Citations

Background: The role of fine-needle aspiration (FNA) in diagnosing parotid tumors remains debated due to varying accuracy. This study evaluates FNA’s accuracy in diagnosing Warthin’s tumor (WT) and its safety in guiding observational management. Study design: Retrospective cohort study. Setting: Single institution, Tertiary referral center. Methods: Data from 2010 to 2022 including demographics, cytology, pathology, and surgical outcomes were extracted. Accuracy was assessed using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: Among 808 patients with parotid tumors, 234 were WTs. Seventy-eight patients underwent surgery with pathology while 156 underwent observation. FNA sensitivity, specificity, PPV, and NPV for WTs were 98.2%, 98.1%, 91.8%, and 99.6% respectively. No observational patients developed clinical signs of malignancy, and the median change in tumor size was 0 cm (range −3.1 to 2.1). Conclusions: FNA is highly specific for WT but limited by nondiagnostic results. Observation is a safe approach with minimal risk of growth, malignancy, or infection.

ABSTRACTObjectiveTo build consensus from different stakeholders on the content and digital interactivity of a shared decision making (SDM) tool to guide patient‐clinician collaborative conversations about treatment for bipolar depression.Patients and MethodsThis study was conducted between September 2022 and September 2023. In the first phase, we conducted a narrative review on pharmacological, neuromodulatory, and psychotherapeutic treatments available for bipolar depression. For each option, we assessed treatment effectiveness, side effects, need for clinical monitoring, clinical considerations, and cost. In the second phase, committees comprised of mental health clinicians and people with lived experience with bipolar disorder from a national mood disorders advocacy group identified key features and content to be included in the SDM tool. A thematic analysis of these data then contributed to populate the SDM tool.ResultsTwenty‐one evidence‐based treatment options identified from the narrative review were presented to the four convened committees (clinical, lived experience, peer council, and integrated steering committees) in five meetings. After discussions and thematic analysis, 12 outcomes of interest for each of the therapeutic interventions were delineated for inclusion in a web‐based SDM tool. A detailed description of the development process and SDM tool is provided.ConclusionThis is the first partnership between clinicians and persons with bipolar disorder lived experience charged with the development of a patient‐centered SDM tool to integrate clinical evidence with real‐world clinical practice and patient preferences for use during clinical encounters. Human‐centered design and testing in real clinical encounters will now contribute to refining the instrument and readying it for rigorous evaluation and implementation in practice.

Abstract Background Despite 40 years of evidence supporting psychosocial interventions as a component of comprehensive cancer care, patients continue to report vast unmet psychosocial needs and distress. Cognitive behavioral therapies for cancer distress (CBT-C) are the most rigorously tested class of psychosocial interventions for cancer care. Purpose To report clinical effectiveness outcomes of cancer-related distress and self-efficacy following implementation of best-evidence CBT-C, adapted for a real-world, billable practice setting. Methods Patients who completed group-delivered, CBT-C (10 intervention hours, 5 sessions) in the practice setting were invited to enroll in a research study to document cancer distress across the year following CBT-C. Participants (n = 65) were primarily middle-aged (mean 50.5 years, 17% were young adults ≤40 years), female, and White. Analyses utilized mixed linear models with intent-to-treat procedures. Given group delivery and social skills training content within CBT-C, social self-efficacy was assessed as a potential treatment mechanism. Results Distress decreased across the year following CBT-C (mean score change of 20 points for YAs, 6 points for non-YAs), with statistically significant age x time effects. Within-person improvements in social self-efficacy scores were related to reductions in cancer distress, including distress subscales of intrusive thoughts, avoidant coping, and hyperarousal. The model explained 76.6% of the total variance in cancer distress. Conclusions This study demonstrates the effective translation of CBT-C from controlled research trials to the practice setting. CBT-C effectiveness within a mixed-cancer population and relatively rural region of the US is also supported. CBT-C can be effectively translated to the practice settings for which it is intended.

