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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.
Subject(s)
Prostatic Neoplasms, Castration-Resistant , Prostatic Neoplasms, Castration-Resistant/diagnosis , Prostatic Neoplasms, Castration-Resistant/therapy , Humans , Male , Neoplasm Staging , Antineoplastic Agents/therapeutic use , Androgen Receptor Antagonists/therapeutic use , Consensus , Brazil , OsteoclastsABSTRACT
Introduction: Prostate cancer is the second most common cancer in men worldwide. In Brazil, regional disparities in incidences of intermediate and high-risk in late-diagnosed PC cases are expected. Objective: To investigate the clinical and demographic profiles of patients treated with metastatic castration-resistant prostate cancer (mCRPC) in Brazil, using real-world data from public databases. Method: Prostate cancer data from the Brazilian cancer registries were filtered from Brazilian public databases from 2008 to 2018. The number of health institutions and registries at a cancer public database were used to separate the Brazilian Federative Units into two comparison groups. mCRPC patients were estimated by using a combination of filters of staging and treatment (Tx, Nx and M1 + chemotherapy). The patients' median age and the number and type of treatments were evaluated. Results: A total of 325,987 patients with prostate cancer and 5,367 patients with mCRPC were identified. The median age of the mCRPC patients was 63 years. The percentage of patients who underwent one, two or three treatments was 21.0%, 43.2% and 28.1%, respectively. In addition, management differences were noticed depending on the group analyzed. Conclusion: The results revealed regional discrepancies in the distribution of registered mCRPC patients in the Brazilian territory and in their treatment. This information can be used to strengthen the recently updated treatment and improve the palliative care offered. This work presents suggestions to improve specific prostate cancer databases
Introdução: O câncer de próstata é o segundo tipo mais comum em homens ao redor do mundo. No Brasil, diferenças regionais de incidência em casos de risco intermediário e alto tardiamente diagnosticados são esperadas. Objetivo: Investigar os perfis clínico e demográfico de pacientes com câncer de próstata metastático resistente à castração (mCRPC) tratados no Brasil usando dados do mundo real de bancos de dados públicos brasileiros. Método: Os casos de câncer de próstata foram filtrados a partir dos registros brasileiros de câncer no período de 2008 a 2018. O número de instituições de saúde que registram esses casos foi usado para separar as Unidades Federativas brasileiras em dois grupos. O número de pacientes com mCRPC foi estimado usando uma combinação de filtros de estadiamento e tratamento (Tx, Nx e M1 + quimioterapia). A idade média e o número e tipos de tratamento realizados foram avaliados. Resultados: O estudo identificou 325.987 pacientes com câncer de próstata e 5.367 com mCRPC. A mediana das idades de pacientes com mCRPC foi de 63 anos. O percentual de pacientes submetidos a um, dois ou três tratamentos foi de 21,0%, 43,2% e 28,1%, respectivamente. Foram observadas diferenças de manejo nos grupos analisados. Conclusão: Os resultados revelaram diferenças regionais nas distribuições de pacientes com mCRPC no território brasileiro e no manejo da doença. Essa informação pode subsidiar decisões de incorporação de novos tratamentos e de melhoria dos cuidados paliativos oferecidos aos pacientes com mCRPC. Este trabalho apresenta sugestões para o desenvolvimento de bancos de dados específicos para câncer de próstata e aprimoramento dos já existentes
Introducción: El cáncer de próstata es el segundo tipo más común en hombres en el mundo. En el Brasil, se espera encontrar diferencias regionales en la incidencia de diagnósticos tardíos de riesgo intermedio y alto. Objetivo: Investigar los perfiles clínico y demográfico de pacientes con cáncer de próstata metastásico resistente a la castración (mCRPC) tratados en el Brasil utilizando datos del mundo real de bases de datos públicas brasileñas. Método: Los casos de cáncer de próstata fueron filtrados a partir de los registros brasileños de cáncer nel período de 2008 a 2018. El número de instituciones registradoras en la base de datos fue utilizado para separar los Estados Brasileños en dos grupos para comparación. El número de pacientes se estimó mediante una combinación de filtros de estadio y tratamiento (Tx, Nx y M1 + quimioterapia). Fueron evaluados la edad media y la cantidad y tipos de tratamiento realizados. Resultados: Se identificaron un total de 325.987 pacientes con cáncer de próstata y 5367 pacientes con mCRPC. La mediana de la edad de los pacientes con mCRPC fue de 63 años. El porcentaje de pacientes sometidos a uno, dos o tres tratamientos fue del 21,0%, 43,2% y 28,1%. Fueron observadas diferencias de manejo según el grupo analizado. Conclusión: Fueron reveladas diferencias regionales en la distribución de los pacientes con mCRPC en el Brasil y, especialmente, en el manejo de la enfermedad a partir de bases de datos públicas. Esta información puede apoyar las decisiones de incorporar nuevos tratamientos y mejorar los cuidados ofrecidos a los pacientes. Se presentan sugerencias para el desarrollo de bases de datos específicas y la mejora de las existentes
