small and subtle lesions at standard colonoscopy. ClinicalTrials.gov, Number: NCT03954548.

The association of FDG PET/CT and NaF PET/CT with survival outcomes in patients (pts) with metastatic genitourinary malignancies (mGU) treated with cabozantinib + nivolumab +/- ipilimumab (CaboNivo +/- Ipi).

452 Background: This study determined the association of functional imaging parameters obtained on FDG PET/CT and NaF PET/CT with OS for pts with mGU malignancies treated on a phase I study with CaboNivo +/- Ipi. Methods: Pts on this phase I study underwent sequential (1-hour apart) FDG PET/CT and NaF PET/CT imaging at baseline and at first-restaging (8 weeks follow up). Scan semi-quantitative parameters measures included: maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) for FDG and MTV for NaF. Total lesion number was captured for all scans. The association of imaging parameters and survival was determined with Kaplan-Meier curves. Baseline values and percent change values were calculated. Results: 81 pts were included in the analysis. 67 (83%) were males; Median age was 63 (range 25-86); Histologically, 30 pts had urothelial carcinoma, 15 clear cell renal cell carcinoma, 9 germ cell tumors, 8 urachal/adenocarcinoma, 8 prostate cancer, 3 penile cancer, 3 squamous cell carcinoma, 3 renal medullary carcinoma, and 2 small cell (1 bladder, 1 prostate). All 81 had a baseline FDG PET scan, 78 pts received baseline NaF PET scans; 66 received both FDG PET and NaF PET baseline and follow up scans. 957 total lesions were detected on FDG PET across all histologies, 87 liver (9%), 252 lung (26%), 152 bone (16%), 411 lymph node (43%), and 55 other visceral metastases (6%). 414 total lesions were detected on NaF imaging. Low vs high baseline FDG MTV (31 vs 11 months, p = 0.0002), TLG (30 vs 11 months, p = 0.0004), Lesion number (49 vs 15 months, p = 0.0005), and SUVmax (25 vs 12 months, p = 0.025), FDG lesion number decrease or no change vs increase (24 vs 12 months, p = 0.0068), and low vs high baseline NaF MTV (26 vs 16 months, p = 0.007), and lesion number (26 vs 16 months, p = 0.007) showed the strongest associations with OS. A multivariable Cox analysis demonstrated that baseline FDG MTV (HR = 2.87, 95% CI 1.62-5.08, p = 0.0003) and FDG lesion number percent change (HR = 2.71, 95% CI 1.40-5.24, p = 0.0031) were jointly associated with OS. Conclusions: Baseline functional imaging parameters and percent change seen on follow imaging with FDG PET and NaF PET are prognostic in mGU pts treated with CaboNivo +/- ipi. Additional parameters and histologic subsets will be presented.

The novel topical herbal gel might be an alternative treatment in patients with acne vulgaris: A randomized, double-blind controlled study

BackgroundAcne vulgaris (AV) is one of the most prevalent skin disorders evolving in pre and post-adolescent periods. Conventional therapies indicate many adverse events and limitations; nonetheless, botanical agents are proposed for minimal side effects and faster action. This study aimed to assess the clinical efficacy of topical Rosmarinus officinalis and clindamycin/benzoyl peroxide in patients with AV. MethodsFifty healthy subjects (42 females, 8 males) with mild to moderate AV were randomly assigned (1:1) into two groups, clindamycin and benzoyl peroxide gel 1%/5% (group A), and rosemary gel (group B). They received a thin layer of topical gels on the affected area twice daily for twelve weeks. A total number of inflammatory lesions (TIL), total number of comedones (TC), and pustules and papules at baseline, weeks 4, 8, and 12 were measured as primary outcomes. Safety evaluations and the DLQI test were also performed. ResultsAfter 12 weeks of therapy, TIL, TC, the number of pustules and papules declined in both groups; however, only group B indicated significant differences at weeks 4, 8, and 12 (p < 0.05). Moreover, TIL and TC diminished more rapidly in group B. Even though all adverse events vanished within the first week of the study, their incidence exhibited significant variations (p < 0.05). ConclusionThis study revealed that rosemary gel significantly improved the healing of AV symptoms, and it might be utilized as a potential agent for treating AV.