5515 Background: Clear cell ovarian carcinoma (CCOC) is a chemoresistant subtype of ovarian cancer. Immune checkpoint inhibitors have been reported to have clinical activity in CCOC. Additionally, CCOC harbors molecular alterations suggesting a role for anti-angiogenic agents. We therefore conducted a single-arm two-stage phase 2 trial to investigate the clinical activity of the combination of the PD-1 inhibitor pembrolizumab with the anti-angiogenic tyrosine kinase inhibitor lenvatinib in patients (pts) with CCOC. Methods: Pts with CCOC and measurable disease received pembrolizumab 200 mg IV every 3 weeks and lenvatinib 20 mg daily. Pts could have received an unlimited number of prior therapies; prior bevacizumab and immune checkpoint inhibitors were allowed, but prior lenvatinib was exclusionary. Malignant bowel involvement was not allowed. Co-primary endpoints were objective response rate (H 0 5%; H a 25%) and rate of PFS at 6 months (mo) per RECIST v1.1 (H 0 10%; H a 30%), restricting the probabilities of type I and type II errors to 10% and 10%, respectively. Two pts with objective responses or 3 pts progression-free and alive at 6 mos were needed to proceed from stage 1 (n=18) to stage 2 (n=13); 5 pts with objective responses or 6 pts progression-free and alive at 6 mos were needed to declare the combination worthy of further study. Results: Data cut-off occurred 22-Oct-2024. Of 30 enrolled pts, 83.3% were white; the mean age among all pts was 54.1 years. 30% of pts (9/30) experienced a confirmed response (2 CR, 7 PR); an additional 3 pts (10%) experienced unconfirmed PRs and 4 pts (13.3%) had SD ≥6 mo. As of data cut-off, 3 pts (10%) had not yet reached their first radiographic assessments, and 17 pts were still receiving study therapy. With a median of 9.72 mo of follow up, 16 pts were alive and progression-free at 6 months. The estimated 6-month PFS was 75.96% (95% CI 53.82-88.51%). Median PFS was 10.9 mo. The estimated 12-month PFS was 48.86% (95% CI 23.67-70.04%). The most common any-grade TRAEs were hypertension (71%), hypothyroidism (66%), and fatigue (60%). There were no unanticipated TRAEs. Conclusions: The combination of pembrolizumab/lenvatinib demonstrates encouraging evidence of clinical activity in CCOC, with 9 pts experiencing a confirmed response and 16 pts alive and progression-free at 6 months. As both co-primary endpoints of the study were met, enrollment closed with 30 pts. Updated data for all pts will be reported. There were no new safety signals. Clinical trial information: NCT05296512 .

e13042 Background: The conventional treatment paradigm for metastatic breast cancer (MBC) is to continue systemic therapy until disease progression. With improved systemic therapy options, some patients (pts) with MBC attain radiographic remission. Tumor-informed circulating tumor (ct)DNA detects molecular disease burden and may guide decision-making. We report on an institutional cohort of pts with MBC in which tumor-informed ctDNA testing was utilized prospectively to guide decisions on systemic therapy or surveillance imaging frequency. Methods: Utilizing an IRB-approved protocol, we retrospectively identified pts monitored with tumor-informed ctDNA using the Signatera™ mPCR-NGS assay (Natera, Inc) as part of routine clinical care in Mayo Clinic, Rochester. We then identified a subset with biopsy-proven MBC who attained radiographic remission of disease following systemic therapy, deemed by the treating medical oncologist as “exceptional responders”. Real-time ctDNA testing was used to inform a decision to either discontinue systemic therapy, treatment de-escalation (remove a component of multi-drug therapy), increase the time interval between restaging scans, or stay off therapy previously stopped due to toxicity . Data on breast cancer characteristics, imaging results, ctDNA test results, and outcomes were collected. Descriptive statistics were used to analyze the data. Results: 10 pts met our study criteria. The median age at MBC diagnosis was 42 years (range 28-61); 5 pts had TNBC, 3 pts had HER2+, and 2 pts with ER+/HER2- MBC. Most pts (60%) were on first or second line therapy (range 1-5). The median duration of the most recent regimen was 27.5 months (range 10-70 months). All pts were without radiographic evidence of active cancer at the time of ctDNA testing with negative results (0 MTM/mL) at the time of clinical decision-making. 4 pts stopped all systemic therapy and proceeded with observation (1 trastuzumab, 1 trastuzumab deruxtecan, 1 pembrolizumab, and 1 talazoparib). 2 pts discontinued a targeted therapy (1 olaparib, 1 abemaciclib) while continuing endocrine therapy. 1 patient stopped targeted therapy (abemaciclib) due to a blood clot, and ctDNA testing guided the decision to not start another CDK4/6 inhibitor while continuing endocrine therapy. In 3 pts the frequency of restaging scans was decreased to either annually or semi-annually. The median follow-up after a ctDNA-informed decision was 11 months (range 1-41 months). At this time, no patient has converted to ctDNA-positivity, experienced resurgence or progression of disease, needed to change systemic therapy or increase imaging frequency. Conclusions: Tumor-informed ctDNA may offer additional confidence to oncologists and pts to deescalate systemic therapy or decrease the interval of imaging frequency in exceptional responders with MBC. Additional data to support this approach is needed.

