OBJECTIVE:In the phase 3, multi-national, open-label, randomized innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628), tisotumab vedotin as second- or third-line therapy significantly improved survival versus chemotherapy in patients with recurrent or metastatic cervical cancer. We report a post hoc analysis of patient-reported outcomes on health-related quality of life from innovaTV 301. METHODS:Patients were randomized 1:1 to tisotumab vedotin or investigator's choice of chemotherapy. Pre-specified secondary end points included assessment of health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module, and EuroQol 5-Dimension 5-Level. This post hoc analysis assessed change from baseline to cycle 13 using a mixed model for repeated measures and time to clinically meaningful deterioration (≥10-point change) or disease progression/death using a Cox proportional hazards model in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales, both adjusted for baseline factors. Proportion of patients with ≥10-point change from baseline in subscales were compared between arms. RESULTS:Mean compliance rates across patient-reported outcome instruments were high (>82%) from baseline to cycle 13. Mixed model for repeated measures analyses showed that patient-reported health-related quality of life, functioning, and symptoms were maintained with tisotumab vedotin therapy over the course of treatment, with no differences by arm. The proportion of patients reporting clinically meaningful (≥10-point) improvement was greater with tisotumab vedotin versus chemotherapy for most European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales. In patients who showed deterioration, time to clinically meaningful deterioration was slower with tisotumab vedotin versus chemotherapy for most European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Cancer Module subscales, most notably nausea/vomiting, pain, dyspnea, insomnia, symptom experience, and lymphedema. CONCLUSIONS:Results suggest tisotumab vedotin maintained health-related quality of life in patients with previously treated recurrent or metastatic cervical cancer and, together with clinical outcomes with innovaTV 301, support tisotumab vedotin as a treatment option in this setting. TRIAL REGISTRATION NUMBER:NCT04697628.

Aim: Lorlatinib and alectinib are next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) approved for the treatment of ALK-positive (ALK+) advanced/metastatic non-small cell lung cancer (NSCLC) after demonstrating superior efficacy over crizotinib (first-generation ALK TKI) in the CROWN and ALEX trials, respectively. This analysis estimated the US population-level clinical impact of first-line (1L) lorlatinib versus alectinib treatment for ALK+ advanced/metastatic NSCLC. Materials & methods: We developed a decision-analytic model comparing lorlatinib versus alectinib use in 1L. We used a three-state partitioned survival model (pre-progression, post-progression and death) and tracked incidence of brain metastases (BMs). Lorlatinib-eligible population estimates were derived from published literature and market forecasts; treatment effectiveness for lorlatinib was derived from CROWN; alectinib comparative effectiveness was informed using a match-adjusted indirect comparison (CROWN vs ALEX). We assumed lorlatinib uptake of 38% in the base case; selected scenarios included different survival extrapolations, assuming 100% lorlatinib uptake and applying risk of BM post-discontinuation. Results: We estimated that 3096 patients in the US would be eligible for lorlatinib. Compared with 1L alectinib use only, our model projected that 1L lorlatinib treatment results in 1620-5170 and 1590-4880 more life-years and quality-adjusted life-years, respectively, over a 20-year time horizon across scenarios. Per-patient incidence of BM ranged from 0.14-0.18 and 0.21-0.40 for lorlatinib and alectinib, respectively, resulting in 68-256 fewer BMs. Separately, for every 5-15 patients treated with 1L lorlatinib instead of 1L alectinib, one BM would be avoided. Conclusion: This analysis projected that 1L lorlatinib treatment in the US could result in more LYs and quality-adjusted life-years and fewer BMs versus 1L alectinib in ALK+ advanced/metastatic NSCLC.

[This corrects the article DOI: 10.3389/fpsyt.2025.1508811.].