Subject(s)
Humans , Male , Female , Prostatic Neoplasms, Castration-Resistant , Public Reporting of Healthcare Data , Neoplasm MetastasisABSTRACT
Retroperitoneal hemorrhage is a rare and life-threatening clinical presentation that may occur in patients with advanced germ cell tumors, typically after chemotherapy. Rapid clinical suspicion is crucial to oï¬er the best treatment. Surgery is usually recommended but dismal complications may occur. We report on a man with metastatic testicular cancer presenting with massive spontaneous retroperitoneal hemorrhage that had not received previous systemic treatment and was managed without surgical treatment, with good clinical outcome.
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PURPOSE: To generate and present survey results on important issues relevant to treatment and follow-up of localized and locally advanced, high-risk prostate cancer (PCa) focusing on developing countries. METHODS: A panel of 99 PCa experts developed more than 300 survey questions of which 67 questions concern the main areas of interest of this article: treatment and follow-up of localized and locally advanced, high-risk PCa in developing countries. A larger panel of 99 international multidisciplinary cancer experts voted on these questions to create the recommendations for treatment and follow-up of localized and locally advanced, high-risk PCa in areas of limited resources discussed in this article. RESULTS: The panel voted publicly but anonymously on the predefined questions. Each question was deemed consensus if 75% or more of the full panel had selected a particular answer. These answers are based on panelist opinion and not on a literature review or meta-analysis. For questions that refer to an area of limited resources, the recommendations considered cost-effectiveness as well as the possible therapies with easier and greater access. Each question had five to seven relevant answers including two nonanswers. Results were tabulated in real time. CONCLUSION: The voting results and recommendations presented in this article can guide physicians managing localized and locally advanced, high-risk PCa in areas of limited resources. Individual clinical decision making should be supported by available data; however, as guidelines for treatment of localized and locally advanced, high-risk PCa in developing countries have not been defined, this article will serve as a point of reference when confronted with this disease.
Subject(s)
Developing Countries , Prostatic Neoplasms , Consensus , Humans , Male , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/therapyABSTRACT
PURPOSE: A group of international urology and medical oncology experts developed and completed a survey on prostate cancer (PCa) in developing countries. The results are reviewed and summarized, and recommendations on consensus statements for very low-, low-, and intermediate-risk PCa focused on developing countries were developed. METHODS: A panel of experts developed more than 300 survey questions of which 66 questions concern the principal areas of interest of this paper: very low, low, and intermediate risk of PCa in developing countries. A larger panel of 99 international multidisciplinary cancer experts voted on these questions to create the recommendations for treatment and follow-up for very low-, low-, and intermediate-risk PCa in areas of limited resources discussed in this manuscript. RESULTS: The panel voted publicly but anonymously on the predefined questions. Each question was deemed consensus if 75% or more of the full panel had selected a particular answer. These answers are based on panelist opinion not a literature review or meta-analysis. For questions that refer to an area of limited resources, the recommendations consider cost-effectiveness and the possible therapies with easier and greater access. Each question had five to seven relevant answers including two nonanswers. The results were tabulated in real time. CONCLUSION: The voting results and recommendations presented in this document can be used by physicians to support management for very low, low, and intermediate risk of PCa in areas of limited resources. Individual clinical decision making should be supported by available data; however, as guidelines for treatment for very low, low, and intermediate risk of PCa in developing countries have not been developed, this document will serve as a point of reference when confronted with this disease.
