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Bone health is central to the management of patients with metastatic castration-resistant prostate cancer (mCRPC). International guidelines recommend giving a bone-protecting agent (BPA) to patients with mCRPC and bone metastases. However, the data supporting these recommendations were generated before androgen receptor pathway inhibitors (ARPIs) were available. Here we publish for the first time fracture rates from an interim safety analysis of the international prospective phase 3 PEACE-3 trial comparing radium-223 ( 223 Ra) combined with enzalutamide for first-line mCPRC to enzalutamide alone. After results from the ERA-223 trial (abiraterone ± 223 Ra) showed a high fracture rate in both arms, the independent data monitoring committee of PEACE-3 mandated BPA use during the trial, which increased BPA use from 46.1% to 97%. For patients who received BPA therapy, fracture rates significantly decreased in both study arms. At 1 year, fractures decreased from 15.6% to 2.6% with a BPA in patients receiving enzalutamide monotherapy. The interim safety analysis of PEACE-3 underscores the high risk of fracture in patients with mCRPC and the necessity of complying with guidelines regarding BPA administration in the ARPI era. The EORTC GUCG-1333 PEACE-3 trial is registered on ClinicalTrials.gov as NCT02194842 and on EudraCT as 2014-001787-36., (Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: The Brazilian Public Health System (BPHS) serves approximately 71,730 patients with prostate cancer (PC) every year for which androgen deprivation therapy (ADT) is the primary treatment for patients with advanced hormone-sensitive prostate cancer (aHSPC). Androgen receptor pathway inhibitors (ARPIs) are not accessible through the BPHS. Using the BPHS as a model, this study assesses the long-term economic effect of surgical versus medical castration in aHSPC treatment to strategize cost reduction and the incorporation of ARPI in developing countries., Patients and Methods: Data of patients with aHSPC (ie, TxN1M0 ineligible for local treatment or TxNxM1) from the BPHS database were analyzed from January 1, 2011, to December 31, 2021, using the TECHTRIALS artificial intelligence platform. The main outcomes were quantitative and descriptive analyses as well as a cost analysis of surgical versus chemical castration., Results: Of the 274,519 patients with aHSPC who received active treatment during the 11-year study period, 90% (n = 246,683) underwent chemical castration and 10% (n = 27,836) underwent bilateral subcapsular orchiectomy (BSO). The median duration of chemical castration was 28 months. The BPHS spent an estimated total of $665,552,091.40 US dollars (USD) on chemical castration and $5,939,348.47 USD on BSO, respectively. The cost per patient was $2,698 USD and $213.37 USD for chemical castration and BSO, respectively. Hypothetically, if all patients with aHSPC had undergone BSO, the total direct cost for the BPHS would have been $42,774,832.20 USD, saving $622,777,259.20 USD over 11 years, making it possible to offer low-dose abiraterone to 65% of aHSPC patients., Conclusion: On the basis of this extensive financial analysis from the world's largest public health system database, BSO appears to be a valuable alternative to chemical castration for treating aHSPC. In resource-limited environments, the cost savings from using BSO may allow access to drugs that will improve survival such as ARPIs.

Introduction: Fibroblast growth factor receptor (FGFR) mutations and fusions are relevant biomarkers in metastatic urothelial carcinoma (mUC). However, the prevalence of genomic alterations and their impact on clinical outcomes in a Latin American population remains unknown. This study aimed to explore the prevalence of FGFR mutations and/or fusions in patients with mUC in Latin America (LATAM) and its association with clinicopathological characteristics, Bellmunt's prognostic model, and survival outcomes., Patients and Methods: A multicenter retrospective cohort study from 2016 to 2019 of patients with mUC from several LACOG LATAM institutions. FGFR alterations were analyzed by real-time PCR and/or next-generation sequencing in tumor samples and clinicopathologic characteristics and survival outcomes data were collected. The prevalence of FGFR, patient characteristics, and treatment in real-world settings were summarized. Kaplan-Meier survival estimates and Cox regression analyses were used to evaluate the associations of FGFR mutation and/or fusion status with median overall survival (mOS), median time to treatment failure (mTTF), and clinicopathological characteristics., Results: In total, 222 patients were screened. Of these, 196 patients were considered eligible and were included in the analysis. FGFR mutations and/or fusions were found in 35 (17.9%) patients. There was no statistical difference in mOS and mTTF in FGFR-altered and non-altered patients (13.1 vs. 16.8 months, P = .20 and 3.9 vs. 4.1 months, P = .96, respectively). Bellmunt's prognostic model correctly predicted overall survival (P = .049)., Conclusions: This is the largest study evaluating the prevalence of FGFR alterations in patients with mUC in the LATAM population. FGFR alterations in mUC were found in 17.9% of the patients, and the presence of this biomarker was not associated with OS. We validated Bellmunt's prognostic model in this cohort., Competing Interests: Disclosure Dr. Gustavo Werutsky reports personal fees from AstraZeneca, Bayer, Beigene, Daiichi Sankyo, Genentech/Roche, GSK, Lilly, MSD, Novartis, Pfizer, Sanofi, and Seattle Genetics outside the submitted work. All remaining authors have declared no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

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., (© The Author(s) 2024. Published by Oxford University Press.)