Purpose: To evaluate spectacle independence in healthy individuals and cataract patients with different types of intraocular lenses (IOLs) and refractive targets using a Dutch translation of The Patient-Reported Spectacle Independence Questionnaire (PRSIQ). The PRSIQ is a patient-reported outcome measure that assesses patient need for, wearing of, and functioning without spectacles for distance, intermediate, and near vision. Setting: Amphia Hospital, Breda, the Netherlands. Design: Prospective, observational, cross-sectional, single-center study. Methods: The English questionnaire was translated to Dutch following the ISPOR guidelines. 361 participants across various groups were included: healthy individuals aged younger than and older than 50 years and cataract patients with bilateral implantation of monofocal, enhanced monofocal, toric monofocal, monofocal with a myopic target, extended depth-of-focus (EDOF), or trifocal IOLs. Results: Dichotomous scoring showed significantly different rates of complete spectacle independence: 28 of 49 (57%) for trifocals, 8 of 47 (17%) for EDOFs, 2 of 44 (5%) for monofocals, 1 of 50 (2%) for enhanced monofocals, 0 of 25 (0%) for toric monofocals, 1 of 46 (2%) for myopic targets, and 10 of 50 (20%) and 1 of 50 (2%) for healthy participants younger than and older than 50 years. Participants with minimal refractive errors reported complete spectacle independence in 20 of 28 (71%) with trifocals and 5 of 21 (24%) with EDOF IOLs. Rasch analysis showed that the questionnaire was multidimensional and thus failed to support interval scaling. Conclusions: The Dutch PRSIQ-NL demonstrated significant differences in self-reported complete spectacle independence across IOL types and refractive targets using dichotomous scoring. Rasch analysis showed PRSIQ-NL cannot be used for interval-scaled measurements. The PRSIQ-NL is valuable for clinical and research applications to evaluate spectacle independence using dichotomous scoring.

IntroductionFew population-based studies have examined associations between psychedelic use and mental health outcomes. This work describes characteristics of exclusive psychedelic mushroom use (referred to as PM use), PMs in combination with other psychedelic substances (multi-psychedelic or MP) use, and non-psychedelic use and explores mental health ratings in non-clinical settings.MethodsThis work uses cross-sectional survey data from American adults collected by Acumen Health Research Institute, including demographic characteristics, general health-related quality of life (Veterans RAND derived mental and physical health composite scores), depression (PHQ 9-item), anxiety (GAD 7-item), comorbid conditions (CCI), health resource utilization, and perceptions, knowledge, and use of psychedelics. Multivariate and descriptive statistics were used to describe participant characteristics. Correlation analysis assessed anxiety and depression scores across groups. Mean anxiety and depression scores were compared using ANOVA and Tukey’s HSD. A multivariate linear regression model controlling for past-year depression, past-year anxiety, age, region, ethnicity, sex, educational attainment, employment, and psychedelic use predicted mental health composite scores (MCS).ResultsOf the 6,869 participants included in the dataset, 256 (3.7%) reported using psychedelics in the last 12 months. Of those using psychedelics, 122 (47.7%) reported PM use and 134 (52.3%) reported MP use. All psychedelic users reported lower MCS and higher levels of anxiety and depression relative to non-users (those who said they had not used psychedelics in the past year). The lowest mental health scores were reported in the MP users followed by the PM users (higher MCS corresponded to better mental health). When controlling for confounding characteristics including past-year anxiety and depression, disparities in mental health scores persisted between those with any psychedelic use and the non-psychedelic group (p<0.001).ConclusionThis paper extends previous work describing the association between psychedelic use and mental health, controlling for confounding mental health factors such as comorbid anxiety and depression. These results suggest psychedelic users may have poorer mental health than their non-using counterparts in certain contexts and emphasize the need for future research in this field. Both non-adjusted and adjusted analyses demonstrate lower mental health scores for PM and MP users relative to non-psychedelic users. These differential effects highlight the need for further detailed, population-based research on the use of exclusive psilocybin and on psychedelics in combination.

