IntroductionGiven the high disparities present in cancer care worldwide and even more challenging infrastructure and access for low- and middle-income countries, adhering precisely to international guidelines has become a challenging and complex task. Recommendations from an independent multidisciplinary panel of experts from 13 countries, including medical oncologists, pathologists, surgeons, and radiation oncologists, who met during IGCS to address some of these challenges.MethodsThe panel met in New York City in September of 2022 during the International Gynecological Cancer Society Congress and was composed of specialists from developing countries in Africa, Asia, Eastern Europe, Latin America, and the Middle East. The panel addressed 103 questions and provided recommendations for the management of early, locally advanced, recurrent, and/or metastatic endometrial cancer. The questions were carefully developed by the group and specifically directed to, and answered by, specialists according to their respective areas of expertise. Consensus was defined as at least 75% of the voting members selecting a particular recommendation, whereas a majority vote was considered when one option garnered between 50.0% and 74.9% of votes. Resource limitation was defined as any issues limiting access to qualified surgeons, contemporary imaging or radiation-oncology techniques, antineoplastic drugs, or funding for providing modern medical care.ResultsEighteen of the 109 (16.5%) questions presented to the panel reached consensus, whereas a majority vote was reached for 43 (39.4%) additional questions. The recommendations for the remaining questions were considerably heterogeneous and were considered experts opinion only.ConclusionEstablishing guidelines with recommendations in areas with resource limitations may help healthcare providers and improve patient care around the world.

PURPOSESpeaker roles at major international oncology meetings mark academic visibility and leadership, yet representation of Latin America and Caribbean (LAC)–affiliated investigators remains poorly characterized. We evaluated LAC-affiliated faculty appearances at the ASCO Genitourinary Cancers Symposium (ASCO GU) from 2021 to 2025.METHODSWe systematically reviewed ASCO GU programs (2021-2025). Eligible sessions included General Session, Oral Abstract Session, and Rapid Oral Abstract Session. Affiliation was determined by institutional listing. We recorded total faculty appearances and stratified faculty appearances into invited educational, abstract-linked, and leadership roles. We additionally examined discussant and moderator appearances separately and identified the assigned speaker for each Oral or Rapid Oral presentation with at least one LAC-affiliated author.RESULTSAmong 84 eligible sessions comprising 540 faculty speakers, only six LAC-affiliated faculty appearances were identified, representing only 1% of the total faculty. No LAC-affiliated faculty appeared in 2021 or 2022, with minimal representation in subsequent years (2023: n = 1; 2024: n = 2; 2025: n = 3). By contrast, LAC-affiliated investigators were identified in 53 appearances as authors or coauthors in Oral or Rapid Oral sessions, predominantly affiliated with institutions in Brazil, Argentina, Chile, Mexico, and Colombia. Three of six LAC-affiliated faculty were linked to specific clinical trial presentations rather than independent educational lectures.CONCLUSIONLAC-affiliated investigators remain markedly under-represented among ASCO GU faculty despite robust scientific contributions, highlighting potential structural inequities and the need for deliberate initiatives to support equitable participation in international scientific discourse.

PURPOSEDisparities in health care access and resource availability in middle-income countries often lead to suboptimal management of localized bladder urothelial carcinoma (UC). However, real-world data describing treatment patterns and outcomes in these settings remain limited.METHODSThis multicenter, retrospective, real-world study included patients with high-risk non–muscle-invasive (HR-NMIBC) and localized muscle-invasive bladder cancer (MIBC) diagnosed between 2017 and 2022 across nine cancer centers in a middle-income setting. Treatment data and clinical outcomes were collected from medical records and analyzed using descriptive statistics and Kaplan-Meier survival estimates.RESULTSAmong 343 patients analyzed, 217 (63.3%) had HR-NMIBC, of whom only 29.5% received adjuvant Bacillus Calmette-Guérin (BCG), often substituted with intravesical gemcitabine because of supply shortages. BCG exposure was associated with superior overall and cancer-specific survival compared with non-BCG patients. In the muscle-invasive cohort (n = 126; 36.7%), cystectomy was performed in 48.4% and significantly improved survival. Perioperative chemotherapy remained limited, with only 39.3% receiving neoadjuvant therapy, and just one third receiving cisplatin-based regimens that conferred the greatest survival benefit.CONCLUSIONThis multicenter real-world study exposes major gaps in the management of localized UC in a middle-income setting. Limited access to BCG, perioperative chemotherapy, and cystectomy remain key barriers to guideline-concordant care, underscoring the urgent need for policy actions to improve treatment delivery and outcomes in comparable health care systems.