4545 Background: The treatment landscape of front-line nccRCC has evolved with recent trials demonstrating the efficacy of combination systemic therapy. However, the efficacy of treatment after combination therapy is unknown. This study evaluates the efficacy of VEGF-based regimens in nccRCC patients (pts) previously treated with combination regimens. Methods: ORACLE is a real-world, multi-center, retrospective database that includes nccRCC patients that received combination systemic therapies (IO+IO, IO+VEGF and VEGF+ mTOR) in any line. Subsequent treatments were categorized as VEGF only regimens (cabozantinib vs other VEGF), IO+ VEGF and VEGF+ mTOR. The primary endpoint was objective response rate (ORR) assessed by investigator review using RECIST 1.1. Secondary endpoints included disease control rate (DCR), defined as the proportion of patients achieving complete or partial responses or stable disease, time to treatment progression (TTP), calculated from the date of VEGF-based initiation to progression or last follow-up using the Kaplan-Meier method. Differences between groups were estimated with the log-rank test, and categorical outcomes were compared with the chi-square test. Results: 105 pts who received VEGF – based regimens after combination therapy were included in the analysis. Baseline characteristics: median age: 59years, 71 % male, 58% white, 25% black, 87% ECOG 0-2. IMDC-risk categories included:21% favorable, 59% intermediate and 20% poor risk. Histology included papillary (40%), unclassified (32%), chromophobe (16%) and other rare subtypes (12%). Prior combination therapies included IO+IO: 62%, IO+ VEGF: 34% and VEGF+ mTORi:4%. 70% pts received combination therapy in the first line setting while the remainder received combination therapy in a second or later line. Outcomes with subsequent treatments are described in Table1. IMDC risk score correlated with TTP. Conclusions: Modest antitumor activity was observed with VEGF- based approaches in combination therapy refractory nccRCC. Optimal management of nccRCC remains an unmet need. Outcomes of nccRCC patients by treatment and histologic type. Outcomes per Treatment n ORR (%) DCR (%) mTTP (mo.) Cabozantinib 56 18 47 3.6 VEGF/mTOR 19 16 42 9.3 IO+VEGF 17 29 47 5.6 Other VEGF 13 15 46 5.5 Outcomes per Histology Papillary 42 19 43 6.5 Unclassified 33 21 42 6.1 Chromophobe 17 29 59 8.9 Other * 13 0 46 NR

This article highlights herpes zoster radiculitis, a condition that predominantly affects elderly patients and classically presents with progressive limb weakness, pain, and vesicular rash. Neuroimaging with MRI may demonstrate nerve root enlargement with T2-hyperintensity and gadolinium enhancement. Diagnosis can be confirmed with varicella zoster virus PCR in CSF. Effective treatment includes IV acyclovir and neuropathic pain agents such as gabapentin, which together can lead to symptomatic improvement. Early diagnosis and comprehensive treatment are crucial to prevent complications. Patients with zoster-associated plexopathy have a higher incidence of postherpetic neuralgia compared to those with herpes zoster rash alone. Thus, multimodal treatment involving antivirals, rehabilitation, and pain management is essential for recovery.