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., (© 2024. The Author(s).)

Introduction: Non-metastatic, castration-resistant prostate cancer (nmCRPC) is an important clinical stage of prostate cancer, prior to morbidity and mortality from clinical metastases. In particular, the introduction of novel androgen-receptor signaling inhibitors (ARSi) has changed the therapeutic landscape in nmCRPC. Given recent developments in this field, we update our recommendations for the management of nmCRPC., Methods: A panel of 51 invited medical oncologists and urologists convened in May of 2021 with the aim of discussing and providing recommendations regarding the most relevant issues concerning staging methods, antineoplastic therapy, osteoclast-targeted therapy, and patient follow-up in nmCRPC. Panel members considered the available evidence and their practical experience to address the 73 multiple-choice questions presented., Results: Key recommendations and findings include the reliance on prostate-specific antigen doubling time for treatment decisions, the absence of a clear preference between conventional and novel (i.e., positron-emission tomography-based) imaging techniques, the increasing role of ARSis in various settings, the general view that ARSis have similar efficacy. Panelists highlighted the slight preference for darolutamide, when safety is of greater concern, and a continued need to develop high-level evidence to guide the intensity of follow-up in this subset of prostate cancer., Discussion: Despite the limitations associated with a consensus panel, the topics addressed are relevant in current practice, and the recommendations can help practicing clinicians to provide state-of-the-art treatment to patients with nmCRPC in Brazil and other countries with similar healthcare settings., (Copyright © 2022. Published by Elsevier Inc.)

Purpose: To present a summary of the recommendations for the treatment and follow-up for metastatic castration-resistant prostate cancer (mCRPC) as acquired through a questionnaire administered to 99 physicians working in the field of prostate cancer in developing countries who attended the Prostate Cancer Consensus Conference for Developing Countries., Methods: A total of 106 questions out of more than 300 questions addressed the use of imaging in staging mCRPC, treatment recommendations across availability and response to prior drug treatments, appropriate drug treatments, and follow-up, and those same scenarios when limited resources needed to be considered. Responses were compiled and the percentages were presented by clinicians to support each response. Most questions had five to seven relevant options for response including abstain and/or unqualified to answer, or in the case of yes or no questions, the option to abstain was offered., Results: Most of the recommendations from this panel were in line with prior consensus, including the preference of a new antiandrogen for first-line therapy of mCRPC. Important aspects highlighted in the scenario of limited resources included the option of docetaxel as treatment preference as first-line treatment in several scenarios, docetaxel retreatment, consideration for reduced doses of abiraterone, and alternative schedules of an osteoclast-targeted therapy., Conclusion: There was wide-ranging consensus in the treatment for men with mCRPC in both optimal and limited resource settings., Competing Interests: Fernando Cotait MalufHonoraria: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Sanofi/Aventis, Merck Serono, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Merck Serono, AstraZenecaResearch Funding: Janssen-Cilag, Merck Sharp & DohmeTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bayer Schering Pharma Felipe MoraesHonoraria: Janssen, Zodiac Pharma, MSD, Libbs, Bayer, AmgenConsulting or Advisory Role: Janssen Adriano Gonçalves SilvaHonoraria: MSD Oncology, Janssen Oncology, Astellas Pharma, Roche, Pfizer/EMD Serono, Bayer, BMS BrazilConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, Pfizer/EMD Serono, MSD OncologyResearch Funding: MSD Oncology, Janssen OncologyTravel, Accommodations, Expenses: Janssen Oncology, Astellas Pharma, MSD Oncology, Roche Aldo Lourenço Abbade DettinoHonoraria: