Citations

Abstract Introduction and Objective This study aims to evaluate the learning curve and perioperative outcomes of single‐port extraperitoneal robotic radical prostatectomy (SP‐EP‐RARP) performed by a single surgeon at a high‐volume academic institution. Methods A retrospective review of a prospectively maintained database was conducted for patients who underwent SP‐EP‐RARP from September 2023 to August 2025. Key metrics included operative time, estimated blood loss, conversion rate, nerve‐sparing status, pathological margin status and continence (0–1 pad for safety), and 30‐day complication rate. Descriptive statistics were used, and outcomes were analysed chronologically to assess for trends suggesting a learning curve. Results The cohort included 53 patients who underwent extraperitoneal SP‐EP‐RARP. Median operative time was 213 min (IQR: 145–281). Median estimated blood loss was 100 mL (IQR: 75–125). Nerve‐sparing was attempted in 75.5% of cases. No assist or plus one ports were utilized. Final pathology revealed pT2 disease in 64.1% (34 cases), pT3a in 32.1% (17 cases) and pT3b in 3.7% (2 cases). Overall positive margin rate was 26.4%. Thirty‐day Clavien–Dindo Grades I–II complication rates were 11.3%, and no major complications or 90‐day complications were reported. Continence rates at 6 weeks, 3 months and 6 months were 72%, 72% and 75%, respectively. Stabilization of operative times and intraoperative outcomes occurred after approximately 25–30 cases. Conclusion SP‐EP‐RARP can be safely implemented by a newly graduated fellowship‐trained robotic surgeon with acceptable oncologic and functional outcomes. Initial learning can be estimated at approximately 25–30 cases.

SUMMARY Goal: The purpose of this study was to enhance access to medication assistance programs (MAPs), which are crucial for providing free medications to patients who cannot afford them. These programs are particularly beneficial for the management of chronic conditions such as diabetes, heart failure, and cancer, for which medication adherence is vital for positive patient outcomes, and cost is a common barrier. Methods: This quality improvement project aimed at optimizing the MAP enrollment process. Interventions included the development of frequently asked questions documents, standardized templates for documentation, establishment of MAP technician office spaces, and standardization of patient referrals. A Mann-Whitney U test and a chi-square test were used to summarize the data in this study. Principal Findings: The project resulted in a 56% increase in new patient enrollments ( p < .01) and a 33% increase in medications provided, with a significant reduction in the average time from patient referral to application approval. Practical Applications: The project improved patient access to MAPs, optimized pharmacy technician resources, and significantly reduced processing times, an important factor in preventing treatment delays and improving patient care. Future plans include expanding the new enrollment process to annual reenrollments, formally establishing the MAP technician within departments, and considering additional pharmacy technician support in response to increasing demand for MAPs.

ABSTRACT Background Primary lateral sclerosis (PLS) is an ultrarare upper motor neuron syndrome with a prognosis unique from classical ALS. The study of PLS is complicated by its rarity and the difficulty distinguishing PLS from ALS. We present data from a 1‐year prospective follow‐up study on PLS and efforts to distinguish it from ALS. Methods Seventy‐six PLS participants enrolled in this prospective natural history study. EMG studies, blood neurofilament light chain levels (NfLs), and demographic characteristics were obtained at baseline. At 1‐year follow‐up, repeat EMG studies were conducted to determine which participants fulfilled criteria for ALS. Baseline characteristics were then compared to determine features that predict reclassification. Results Seventy participants completed 1‐year follow‐up. Five of the 70 were reclassified to ALS (7.1%). Those reclassified had higher trends in baseline blood NfL levels (91.4 vs. 34.0 pg/mL, p = 0.13) and shorter symptom duration (39 vs. 69 months in the PLS group, p = 0.15). Reclassification was noted in both probable and definite PLS participants. All cases with a symptomatic duration of less than 2 years retained the PLS phenotype (5 of 5). NfL levels over 90 pg/mL predicted reclassification with 94% specificity and 60% sensitivity. No other features predicted reclassification to ALS. Conclusions In our population, reclassification of PLS to ALS occurred at a low frequency at 1 year follow‐up (7.1%). Baseline NfL was the strongest predictor in differentiating UMN dominant ALS from PLS at 1‐year follow‐up. Based on our data, we propose EMG and NfL criteria for enrollment in future PLS trials.