Local ablative radiotherapy on oligo-progression while continued on epidermal growth factor receptor tyrosine kinase inhibitors in advanced non-small cell lung cancer patients: A longer cohort.

The effect of adding local ablative radiotherapy on oligo-progression while continuing EGFR-TKIs in advanced non-small cell Lung cancer (NSCLC) patients is to be determined. Outcomes of patients with stage IV NSCLC harboring EGFR-activating mutations having≤5 sites of oligo-progression while on EGFR-TKIs and given one to eight fractions of local ablative radiotherapy (LAR) were reviewed from 2012 to 2019. The time of starting first-line EGFR-TKIs to LAR is defined as progression-free survival 1 (PFS1; >one line of prior treatment allowed). The primary endpoint was PFS from LAR to further progression that led to stop of EGFR-TKIs (PFS2). The secondary endpoint was overall survival from LAR (OS). Factors affecting PFS2 and OS were analyzed with Cox regression. There were total 55 eligible patients. The median follow-up time was 13.3 months. Majority (89%) had sensitive mutations (exon 19 deletion and exon 21 L858R mutation). Total number of lesions treated were 75, including lung (n=45), bone (n=15), cervical lymph node (n=1), adrenal (n=1), and brain (n=13). The median PFS2 was 6.9 months. The median OS was 25.1 months. On multivariable analysis, it was found that EGFR mutation type (exon 19 deletion / exon 21 L858R mutation vs. other rarer mutations), time from diagnosis to LAR within 70 days, and fewer lines of prior TKIs (1 or 2vs. 3) had favorable effect on PFS2 (p=0.006/0.00003; 0.046; 0.001/0.005, respectively). LAR is a noninvasive and effective modality in treatment of oligo-progressive diseases for patients with EGFR mutations positive NSCLC while on EGFR-TKIs.

P171 PSC/IBD and IBD have similar type and location of colonic lesions, but Dye ChromoEndoscopy (DCE) increases detection rate compared to White Light Endoscopy (WLE)

Abstract Background Inflammatory bowel disease (IBD) increases the risk of colorectal cancer proportionally to the extent and duration of the disease. Moreover, up to 5% of IBD patients have concomitant PSC, an additional risk factor, especially for right colon cancer. To mitigate this risk patients with PSC-IBD undergo stricter annual surveillance colonoscopy. We aimed to analyze differences in incidence, location and type of lesions detected during surveillance colonoscopies in PSC/IBD and only IBD. In addition, we assessed the impact of dye spray chromoendoscopy on detection rates. Methods In a retrospective single-center study, we collected all surveillance colonoscopies performed at Birmingham University Hospital between January 2014 and August 2019. The procedures were divided for patient diagnosis in PSC-IBD or IBD-only. Demographic, clinical, endoscopic and histologic data were retrieved from electronic medical records. Categorical variables are presented as absolute and relative frequencies and compared using chi-square test and Fisher’s exact test. Continuous variables are presented as mean and compared by Student t-test after testing for normality. Results We retrieved 856 colonoscopies from 622 patients, of these 282 colonoscopies were performed in 147 patients with PSC, the remaining 574 in 475 patients with IBD-only. Demographic data are presented in (Table 1). In 64 (22%) colonoscopies in PSC/IBD and 173 (30%) in PSC/IBD at least one lesion was found (p=0.02). The total number of lesions was 70 for PSC/IBD (0.248 lesions per procedure) and 226 for IBD-only (0.394 per procedure) (p=0.02). While these differences were statistically significant, PSC/IBD patients had 58% (1.2 vs 1.9) more colonoscopies, due to the stricter surveillance regimen, thus likely reducing the rate of lesions per procedure (Table 2 and 3). There was no statistically significant difference in histologic type and localization of lesions between the two groups (Table 3). Dye spray chromoendoscopy (DCE) was used in 52% of procedures in the IBD-only group, and 65% of the PSC-IBD. Colonoscopies with DCE were significantly more likely to detect lesions both in PSC-IBD and IBD-only cohorts (both p&amp;lt;0.05). Table 4. Conclusion We found a higher detection rate of colonic lesions in colonoscopies of the general IBD population compared to those PSC-IBD patients, though this might be influenced by the frequency of surveillance. The location and type of polyps were similar between groups. DCE increased the rate of detection compared with no DCE regardless of disease phenotype.