Janssen-Cilag, Bayer, Astellas Pharma, RocheConsulting or Advisory Role: NovartisResearch Funding: Janssen, RocheTravel, Accommodations, Expenses: MSD Oncology Ana Paula Garcia CardosoConsulting or Advisory Role: Janssen Oncology, Pfizer, Astellas PharmaSpeakers' Bureau: Janssen Oncology, Novartis, MSD Oncology, Astellas Pharma, AstraZeneca, BayerTravel, Accommodations, Expenses: Ipsen, Janssen Oncology, Bristol-Myers Squibb André Seeke SasseHonoraria: Roche, Astellas Pharma, Janssen-Cilag, Bristol-Myers Squibb, Merck KGaA, MSD Oncology, NovartisConsulting or Advisory Role: Astellas Pharma, Janssen-Cilag, Merck KGaA, Novartis, RocheResearch Funding: Bristol-Myers SquibbTravel, Accommodations, Expenses: MSD Oncology, Janssen-Cilag Andrey SoaresHonoraria: Janssen, Pfizer, Bayer, Novartis, AstraZeneca, Astellas Pharma, Pierre Fabre, Merck Serono, Sanofi, Roche, MSDConsulting or Advisory Role: Astellas Pharma, Janssen, Roche, Bayer, Lilly, AstraZeneca, Novartis, MSD, Bristol-Myers SquibbResearch Funding: Bristol-Myers SquibbTravel, Accommodations, Expenses: AstraZeneca, Pfizer, Astellas Pharma, Bristol-Myers Squibb, Bayer, Roche, Janssen, Merck Serono, Sanofi, Ipsen, MSD Ariel Galapo KannConsulting or Advisory Role: Janssen OncologySpeakers' Bureau: Janssen Oncology, GlaxoSmithKline, Roche Daniel HerchenhornConsulting or Advisory Role: Janssen-Cilag Denis Leonardo Fontes JardimHonoraria: Janssen-Cilag, Roche/Genentech, Astellas Pharma, MSD Oncology, BMS Brazil, Pfizer, Libbs, MerckConsulting or Advisory Role: Janssen-Cilag, Pfizer, MSDTravel, Accommodations, Expenses: MSD, BMS Brazil, Janssen-Cilag Diego Emilio Lopera CortésConsulting or Advisory Role: Bristol-Myers Squibb, Pfizer, NovartisSpeakers' Bureau: Dr Reddy's Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim, PfizerTravel, Accommodations, Expenses: MSD Oncology Fábio Roberto KaterConsulting or Advisory Role: Janssen-Cilag, PfizerTravel, Accommodations, Expenses: Janssen-Cilag Igor A. Protzner MorbeckHonoraria: Janssen-Cilag, BMS Brazil, AstraZeneca, MSD Oncology, Astellas PharmaConsulting or Advisory Role: BMS Brazil, Janssen-Cilag, TakedaTravel, Accommodations, Expenses: Astellas Pharma, BMS Brazil Juan Jose ZarbáConsulting or Advisory Role: Pfizer/EMD Serono, Astellas PharmaResearch Funding: MSD Oncology, Lilly, Exelixis, Astellas PharmaExpert Testimony: LillyTravel, Accommodations, Expenses: Roche, Pfizer Karine Martins da TrindadeHonoraria: BMS Brazil, Janssen-Cilag, MSD OncologyConsulting or Advisory Role: MSD Oncology, Janssen-Cilag, Astellas PharmaResearch Funding: BMS Brazil, Roche/Genentech, MSD Oncology, Janssen-CilagTravel, Accommodations, Expenses: Janssen-Cilag, BMS Brazil, Ipsen Leonardo Atem G. A. CostaHonoraria: Janssen Oncology, Astellas Pharma, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, AstraZenecaTravel, Accommodations, Expenses: Janssen Oncology, Boehringer Ingelheim, Astellas Pharma, AstraZeneca Lucas V. dos SantosStock and Other Ownership Interests: Merck Sharp & Dohme, Eisai, Fleury GroupHonoraria: BMS Brazil, United Medical, Roche/GenentechConsulting or Advisory Role: Lilly, Bristol-Myers Squibb, MSD, Roche/GenentechSpeakers' Bureau: BMS Brazil, United MedicalResearch Funding: Roche/Genentech, Janssen Oncology, Novartis, GlaxoSmithKline, Amgen, Boston Scientific, Takeda, BMS Brazil, MSD, Exelixis Manuel Caitano MaiaConsulting or Advisory Role: AstraZeneca, Janssen OncologySpeakers' Bureau: Janssen Oncology, AstraZeneca, Bayer, MSD Oncology, Pfizer, Astellas PharmaExpert Testimony: MSD OncologyTravel, Accommodations, Expenses: Astellas Pharma, Janssen Oncology Mariana Bruno SiqueiraConsulting or Advisory Role: Novartis, Janssen-CilagSpeakers' Bureau: Novartis, MSD Oncology, Bayer, Janssen-CilagTravel, Accommodations, Expenses: Roche, Pfizer, Ipsen Silke GillessenConsulting or Advisory Role: Astellas Pharma, Advanced Accelerator Applications, Roche, Janssen, Bayer, Orion Pharma GmbH, Menarini Silicon Biosystems, Tolero Pharmaceuticals, MSD Oncology, Amgen, PfizerSpeakers' Bureau: Janssen-CilagPatents, Royalties, Other Intellectual Property: Method for biomarker (WO 3752009138392 A1)Travel, Accommodations, Expenses: ProteoMedixOther Relationship: ProteoMediX, Aranda PharmaNo other potential conflicts of interest were reported.

