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208 Background: In the Phase 3 PRESTO study, intensified androgen deprivation therapy (ADT) with apalutamide (APA) with or without abiraterone acetate plus prednisone (AAP), administered for a finite treatment period of 52 weeks, prolonged prostate-specific antigen progression-free survival (PSA PFS) in pts with high-risk biochemically relapsed prostate cancer (BRPC). We evaluated baseline factors associated with PSA PFS in this study. Methods: PRESTO is a randomized phase 3, open-label trial in pts with BRPC following radical prostatectomy (RP) and PSA doubling time (PSADT) ≤ 9 months (mo), without distant metastases on conventional imaging (NCT03009981). Pts were randomized 1:1:1 to receive a finite 52-week treatment course with ADT, ADT + APA, or ADT + APA + AAP, stratified by PSADT (< 3 vs 3–9 mo), with post-treatment follow-up. Baseline factors associated with PSA PFS including Gleason sum at RP (6-7, 8, ≥ 9) were analyzed in a post hoc fashion. Results: 504 pts were randomized to ADT alone (N = 167), ADT + APA (N = 168) or ADT + APA + AAP (N = 169). Baseline patient characteristics including Gleason sum at diagnosis, serum PSA and PSADT at study entry, time interval from radical prostatectomy, and receipt of prior radiation (none, adjuvant, salvage) were well balanced across the three treatment arms. At the first planned interim analysis, both experimental arms significantly prolonged PSA PFS compared to the control arm (median 24.9 mo for ADT + APA vs 20.3 mo for ADT, HR = 0.52 (95% CI: 0.35–0.77); median 26.0 mo for ADT + APA + AAP vs 20.0 mo for ADT, HR = 0.48 (95% CI: 0.32–0.71)). Across the study cohort, Gleason sum ≥ 9 at diagnosis was associated with shorter PSA PFS (median 21.9 mo for Gleason ≥ 9 vs. 31.1 mo for Gleason 8 vs. 25.2 mo for Gleason 6-7, log-rank p-value = 0.0409). In addition, within each treatment arm, a shorter observed median PSA PFS was detected for patients with Gleason ≥ 9 prostate cancer. Serum PSA and PSADT at study entry, time from prior radical prostatectomy, and prior radiation were not associated with PSA PFS in the overall study cohort or in individual study arms. Conclusions: Gleason sum ≥ 9 prostate cancer at diagnosis was associated with shorter time to PSA progression following subsequent intensified ADT administered for a finite treatment interval in BRPC. Follow-up is ongoing to integrate genomic profiling of primary prostate cancer tissue with these results and validate with longer term endpoints including metastasis-free survival. Clinical trial information: NCT03009981 .

AbstractBackgroundIrritable bowel syndrome (IBS) is characterized as a central sensitization syndrome (CSS), a group of conditions including fibromyalgia, chronic fatigue, and restless leg syndrome (RLS) among others with frequent comorbidities of anxiety, depression, and chemical sensitivity. The prevalence of comorbid conditions and their impact on IBS symptom severity and quality of life in rural community populations has not been described.MethodsWe administered a cross‐sectional survey to patients with a documented CSS diagnosis in rural primary care practices to evaluate the relationship between CSS diagnoses, quality of life, symptom severity, and interactions with healthcare providers utilizing validated questionnaires. Subgroup analysis was performed on the IBS cohort. Mayo Clinic IRB approved the study.Key ResultsSeven hundred seventy‐five individuals out of 5000 completed the survey (15.5% response rate) with 264 (34%) reporting IBS. Only 3% (n = 8) of IBS patients reported IBS alone without comorbid CSS condition. Most respondents reported overlapping migraine (196, 74%), depression (183, 69%), anxiety (171, 64%), and fibromyalgia (139, 52%). IBS patients with more than two comorbid CS condition showed significantly higher symptom severity with linear increase. Quality of life was lower in IBS with comorbid conditions, particularly in patients with IBS and RLS (mean EQ5‐D 0.36 vs. 0.8 in IBS only, p < 0.01). Quality of life declined as number of comorbid conditions increased.Conclusions & InferencesPatients with IBS often have multiple CS disorders which increases symptom severity and lowers quality of life. Understanding the impact of multiple CSS diagnoses and treating these as a global condition may improve patient experience.