Subject(s)
Physicians , Prostatic Neoplasms , Consensus , Developing Countries , Humans , Male , Prostatic Neoplasms/therapySubject(s)
Humans , Male , Physicians , Prostatic Neoplasms, Castration-Resistant/drug therapy , Perception , Brazil , Treatment Outcome , ConsensusABSTRACT
ABSTRACT Prostate cancer is the second most common cancer and the fifth leading cause of cancer deaths. In Brazil, it is likewise the second most common cancer among men, second only to non-melanoma skin cancers. The aim of this consensus is to align different opinions and interpretations of the medical literature in a practical and patient-oriented approach. The first Brazilian Consensus on the Treatment of Advanced Prostate Cancer was published in 2017, with the goal of reducing the heterogeneity of therapeutic conduct in Brazilian patients with metastatic prostate cancer. We acknowledge that in Brazil the incorporation of different technologies is a big challenge, especially in the Sistema Único de Saúde (SUS), which allows for the disparity in the options available to patients treated in different institutions. In order to update the recommendations and to make them objective and easily accessible, once more a panel of specialists was formed in order to discuss and elaborate a new Brazilian Consensus on Advanced Prostate Cancer. This Consensus was written through a joint initiative of the Brazilian Society of Clinical Oncology (SBOC) and the Brazilian Society of Urology (SBU) to support the clinical decisions of physicians and other health professionals involved in the care of patients with prostate cancer.
Subject(s)
Humans , Male , Prostatic Neoplasms/therapy , Practice Guidelines as Topic , Consensus , Prostatic Neoplasms/pathology , Societies, Medical , Brazil , Clinical Decision-Making , Neoplasm Metastasis , Antineoplastic Agents/therapeutic useABSTRACT
Prostate cancer is the second most common cancer and the fi fth leading cause of cancer deaths. In Brazil, it is likewise the second most common cancer among men, second only to non-melanoma skin cancers. The aim of this consensus is to align different opinions and interpretations of the medical literature in a practical and patient-oriented approach. The fi rst Brazilian Consensus on the Treatment of Advanced Prostate Cancer was published in 2017, with the goal of reducing the heterogeneity of therapeutic conduct in Brazilian patients with metastatic prostate cancer. We acknowledge that in Brazil the incorporation of different technologies is a big challenge, especially in the Sistema Único de Saúde (SUS), which allows for the disparity in the options available to patients treated in different institutions. In order to update the recommendations and to make them objective and easily accessible, once more a panel of specialists was formed in order to discuss and elaborate a new Brazilian Consensus on Advanced Prostate Cancer. This Consensus was written through a joint initiative of the Brazilian Society of Clinical Oncology (SBOC) and the Brazilian Society of Urology (SBU) to support the clinical decisions of physicians and other health professionals involved in the care of patients with prostate cancer.
Subject(s)
Consensus , Practice Guidelines as Topic , Prostatic Neoplasms/therapy , Antineoplastic Agents/therapeutic use , Brazil , Clinical Decision-Making , Humans , Male , Neoplasm Metastasis , Prostatic Neoplasms/pathology , Societies, MedicalABSTRACT
INTRODUCTION: Although prostate cancer constitutes one of the most important, death-related diseases in the male population, there is still a need for identification of sensitive biomarkers that could precociously detect the disease and differentiate aggressive from indolent cancers, in order to decrease overtreatment. Proteomics research has improved understanding on mechanisms underlying tumorigenesis, cancer cells migration and invasion potential, and castration resistance. This review has focused on proteomic studies of prostate cancer published in the recent years, with a special emphasis on determination of biomarkers for cancer progression and diagnosis. Areas covered: Shotgun and targeted-proteomic studies of prostate cancer in different matrices are reviewed, i.e., prostate tissue, prostate cell lines, blood (serum and plasma), urine, seminal plasma, and exosomes. The most important biomarkers for cancer diagnosis and aggressiveness characterization are highlighted. Expert commentary: In general, results demonstrate alteration in cell cycle control, DNA repair, proteasomal degradation, and metabolic activity. However, these studies suffer from low reproducibility due to heterogeneity of the cancer itself, as well as to techniques utilized for protein identification/quantification. Downstream confirmatory studies in separate cohorts are warranted in order to demonstrate accuracy of these results.