Multiplicity does not significantly affect outcomes in brain metastasis patients treated with surgery.

BackgroundBrain metastasis quantity may be a negative prognostic factor for patients requiring resection of at least one lesion.MethodsWe retrospectively reviewed patients who underwent surgical resection of brain metastases from July 2018 to June 2019 at our institution, and examined outcomes including overall survival (OS), progression free survival (PFS), and rates of local failure (LF). Patients were grouped according to the number of metastases at the time of surgery (single vs multiple).ResultsWe identified 130 patients who underwent surgical resection as the initial treatment modality. At the time of surgery, 87 patients had only one lesion (control) and 43 had multiple (>1). Two-year OS for the entire cohort was 46%, with equal rates in both the multiple metastases group and the control group (P = .335). 2-year PFS was 27%; 21% in the multiple metastases group and 31% in the control group (P = .766). The rate of LF at 2 years was 32%, with equal rates in both the multiple lesion group and control group (P = .889). On univariate analysis, multiplicity was not significantly correlated to OS (HR = 0.80, 95% CI: 0.51–1.26, P = .336), PFS (HR = 1.06, 95% CI: 0.71–1.59, P = .766) or LF (HR = 1.06, 95% CI: 0.57–1.97, P = .840). Multivariate analysis revealed preoperative tumor volume of the resected lesion to be the single correlate for OS (P = .0032) and PFS (P = .0081).ConclusionsHaving more than one metastasis does not negatively impact outcomes in patients treated with surgery. In carefully selected patients, especially those with large tumors, surgery should be considered regardless of the total number of lesions.

Sensitivity of Contrast-Enhanced Breast MRI vs X-ray Mammography Based on Cancer Histology, Tumor Grading, Receptor Status, and Molecular Subtype: A Supplemental Analysis of 2 Large Phase III Studies.

Background:The impact of certain tumor parameters on the sensitivity of imaging tools is unknown. The purpose was to study the impact of breast cancer histology, tumor grading, single receptor status, and molecular subtype on the sensitivity of contrast-enhanced breast magnetic resonance imaging (CE-BMRI) vs X-ray mammography (XRM) to detect breast cancer.Materials and Methods:We ran a supplemental analysis of 2 global Phase III studies which recruited patients with histologically proven breast cancers. The sensitivity of CE-BMRI vs XRM to detect cancer lesions with different histologies, tumor grading, single receptor status, and molecular subtype was compared. Six blinded readers for each study evaluated the images. Results were summarized as the “Mean Reader.” For each reader, sensitivity was defined as the proportion of detected lesions vs the total number of lesions identified by the standard of reference. Two-sided 95% confidence intervals were calculated for within-group proportions, and for the difference between CE-BMRI and XRM, using a normal approximation to the binomial distribution.Results:In 778 patients, 1273 cancer lesions were detected. A total of 435 patients had 1 lesion, 254 had 2 lesions, and 77 had 3 or more lesions. The sensitivity of CE-BMRI was significantly higher compared with XRM irrespective of the histology. The largest difference was seen for invasive lobular carcinoma (22.3%) and ductal carcinoma in situ (19%). Across all 3 tumor grades, the sensitivity advantage of CE-BMRI over XRM ranged from 15.7% to 18.5%. Contrast-enhanced breast magnetic resonance imaging showed higher sensitivity compared with XRM irrespective of single receptor expressions (15.3%-19.4%). The sensitivities for both imaging methods were numerically higher for the more aggressive ER– (estrogen receptor), PR– (progesterone receptor), and HER2+ (human epidermal growth factor receptor 2) tumors. Irrespective of molecular subtype, sensitivity of CE-BMRI was 14.8% to 18.9% higher compared with XRM.Conclusions:Contrast-enhanced breast magnetic resonance imaging showed significantly higher sensitivity compared with XRM independent of tumor histology, tumor grading, single receptor status, and molecular subtype.Trial Registration: ClinicalTrials.gov: NCT01067976 and NCT01104584.