Purpose: To present a summary of the treatment and follow-up recommendations for the biochemical recurrence in castration-sensitive prostate cancer (PCa) acquired through a questionnaire administered to 99 PCa experts from developing countries during the Prostate Cancer Consensus Conference for Developing Countries., Methods: A total of 27 questions were identified as related to this topic from more than 300 questions. The clinician's responses were tallied and presented in a percentage format. Topics included the use of imaging for staging biochemical recurrence, treatment recommendations for three different clinical scenarios, the field of radiation recommended, and follow-up. Each question had 5-7 relevant response options, including "abstain" and/or "unqualified to answer," and investigated not only recommendations but also if a limitation in resources would change the recommendation., Results: For most questions, a clear majority (> 50%) of clinicians agreed on a recommended treatment for imaging, treatment scenarios, and follow-up, although only a few topics reached a consensus > 75%. Limited resources did affect several areas of treatment, although in many cases, they reinforced more stringent criteria for treatment such as prostate-specific antigen values > 0.2 ng/mL and STAMPEDE inclusion criteria as a basis for recommending treatment., Conclusion: A majority of clinicians working in developing countries with limited resources use similar cutoff points and selection criteria to manage patients treated for biochemically recurrent castration-sensitive PCa., Competing Interests: Fernando S. M. MonteiroConsulting or Advisory Role: Bristol Myers Squibb, Roche, MSD Oncology, JanssenSpeakers' Bureau: Janssen, MSD Oncology, IpsenResearch Funding: Janssen (Inst)Travel, Accommodations, Expenses: Janssen, Roche, Bristol Myers Squibb Fabio A. SchutzEmployment: Ipsen (I)Consulting or Advisory Role: Bayer, Janssen Oncology, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, Pfizer, Astellas Pharma, AstraZenecaSpeakers' Bureau: Janssen Oncology, Astellas Pharma, Bayer, Pfizer, Bristol Myers Squibb, AstraZeneca, Merck Sharp & Dohme, RocheResearch Funding: Janssen OncologyTravel, Accommodations, Expenses: Merck Sharp & Dohme, Roche, Bristol Myers Squibb, Astellas Pharma, Janssen-Cilag Igor A. P. MorbeckHonoraria: Janssen-Cilag, BMS Brazil, AstraZeneca, MSD Oncology, Astellas PharmaConsulting or Advisory Role: BMS Brazil, Janssen-Cilag, TakedaTravel, Accommodations, Expenses: Astellas Pharma, BMS Brazil Diogo A. BastosHonoraria: MSD, Roche, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, AstraZeneca, BayerConsulting or Advisory Role: Roche, Bayer, Janssen-Cilag, MSD OncologyResearch Funding: Janssen-Cilag (Inst), Pfizer (Inst), Astellas Pharma (Inst)Travel, Accommodations, Expenses: Janssen-Cilag, Bayer Leonardo A. G. A. CostaHonoraria: Janssen Oncology, Astellas Pharma, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, AstraZenecaTravel, Accommodations, Expenses: Janssen Oncology, Boehringer Ingelheim, Astellas Pharma, AstraZeneca Manuel C. MaiaConsulting or Advisory Role: AstraZeneca, Janssen OncologySpeakers' Bureau: Janssen Oncology, AstraZeneca, Bayer, MSD Oncology, Pfizer, Astellas PharmaExpert Testimony: MSD OncologyTravel, Accommodations, Expenses: Astellas Pharma, Janssen Oncology Stenio de Cassio ZequiConsulting or Advisory Role: Pfizer, Astellas BrazilSpeakers' Bureau: Pfizer, Astellas Pharma, Bayer, Janssen, Astra Zeneca Brazil Karine M. da TrindadeHonoraria: BMS Brazil, Janssen-Cilag, MSD OncologyConsulting or Advisory Role: MSD Oncology, Janssen-Cilag, Astellas PharmaResearch Funding: BMS Brazil, Roche/Genentech, MSD Oncology, Janssen-CilagTravel, Accommodations, Expenses: Janssen-Cilag, BMS Brazil, Ipsen Lucas V. dos SantosStock and Other Ownership Interests: Merck Sharp & Dohme, Eisai, Fleury GroupHonoraria: BMS Brazil, United Medical, Roche/GenentechConsulting