Adding CDK4/6 inhibitors (CDK4/6is) to endocrine therapy (ET) for HR+/HER2− early breast cancer (EBC) demonstrated statistically significant invasive disease-free survival (iDFS) benefits in monarchE (node positive, high risk, stage II/III) and NATALEE (select N0 and all macroscopic N1, stage II/III). This study evaluated patient preferences for EBC treatment attributes and how these may translate for CDK4/6i selection. A web-based discrete choice experiment survey was conducted among US-based adult women with self-reported stage II/III HR+/HER2− EBC. Eight attributes were included, informed by 14 qualitative interviews (to identify most relevant attributes), expert clinical input, and differentiating features between CDK4/6is: efficacy (5-year iDFS), adverse events (venous thromboembolic event [VTE], diarrhea, fatigue), number of blood tests, number of electrocardiograms (EKGs), treatment duration, and schedule. Participants selected scenarios that best reflected their preferences from 10 choice cards, each displaying a pair of hypothetical treatment profiles. A conditional logit regression model was used to estimate preference weights and relative importance (RI) of attributes. A total of 409 women participated. Patient preferences, from high to low RI, were higher efficacy, lower diarrhea risk, lower fatigue risk, shorter treatment duration, and lower VTE risk. Number of blood tests, number of EKGs, and treatment schedule were less important. Utility scores were higher for reconstructed treatment profiles that resembled ribociclib. This study demonstrated that patients prefer adjuvant treatment with higher efficacy and lower risk of adverse events. These data will aid shared decision-making when discussing the addition of CDK4/6is to adjuvant ET for eligible patients with HR+/HER2− EBC.

BACKGROUND:Chronic idiopathic constipation (CIC) is a disorder of gut-brain interaction characterized by a variety of bowel movement-related and abdominal symptoms. A greater understanding of medication use and satisfaction with symptom control may provide insights to optimize patient care. Therefore, we explored these aspects of the disorder in adults with CIC. METHODS:This study assessed data collected from a large nationwide survey of adult participants in the United States, querying demographics, clinical characteristics, and comorbid conditions, as well as medication use, care-seeking behaviors, and satisfaction with symptom control. Participants were grouped into the CIC cohort if they met Rome IV criteria, with controls matched 1:1 according to age, sex, race, region, and Charlson Comorbidity Index score. All data were self-reported. KEY RESULTS:Two thousand five hundred and thirty-three participants with CIC were matched 1:1 to controls. In the CIC cohort, abdominal pain was the most reported symptom leading to medication use: 15.9% of respondents were receiving a prescription medication in addition to an over-the-counter medication, while 26.3% were taking neither. In addition, only one-third were satisfied with the control of their symptoms; however, satisfaction was significantly higher in respondents taking a prescription medication (p < 0.001). The proportion of reported comorbidities was significantly higher in the CIC cohort versus the control cohort, with chronic pain, anxiety, and depression among the highest (p < 0.001 for all). CONCLUSIONS AND INFERENCES:This study emphasizes the need for better communication regarding prescription medications and their benefits, with the goal of further improving CIC patients' overall symptoms.