Utility of 3D Double Inversion Recovery Sequence in Paediatric Epilepsy and its Comparison to 3D Fluid Attenuation Inversion Recovery Sequence and T1 Inversion Recovery Sequence : A Cross-sectional Study

Introduction: Epilepsy is a disease with predisposition to generate epileptic seizures, associated with neurobiological, cognitive, psychological, and social consequences. Nearly 30% of children undergoing medical treatment for epilepsy become refractive to the treatment. For those children, the ability to find the epileptogenic area is higher with Magnetic Resonance Imaging (MRI) of the brain. The traditional 2D spin-echo sequences used in epilepsy protocol for adults cannot be used alone in paediatric structural neuroimaging. Additional sequences are needed to identify epileptogenic areas due to differences in myelination. Here, present study compared the role of three volumetric sequences 3D-Fluid Attenuated Inversion Recovery (FLAIR) , 3D-T1 weighted Inversion Recovery (T1-IR) and 3D-Double Inversion Recovery (DIR) for paediatric epilepsy as part of structural neuroimaging. Aim: To assess the utility of 3D-DIR in paediatric epilepsy disorders and localisation of epileptogenic foci in brain, congenital malformations of brain and compare its findings with 3D-FLAIR and 3D-T1-IR. Materials and Methods: The present study was a cross-sectional study of children diagnosed with paediatric epilepsy, who were evaluated with MRI brain at Stanley Medical College, Chennai, Tamil Nadu, India, between April 2020 to April 2021 with three sequences, 3D-DIR, 3D-T1-IR and 3D-FLAIR. Lesions of atleast 3 mm in diameter were identified as foci of high signal intensity and counted in each of the three sequences separately and classified according to their location. Then, average signal intensities of the lesions were calculated manually on each of sequences using Region of Interest (ROI) analysis which had a mean size of 3 mm2 . Then the Signal-to-Noise Ratio (SNR), Contrast to-Noise Ratio (CNR), Contrast Ratio (CR), and Asymmetry Signal Ratio (ASR) were calculated. Results: Evaluation was done on 51 paediatric epilepsy patients and showed the total number of lesions detected (208 lesions) and measured contrast parameters (CR, CNR and ASR) which were found to be significantly higher in 3D-DIR, showed higher detection of the intracortical and white matter lesions than 3DFLAIR and 3D-T1-IR. SNR was higher in 3D-FLAIR. Conclusion: Present study concluded that the greatest value of the DIR sequence has a higher ability in detecting epileptogenic foci and congenital malformations of the lesions in comparison with FLAIR and T1-IR.

The Overall Number of Actinic Keratosis Lesions Is Not Predictable by the Number of Visible Lesions: Consequences for Field-Directed Therapies

Actinic keratoses are keratotic lesions occurring on skin areas extensively damaged by sunlight. Using data from a previously published Phase III randomized, controlled clinical trial in patients with at least 5 actinic keratoses, we explored the potential link between the number of visible actinic keratosis lesions before any treatment and the total number of lesions of the field cancerization as revealed by 5-fluorouracil cream. Our analysis suggests that the baseline number of visible actinic keratoses is a poor indicator of the real number of lesions in the field of cancerization, reinforcing the need to explain the field cancerization concept to patients. (Curr Ther Res Clin Exp. 2022; 82:XXX–XXX) © 2022 Elsevier HS Journals, Inc.