or Advisory Role: Lilly, Bristol Myers Squibb, MSD, Roche/GenentechSpeakers' Bureau: BMS Brazil, United MedicalResearch Funding: Roche/Genentech (Inst), Janssen Oncology (Inst), Novartis (Inst), GlaxoSmithKline (Inst), Amgen (Inst), Boston Scientific (Inst), Takeda (Inst), BMS Brazil (Inst), MSD (Inst), Exelixis (Inst) Diogo A. R. da RosaHonoraria: RocheConsulting or Advisory Role: Janssen-Cilag, Bristol Myers Squibb, AstraZeneca, Astellas PharmaSpeakers' Bureau: AstraZeneca, Dr Reddy's Laboratories, Roche, MSD Oncology, BMS BrazilTravel, Accommodations, Expenses: Janssen-Cilag, Roche, BMS Brazil, Ipsen Francisco J. OrlandiHonoraria: Roche/GenentechConsulting or Advisory Role: AstraZeneca, Roche/Genentech, Bristol Myers Squibb, MSD Oncology, Pfizer, Novartis, SanofiSpeakers' Bureau: AstraZeneca/MedImmune, RocheResearch Funding: AstraZeneca/MedImmune, Amgen, Genentech/Roche, Boehringer Ingelheim, Astellas Medivation, MSD Oncology, Bristol Myers Squibb, Celltrion, Pfizer, mAbxience, Nektar, SanofiTravel, Accommodations, Expenses: MSD Oncology, Genentech/Roche Fernando N. G. de OliveiraConsulting or Advisory Role: Janssen OncologySpeakers' Bureau: Janssen Oncology, Astellas Pharma, MSD OncologyTravel, Accommodations, Expenses: Astellas Pharma, MSD Oncology Andrey SoaresHonoraria: Janssen, Pfizer, Bayer, Novartis, AstraZeneca, Astellas Pharma, Pierre Fabre, Merck Serono, Sanofi, Roche, MSDConsulting or Advisory Role: Astellas Pharma, Janssen, Roche, Bayer, Lilly, AstraZeneca, Novartis, MSD, Bristol Myers Squibb (Inst)Research Funding: Bristol Myers Squibb (Inst)Travel, Accommodations, Expenses: AstraZeneca, Pfizer, Astellas Pharma, Bristol Myers Squibb, Bayer, Roche, Janssen, Merck Serono, Sanofi, Ipsen, MSDNo other potential conflicts of interest were reported.

Background: Non-metastatic castration resistant prostate cancer (M0 CRPC) has seen important developments in drugs and diagnostic tools in the last two years. New hormonal agents have demonstrated improvement in metastasis free survival in M0 CRPC patients and have been approved by regulatory agencies in Brazil. Additionally, newer and more sensitive imaging tools are able to detect metastasis earlier than before, which will impact the percentage of patients staged as M0 CRPC. Based on the available international guidelines, a group of Brazilian urology and medical oncology experts developed and completed a survey on the diagnosis and treatment of M0 CRPC in Brazil. These results are reviewed and summarized and associated recommendations are provided., Objective: To present survey results on management of M0 CRPC in Brazil., Design, Setting, and Participants: A panel of six Brazilian prostate cancer experts determined 64 questions concerning the main areas of interest: 1) staging tools, 2) treatments, 3) side effects of systemic treatment/s, and 4) osteoclast-targeted therapy. A larger panel of 28 Brazilian prostate cancer experts answered these questions in order to create country-specific recommendations discussed in this manuscript. Outcome measurements and statistical analysis: The panel voted publicly but anonymously on the predefined questions. These answers are the panelists' opinions, not a literature review or meta-analysis. Therapies not yet approved in Brazil were excluded from answer options. Each question had five to seven relevant answers including two non-answers. Results were tabulated in real time., Conclusions: The results and recommendations presented can be used by Brazilian physicians to support the management of M0 CRPC patients. Individual clinical decision making should be supported by available data, however, for Brazil, guidelines for diagnosis and management of M0 CRPC patients have not been developed. This document will serve as a point of reference when confronting this disease stage., Competing Interests: None declared., (Copyright® by the International Brazilian Journal of Urology.)