PURPOSEThe Brazilian Public Health System (BPHS) provides sole health coverage for approximately 77% of the population. Analyzing BPHS data enables nationwide assessment of epidemiology, treatment patterns, and costs for men with prostate cancer (PCa).METHODSWe conducted a retrospective, population-based cohort study using linked administrative data from the BPHS Database DATASUS for patients with PCa treated in the BPHS from January 1, 2008, to March 31, 2023. Variables include demographics, clinical features, stage, treatments, and health care utilization. The primary objective was to evaluate the impact of race on stage at diagnosis, treatment delivery, and treatment costs.RESULTSA total of 670,205 patients with PCa were treated during the study period; 277,030 (41.4%) were White and 393,175 (58.6%) non-White. Mean age at diagnosis was 72.9 years (40-99). Approximately 56% were diagnosed with stage I-III disease (56.1% v 55.5%), and 21% with metastatic disease (19.7% v 21.2%), with non-White men more frequently presenting with advanced stage (P < .001). White men more commonly received local therapy in stage I, whereas non-White men received local therapy more frequently in stage III (P < .001). Among 125,759 men with stage IV disease who received systemic therapy, only 22,393 (17.8%) received docetaxel, while use of first-generation antiandrogens and estrogens remained high (25%). Total PCa-directed expenditures reached In$ 1.83 billion, with mean costs 16.2% higher for White patients than for non-White patients.CONCLUSIONIn the BPHS, race was associated with more advanced stages at diagnosis and differences in treatment delivery. High rates of de novo metastatic disease, underuse of docetaxel, and persistent use of agents without survival benefit highlight urgent gaps in PCa care. These findings may guide PCa policy in Brazil and other low- and middle-income countries.

44 Background: Latin American (LATAM) investigators contribute substantially to global genitourinary (GU) cancer research through participation in multinational studies. However, their representation as speakers in leading international forums remains uncertain. This study evaluated LATAM participation as oral presenters and as co-authors of abstracts presented in oral and rapid-oral sessions at the ASCO Genitourinary Cancers Symposium over a five-year period. Methods: A retrospective descriptive review was performed using the official programs of ASCO GU meetings held between 2021 and 2025. Session types analyzed included oral abstract, rapid-oral, and case-based discussions. Author affiliations were examined to identify LATAM representation. For each session, the total number of speakers, the number of LATAM-affiliated speakers, and LATAM co-authors of abstracts presented in oral or rapid-oral sessions were recorded. Results: Across 94 sessions (65 oral/rapid-oral and 29 case-based or educational), more than 500 invited speakers were identified. Only four LATAM speakers appeared during the study period (2025 n = 1; 2024 n = 2; 2023 n = 1; 2021–2022 n = 0). In contrast, 48 LATAM authors were listed among abstracts presented in oral or rapid-oral sessions, originating primarily from Brazil, Argentina, Chile, Mexico, and Colombia. Notably, only one of these appearances resulted from a direct invitation by conference scientific organization, whereas the remaining participations were linked to investigator roles within multinational clinical trials. Despite recurrent authorship in pivotal studies, such as those evaluating novel hormonal agents, immune checkpoint inhibitors, and targeted therapies, LATAM investigators seldom served as the designated presenters of their collaborative work. Conclusions: From 2021 to 2025, Latin American oncologists accounted for <0.5% of all ASCO GU speakers despite frequent authorship in major oral abstracts. The findings reveal a persistent gap between scientific contribution and visibility, emphasizing the importance of intentional strategies by international societies to promote equitable regional representation and recognition in global oncology.

Importance:Advanced penile squamous cell carcinoma (PSCC) is associated with poor survival, and no new treatment strategies have changed clinical outcomes in past decades. This highlights the unmet need to understand the biology and develop more effective and tolerable treatment options. Objective:To evaluate the efficacy and safety of adding an immune checkpoint inhibitor to chemotherapy for advanced PSCC. Design, Setting, and Participants:HERCULES (LACOG 0218) was a phase 2 single-arm nonrandomized clinical trial evaluating pembrolizumab plus platinum-based chemotherapy as first-line treatment in patients with advanced PSCC from August 2020 to December 2022. Patients were followed up for 24 months. Patients with metastatic, recurrent, or locally advanced disease not amenable to curative-intent therapy were included. Statistical analyses were performed between November 21, 2023, and January 25, 2024. Intervention:Fluorouracil, 1000 mg/m2 per day, intravenously for days 1 to 4; cisplatin, 70 mg/m2 (or carboplatin, area under the curve, 5) intravenously on day 1; and pembrolizumab, 200 mg, intravenously on day 1 every 3 weeks for 6 cycles, followed by pembrolizumab, 200 mg, intravenously every 3 weeks for up to 34 cycles. Main outcome:The primary end point was the overall response rate (ORR) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Results:Overall, 37 patients were enrolled in 11 Brazilian centers and 33 patients were eligible for efficacy analysis. The median (range) age was 56 (30-76) years, 24 patients (64.9%) had metastatic disease, 8 (21.6%) had recurrent disease, and 5 (13.5%) had locally advanced disease. ORR was 39.4% (95% CI, 22.9%-57.9%). At median follow-up of 24.0 months (cut-off date January 24, 2024), median progression-free survival was 5.4 (95% CI, 2.7-7.2) months and median overall survival was 9.6 (95% CI, 6.4-13.2) months. Treatment-related adverse events (AE) rates of any grade and grades 3 to 4 were 91.9% and 51.4%. Immune-related AE rates of any grade were 21.6% and grade 3 to 4 were 5.4%. There were no treatment-related deaths. Conclusion and Relevance:The HERCULES clinical trial is the first trial to demonstrate the efficacy of immune checkpoint inhibitors combined with chemotherapy in patients with advanced PSCC with a manageable safety profile. Trial Registration:ClinicalTrials.gov Identifier: NCT04224740.