Abstract Background: Patients (pts) with stage II/III HR+/HER2− early breast cancer (EBC) are at risk of recurrence that persists over years. The addition of a CDK4/6 inhibitor (CDK4/6i) to adjuvant endocrine therapy (ET) was investigated in monarchE, evaluating abemaciclib (ABE) in lymph node (LN)+ high-risk pts, and NATALEE, using ribociclib (RIB) in stage II/III disease, including pts with N0 disease. ABE was FDA approved in this indication in 2021, while NATALEE recently reported statistically significant iDFS results. Both efficacy and tolerability are relevant for pts treated in a curative setting. This prospective study evaluated the extent pts with EBC value different treatment (tx) attributes and how these may translate into preferences between the two CDK4/6i in the US. Methods: A web-based discrete choice experiment survey was conducted among pts with EBC between Jan and May 2023 before NATALEE results were available. Eligible pts were adult women in a US clinical practice setting with self-reported stage II/III HR+/HER2− EBC +/- prior chemotherapy receiving only adjuvant ET at the time of survey, who completed curative surgery 1-3 years ago. Pts selected the scenario that best reflected their preferences from a series of choice cards, each displaying a pair of hypothetical tx profiles. A total of 8 attributes related to efficacy (5-year iDFS), adverse events (AEs), monitoring requirements, tx duration, and schedule were included (Table 1). Attributes were included based on an initial pilot qualitative assessment that selected efficacy and safety attributes most relevant to pts, clinical input, and differentiating features between CDK4/6i. A conditional logit regression model was used to estimate preference weights and relative importance (RI) of each attribute. Utility scores, summarizing overall preference for CDK4/6i tx profiles, were estimated from the model, and various scenarios were tested. Subgroup analyses by menopausal status and BC stage will be presented. Results: 409 pts participated in the survey (median age, 53 years; White/Black/other race, 59%/23%/18%; BC stage II/III, 48%/52%; employed, 38%). Pt preferences for attributes that significantly impacted tx decision, in order of high to low RI, were higher efficacy (iDFS), lower risk of diarrhea, lower risk of fatigue, shorter tx duration, and lower risk of venous thromboembolic events. Attributes based on monitoring or schedule, including number of blood tests, number of EKGs, and tx schedule, did not affect tx choice (Table 2). Overall utility scores were consistently higher for reconstructed tx profiles that resembled RIB features, including under conservative scenarios where efficacy of RIB was assumed to be equivalent or lower than that of ABE. Conclusions: This study showed that, driven by strong preference for lower risk of AEs, pts with HR+/HER2− EBC prefer tx profiles that more closely resemble the clinical experience of receiving RIB. These pt preferences are important for shared decision making when discussing the addition of a CDK4/6i to adjuvant tx for eligible pts with HR+/HER2− EBC. Discrete Choice Experiment Attributes and Levels Estimated Preference Weight and Relative Importance Citation Format: Erica Mayer, Mary Lou Smith, Annie Guerin, Dominick Latremouille-Viau, Nisha C. Hazra, Yan Meng, Wendi Qu, Remi Bellefleur, Vaidyanathan Ganapathy, Liz Santarsiero, Robert Morlock, Maryam Lustberg. Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-01-09.

ObjectiveThe objective of this study was to assess the burden of gout flares and examine associated patient characteristics and outcomes in a sample of US adults.MethodsData were collected via an online survey of US adults ≥18 years using a random stratified sampling framework. Participants with gout completed questions about treatments, serum urate (SU) levels, severity, satisfaction with control, and gout flares. All participants completed the Veterans RAND 12‐Item Health Survey, the Generalized Anxiety Disorder 7‐Item Scale, and the Patient Health Questionnaire 9‐Item Scale. Data were summarized using descriptive statistics. Multivariable‐adjusted logistic regression analyses examined factors predictive of reporting gout flares to a physician.ResultsA total of 933 participants met the study criteria for having gout. Those with gout tended to be older (58.3 [SD 13.3] years vs 45.4 [SD 16.1] years; P < 0.001), male (76.3% vs 46.9%; P < 0.001), White (80.5% vs 76.8%; P = 0.01), and married or living with their partner (58.9% vs 52.8%; P < 0.001) compared with those without gout (n = 30,146). The total gout flare burden for those with gout was 6.6 gout flares per year. Nearly 72% of gout flares were either not reported to physicians or pretreated or prevented. Characteristics of those who were less likely to report gout flares included being younger, being less educated, having a lower Charlson Comorbidity Index score, not being diagnosed with gout by their doctor, and not taking a urate‐lowering therapy.ConclusionThis study confirmed that gout flares are common in US adults with gout and found that gout flares are underreported. Reliance on clinical documentation of physician‐reported gout flares is insufficient to assess the true patient burden of gout.