A 79-year-old man was referred for evaluation of a recurrent neoplasm of the left scrotum.

LBA629 Background: Whether BCG strain influences clinical efficacy is unclear. BCG shortages and a reliance on a single strain may impact disease outcomes. Evidence also suggests that priming with intradermal (ID) BCG vaccination prior to intravesical (IVe) BCG enhances anti-tumor immunity and cancer clearance. Co-primary objectives address these issues. Methods: The trial design calls for 924 eligible patients with BCG naïve non-muscle invasive bladder cancer (NMIBC) (HG Ta/T1 +/- CIS or CIS alone) with negative purified protein derivative (PPD) to be randomized in a 1:1:1 ratio, to IVe TICE (Arm 1), IVe Tokyo-172 (Arm 2), or ID + IVe Tokyo-172 (Arm 3) BCG, stratifying on age group and clinical stage. IVe BCG included 6 weekly instillations (induction) and three weekly instillations (maintenance) at 3 and 6 months (mo), then every 6 mo for 3 years. Objective 1 tests whether Tokyo-172 BCG is non-inferior (NI) to TICE BCG, specifying a NI hazard ratio=1.34 (84% power). Objective 2 tests whether priming with ID prior to IVe Tokyo-172 is superior to IVe Tokyo-172 (HR=0.71, 83% power). The primary endpoint is high-grade recurrence-free survival (HG-RFS) censored at last cystoscopy, using a one-sided α=0.021 for each test. A Cox model adjusting for the stratification factors is used. Secondary endpoints include adverse events, 6-mo biopsy-proven complete response (CR) in patients with CIS +/- Ta, T1, duration of CR, PPD conversion and HG-RFS, progression-free survival (PFS) and quality of life. Max follow-up is 5 years. Results: 1000 (984 eligible) patients were enrolled from 2/17-12/20. Median (IQR) follow up is 4.6 (3.6, 5.0) yrs. Median age (range) is 70 yrs (26, 99), 17% are female, 9% are non-white, and 34% had CIS at entry. HG-RFS, CR, duration of CR at 4 yrs, and PFS were similar among arms (Table). PPD conversion occurred in 29% and was not correlated with HG-RFS. Gr 1-2 AE rate was similar (67%, 71%, and 67%) and Gr 3-4 (no Gr 5s) rate was 6%, 11%, and 14% for Arms 1,2, and 3, respectively. Conclusions: Tokyo-172 is non-inferior to TICE BCG in terms of HG RFS and CIS CR and is similar for PFS. Gr 3-4 AE rate is higher with Tokyo-172. Priming with Tokyo-172 BCG does not improve HG RFS. PPD conversion is not prognostic. Clinical trial information: NCT #03091660 . CIS Component N (eligible) 5-yr HG RFS HG RFSHR (95.8% CI) @ 5-yrPFS PFS HR(95% CI) @ CR %(95% CI) 4 yr CR duration Tice Ive 333 (330) 58% 79% 62%; 71/114(53%, 71%) 80% Tokyo Ive 332 (327) 64% *0.82(0.63, 1.08) 79% *0.99(0.70, 1.39) 60%; 66/110(50%, 69%) 83% Tokyo ID + Ive 335 (327) 63% **1.00(0.76, 1.33) 77% **1.07(0.76, 1.51) 63%; 69/109(54%, 72%) 80% 3 mo. PPD + conversionY vs. N 782 evaluable225 (29%)557 (71%) 69%67% ^HR=0.91(0.68, 1.22) * Tokyo-172 vs. Tice, ** Tokyo Priming vs. Tokyo no priming. ^conversion to PPD + vs. – @ adjusted for 2 strat factors (and arms for PPD model). PFS event = MIBC, metastasis, or death.