BACKGROUND AND OBJECTIVE:Innovations have improved outcomes in advanced prostate cancer (PC). Nonetheless, we continue to lack high-level evidence on a variety of topics that greatly impact daily practice. The 2024 Advanced Prostate Cancer Consensus Conference (APCCC) surveyed experts on key questions in clinical management in order to supplement evidence-based guidelines. Here we present voting results for questions from APCCC 2024. METHODS:Before the conference, a panel of 120 international PC experts used a modified Delphi process to develop 183 multiple-choice consensus questions on eight different topics. Before the conference, these questions were administered via a web-based survey to the voting panel members ("panellists"). KEY FINDINGS AND LIMITATIONS:Consensus was a priori defined as ≥75% agreement, with strong consensus defined as ≥90% agreement. The voting results show varying degrees of consensus, as discussed in this article and detailed in the Supplementary material. These findings do not include a formal literature review or meta-analysis. CONCLUSIONS AND CLINICAL IMPLICATIONS:The voting results can help physicians and patients navigate controversial areas of clinical management for which high-level evidence is scant or conflicting. The findings can also help funders and policymakers in prioritising areas for future research. Diagnostic and treatment decisions should always be individualised on the basis of patient and cancer characteristics, and should incorporate current and emerging clinical evidence, guidelines, and logistic and economic factors. Enrolment in clinical trials is always strongly encouraged. Importantly, APCCC 2024 once again identified important gaps (areas of nonconsensus) that merit evaluation in specifically designed trials.

BACKGROUND:Penile squamous cell carcinoma (PSCC) is a rare malignancy. However, in developing countries the incidence rate is higher. The understanding of molecular alterations is essential for evaluating possible targets for more effective systemic therapies. METHODS:We retrospectively collected clinical data of metastatic PSCC (mPSCC) patients who had received at least one prior systemic treatment from 3 Brazilian hospitals. Tumor samples were evaluated using the next-generation sequencing (NGS) Foundation One DX and immunohistochemistry (IHC). The objective was to identify and describe somatic genomic alterations known to be functional or pathogenic and their association with survival outcomes. RESULTS:Twenty-three patients were identified, 22 and 18 patients had tumor samples analyzed by IHC and NGS, respectively. PD-L1 expression (CPS ≥ 1%) was positive in 14 patients (63.6%). Regarding the genomic alterations, 16 patients (88.9%) had some clinically relevant genomic alterations. TP53, TERT, CDKN2A, PIK3CA, NOTCH1, and CDKN2B loss were identified in 66.7%, 50%, 50%, 33.3%, 27.8%, and 22.2% of the patients, respectively. No MSI or TMB high (≥10 mutations/MB) cases were identified. NOTCH1 mutation was identified only in HPV-negative patients and it was associated with worse OS (yes: 5.5 vs no: 12.8 months, P = .049) and progression-free survival (yes: 5.5 vs no: 11.7 months, P = .032). CONCLUSION:This study demonstrated that molecular alterations in mPSCC from developing countries are similar to those from developed countries. Predictive biomarkers for immunotherapy response such as TMB high or MSI were not identified. Specific gene mutations may identify patients with worse prognoses and open new avenues for therapeutic development.

