In 2008, bevacizumab received accelerated Food and Drug Administration (FDA) approval for use in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Based on the preclinical and preliminary clinical activity of the trastuzumab and bevacizumab combination, ECOG-ACRIN E1105 trial was developed to determine if the addition of bevacizumab to a chemotherapy and trastuzumab combination for first-line therapy would improve progression-free survival (PFS) in patients with HER2-positive MBC. 96 patients were randomized to receive standard first-line chemotherapy and trastuzumab with or without bevacizumab between November 2007 and October 2009, and 93 began protocol therapy. Induction therapy was given for 24 weeks, followed by maintenance trastuzumab with or without bevacizumab. 60% (56/93) began carboplatin and 74% (69/93) completed 6 cycles of induction therapy. Primary endpoint was PFS. Median PFS was 11.1 and 13.8 months for placebo and bevacizumab arms, respectively (hazard ratio [HR] 95%, Confidence Interval [Cl] for bevacizumab vs. placebo: 0.73 [0.43-1.23], p = 0.24), and at a median follow-up of 70.7 months, median survival was 49.1 and 63 months (HR [95% Cl] for OS: 1.09 [0.61-1.97], p = 0.75). The most common toxicities across both arms were neutropenia and hypertension, with left ventricular systolic dysfunction, fatigue, and sensory neuropathy reported more frequently with bevacizumab. In this trial, the addition of bevacizumab did not improve outcomes in patients with metastatic HER2-positive breast cancer. Although the trial was underpowered due to smaller than anticipated sample size, these findings corroborated other clinical trials during this time.

Abstract Introduction There has been a significant increase in the accessibility of pharmacologic erectile dysfunction (ED) treatments through direct-to-consumer platforms. However, the impact of this broad accessibility on usage in young adult men has not been studied. Objective We sought to assess demographic, socioeconomic, and health factors associated with erectile dysfunction medication use among men aged 18-40 years. Methods We created a survey assessing prior phosphodiesterase-5 inhibitor (PDE-5) use, means of acquisition, and receipt of counseling prior to use. The survey was disseminated with the modified International Index of Erectile Function (IIEF-5) questionnaire to a convenience sample of men ages 18-40 via Research Match, an NIH-funded database of research participants. Demographic data including age, race, ethnicity, education level, insurance status, sexual orientation, and relationship status were collected. Descriptive statistics were performed using t-test, chi-squared test, and univariable and multivariable logistic regression with significance defined as p<0.05. Results Among 210 respondents, 82 (39.0%) indicated prior use of ED medication. Men identifying as Black or African American (OR = 3.54, 95% CI: 1.82-6.88, p<0.001) and Hispanic or Latino (3.32, 95% CI: 1.45-7.62, p=0.01) were more likely to have reported prior use. Higher rates of utilization were similarly observed among men insured by Medicare or Medicaid (OR = 6.07, 95% CI: 3.10-11.87, p<0.001). Income >$200,000 per year was associated with decreased utilization (OR 0.23, 95% CI: 0.06-0.92, p=0.04). Mild, mild to moderate, and severe erectile dysfunction per the modified IIEF scale were associated with increased utilization (OR = 3.09, 13.70, 20.25 and p-values = 0.01, <0.001, <0.001, respectively). There were no statistically significant differences among usage patterns with respect to age, education level, relationship status, or sexual orientation. Medicare or Medicaid coverage (p<0.001) and IIEF symptom severity were significant independent predictors on multivariable regression. Performance anxiety with a partner (56.6%), difficulty maintaining erections (46.9%), and providing confidence during intercourse (39.5%) were the most frequently cited reasons behind use. Primary care providers were the most frequent source of initial procurement (30.9%), followed by friends, family members, or partners (25.9%) and direct-to-consumer online platforms (18.5%). The most important factors considered in procuring medications were privacy (61.7%) and cost (54.3%). Despite 72.8% of men reporting counseling on proper use and risks, only 28.0% were able to correctly identify four key features surrounding proper use (including medication timing, dosage interval, prolonged erections, and sexual stimulation requirement). Conclusions We found high use of ED medication among young adult men, particularly among those identifying as Black or African American and Hispanic or Latino, as well as those insured by Medicare or Medicaid. The emphasis on privacy over cost and convenience in obtaining medications likely demonstrates continued stigma surrounding men’s health and sexual health issues. Despite most men reporting counseling on proper use, a stark knowledge gap exists as only a minority of men can correctly identify proper use. This underscores the need for healthcare professionals to provide thorough patient education and guidance to ensure safe and effective use of these medications in young men. Disclosure No.