Production of bowel sounds, established in the 1900s, has limited application in existing patient-care regimes and diagnostic modalities. We review the physiology of bowel sound production, the developments in recording technologies and the clinical application in various scenarios, to understand the potential of a bowel sound recording and analysis device—the phonoenterogram in future gastroenterological practice. Bowel sound production depends on but is not entirely limited to the type of food consumed, amount of air ingested and the type of intestinal contractions. Recording technologies for extraction and analysis of these include the wavelet-based filtering, autoregressive moving average model, multivariate empirical mode decompression, radial basis function network, two-dimensional positional mapping, neural network model and acoustic biosensor technique. Prior studies evaluate the application of bowel sounds in conditions such as intestinal obstruction, acute appendicitis, large bowel disorders such as inflammatory bowel disease and bowel polyps, ascites, post-operative ileus, sepsis, irritable bowel syndrome, diabetes mellitus, neurodegenerative disorders such as Parkinson’s disease and neonatal conditions such as hypertrophic pyloric stenosis. Recording and analysis of bowel sounds using artificial intelligence is crucial for creating an accessible, inexpensive and safe device with a broad range of clinical applications. Microwave-based digital phonoenterography has huge potential for impacting GI practice and patient care.

LBA661 Background: Liposomal irinotecan administered with 5-fluorouracil/leucovorin (5-FU/LV) is approved in the USA and Europe for mPDAC following progression with gemcitabine-based therapy. A phase 1/2 study (Wainberg et al. Eur J Cancer 2021;151:14–24; NCT02551991) demonstrated promising anti-tumor activity in patients with mPDAC who received first-line liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2 (NALIRIFOX). Herein, we present results from NAPOLI-3 (NCT04083235), a randomized, open-label, phase 3 study investigating the efficacy and safety of NALIRIFOX compared with nab-paclitaxel + gemcitabine as first-line therapy in patients with mPDAC. Methods: Eligible patients with histopathologically/cytologically confirmed untreated metastatic PDAC were randomized (1:1) to receive NALIRIFOX on days 1 and 15 of a 28-day cycle or nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 (Gem+NabP) on days 1, 8 and 15 of a 28-day cycle. Randomization was stratified by ECOG performance status, geographic region and presence or absence of liver metastases. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), overall response rate (ORR) and safety. OS was evaluated when ≥ 543 events were observed using a stratified log-rank test with an overall 1-sided significance level of 0.025. Results: Overall, 770 patients (NALIRIFOX, n = 383; Gem+NabP, n = 387) were included. Baseline characteristics were well balanced between arms. At a median follow-up of 16.1 months, 544 events had occurred. The median OS was 11.1 months in the NALIFIROX arm as compared with 9.2 months in the Gem+NabP arm (HR 0.84 [95% CI 0.71–0.99]; p = 0.04); PFS was also significantly improved (7.4 months vs 5.6 months; HR 0.70 [0.59–0.84]; p = 0.0001). Grade 3/4 treatment-emergent adverse events (TEAEs) with ≥ 10% frequency in patients receiving NALIRIFOX versus Gem+NabP included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%) and neutropenia (14.1% vs 24.5%). Conclusions: First-line NALIRIFOX demonstrated clinically meaningful and statistically significant improvement in OS and PFS compared with Gem+NabP in treatment-naïve patients with mPDAC. The safety profile of NALIRIFOX was manageable and consistent with the profiles of the treatment components. Funding: Funded by Ipsen. Clinical trial information: NCT04083235 .[Table: see text]

Abstract Background Engineering self‐efficacy, or the belief in one's own capabilities to complete engineering tasks, has been shown to predict greater motivation, academic performance, and retention of engineering students. Investigating the types of experiences that influence engineering students' self‐efficacy can reveal ways to support students in their undergraduate engineering programs. Purpose/Hypothesis(es) The purpose of this study was to qualitatively examine how undergraduate engineering students describe the sources of their engineering self‐efficacy and whether patterns in students' responses differed by gender. Design/Method Participants ( N = 654) were undergraduate engineering students attending two public, land‐grant universities in the U.S. Open‐ended survey questions were used to identify the events, social experiences, and emotions that students described as relevant to their engineering self‐efficacy. Chi‐square analyses were used to investigate whether response patterns varied by gender. Results Students described enactive performances as their most salient source of self‐efficacy, but interesting insights also emerged about how engineering students draw from social and emotional experiences when developing their self‐efficacy. Women more often referred to social sources of self‐efficacy and reported fewer positive emotions than did men. Conclusion Findings suggest ways that educators can provide more targeted opportunities for students to develop their self‐efficacy in engineering.