Advanced penile squamous cell carcinoma (PSCC) is associated with poor survival, and no new treatment strategies have changed clinical outcomes in past decades. This highlights the unmet need to understand the biology and develop more effective and tolerable treatment options. To evaluate the efficacy and safety of adding an immune checkpoint inhibitor to chemotherapy for advanced PSCC. HERCULES (LACOG 0218) was a phase 2 single-arm nonrandomized clinical trial evaluating pembrolizumab plus platinum-based chemotherapy as first-line treatment in patients with advanced PSCC from August 2020 to December 2022. Patients were followed up for 24 months. Patients with metastatic, recurrent, or locally advanced disease not amenable to curative-intent therapy were included. Statistical analyses were performed between November 21, 2023, and January 25, 2024. Fluorouracil, 1000 mg/m 2 per day, intravenously for days 1 to 4; cisplatin, 70 mg/m 2 (or carboplatin, area under the curve, 5) intravenously on day 1; and pembrolizumab, 200 mg, intravenously on day 1 every 3 weeks for 6 cycles, followed by pembrolizumab, 200 mg, intravenously every 3 weeks for up to 34 cycles. The primary end point was the overall response rate (ORR) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Overall, 37 patients were enrolled in 11 Brazilian centers and 33 patients were eligible for efficacy analysis. The median (range) age was 56 (30-76) years, 24 patients (64.9%) had metastatic disease, 8 (21.6%) had recurrent disease, and 5 (13.5%) had locally advanced disease. ORR was 39.4% (95% CI, 22.9%-57.9%). At median follow-up of 24.0 months (cut-off date January 24, 2024), median progression-free survival was 5.4 (95% CI, 2.7-7.2) months and median overall survival was 9.6 (95% CI, 6.4-13.2) months. Treatment-related adverse events (AE) rates of any grade and grades 3 to 4 were 91.9% and 51.4%. Immune-related AE rates of any grade were 21.6% and grade 3 to 4 were 5.4%. There were no treatment-related deaths. The HERCULES clinical trial is the first trial to demonstrate the efficacy of immune checkpoint inhibitors combined with chemotherapy in patients with advanced PSCC with a manageable safety profile. ClinicalTrials.gov Identifier: NCT04224740

TPS276 Background: Prostate cancer has an intrinsic dependence on androgens and androgen receptor (AR) regulation. Suppression of gonadal androgen synthesis known as androgen deprivation therapy (ADT), either by orchiectomy or by pharmacological modulation, represents the treatment backbone of metastatic disease. Unfortunately, almost invariably, patients develop resistance to ADT, progressing to a state called castration-resistant prostate cancer (CRPC), defined as disease progression at serum testosterone levels in the castrate range. Bipolar Androgen Therapy (BAT), consisting of exogenous supraphysiological doses of testosterone followed by castrate levels, has shown clinical activity in multiple early phase clinical trials, in addition to improvement of quality of life (QoL) in CRPC patients. Alternated administration of BAT and novel AR-targeted therapies, a strategy entitled by our group as Extreme Bipolar Androgen Therapy (ExBAT), has never been tested in patients with CRPC. The objective of our study is to assess the ExBAT approach in metastatic CRPC. Methods: ExBAT (NCT04558866) is a phase 2, single-arm, multicenter trial assessing patients with mCRPC who progressed to abiraterone by PCWG3 criteria. Prior docetaxel for metastatic hormone-sensitive disease is allowed if ≥ 12 months elapsed from last dose of docetaxel. Included patients receive testosterone cypionate 400 mg IM on day 1 followed by darolutamide 1,200 mg/day orally for 4 weeks (starting on day 29 through day 56) on 63-day cycles. The primary endpoint is radiographic progression-free survival (rPFS) at 12 months. Secondary endpoints include PSA decline rates, overall survival, toxicity, quality of life, and predictive biomarkers of response/survival. Tumor assessments are performed every 9 weeks, for the first 2 cycles and every 18 weeks thereafter up to 12 months. Patients with disease progression with clinical benefit are allowed to continue treatment. Patients without disease progression after 12 months are allowed to receive study treatment on Extension Phase. The sample size of 47 patients (considering 5% drop-out) was calculated based on the primary endpoint using a two-sided 5% significance level Chi-square Test for One Proportion and achieves 80% power to detect the difference between a 50% rPFS at 12 months comparing with 30% in the historic control group. NCT04558866. From June2021 to September2022, 31 of planned 47 patients have been enrolled in 8 Brazilian centers. Results are not available at the time of submission. Clinical trial information: NCT04558866 .