PURPOSE The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinical trial conduct in patients with advanced prostate cancer. Methods We convened an international expert committee of diverse working groups, the Prostate Cancer Working Group 4 (PCWG4), between 2016 and 2025. Our objective was to formulate updated criteria based on emerging evidence and clinical trial data in a biomarker context to provide guidance for clinical trial design, eligibility, and end point assessments for patients with advanced prostate cancer. RESULTS PCWG4 redefines terminology around the disease state and previous therapies in a patient-centric context and terminology focused on androgen pathway modulation. We consider imaging, with a particular focus on positron emission tomography (PET)–defined disease. New recommendations are provided for disease state terminology, defining eligibility criteria, response and delay/prevent end points, intervals for reassessments including imaging, and patient-reported outcome determination. We provide recommendations in a biomarker-based context of use for the intended indication, reflective of patient benefit for specific interventions. We emphasize the need for development of validated PET imaging and molecular and phenotypic criteria as well as trial designs to appropriately risk stratify patients, predict and assess benefit, and measure post-treatment outcomes reliably in a trial framework. CONCLUSION PCWG4 updates recommendations on patient and tumor characterization, therapy development, and imaging criteria and extends guidance into earlier androgen pathway modulator–naïve/sensitive disease states to reflect an evolving, heterogeneous, and diverse patient population to optimize treatment benefits for all patients.

Abstract BACKGROUND: Obesity is prevalent in Hispanic patients (pts) with breast cancer (BC), but this population is often underrepresented in studies of weight loss interventions (WLIs). The BWEL trial (Alliance A011401; NCT02750826) is a phase III randomized trial testing the impact of a 2-year (yr) telephone-based WLI on invasive disease-free survival in pts with stage II-III HER2-negative BC and a body mass index (BMI) &gt; 27 kg/m2. At 12 months (mo), Hispanic pts lost less weight than White pts on the WLI. Here, we evaluate differences in intervention engagement over the first 12 mo by language preference and ethnicity among BWEL pts on the WLI. METHODS: BWEL randomized pts 1:1 to WLI + health education (HE) or HE alone. WLI +HE pts received semi-structured telephone-based health coaching in English or Spanish, in addition to access to an activity monitor, wireless scale and meal replacement shakes. Pts self-reported ethnicity and their preferred language for the WLI. Kruskal Wallis and chi-square tests were used to assess language and ethnicity differences in demographic and treatment factors for continuous and categorical variables, respectively. Percent weight change and mean values for intervention attrition, number of calls, call duration, number of shake shipments, and frequency of activity monitor use and weight tracking over 12 mo were compared between Spanish-preferred Hispanic pts (SH), English-preferred Hispanic (EH) pts and non-Hispanic (NH) pts using ANOVA. Pts with missing language, ethnicity or 12 mo weight data were excluded from analysis. RESULTS: 1591 pts were randomized to the WLI + HE from 08/2018 to 02/2021. 80.5% of pts were White, 12.8% Black and 7.1% Hispanic. 1190 pts had 12 mo weight and language available. Among the 87 WLI + HE pts who had available data and identified as Hispanic, 34% were SH and 66% EH. SH WLI pts were younger (in yrs: 49.5 SH, 51.1 EH, 53.9 NH, p=0.006) and had lower BMI (32.2 SH, 35.1 EH, 34.5 NH, p=0.007). At 12 mo, SH WLI pts lost 2.4% of baseline body weight vs 3.3% in EH and 5.1% in NH (p=0.051) (Table). Compared with EH and NH WLI pts, SH WLI pts participated in fewer calls (15.7 SH, 21.1 EH, 24.3 NH, p&lt; 0.0001), had fewer days of activity monitor use (134.2 SH, 177.3 EH, 205.3 NH, p=0.015) and fewer days of weight tracking (65.3 SH, 96.8 EH, 148.2 NH, p&lt;0.0001), but had more shake shipments (3.9 SH, 3.5 EH, 3.0 NH, p=0.015). There were no significant differences in attrition rate or call duration by language preference or ethnicity. CONCLUSIONS: In a large phase III WLI study in breast cancer patients, engagement with the WLI appeared lower in SH pts, despite provision of the intervention in Spanish. More work is needed to improve accessibility and efficacy of WLI studies among non-English speaking populations. Support: U10CA180821, U10CA180882, UG1CA189823; https://acknowledgments.alliancefound.org. Citation Format: A. Odai-Afotey, K. V. Ballman, L. M. McCall, C. Cao, C. Alfano, V. Bernstein, T. E. Crane, L. M. Delahanty, L. Frank, P. J. Goodwin, O. Hahn, D. L. Hershman, J. O. Hopkins, M. Irwin, E. L. Mayer, L. Minasian, L. Nebeling, M. Neuhouser, E. D. Paskett, P. A. Spears, V. Stearns, C. A. Thomson, T. A. Wadden, A. Weiss, J. White, C. Hudis, E. P. Winer, L. Carey, A. H. Partridge, J. Ligibel. Variation in weight loss and intervention engagement in the Breast Cancer Weight Loss (BWEL) trial by language and ethnicity (Alliance) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS4-09-29.