This study reports the development activities for the Treatment Preference Myelodysplasia Questionnaires (TPMQ) for clinicians (mTPMQ), carers (cTPMQ), and patients (pTPMQ). These tools are intended to evaluate treatment preferences for patients with myelodysplastic syndromes (MDS). This was a non-interventional, cross-sectional qualitative interview study consisting of interviews with clinicians, patients, and those caring for patients with MDS. All participants were located in Australia and data were collected from qualitative mixed-method interviews composed of concept elicitation and cognitive debriefing related to initial drafts of the questionnaires. Fifteen individuals participated in interviews (five from each group). Based on the concept elicitation portion of interviews, concepts of importance were classified and reasons for treatment preference were documented. From cognitive debriefing, the questionnaires were generally deemed to be clear and easy to understand. Participant input from both concept elicitation and cognitive debriefing portions was used to revise initial drafts of the questionnaires. The mTPMQ, cTPMQ, and pTPMQ were developed with direct input from clinicians, patients, and caregivers to assess the key concepts of interest related to the preference for the treatment of MDS and are ready to be used and evaluated further in clinical trials.

BACKGROUND:Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by abdominal pain and altered bowel habits, with patient-perceived dissatisfaction of treatment symptom control. We assessed disease burden, satisfaction with medication use, and impact on activities, in participants with IBS with constipation (IBS-C) and diarrhea (IBS-D). METHODS:This study assessed data from a large, United States survey of adults querying demographics, comorbid conditions, quality of life, medication use, satisfaction with symptom control, and work productivity. Participants were grouped into the IBS-C or IBS-D cohort if they met Rome IV criteria, with controls matched 1:1 according to age, sex, race, region, and Charlson Comorbidity Index score. All data were self-reported. KEY RESULTS:Nine hundred and ten participants with IBS-C and 669 with IBS-D were matched to controls. The most reported symptoms were abdominal discomfort for IBS-C and abdominal pain and abdominal discomfort for IBS-D. Among the IBS-C and IBS-D cohorts, 74.2% and 65.9%, respectively, took prescription and/or over-the-counter medication for their symptoms. Respondents were more dissatisfied than satisfied with control of their symptoms. Respondents taking prescription medication(s) with or without over-the-counter medication(s) reported better symptom control than respondents only taking over-the-counter medications (p < 0.001). There was significantly higher mean presenteeism, work productivity loss, and daily activity impairment (p < 0.001 for all) in respondents with IBS compared with controls. CONCLUSIONS AND INFERENCES:This study provides insight into respondents' experiences of IBS symptoms, including the impact on daily activity, as well as satisfaction with control of symptoms and prescription and over-the-counter medications.