Abstract Introduction While the epidemiology of male sexual dysfunction in the general population is well studied, little is known regarding the prevalence of sexual dysfunction in male physicians and their likelihood of seeking treatment. Objective To characterize the prevalence of sexual dysfunction, evaluation patterns, and barriers to treatment among male physicians. Methods Between June 2022 and October 2022, male physicians were invited to complete a questionnaire regarding sexual function. Surveys were disseminated electronically via social media and professional medical societies using Qualtrics (Provo, UT). Results 235 responses were included in the final analysis. The mean age of respondents was 36.3 ± 7.4 years. 27 (11.5%) reported having seen a doctor for sexual health. Of these 27,11 (40.7%) saw a physician for erectile dysfunction, 8 (29.6%) for low libido, 6 (22.2%) for premature ejaculation, 2 (7.4%) for delayed ejaculation, and 9 (33.3%) for some other concern. An additional 29 (13.9%) respondents considered establishing care for sexual issues but didn’t, mostly due to being too busy (N=18, 62.1%). Of the 56 respondents who had either seen or thought about seeing a physician for sexual health issues, the mean IIEF score was 24.4 ± 8.7 with 18 (32.1%) qualifying as having at least mild ED and 7 (12.5%) having severe ED (Table 2). 46 (19.6%) respondents reported having taken medication to improve erectile function. Only 12 (5.1%) respondents reported having ever been diagnosed with low testosterone. Among the 56 respondents who had either seen or thought about seeing a physician for sexual health issues, those who worked more hours (>60 hours per week) were least likely to see a physician (7.2%) compared to those working the fewest hours (33.3%), p=0.02. Conclusions In a cohort of young male physicians, 25.4% had seen or considered seeing a doctor for sexual health concerns, and nearly 1 in 5 had taken medication for erectile dysfunction. Given the highly demanding work schedules, occupational stress, and a variety of other factors associated the medical profession, male physicians appear to be at higher risk for sexual dysfunction than the general population. Moreover, male physicians face significant and unique barriers in access to care for sexual dysfunction. Disclosure No.

Abstract Introduction Given the rise of digital health applications and direct-to-consumer (DTC) testosterone platforms, testosterone-related mobile applications (apps) pose significant challenges for both consumers and healthcare professionals. Objective The purpose of this study is to investigate trends and characterize the landscape of currently offered testosterone-related mobile health applications. Methods A search query of the term “testosterone” was conducted on the Apple app store. A comprehensive analysis of 23 testosterone-related apps was conducted, evaluating them based on categorization, primary service, specific health topics addressed, release years, cost model, user ratings, and evidence base. Apps were also evaluated on an established misinformation index score from one to five, whereby a score of five indicated complete accuracy and one, complete inaccuracy. Results Most apps were categorized as Health and Fitness apps, focused on sexual performance optimization, and addressed specific testosterone-related issues. A marked 600% increase in app releases were observed from 2020-22 when compared to prior to 2018. Apps frequently claimed to improve testosterone-related issues, but few cited scientific literature, resulting in a mean misinformation index score of 3.0. Conclusions The findings highlight the urgent need for healthcare professionals' active involvement in guiding patients through the digital health landscape. It is crucial to establish guidelines that ensure the provision of accurate, evidence-based information in health apps. Further research should focus on assessing the real-world impact of these apps on patient outcomes and developing strategies to mitigate digital health misinformation risks. Disclosure No.

To assess whether office-based fulguration (OF) under local anaesthesia for small, recurrent, pathological Ta low-grade (LG) non-muscle-invasive bladder cancer (NMIBC) is an effective alternative to transurethral resection of bladder tumour (TURBT), avoiding the costs and risks of procedure, and anesthesia. Of 521 patients with primary TaLG NMIBC, this retrospective study included 270 patients who underwent OF during follow-up for recurrent, small, papillary LG-appearing tumours at a university centre (University Health Network, University of Toronto, Canada). We assessed the cumulative incidence of cancer-specific mortality (CSM) and disease progression (to MIBC or metastases), as well as possible direct cost savings. In the 270 patients with recurrent TaLG NMIBC treated with OF, the mean (sd) age was 64.9 (13.3) years, 70.8% were men, and 60.3% had single tumours. The mean (sd, range) number of OF procedures per patient was 3.1 (3.2, 1-22). The median (interquartile range) follow-up was 10.1 (5.8-16.2) years. Patients also underwent a mean (sd) of 3.6 (3.0) TURBTs during follow-up in case of numerous or bulkier recurrence. In all, 44.4% of patients never received intravesical therapy. The 10-year incidence of CSM and progression were 0% and 3.1% (95% confidence interval 0.8-5.4%), respectively. Direct cost savings in Ontario were estimated at $6994.14 (Canadian dollars) per patient over the study follow-up. This study supports that properly selected patients with recurrent, apparent TaLG NMIBC can be safely managed with OF under local anaesthesia with occasional TURBT for larger or numerous recurrent tumours, without compromising long-term oncological outcomes. This approach could generate substantial cost-saving to healthcare systems, is patient-friendly, and could be adopted more widely.