373 Background: During the COVID-19 pandemic resources from the Brazilian Public Health System (BPHS) were directed to the treatment of COVID-19. The impact of the pandemic on the treatment of prostate cancer in Brazil has not yet been rigorously evaluated. Methods: We compared the number of radical prostatectomies (RP), radiotherapy (RT), and hormonal (HT) and chemotherapy (CT) treatments from March 1st, 2020 to February 29th, 2022, with that of the two pre-pandemic years (March 1st, 2018, to February 28th, 2020). Additionally, we evaluated the post-pandemic period from March 1st, 2022 to February 28th, 2024. A large proprietary healthcare data science platform offered by TECHTRIALS was surveyed. Results: In the pandemic, 15,364RPs were performed in the BPHS, (U$14,271,297); there was a 23.3% reduction in the number of surgeries compared with the pre-pandemic years: 19,778RPs, (U$18,056,470). In the post-pandemic years 18,716 RPs were performed (U$ 18,373,781.92), an increase of 21.8% in those treated by surgery. In the pandemic, 34,922 men received RT (U$39,616,736), a 18.7% reduction in the number of patients as compared with the two pre-pandemic years, when 42,614 men were treated (U$44,148,190). In the post-pandemic years, 43,142 men received RT, an increase of 19% compared to the pandemic years (U$48,870,739.03). Regarding HT, 116,490 men were treated during the pandemic (U$74,834,615); in the pre-pandemic, 115,949 patients received HT (U$75,179,674). In the post-pandemic years, 127,602 men were treated with HT (U$80,078,824), an increment of 6.5% in cost and 10% in the number of patients treated compared to the pandemic years. As to CT for hormone-resistant disease, in the pandemic period 14,946 men were treated (U$23,402,947) compared with 12,695 men treated in the two pre-pandemic years (U$19,239,099). In the post-pandemic years 18,850 men were treated (U$33.571.073,40) an increment of 48.4% in number of patients treated and with an increase of 74% in costs compared to the pandemic period. Conclusions: During the pandemic years, there was a significant reduction of potentially curative treatments for prostate cancer in the BPHS. The number of systemic therapies increased, probably reflecting the policy of maintaining systemic therapies active during the pandemic. In the post-pandemic years, there was an increase in the number of systemic treatments, while RT and RP returned to a state very close to their pre-pandemic numbers. The impact of the COVID-19 pandemic on prostate cancer mortality in Brazil remains speculative.

5531 Background: Tisotumab vedotin (TV) is an antibody-drug-conjugate directed to tissue factor with a microtubule-disrupting agent, MMAE, payload. The ENGOT-cx12/GOG-3057/innovaTV study 301 (NCT04697628) was the first to report OS benefit for TV vs chemotherapy in 2L/3L recurrent or metastatic cervical cancer (r/mCC), including in pts who have received prior anti-PD-(L)1 (HR 0.70; Vergote, Ann Oncol 2023). This abstract presents additional data on the use of subsequent therapies in this study. Methods: innovaTV 301 is a global, randomized, open-label phase 3 study. Eligible pts had r/mCC with disease progression on/after chemotherapy doublet ± bevacizumab and an anti-PD-(L)1 agent, if eligible and available. Pts were randomized 1:1 to TV monotherapy (2.0 mg/kg Q3W) or investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). Primary endpoint was OS. Descriptive analyses on type and time to first subsequent anticancer therapy are reported. Results: 502 pts were randomized (TV: 253; chemotherapy: 249). All pts received prior systemic therapy; 63.9% of pts had prior bevacizumab and 27.5% of pts had prior anti-PD-(L)1. Observed OS and PFS benefits for TV vs chemotherapy were generally consistent in prespecified subgroups, notably regardless of prior exposure to anti-PD-(L)1. In the ITT population, ORR was 17.8% (95% CI, 13.3-23.1) vs 5.2% (95% CI, 2.8-8.8) and DCR was 75.9% (95% CI, 70.1-81.0) vs 58.2% (95% CI, 51.8-64.4) in the TV vs chemotherapy arms, respectively. Median time-to-response was 1.58 mo and 1.74 mo in the TV and chemotherapy arms, respectively. Following discontinuation of study treatment, 127 (50.2%) pts on the TV arm and 108 (43.4%) on the chemotherapy arm received subsequent anticancer therapy, of which the majority received systemic therapy for progressive disease, including 112 (88.2%) pts on the TV arm and 91 (84.3%) pts on the chemotherapy arm. Median time from last dose of study treatment to first subsequent therapy was 6.7 weeks (range: 1-35) for pts treated with TV and 5.4 weeks (range: 1-51) for pts treated with chemotherapy. The most common types of subsequent systemic therapies were cytotoxic chemotherapy (82/112 [73.2%] vs 57/91 [62.2%] on the TV and chemotherapy arms, respectively) and immunotherapy (42/112 [37.5%] and 32/91 [35.2%] on the TV and chemotherapy arms, respectively). Conclusions: TV previously demonstrated a significant improvement in OS vs chemotherapy that was generally consistent across prespecified subgroups. Additionally, a meaningful proportion of pts received subsequent anticancer therapy in both treatment arms, with cytotoxic chemotherapy and immunotherapy as the most common choices. These data show that TV provides meaningful clinical benefit and does not prevent pts from receiving subsequent therapies, including immunotherapy. Clinical trial information: NCT04697628 .