Purpose: The outcome of RCC has improved considerably in the last few years, and the treatment options have increased. LACOG-GU and LARCG held a consensus meeting to develop guidelines to support the clinical decisions of physicians and other health professionals involved in the care of RCC patients., Methods: Eighty questions addressing relevant advanced RCC treatments were previously formulated by a panel of experts. The voting panel comprised 26 specialists from the LACOG-GU/LARCG. Consensus was determined as 75% agreement. For questions with less than 75% agreement, a new discussion was held, and consensus was determined by the majority of votes after the second voting session., Results: The recommendations were based on the highest level of scientific evidence or by the opinion of the RCC experts when no relevant research data were available., Conclusion: This manuscript provides guidance for advanced RCC treatment according to the LACOG-GU/LARCG expert recommendations.

Background: Renal cell cancer (RCC) is one of the 10 most common cancers in the world, and its incidence is increasing, whereas mortality is declining only in developed countries. Therefore, two collaborative groups, The Latin American Oncology Cooperative Group-Genitourinary Section (LACOG-GU) and the Latin American Renal Cancer Group (LARCG), held a consensus meeting to develop this guideline., Methods: Issues (134) related to the treatment of RCC were previously formulated by a panel of experts. The voting panel comprised 26 specialists (urologists and medical oncologists) from the LACOG-GU/LARCG. A consensus was reached if 75% agreement was achieved. If there was less concordance, a new discussion was undertaken, and a consensus was determined by the most votes after a second voting session., Results: The expert meeting provided recommendations that were in line with the global literature; 75.0% of the recommendations made by the panel of experts were evidence-based level A, 22.5% of the recommendations were level B, and 2.5% of the recommendations were level D., Conclusions: This review suggests recommendations for the surgical treatment of RCC according to the LACOG-GU/LARCG experts., Competing Interests: Conflict of interest statement: Adriano Gonçalves e Silva, Speaker Fee: Janssen, Pfizer, Bayer, AstraZeneca, Astellas, Pierre-Fabre, Sanofi, Roche, Merck Sharp & Dohme, Bristol-Myers Squibb. Advisory Board: Astellas, Janssen, Roche, Merck Sharp & Dohme, Bristol-Myers Squibb, Pfizer, Sanofi. André Deeke Sasse, Honoraria: Janssen, Astellas, Roche, Merck Sharp & Dohme. Advisory Board: Janssen, Astellas, Roche, Merck Sharp & Dohme, Bristol-Myers Squibb. Events Sponsorship: Janssen, Roche. André P. Fay, Honoraria: Pfizer, Astellas, Bristol-Myers Squibb, Novartis, Roche, AstraZeneca, Merck Sharp & Dohme. Advisory Board: Janssen, Novartis, Roche, Pfizer, Ipsen. Research Funding: CAPES, CNPq, Bristol-Myers Squibb, AstraZeneca, Roche, Merck Sharp & Dohme, Pfizer. Andrey Soares, Speaker Fee: Janssen, Pfizer, Bayer, Novartis, AstraZeneca, Astellas, Pierre-Fabre, Merck-Serono, Sanofi, Roche. Events sponsorship: AstraZeneca, Pfizer, Astellas, Bristol-Myers Squibb, Bayer, Roche, Janssen, Merck Serono, Sanofi, Ipsen. Advisory Board: Astellas, Janssen, Roche, Bayer, Lilly, AstraZeneca, Novartis, Merck Sharp & Dohme, Bristol-Myers Squibb. Research Funding: Bristol-Myers Squibb. Denis Leonardo Jardim, Speaker Fee: Roche, Janssen, Astellas, Merck Sharp & Dohme, Bristol-Myers Squibb and Libbs. Advisory Board: Janssen, Bristol-Myers Squibb and Libbs. Deusdedit Cortez Vieira da Silva Neto, Speaker Fee: Janssen, Astellas, Pfizer. Advisory