Abstract Purpose: There are limited prospective data on the efficacy, tolerability, and functional impact of treatments for older and frail adults with HER2+ early breast cancer. We report the first-ever, US-based adjuvant trial dedicated to this population. Methods: We conducted a single arm, phase II, multicenter, investigator-initiated study of adjuvant ado-trastuzumab emtansine (T-DM1) in patients aged 60 and older with stage I-III HER2+ breast cancer who either declined standard adjuvant therapy or were deemed by their physician not to be candidates for standard treatment for any reason. Protocol therapy included postoperative administration of T-DM1 (3.6 mg/kg) every 21 days for one year (17 cycles). The primary endpoint was 5-year invasive disease-free survival (iDFS) with a 2-sided 90% confidence interval. Secondary endpoints presented here are toxicity and 3-year iDFS, invasive breast cancer-free survival (iBCFS), and overall survival (OS). All survival analyses were evaluated using Kaplan Meier methods and began at the time of C1D1 of T-DM1. Results: ATOP enrolled 111 evaluable patients during 2015-2020; median follow-up is 4.9 years (IQR 4.2-5.5). The median age was 71 (range 60-88); 50.4% were aged &gt;70 and 11.7% were aged &gt;80. Overall, 69.4% had stage I, 26.1% had stage II, and 4.5% had stage III disease; 70.3% had hormone receptor-positive tumors. The 5-year iDFS = 84.2% (90% CI 77.1-92.0%). The 3-year iDFS = 91.2% (90% CI 85.9%, 96.9%) and iBCFS = 94.1% (90% CI 89.7-98.8%) (see Table for event details); 3-year OS = 96.1% (90% CI 92.4-99.9%). In total, there were 3 distant recurrences and 2 breast cancer-related deaths. Overall, 82% reported grade 2+ toxicity during treatment; the most common grade 2+ events were fatigue (30.6%) and peripheral sensory neuropathy (19.8%). The most frequent grade 3 events were liver function abnormality, anemia, decreased neutrophil count, and neuropathy (&lt;5% for each); one patient (0.9%) had grade 4 thrombocytopenia. Sixty-five (58.6%) completed all 17 cycles of protocol therapy; 27 (24.3%) completed 10-16 cycles, and 19 (17.1%) completed 1-9 cycles. Reasons for early treatment discontinuation in the remaining 41.4% included toxicity (28.8%), patient withdrawal (6.3%), other (3.6%), disease progression (0.9%), death on study (0.9%, deemed unrelated to treatment), and other complicating disease (0.9%). Conclusions: The ATOP trial demonstrated a favorable 5-year iDFS and manageable toxicity among older adults with early stage HER2+ breast cancer. Although iDFS was numerically worse than historical controls (i.e., 5-year iDFS in the ‘ATEMPT’ trial by Tolaney et al. J Clin Oncol, 2024 was 97% [95% 95.2-98.7]), ATOP’s participants had higher-risk cancers, advanced age, and more competing non-breast cancer events. Future endpoints will include in-depth analyses of patient-reported outcomes, biomarkers of aging, and longitudinal functional status. Citation Format: R. A. Freedman, H. Heiling, K. J. Ruddy, L. Rogak, M. Sedrak, A. Dueck, H. Liu, A. Fraettarelli, S. Atanasov, M. DeMeo, P. Lange, A. Perilla Glen, S. Sinclair, D. Dillon, J. Mortimer, M. Fenton, J. Walsh, L. Spring, H. Muss, N. Sinclair, E. Hamilton, C. Dang, S. Giordano, M. Faggen, S. Lo, C. Kuzma, S. Lemke, P. Stella, R. Mowat, M. Wilkinson, J. Rauch, N. Tayob, E. Winer. Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients with HER2+ Breast Cancer - Results from the ATOP Study [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS3-11-04.