Ehman, Eric C.

Abstract Background Preparing tumor board patient summaries is time intensive. Large-language-model based systems may automate summarization but require real-world evaluation prior to clinical use. We performed an exploratory retrospective evaluation of the Microsoft Healthcare Agent Orchestrator (HAO), deployed in a Mayo Clinic–controlled staged environment, to generate tumor board–style patient summaries from retrospective Electronic Health Record (EHR) notes. Methods HAO generated summaries for breast, hepatobiliary, and neuro-oncology tumor board cases using up to the most recent 1,000 clinical notes. Clinician reviewers evaluated outputs via REDCap surveys across perceived factuality, completeness, clarity/conciseness, temporal cohesion, comparative performance, safety, and clinical utility (0–4 Likert scale). Reviewers were permitted to query the HAO chat interface to address missing details. Automated factuality was assessed using TBFact (bidirectional entailment), reporting precision and recall against available reference summaries. Results Among 57 survey responses from 5 different physicians, mean scores exceeded 2.8 across domains, with medians of 3 for most axes. In an exploratory comparison, oncology fellows required less time to review HAO-generated summaries than to manually generate patient summaries (mean difference 13.57 minutes per patient, p<0.001), although this difference may be influenced by prior familiarity with the same cases; 96% of survey responses indicated that HAO would save time. TBFact evaluations showed higher recall than precision across domains, consistent with broad capture of reference content alongside additional content that was not present in gold-standard summaries. Attribution was viewed favorably but showed issues with primary-source specificity and link reliability. Conclusions In a controlled Mayo environment, HAO demonstrated moderate performance and was associated with reduced review time for tumor board preparation. These findings are promising but preliminary and do not establish clinical safety, noninferiority to manual review, or readiness for routine clinical use. Limitations, including verbosity, specialty-specific content gaps, and inconsistent attribution, highlight the need for iterative refinement and further evaluation. Graphical Abstract Created using ChatGPT

Background The optimal management of biochemical recurrence (BCR) after radical prostatectomy (RP) remains controversial, particularly in the absence of clinical or radiographic evidence of disease. Salvage radiotherapy (SRT) remains standard of care, but it is unclear whether SRT benefits patients when modern imaging with a multiparametric magnetic resonance imaging (mpMRI) and prostate‐specific membrane antigen‐positron emission tomography/computed tomography (PSMA‐PET/CT) are negative for local recurrence. Retrospective data comparing SRT to observation for such patients is fraught with selection bias, underscoring the need for a prospective randomised controlled trial. Study Design and Methods The Biochemical Recurrence Irradiation or Observation (BRIO) is a randomised study under the DIVINE trial framework (NCT06378866) enrolling men with BCR (prostate‐specific antigen [PSA] level ≥0.2, up to 1.5 ng/mL) after RP with no radiographic evidence of recurrence on mpMRI and PSMA‐PET/CT. Major inclusion criteria include age ≥18 years, biochemically recurrent prostate cancer after RP with a PSA level between 0.2 and 1.5 ng/mL, and no local or metastatic recurrence on imaging. A total of 312 patients will be enrolled. Participants are randomised 1:1 to standard‐of‐care SRT followed by surveillance (Group A), or initial observation with subsequent image‐guided therapy at radiographic progression (Group B). Based on historical analysis, a total of 30 metastasis events provides 80% power to detect a significant improvement (hazard ratio 0.5 corresponding to a 5‐year metastasis‐free proportion of 80.7% in the control group and 89.8% in the experimental group with one‐sided type I error rate of 0.15). All participants undergo baseline blood collection to measure prostate cancer‐extracellular vesicles and cell‐free DNA for biomarker development. Participants are followed in a 16‐week cycle with serial PSA measurements, repeat imaging if PSA doubles, safety assessment, and patient‐reported outcomes. Endpoints The primary endpoint is distant recurrence‐free survival at 5‐years using a 12‐month landmark to mitigate bias arising from differing assessment schedules for patients receiving optional 6 months of androgen deprivation therapy. Key secondary outcomes include time to hormone therapy, quality of life measures, adverse effects, and novel blood and urine biomarkers. Conclusion The BRIO study will clarify the clinical benefit of immediate SRT vs observation with image‐guided intervention in mpMRI and PET‐negative BCR after RP.