Board: Janssen. Diogo Assed Bastos, Research Funding: Janssen, Astellas, Pfizer, Merck Sharp & Dohme. Honoraria/Advisory Board: Janssen, Astellas, Bristol-Myers Squibb, Merck Sharp & Dohme, Roche, Pfizer, Novartis, Bayer. Diogo Augusto Rodrigues da Rosa, Research Funding: Roche, Bristol-Myers Squibb, Janssen, Lilly, AstraZeneca, Merck Sharp & Dohme. Speaker Fee: Janssen, Pfizer, AstraZeneca, Astellas, Roche, Amgen, Dr Reddy’s, Merck Sharp & Dohme. Events Sponsorship: Janssen, AstraZeneca, Astellas, Bristol-Myers Squibb, Bayer, Roche, Janssen, Ipsen. Advisory Board: Janssen, Bayer, AstraZeneca. Evanius Wierman, Honoraria: Janssen, Libbs. Advisory Board: Janssen. Fabio Kater, Speaker Fee: Janssen, Roche, Amgen, Merck Sharp & Dohme, AstraZeneca, Astellas. Events Sponsorship: Roche, Janssen. Fabio A. Schutz, Advisory Board: Bristol-Myers Squibb, Merck Sharp & Dohme, Ipsen, Pfizer. Speaker’s bureau: Roche, Novartis, Pfizer, Bristol-Myers Squibb, Merck Sharp & Dohme, Janssen, Astellas. Felipe de Almeida e Paula, None. Fernando Cotait Maluf, Research Funding: Roche, Bristol-Myers Squibb, Novartis, Janssen. Speaker Fee: Sanofi, Novartis, Bayer, Janssen, Astellas, Bristol-Myers Squibb, Pfizer. Advisory Board: Sanofi, Bayer, Janssen, Astellas, Novartis, Roche. Fernando Korkes, None. Fernando Nunes Galvão de Oliveira, Speaker Fee: Astellas, Janssen, Merck Sharp & Dohme, Bayer, Roche, AstraZeneca, Libbs. Advisory Board: Merck Sharp & Dohme, Janssen, Ferring. Fernando Sabino Marques Monteiro, Speaker and Advisory Board: Bristol-Myers Squibb. Gustavo Franco Carvalhal, None. Igor Alexandre Protzner Morbeck, Research Funding: Astellas. Honoraria/Advisory Board: Janssen, Astellas, Bristol-Myers Squibb, Merck Sharp & Dohme, Roche, Pfizer, Novartis and Bayer. José Augusto Rinck Júnior, Speaker Fee/Events sponsorship: Pfizer, Astellas, Bristol-Myers Squibb, Merck Sharp & Dohme, Bayer, Roche, Janssen, Aché. Karine Martins da Trindade, Research Funding: Roche, Bristol-Myers Squibb, Merck Sharp & Dohme. Speaker Fee: Janssen, AstraZeneca, Astellas, Bristol-Myers Squibb, Roche, Pfizer, Merck Serono. Events Sponsorship: Janssen, Astellas, Bristol-Myers Squibb, Roche, AstraZeneca, Pfizer, Astellas, Merck Serono, Sanofi, Novartis. Advisory Board: Janssen, Roche, Bristol-Myers Squibb. Lucas Nogueira, Speaker Fee: Janssen, Pfizer, Bayer, Astellas, Pierre-Fabre, Roche, Merck Sharp & Dohme. Events Sponsorship: Astellas, Bayer, Janssen. Advisory Board: Astellas, Janssen, Merck Sharp & Dohme. Manuel Caitano Maia, Speaker Fee: Pfizer. Events Sponsorship: Pfizer, Astellas, Bristol-Myers Squibb, Bayer, Roche, Janssen, Libbs. Roni de Carvalho Fernandes, Events Sponsorship: Astellas, Janssen, Handle/Cook. Speaker Fee: Janssen, Aché. Advisory Board: Janssen. Rodolfo Borges dos Reis, Speaker Fee: Janssen, AstraZeneca. Advisory Board: Janssen, Astellas. Research Funding: AstraZeneca. Events Sponsorship: Janssen, Pfizer, Astellas, Roche. Stênio de Cássio Zequi, Speaker fee: Bristol-Myers Squibb, Pfizer and AstraZeneca. Research funding: Merck Sharp & Dohme. Events sponsorship: Astellas. Vinicius Carrera Souza, Research Funding: Bristol-Myers Squibb, Janssen. Speaker Fee: Bayer, Janssen, Novartis, AstraZeneca, Merck Sharp & Dohme. Advisory Board: Roche, Janssen. Wagner Eduardo Matheus, Speaker Fee: Astellas, Janssen, Zodiac, AstraZeneca, Aché. Events Sponsorship: Astellas, Zodiac, Janssen, AstraZeneca. Walter Henriques da Costa, None. Speaker Fee: Astellas, Janssen, Bristol-Meyers Squibb, Bayer. Events sponsorship: Astellas, Janssen, Zodiac. Research Funding: Bristol-Meyers Squibb. Wilson Francisco Schreiner Busato Jr, None.