Breast cancer accounts for up to 30% of cancer cases in women in the US. Diabetes mellitus has been recognized as a risk factor for breast cancer. Some studies have suggested that prediabetes may also be associated with breast cancer whereas other studies have shown no or an inverse association; thus, we conducted a meta-analysis to assess the risk of breast cancer in prediabetes. We searched PubMed/Medline, EMBASE, Google Scholar, and Scopus to identify studies that reported breast cancer risks in patients having prediabetes compared to normoglycemic patients. Binary random-effects model was used to calculate a pooled odds ratio (OR) with 95% confidence intervals. I2 statistics were used to assess heterogeneity. Leave-one-out sensitivity analysis and subgroup analyses were performed. We analyzed 7 studies with 24,586 prediabetic and 224,314 normoglycemic individuals (783 and 5739 breast cancer cases, respectively). Unadjusted odds ratio (OR) for breast cancer was 1.45 (95% CI = 1.14, 1.83); adjusted OR was 1.19 (95% CI = 1.07, 1.34) in prediabetes. Subgroup analysis revealed a higher breast cancer risk in individuals aged less than 60years (OR = 1.86, 95% CI = 1.39, 2.49) than in those aged 60years or more (OR = 1.07, 95% CI = 0.97, 1.18). Subgroup analysis by median follow-up length indicated a higher risk of breast cancer for follow-ups of less than or equal to 2years (OR = 2.34, 95% CI = 1.85, 2.95) than in those of over 10years (OR = 1.1, 95% CI = 0.99, 1.23) and 6 to 10years (OR = 1.03, 95% CI = 0.88, 1.21). In conclusion, individuals with prediabetes have higher risk of developing breast cancer than those with normoglycemia, especially younger prediabetes patients. These individuals may benefit from early identification, monitoring, and interventions to reverse prediabetes.

Patients with breast cancer and comorbid HIV experience higher mortality than other patients with breast cancer. To compare time to cancer treatment initiation and relative dose intensity (RDI) of neoadjuvant and adjuvant chemotherapy among patients with breast cancer with vs without HIV. A retrospective, matched cohort study enrolled women who received a diagnosis of breast cancer from January 1, 2000, through December 31, 2018. The electronic medical records of 3 urban, academic cancer centers were searched for women with confirmed HIV infection prior to or simultaneous with diagnosis of stage I to III breast cancer. Tumor registry data were used to identify 2 control patients with breast cancer without HIV for each participant with HIV, matching for study site, stage, and year of cancer diagnosis. Statistical analysis was performed from December 2022 to October 2023. HIV infection detected before or within 90 days of participants' breast cancer diagnosis. The primary outcome was time to breast cancer treatment initiation, defined as the number of days between cancer diagnosis and first treatment. The secondary outcome was overall RDI for patients who received chemotherapy. These outcomes were compared by HIV status using Cox proportional hazards regression and linear regression modeling, respectively, adjusting for confounding demographic and clinical factors. Exploratory outcomes included instances of anemia, neutropenia, thrombocytopenia, and liver function test result abnormalities during chemotherapy, which were compared using Fisher exact tests. The study enrolled 66 women with comorbid breast cancer and HIV (median age, 51.1 years [IQR, 45.7-58.2 years]) and 132 with breast cancer alone (median age, 53.9 years [IQR, 47.0-62.5 years]). The median time to first cancer treatment was not significantly higher among patients with HIV than those without (48.5 days [IQR, 32.0-67.0 days] vs 42.5 days [IQR, 25.0-59.0 days]; adjusted hazard ratio, 0.78, 95% CI, 0.55-1.12). Among the 36 women with HIV and 62 women without HIV who received chemotherapy, the median overall RDI was lower for those with HIV vs without HIV (0.87 [IQR, 0.74-0.97] vs 0.96 [IQR, 0.88-1.00]; adjusted P = .01). Grade 3 or higher neutropenia during chemotherapy occurred among more women with HIV than those without HIV (13 of 36 [36.1%] vs 5 of 58 [8.6%]). This matched cohort study suggests that patients with breast cancer and HIV may have experienced reduced adjuvant chemotherapy RDI, reflecting greater dose reductions, delays, or discontinuation. Strategies for supporting this vulnerable population during chemotherapy treatment are necessary.