INTRODUCTION: Advanced therapies infrequently achieve complete fistula closure in patients with Crohn's disease (CD). The primary objective of the STOMP2 clinical trial was to determine whether the implantable autologous cell therapy AVB-114 is effective in inducing remission of persistent Crohn's perianal fistulas versus standard of care. METHODS: Eligible patients had a single perianal fistula tract and had failed previous treatment or had documented medication intolerance to biologic or conventional CD therapy. All enrolled subjects underwent surgical fistula optimization and adipose tissue biopsy collection (to manufacture AVB-114) followed by 1:1 randomization to either standard of care (repeat fistula optimization including seton replacement) or AVB-114 implantation. The primary end point was combined fistula remission at 36 weeks, defined as closure of the external opening, no drainage of fluid despite gentle finger compression, and no collections >2 cm in at least 2 of the 3 dimensions on MRI. RESULTS: Subjects at 14 US sites were equally randomized to SoC (N = 24) or AVB-114 (N = 24). Week 36 combined remission was 8.3% and 45.8% for subjects randomized to SoC and AVB-114, respectively (38% difference, 95% CI 11%–60%; P = 0.0078). At week 36, MRI revealed no subjects with collections >2 cm, radiological improvement (≥50% decrease in the Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease (MAGNIFI-CD) score from baseline) in 1 SoC subject and 3 AVB-114 subjects, and radiological healing (complete resolution of T2-weighted hyperintensity in fistula tract) in 2 SoC subjects and 5 AVB-114 subjects. Through week 36, there were 40 and 56 treatment emergent adverse events for SoC and AVB-114, respectively. There were no serious treatment emergent adverse events in the AVB-114 group through week 36. DISCUSSION: A significantly higher proportion of patients treated with AVB-114 achieved combined remission vs SoC, and the treatment was well tolerated. These data support the safety and efficacy of AVB-114 in persistent Crohn's perianal fistulas.

Abstract Background The STOMP2 trial sought to determine whether the implantable autologous cell therapy AVB-114 is an effective add-on therapy for patients with persistent Crohn’s perianal fistulas. The trial design incorporated wait-list controlled (WLC) elements, allowing eligible control group subjects who completed the 9 mo primary endpoint visit in Part 1 to request AVB-114 treatment in Part 2 and strengthen the evaluation of AVB-114’s safety and effectiveness. Methods Eligible patients had a single perianal fistula tract and had failed prior treatment or had documented medication intolerance to biologic or conventional Crohn’s disease therapy. Subjects at 14 U.S. sites were randomized 1:1 to either standard of care (SoC; fistula optimization including seton placement) or AVB-114 implantation. The primary endpoint was combined fistula remission at 9 mo, defined as no collections &gt;2cm on MRI, visual closure of the external opening, and no drainage of fluid despite gentle finger compression. A logistic regression time from exposure model through 9 mo utilized complete Part 1 data and all available Part 2 data to estimate combined AVB-114 effectiveness. Results Part 1 combined remission (using Non-Responder Imputation) was 8.3% (2/24) for SoC and 45.8% (11/24) for AVB-114 (38% difference, 95% CI 11 – 60%, post-hoc p-value of 0.0078). Twenty SoC subjects were treated with AVB-114 in Part 2. Four of the 9 Part 2 subjects with 9 mo combined remission data available were in combined fistula remission (44.4%). No subjects failed 9 mo radiological remission (first component of the primary endpoint), thus clinical remission (composite of the latter two components) was equivalent to combined remission. AVB-114 clinical remission in Part 1 and Part 2 to-date were similar, and when combined provided narrower estimates with the same coverage (Figure 1). Mean (SD) 9 mo perianal disease activity index (PDAI) scores for SoC, Part 1 AVB-114, and Part 2 AVB-114 were 5.0 (2.6), 4.1 (2.9), and 3.8 (3.5), respectively. Lower 9 mo scores and decreases from baseline were independently associated with an increased probability of clinical remission. Two serious treatment-emergent adverse events (TEAEs; pseudopolyposis and proctalgia) occurred, with the latter attributed to AVB-114. Non-serious product related TEAE were predominantly related to postoperative perianal pain. Two grade 2 (moderate) AEs of cellulitis and abdominal wall abscess were attributed to adipose tissue collection. Conclusion Both the randomized and combined (all-treated) analyses demonstrated substantial AVB-114 effectiveness through 9 mo in this challenging patient population. AEs were anticipated, and generally mild and infrequent. Conflict of interest: Schwartz, David: 1) Abbvie: consultant 2) Janssen: Consultant 3) Takeda: Consultant 4) Avbios- consultant 5) Olympus- consultant Dozois, Eric: TBD Ehman, Eric: TBD Faubion, William: TBD Hudesman, David: Consultant: Avalo, Abbvie, Abivax, Biocon, BMS, CorEvitas, Eli Lilly, Johnson and Johnson, Pfizer, Prometheus, Sanofi, Takeda, Fresenius Kabi Research Support: Pfizer and Johnson and Johnson Espen, Benjamin: employee of Avobis Bio LLC Pabla, Baldeep: Astellas, J & J - Advisory Board Prometheus - Speaker Eli Lilly - Speaker Papadakis, Konstantinos: TBD