Introduction: Chronic abdominal and bowel-related symptoms are associated with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), and quality of life (QoL) is decreased in these patient populations. This analysis evaluated whether QoL of survey participants who met Rome IV criteria for IBS-C or CIC improved in those reporting satisfaction with over-the-counter (OTC) and/or prescription medications for symptom management. Methods: Self-reported data were collected from a large, nationwide survey of adults in the United States from August 2020 to December 2021. Participants who selected IBS, constipation, or diarrhea in the survey comorbid conditions checklist and met Rome IV criteria for IBS-C or CIC were matched 1:1 with controls who did not select those conditions. Participants with IBS-C and CIC were assigned to cohorts based on reported medication use including OTC only, prescription ± OTC, and linaclotide ± OTC. Overall satisfaction with control of bowel and abdominal symptoms were evaluated for each cohort on a 7-point scale ranging from extremely dissatisfied to extremely satisfied. QoL was assessed for participants who were satisfied with control of their bowel, abdominal, or both symptoms (bowel symptom responders, abdominal symptom responders, or both symptoms responders, respectively) compared to controls using the Veterans Rand 12-item health survey (VR-12) which scores a physical component (PCS), a mental component (MCS), and health utility (VR-6D). Results: Participants taking prescription medications for IBS-C and CIC were more likely to be satisfied with control of bowel or abdominal symptoms than participants taking only OTC medication (Figure 1). Overall, the IBS-C (n = 910) and CIC (n = 2533) groups reported significantly worse scores than the control groups for PCS, MCS, and VR-6D. There were no significant differences in MCS compared to control in participants with IBS-C or CIC taking linaclotide who were satisfied with control of their bowel, abdominal, or both of their symptoms (Table 1). Conclusion: IBS-C and CIC were associated with worse QoL. However, participants taking prescription medications such as linaclotide, who reported being more satisfied with their symptom management compared to participants taking OTC alone, had better mental health scores, which was comparable to controls. These findings indicate that satisfactory management of IBS-C/CIC with prescription medications may restore declined QoL.Figure 1.: Satisfaction with the control of (a) abdominal symptoms in IBS-C, (b) bowel symptoms in IBS-C, (c) abdominal symptoms in CIC, and (d) bowel symptoms in CIC. Table 1. - Quality of life: IBS-C or CIC and responder cohorts versus controls Control IBS-C or CIC Cohort Prescription ± OTC Linaclotide ± OTC Bowel Symptom Respondera Abdominal Symptom Respondera Both Symptoms Respondera Bowel Symptom Respondera Abdominal Symptom Respondera Both Symptoms Respondera IBS-C, Nb 910 910 106 116 89 22 21 17 VR-12 MCS, mean (SD) 44.5 (12.2) 38.0** (12.5) 43.2 (11.4) 42.8 (11.4) 43.8 (11.3) 42.9 (13.1) 44.1 (12.8) 45.0 (12.6) VR-12 PCS, mean (SD) 45.6 (10.3) 41.2** (10.7) 42.0** (9.5) 42.2** (9.3) 42.5* (9.4) 42.2 (12.8) 43.1 (12.3) 42.3 (13.3) VR-6D, mean (SD) 0.68 (0.12) 0.61** (0.11) 0.64** (0.11) 0.64** (0.11) 0.65* (0.11) 0.65 (0.15) 0.67 (0.14) 0.67 (0.15) CIC, Nb 2533 2533 381 387 315 55 50 41 VR-12 MCS, mean (SD) 45.0 (12.4) 40.1** (12.3) 43.2* (9.9) 43.1* (10.2) 43.7 (9.8) 44.6 (10.8) 45.4 (11.4) 45.0 (11.2) VR-12 PCS, mean (SD) 45.8 (9.9) 40.9** (11.2) 40.3** (10.1) 40.2** (10.0) 40.3** (10.1) 40.1** (12.6) 39.6** (12.5) 40.5** (12.7) VR-6D, mean (SD) 0.69 (0.12) 0.62** (0.11) 0.63** (0.10) 0.63** (0.10) 0.63** (0.10) 0.64* (0.12) 0.64* (0.12) 0.64* (0.12) *Significance ≤0.05; **Significance ≤0.001. Significances compare to the control group.aParticipants were classified as a responder if they reported being satisfied (satisfied, very satisfied, or extremely satisfied on a 7-point scale) with control of bowel-movement-related symptoms (bowel symptom responder), control of abdominal symptoms (abdominal symptom responder), or control of bowel movement-related and abdominal symptoms (both symptoms responder). bOnly participants who answered this question were included. CIC, chronic idiopathic constipation; IBS-C irritable bowel syndrome with constipation; MCS, Mental Component Summary score; OTC, over-the-counter; PCS, Physical Component Summary score; SD, standard deviation; VR-12, Veterans RAND 12-item.