27 Background: Prostate cancer is the second leading cause of cancer death in men worldwide. In Brazil, 75% of patients (pts) rely on the public healthcare system, where access to novel therapies is limited. This disparity may lead to significant differences in survival outcomes. The LACOG 1818 study aims to address this gap by evaluating survival outcomes and treatment patterns among Brazilian pts diagnosed with metastatic castration resistant prostate cancer (mCRPC) in different healthcare settings (public versus private). Methods: LACOG 1818 is a retrospective cohort that included Brazilian pts from 18 research sites diagnosed with mCRPC between Jan 2014 and Dec 2017. Data on pts demographics, clinicopathological features, treatment patterns, and overall survival (OS) were collected from medical records. The primary endpoint was cause-specific survival (CSS) estimated by Kaplan-Meier method. Comparisons between groups (public vs. private healthcare) were assessed by chi-square and the log-rank tests. Results: From Jan 2020 to Jan 2022, 582 eligible pts were included. The median age was 49 (26-53) years, 259 (45%) were white and 85 (15%) were black/brown. Most had bone metastases (n=499, 86%), followed by non-regional lymph-nodes (n=239, 41%). A total of 323 (55%) pts had public and 259 (45%) had private health coverage. The main modality of castration was biochemical castration (n=442, 76% [public 60% vs. private 96%; p<0.0001]), followed by bilateral orchiectomy (n=140, 24% [public 40% vs. private 4%; p<0.0001]). 499 pts had available data on systemic treatment for mCRPC: 473 (95%) received first line; 247 (49%) second line; and 147 (29%) ≥ 3 lines. 378 (65%) pts received a bone protector agent (63% in public vs. 68% in private; p <0.001). At median follow-up of 59 months (95% CI 54.3-62.1), median OS was 57.1 months (95% CI 47.0-65.2) in overall sample; 44.8 months (95% CI 36.0-57.1) in public versus 65.7 months (95% CI 59.8-79.1) in private (HR 1.4 [95%IC 1.1-1.8] p=0.0051). The median CSS was 73.8 months (95% CI 55.1.-NR) in public versus 102.4 months (95% CI 83.4-102.4) in private (HR 1.9 [95%IC 1.4-2.6] p<0.0001). Conclusions: LACOG 1818 study demonstrated significant disparities in treatment patterns and survival outcomes between public and private settings for Brazilian pts with mCRPC. Pts with private coverage had longer OS and CSS. These findings underscore the need for improved access to novel therapies and comprehensive cancer care in Brazil's public healthcare system to reduce survival disparities. Clinical trial information: NCT04962919 . Private Public P First-line N=221 N= 251 <0.0001 ARPI 132 (60%) 18 (7%) Antiandrogen 30 (13%) 127(51%) Chemotherapy 59 (27%) 106 (42%) Second-line N=132 N=110 <0.0001 ARPI 75 (57%) 25 (23%) Antiandrogen 5 (4%) 22 (20%) Chemotherapy 52 (39%) 63 (57%) ARPI= Antiandrogen receptor pathways inhibitor. Antiandrogen= bicalutamide, flutamide, cyproterone and DES.

Importance:The open-label randomized phase 2 LACOG0415 trial evaluated 3 treatment strategies for patients with advanced castration-sensitive prostate cancer (CSPC): androgen deprivation therapy (ADT) plus abiraterone acetate and prednisone (AAP), apalutamide (APA) alone, or APA plus AAP. Objective:To investigate the association of ADT plus AAP, APA alone, or APA plus AAP with health-related quality of life (HRQOL) in patients with advanced CSPC in the LACOG0415 trial. Design, Setting, and Participants:The LACOG0415 randomized clinical trial comprised 128 patients with advanced CSPC who were randomized (1:1:1) to 1 of 3 treatment arms from October 16, 2017, to April 23, 2019. Statistical analysis was conducted from March to September 2022. Interventions:Patients were randomized (1:1:1) to 1 of 3 treatment arms: ADT plus AAP, APA alone, or APA plus AAP. Main Outcomes and Measures:Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, including its subscales, completed at baseline and every 4 weeks until week 25. FACT-P scores range from 0 to 156, and higher scores indicate better HRQOL. Mean changes in score from baseline to week 25 were adjusted by baseline score and were calculated to evaluate whether there was a difference according to the treatment arm using a mixed-effect model for repeated measures. Time to deterioration was estimated by Kaplan-Meier curves and compared by stratified log-rank test. Analysis was performed on an intention-to-treat basis. Results:A total of 128 patients with advanced CSPC were randomized to receive ADT plus AAP (n = 42; median age, 69.8 years [IQR, 58.9-71.6 years]), APA alone (n = 42; median age, 69.5 years [IQR, 59.8-72.6 years]), or APA plus AAP (n = 44; median age, 71.0 years [IQR, 63.0-72.3 years]). Metastatic disease was present in 95 patients (74.2%), high-risk biochemical recurrence disease in 22 (17.2%), and locally advanced disease in 11 (8.6%). There was no significant difference in baseline mean (SD) FACT-P total scores and subscales among the 3 treatment arms (FACT-P total score: ADT plus AAP arm, 118.5 [24.3]; APA alone arm, 116.1 [23.9]; AAP plus APA arm, 114.9 [18.1]; P = .69). Health-related quality of life was maintained during treatment period, and there were no statistically significant differences at 25 weeks in mean (SD) FACT-P total scores or subscales between treatment arms (FACT-P total score: ADT plus AAP arm, 122.3 [20.4]; APA alone arm, 119.5 [16.4]; AAP plus APA arm, 119.9 [20.3]). The APA alone and AAP plus APA arms were not associated with meaningful improvements in HRQOL compared with the ADT plus AAP arm, except in time to deterioration of the emotional well-being score, which was more favorable in the APA alone arm (reference arm: ADT plus AAP arm; APA alone arm: hazard ratio, 0.37 [0.15-0.85]; P = .02; ADT plus AAP arm: hazard ratio, 0.56 [0.26-1.19]; P = .13). Limitations include short follow-up period and the absence of other questionnaires to capture differences between therapies. Conclusions and Relevance:In this prespecified secondary analysis of a randomized clinical trial of ADT plus AAP, APA alone, or APA plus AAP for patients with advanced CSPC, HRQOL was not statistically different between treatments with APA alone or APA plus AAP as compared with ADT plus AAP. Larger studies with longer follow-up and more specific questionnaires are needed to further evaluate HRQOL with these treatment strategies. Trial Registration:ClinicalTrials.gov Identifier: NCT02867020.