Radiologists are integral members of the interdisciplinary team for patients with mucinous appendiceal neoplasms and can directly affect care by suggesting the diagnosis of pseudomyxoma peritonei, optimizing imaging protocols for evaluating peritoneal implants, and reporting the primary tumor and spilled tumor cells thoroughly.

Abstract Objectives: Radiologist participation in multidisciplinary tumor board can be time-consuming and demanding, requiring substantial preparation. Anecdotally radiologist participation is felt to help identify discrepancies in previous interpretations; however, there are limited data assessing the actual impact of their tumor board review on patient management. This prospective study aims to evaluate how the reinterpretation of outside imaging and review at hepatobiliary tumor board (HBTB) affects the diagnosis and management of patients with hepatobiliary neoplasms. Methods: This prospective analysis included all patients presented at the weekly HBTB between 6/13/2023 - 6/25/2024. One radiologist reviewed the available reports of outside imaging, the local reinterpretation of outside imaging, the updated local imaging, and documented conclusions from discussion of the case at HBTB. HBTB included 4 radiologists who had reviewed each case. Discrepancies (presence/absence, number, and reasons for) were recorded. When discrepancies occurred, the impact on patient management (5-point Likert scale) was determined by two of the radiologists present at the HBTB in consensus, with input from clinicians if needed. A six-month follow-up was performed to confirm suspected diagnoses. Results: 208 cases (128 males, 104 chronic liver disease patients) were presented at HBTB. Disagreements in the detection or characterization of lesions were found in 59/208 (28.4%) of cases. A change in management occurred in 38/59 (64.6%) of these discrepant cases. In cases with recorded discrepancies in which follow-up confirmation was available, the final interpretation was confirmed in 34/41 (82.9%) of cases. Conclusion: Our study found a discrepant interpretation in nearly one-third of cases presented at a weekly HBTB and a resultant change in management in 65% of those cases. These findings highlight the importance of reinterpretation of prior imaging studies and the presence of radiologists at HBTB to guide optimal patient management.

Abstract Background Perianal draining tunnels in hidradenitis suppurativa (HS) and perianal fistulizing inflammatory bowel disease (IBD) present diagnostic and management dilemmas. Methods We conducted a retrospective chart review of patients with perianal disease evaluated at Mayo Clinic from January 1, 1998, through July 31, 2021. Patients' demographic and clinical data were extracted, and 28 clinical features were collected. After experimenting with several machine learning techniques, random forests were used to select the 15 most important clinical features to construct the diagnostic prediction model to distinguish perianal HS from fistulizing perianal IBD. Results A total of 263 patients were included (98 with HS, 100 with IBD, and 65 with both IBD and HS). Patients with HS had a higher mean body mass index, a higher smoking rate, and more commonly showed cutaneous manifestations of tunnels and comedones, while fistulas, abscesses, induration, anal tags, ulcers, and anal fissures were more common in patients with IBD. In addition to having lesions in the perianal area, patients with IBD often had lesions in the buttocks and perineum, while those with HS had additional lesions in the axillae and groin. Among the statistically significant features, the 15 most important were identified by random forest: fistula , tunnel , digestive symptom , knife‐cut ulcer , perineum , body mass index , age , axilla , abscess , tags , smoking , groin , genital cutaneous edema , erythema , and bilateral/unilateral . Conclusions The results of this study may help differentiate perianal lesions, especially perineal HS and fistulizing perineal IBD, and provide promise for a better therapeutic outcome.