5078 Background: Androgen deprivation therapy (ADT) is standard care first-line (1L) systemic treatment for advanced and metastatic prostate cancer (PC). Currently, there are no population-level studies assessing the duration of 1L ADT and time to treatment escalation (chemotherapy [CT], novel hormonal therapy [NHT], or non-steroidal antiandrogen [NSAA]). Methods: We performed a retrospective population-level analysis to assess the association between race and time to treatment escalation after ADT in the Veterans Affairs Health Care System. From 2001-2021, 164,477 patients (pt) diagnosed with PC and treated with ADT alone were identified. Baseline demographic and clinical characteristics were sorted by race: Non-Hispanic White (NHW), Non-Hispanic Black (NHB), Hispanic, Other and compared among groups using chi square tests for categorical variables and Kruskal-Wallis tests for continuous variables. The primary outcome was time from ADT to treatment escalation, defined as receipt of NHT, NSAA, or CT. Men with no evidence of treatment escalation were censored at time of death or most recent visit. We estimated 5-year event rates by race using Kaplan-Meier (KM) analyses. Univariable and multivariable Cox proportional hazards models were used to test the association between race and time to treatment escalation with time of ADT as time zero. Multivariable models were adjusted for age, year, time from PC diagnosis to ADT, Charlson Comorbidity Index and BMI at ADT start along with PSA, testosterone level, and receipt of radiation therapy (RT) prior to ADT. Results: NHB were youngest (p<0.001), started ADT in more recent years (p<0.001), had the highest pre-ADT PSA (p<0.001) and testosterone levels (p<0.001), the most comorbidities (p<0.001), and the highest rate of RT prior to ADT (p<0.001) relative to other groups. During a median (Q1, Q3) follow-up of 55.2 (25.0, 102.4) months, 31,288 pt (19%) had treatment escalation, of which 12,093 (39%) were NHTs, 14,842 (47%) were NSAAs, 3,895 (12%) were CT and 458 (2%) were other 2 nd line therapies. Compared to NHW, NHB had significantly lower rate of treatment escalation in univariable (HR=0.89, 95% CI=0.87-0.92) and multivariable analysis (HR=0.82, 95% CI=0.80-0.84). KM estimates at 5-year for the percent free from escalation was 80.5 (80.2-80.8%) in NHW vs. 83.0 (82.6-83.4%) in NHB. Rate of treatment escalation was similar for Hispanics and other races compared to NHW, with 5-year KM estimates of 81.0 (80.3-81.7%) and 81.0 (80.0-82.0%) for Hispanics and other races, respectively. Conclusions: This study assessing racial differences in time to treatment escalation of men receiving 1L ADT found that NHB had a significantly lower rate of treatment escalation. Whether this decreased rate of treatment escalation among NHB men represents improved outcomes (i.e. lower risk of progression) or undertreatment requires further study.

Using PRPS thresholds identify the proportion of potential PBO responders by disease severity and assess which items are most predictive. A 2021 cross-sectional survey of US adults assessed the rate and severity of health conditions. Participants, ≥18 years old, were recruited using a random stratified sampling framework to ensure demographic composition representative of the US population. Participants with anxiety, depression, schizophrenia, or bipolar completed the anxiety (GAD7) and depression (PHQ9) screening questionnaires as well as the PRPS. The proportion of likely PBO responders are identified in those with no/mild, moderate and severe anxiety and depression and summarized using descriptive statistics. NetraMark’s DeepCrush Artificial Intelligence (AI) identified groups of items within disease severity clusters most likely to predict PBO response. Of the 925 individuals participating in the study 32.3% (299) reported having psychiatric condition. The PHQ9 classified 25.4% (76), 49.2% (147) and 25.4% (76) having no/minimal, mild/moderate and severe depression, respectively. The GAD7 classified 27.1% (81), 54.5% (163) and 18.4% (55) having no/minimal, mild/moderate and severe anxiety, respectively. The propensity for PBO response was highest in those with the lowest PHQ9 and GAD7 scores. Of those with no/low depression classification 65% had a high probability of PBO whereas only 29% of those with severe depression had a high probability of PBO response. Of those with no/low anxiety classification 56% had a high probability of PBO whereas only 18% of those with severe anxiety had a high probability of PBO response. Using AI, PRPS items related to time with condition, expectations about medications and probability of taking a placebo mapped to PBO response and replicated in terms of cross validation. Although PBO response is likely to decrease with higher levels of disease severity required for trial entry, a significant number of potential PBO responders exist even in those with highest disease severity.