ABSTRACTBackgroundRenal medullary carcinoma (RMC) is an aggressive tumor associated with sickle cell trait. Despite treatment advances for other rare renal tumors, RMC survival remains poor. We aimed to describe the contemporary management and survival of children and adults with RMC.ProcedureIn this multicenter retrospective cohort study, Pediatric Surgical Oncology Research Collaborative sites searched their databases for patients diagnosed with RMC (2000–2022). Descriptive statistics were calculated and survival analyses performed using Kaplan–Meier and Cox regression.ResultsThirty‐four patients with RMC were identified. Median age was 19 years (IQR: 15–28; range: 7–52). Most were male (24/34; 71%), Black (27/32; 84%), had sickle cell trait or disease (30/33; 91%), presented with metastatic disease (27/34; 79%), and were symptomatic at presentation (32/34; 94%). Median overall survival (OS) was 24 months from diagnosis (16 months for children, 28 months for adults, p = 0.6). Receipt of platinum‐based chemotherapy (23/34; 68%) was associated with significantly higher OS than other regimens (35 vs. 5 months, p < 0.001). Nephrectomy (24/34; 71%) was associated with significantly improved OS compared with non‐operative management (34 vs. 7 months, p = 0.001). Immunotherapy, targeted therapy, or radiation therapy were not associated with significant differences in OS, nor were age, sex, race, sickle cell status, SMARCB1/INI‐1, stage, nephrectomy approach, retroperitoneal lymph node dissection, gross residual disease, margins, or tumor size.ConclusionsRMC survival remains poor despite newer therapies. Nephrectomy and platinum‐based chemotherapy should be considered in locally advanced and metastatic disease. Coordinated international cooperative group studies are needed to meaningfully improve RMC survival.

Study Design Retrospective Cohort Study. Objectives To determine if 3D printed porous titanium (Ti) cages compared to non-porous polyetheretherketone (PEEK) cages predicted improved fusion rate or clinical outcomes after transforaminal lumbar interbody fusion (TLIF). Methods All adult patients who underwent one- and two-level TLIF for degenerative conditions by a single surgeon at an academic center between 2017-2021 were retrospectively identified. Patients were dichotomized into porous Ti and non-porous PEEK interbody cage groups. Fusion status was assessed by at 6-months and 1-year postoperatively by CT Bridwell scale and flexion/extension X-Rays. Postoperative complications (CT-based subsidence, adjacent segment disease, reoperation rates) and interval changes in lumbar radiographic alignment at short- and long-term follow-up were determined. Univariate and multivariate analysis compared patient and surgical factors, fusion rates, alignment, and complications across interbody groups. Results A total of 136 patients with 169 unique fusion levels (125 Ti cages, 44 PEEK cages) met the inclusion/exclusion criteria. Ti relative to PEEK interbodies had significantly decreased surface area and increased height and lordosis. Ti cage use was associated with greater subsidence ( P < 0.001) but did not independently predict maximum subsidence on regression ( P = 0.109). In the overall cohort, there were no significant differences in fusion rates or lumbopelvic alignment between interbody groups. Reoperation (Ti: 10.9% vs PEEK: 28.6%, P = 0.026) and reoperation for pseudoarthrosis (Ti: 2.0% vs PEEK: 11.4%, P = 0.038) was significantly more likely in the PEEK relative to the Ti group. Conclusions Use of 3D printed porous Ti cages relative to non-porous PEEK cages may mitigate pseudoarthrosis related reoperation after TLIF.