The diagnosis, treatment, and management of gynecologic malignancies benefit from both positron emission tomography/computed tomography (PET/CT) and MRI. PET/CT provides important information on the local extent of disease as well as diffuse metastatic involvement. MRI offers soft tissue delineation and loco-regional disease involvement. The combination of these two technologies is key in diagnosis, treatment planning, and evaluating treatment response in gynecological malignancies. This review aims to assess the performance of PET/MRI in gynecologic cancer patients and outlines the technical challenges and clinical advantages of PET/MR systems when specifically applied to gynecologic malignancies.

Positron emission tomography (PET) imaging in prostate cancer has advanced significantly in the past decade with prostate cancer targeted radiopharmaceuticals now playing a growing role in diagnosis, staging, and treatment. This narrative review focuses on the most commonly used PET radiopharmaceuticals in the USA: prostate-specific membrane antigen (PSMA), fluciclovine, and choline. 18F-fluorodeoxyglucose (FDG) is used in many other malignancies, but rarely in prostate cancer. Previous literature is discussed regarding each radiopharmaceutical’s utility in the settings of screening/diagnosis, initial staging, biochemical recurrence, advanced disease, and evaluation prior to targeted radiopharmaceutical therapy and radiation therapy. PET imaging has demonstrated utility over traditional imaging in various scenarios; however, there are few head-to-head studies comparing PET radiopharmaceuticals. PSMA radiopharmaceuticals are the newest tracers developed and have unique properties and uses, especially at low prostate-specific antigen (PSA) levels. However, each PET radiopharmaceutical has different properties which can affect image interpretation. Choline and fluciclovine have minimal urinary activity, whereas PSMA agents can have high urinary activity which may affect locoregional disease evaluation. Of the three radiopharmaceuticals, only PSMA is approved for both diagnostic and therapeutic indications with 177 Lu-PSMA. A variety of diagnostic PET radiotracers for prostate cancer allows for increased flexibility, especially in the setting of supply chain and medication shortages. For the time being, keeping a diverse group of PET radiopharmaceuticals for prostate cancer is justifiable.

Evaluate the quantitative, subjective (Deauville score [DS]) and reader agreement differences between standard ordered subset expectation maximization (OSEM) and Bayesian penalized likelihood (BPL) positron emission tomography (PET) reconstruction methods. A retrospective review of 104 F-18 fluorodeoxyglucose PET/computed tomography (CT) exams among 52 patients with diffuse large B-cell lymphoma. An unblinded radiologist moderator reviewed both BPL and OSEM PET/CT exams. Four blinded radiologists then reviewed the annotated cases to provide a visual DS for each annotated lesion. Significant (P < .001) differences in BPL and OSEM PET methods were identified with greater standard uptake value (SUV) maximum and SUV mean for BPL. The DS was altered in 25% of cases when BPL and OSEM were reviewed by the same radiologist. Interobserver DS agreement was higher for OSEM (>1 cm lesion = 0.89 and ≤1 cm lesion = 0.84) compared to BPL (>1 cm lesion = 0.85 and ≤1 cm lesion = 0.81). Among the 4 readers, average intraobserver visual DS agreement between OSEM and BPL was 0.67 for lesions >1cm and 0.4 for lesions ≤1 cm. F-18 Fluorodeoxyglucose PET/CT of diffuse large B-cell lymphoma reconstructed with BPL has higher SUV values, altered DSs and reader agreement when compared to OSEM. This report finds volumetric PET measurements such as metabolic tumor volume to be similar between BPL and OSEM PET reconstructions. Efforts such as adoption of European Association Research Ltd accreditation should be made to harmonize PET data with an aim at balancing the need for harmonization and sensitivity for lesion detection.