ImportanceThe open-label randomized phase 2 LACOG0415 trial evaluated 3 treatment strategies for patients with advanced castration-sensitive prostate cancer (CSPC): androgen deprivation therapy (ADT) plus abiraterone acetate and prednisone (AAP), apalutamide (APA) alone, or APA plus AAP.ObjectiveTo investigate the association of ADT plus AAP, APA alone, or APA plus AAP with health-related quality of life (HRQOL) in patients with advanced CSPC in the LACOG0415 trial.Design, Setting, and ParticipantsThe LACOG0415 randomized clinical trial comprised 128 patients with advanced CSPC who were randomized (1:1:1) to 1 of 3 treatment arms from October 16, 2017, to April 23, 2019. Statistical analysis was conducted from March to September 2022.InterventionsPatients were randomized (1:1:1) to 1 of 3 treatment arms: ADT plus AAP, APA alone, or APA plus AAP.Main Outcomes and MeasuresHealth-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire, including its subscales, completed at baseline and every 4 weeks until week 25. FACT-P scores range from 0 to 156, and higher scores indicate better HRQOL. Mean changes in score from baseline to week 25 were adjusted by baseline score and were calculated to evaluate whether there was a difference according to the treatment arm using a mixed-effect model for repeated measures. Time to deterioration was estimated by Kaplan-Meier curves and compared by stratified log-rank test. Analysis was performed on an intention-to-treat basis.ResultsA total of 128 patients with advanced CSPC were randomized to receive ADT plus AAP (n = 42; median age, 69.8 years [IQR, 58.9-71.6 years]), APA alone (n = 42; median age, 69.5 years [IQR, 59.8-72.6 years]), or APA plus AAP (n = 44; median age, 71.0 years [IQR, 63.0-72.3 years]). Metastatic disease was present in 95 patients (74.2%), high-risk biochemical recurrence disease in 22 (17.2%), and locally advanced disease in 11 (8.6%). There was no significant difference in baseline mean (SD) FACT-P total scores and subscales among the 3 treatment arms (FACT-P total score: ADT plus AAP arm, 118.5 [24.3]; APA alone arm, 116.1 [23.9]; AAP plus APA arm, 114.9 [18.1]; P = .69). Health-related quality of life was maintained during treatment period, and there were no statistically significant differences at 25 weeks in mean (SD) FACT-P total scores or subscales between treatment arms (FACT-P total score: ADT plus AAP arm, 122.3 [20.4]; APA alone arm, 119.5 [16.4]; AAP plus APA arm, 119.9 [20.3]). The APA alone and AAP plus APA arms were not associated with meaningful improvements in HRQOL compared with the ADT plus AAP arm, except in time to deterioration of the emotional well-being score, which was more favorable in the APA alone arm (reference arm: ADT plus AAP arm; APA alone arm: hazard ratio, 0.37 [0.15-0.85]; P = .02; ADT plus AAP arm: hazard ratio, 0.56 [0.26-1.19]; P = .13). Limitations include short follow-up period and the absence of other questionnaires to capture differences between therapies.Conclusions and RelevanceIn this prespecified secondary analysis of a randomized clinical trial of ADT plus AAP, APA alone, or APA plus AAP for patients with advanced CSPC, HRQOL was not statistically different between treatments with APA alone or APA plus AAP as compared with ADT plus AAP. Larger studies with longer follow-up and more specific questionnaires are needed to further evaluate HRQOL with these treatment strategies.Trial RegistrationClinicalTrials.gov Identifier: NCT02867020