Diffuse intrinsic pontine glioma is a pediatric oncologic disease with dismal prognosis and no effective treatment. Since 2007, our patients have been using valproic acid as prophylactic anticonvulsant. We have undertaken a retrospective study in order to evaluate the influence of valproate in the outcomes of children with this disease in our center. Patients were treated with weekly carboplatin and vincristine and received conformal radiotherapy, either concurrent or sequential. Event-free survival and overall survival of patients not treated with valproic acid were 6.5 and 7.8 months. Accelerated failure time model (a parametric multivariate regression test for time-to-failure data) showed a statistically significant superiority of the median event-free survival of treated patients (6.5 vs. 9.5 months in treated patients; HR 0.54-95 % CI 0.33-0.87; p < 0.05) and also of overall survival (7.8 vs. 13.4 months in treated patients; HR 0.60-95 % CI 0.37-0.98; p = 0.05).

Purpose: The treatment of pediatric patients with malignant brain tumors has evolved considerably in the past decades. However, results are still unsatisfactory for some patients. Valproate has been shown to positively affect the survival of adult glioblastoma patients. We have been giving prophylactic antiepileptic drugs to newly diagnosed children with brain tumors. Since then, we noted a trend towards a better survival from our patients. In order to study this, we performed a retrospective evaluation in our institution., Methods: Standard survival analysis was used, calculating survival until death by all causes or censoring. Comparisons were made by Cox's proportional hazards model regression., Results: Between 2000 and 2010, 94 patients were treated (12 with high-grade gliomas, 56 medulloblastomas, and 26 ependymomas); median and mean ages were 7.7 and 7.8 years. Median follow-up was 60 months (35 for treated and 109 for untreated patients). Of these, 47 received valproate 10-15 mg/kg/day every 8-12 h and 47 did not. Patients who received valproate had a median survival of 34 months, whereas the other group had a median survival of 24 months (hazard ratios = 0.99, 0.57-1.75, p = 0.99)., Conclusions: These results do not prove that valproate prophylactic treatment in pediatric patients with malignant brain tumors had an influence on their survival. However, our cohort showed an effect of higher size than the recent European Organization for Research and Treatment of Cancer trial analysis, even though not significant. Clinical trials with valproate in pediatric malignant brain tumors should be carefully planned, in order to detect a possible effect of this drug in survival.

Although substantial progress has been made in pediatric brain tumor management, patients with brainstem tumors and high-grade gliomas, as well as patients less than 3 years of age with high-risk malignant tumors, have a poorer prognosis. The authors have been treating these patients with radiotherapy and standard carboplatin and vincristine chemotherapy. Since January 2007 the authors have been using valproate as anticonvulsant for prophylaxis. The authors performed a retrospective cohort analysis of pediatric patients with high-risk brain tumors treated with chemotherapy, radiotherapy, and valproate prophylaxis, comparing this group with a historical control. The 2007-2008 group was comprised of 22 patients, 15 with brainstem tumors (7 diffuse intrinsic pontine glioma [DIPG], 3 focal, the remaining infiltrating with a solid portion), 4 with diencephalic tumors (2 thalamic), and 3 with supratentorial high-grade tumors (1 glioblastoma, 1 recurrent grade III ependymoma, 1 with gliomatosis). There were 15 patients alive (68%) after a mean follow-up time of 19 months. Survival function comparison by log rank test was highly significant (P = .004) with a hazard ratio of 0.31 (0.14-0.70). Radiological response showed 3 complete responses (14%), 8 partial responses (36%), 5 stable diseases (23%), and 5 progresssive diseases (23%). The authors hypothesize that valproate may have potentiated the antiangiogenic effect of vincristine, diminished expression of resistance to carboplatin, and sensitized tumor cells to radiotherapy. The authors suggest that clinical trials of carboplatin and vincristine associated with oral continuous low-dose valproate are indicated for pediatric patients with high-risk brain tumor.