Background Premenopausal, high-risk, hormone receptor-positive breast cancer patients are often treated with ovarian suppression in combination with aromatase inhibitors. This combination has important adverse effects, particularly in sexual function, such as vaginal dryness and loss of libido. There is no effective therapy for reduced sexual function in this setting. Our study aimed to determine the efficacy and safety, particularly regarding sexual function, of a low-dose, topical testosterone gel administration.Methods This is a pilot, single-center study, designed to evaluate the efficacy of topical testosterone gel (3 mg/day) in improving sexual function in 29 premenopausal patients on ovarian suppression in combination with an aromatase inhibitor. The primary safety endpoint was to determine serum estradiol, measured by liquid chromatography-mass spectrometry monthly for three consecutive months. The primary efficacy endpoint was assessed by means of the Female Sexual Function Index questionnaire, which include various domains of sexual function such as libido, sexual satisfaction and vaginal lubrication.Results We report the results on 29 patients. Twenty-two patients (75%) completed the 3-month treatment, and seven discontinued treatment. One was excluded after the first visit because she was postmenopausal, one had a mild skin reaction and five discontinued treatment over the three months mainly due to logistical difficulties related to the COVID-19 pandemic. A total of 29 patients maintained the value of baseline mass spectrometry assay for estradiol of less than 2.7 pg/mL during the 3-month treatment in all three measurements. We observed a significant improvement in Female Sexual Function Index measures over the visits, with an increase from a mean of 11.7 at baseline to 19.1 in the third month (p < 0.001), with the greatest improvement observed between the second and third months. Regarding the domains of the questionnaire evaluated separately, desire, excitement, lubrication, orgasm and satisfaction all showed significant improvement over three months of the protocol.Conclusions Our findings suggest that topical testosterone seems to be safe and may be effective in improving sexual function in patients on ovarian suppression and AI. A randomized phase 2 study is warranted.Trial registration The project was submitted and approved through the hospital's SGPP platform in 11/26/2019 (Project No. SGPP: 3938-19) and CAAE (Research Ethics Committee) (CAAE No: 25609719.5.0000.007)

Purpose Renal cell carcinoma is an aggressive disease with a high mortality rate. Management has drastically changed with the new era of immunotherapy, and novel strategies are being developed; however, identifying systemic treatments is still challenging. This paper presents an update of the expert panel consensus from the Latin American Cooperative Oncology Group and the Latin American Renal Cancer Group on advanced renal cell carcinoma management in Brazil.Methods A panel of 34 oncologists and experts in renal cell carcinoma discussed and voted on the best options for managing advanced disease in Brazil, including systemic treatment of early and metastatic renal cell carcinoma as well as nonclear cell tumours. The results were compared with the literature and graded according to the level of evidence.Results Adjuvant treatments benefit patients with a high risk of recurrence after surgery, and the agents used are pembrolizumab and sunitinib, with a preference for pembrolizumab. Neoadjuvant treatment is exceptional, even in initially unresectable cases. First-line treatment is mainly based on tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs); the choice of treatment is based on the International Metastatic Database Consortium (IMCD) risk score. Patients at favourable risk receive ICIs in combination with TKIs. Patients classified as intermediate or poor risk receive ICIs, without preference for ICI + ICIs or ICI + TKIs. Data on nonclear cell renal cancer treatment are limited. Active surveillance has a place in treating favourable-risk patients. Either denosumab or zoledronic acid can be used for treating metastatic bone disease.Conclusion Immunotherapy and targeted therapy are the standards of care for advanced disease. The utilization and sequencing of these therapeutic agents hinge upon individual risk scores and responses to previous treatments. This consensus reflects a commitment to informed decision-making, drawn from professional expertise and evidence in the medical literature.

Premenopausal, high-risk, hormone receptor-positive breast cancer patients are often treated with ovarian suppression in combination with aromatase inhibitors (AI). This combination has important adverse effects, particularly in sexual function, such as vaginal dryness and loss of libido. There is no effective therapy for reduced sexual function in this setting. Our study aimed to determine the efficacy and safety, particularly regarding sexual function, of a low-dose, topical testosterone gel administration. This is a pilot, single-center study, designed to evaluate the efficacy of topical testosterone gel (3 mg/day) in improving sexual function in 29 premenopausal patients on ovarian suppression in combination with an AI. The primary safety endpoint was to assess serum estradiol elevation. The primary efficacy endpoint was sexual function improvement, assessed by the Female Sexual Function Index questionnaire. We report the results on 29 patients. Twenty-two patients (75