Subject(s)
Biomarkers, Tumor , Prostatic Neoplasms/diagnosis , Proteins , Proteomics , Animals , Biomarkers, Tumor/analysis , Humans , Male , Proteins/analysisABSTRACT
ABSTRACT Introduction Prostate cancer still represents a major cause of morbidity, and still about 20% of men with the disease are diagnosed or will progress to the advanced stage without the possibility of curative treatment. Despite the recent advances in scientific and technological knowledge and the availability of new therapies, there is still considerable heterogeneity in the therapeutic approaches for metastatic prostate cancer. Objectives This article presents a summary of the I Brazilian Consensus on Advanced Prostate Cancer, conducted by the Brazilian Society of Urology and Brazilian Society of Clinical Oncology. Materials and Methods Experts were selected by the medical societies involved. Forty issues regarding controversial issues in advanced disease were previously elaborated. The panel met for consensus, with a threshold established for 2/3 of the participants. Results and Conclusions The treatment of advanced prostate cancer is complex, due to the existence of a large number of therapies, with different response profiles and toxicities. The panel addressed recommendations on preferred choice of therapies, indicators that would justify their change, and indicated some strategies for better sequencing of treatment in order to maximize the potential for disease control with the available therapeutic arsenal. The lack of consensus on some topics clearly indicates the absence of strong evidence for some decisions.
Subject(s)
Humans , Male , Prostate/pathology , Consensus , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/therapy , Brazil , Practice Guidelines as TopicABSTRACT
INTRODUCTION: Prostate cancer still represents a major cause of morbidity, and still about 20% of men with the disease are diagnosed or will progress to the advanced stage without the possibility of curative treatment. Despite the recent advances in scientific and technological knowledge and the availability of new therapies, there is still considerable heterogeneity in the therapeutic approaches for metastatic prostate cancer. OBJECTIVES: This article presents a summary of the I Brazilian Consensus on Advanced Prostate Cancer, conducted by the Brazilian Society of Urology and Brazilian Society of Clinical Oncology. MATERIALS AND METHODS: Experts were selected by the medical societies involved. Forty issues regarding controversial issues in advanced disease were previously elaborated. The panel met for consensus, with a threshold established for 2/3 of the participants. RESULTS AND CONCLUSIONS: The treatment of advanced prostate cancer is complex, due to the existence of a large number of therapies, with different response profiles and toxicities. The panel addressed recommendations on preferred choice of therapies, indicators that would justify their change, and indicated some strategies for better sequencing of treatment in order to maximize the potential for disease control with the available therapeutic arsenal. The lack of consensus on some topics clearly indicates the absence of strong evidence for some decisions.
Subject(s)
Consensus , Practice Guidelines as Topic , Prostatic Neoplasms/therapy , Brazil , Humans , Male , Prostate/pathology , Prostatic Neoplasms/diagnosisABSTRACT
Solitary fibrous tumor (SFT) is a rare neoplasia of mesenchymal origin, initially described in visceral pleura and lately discovered to have ubiquitous distribution. SFT of the urogenital tract is uncommon and appears to have similar morphologic features and biologic behaviors as SFTs found elsewhere. We present two new cases of SFT of the bladder and review 22 similar cases published in the literature. Due to the general indolent behavior of these lesions, a complete but organ sparing surgical excision should be considered when technically feasible. Therefore, proper identification and characterization of SFT through morphological and immunohistochemical criteria on biopsy specimens are mandatory in the differential diagnosis from other more aggressive spindle-cell tumors, thus avoiding unnecessary radical surgery.
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OBJECTIVE: Prostate cancer is the most common nonskin cancer and second most common cause of cancer mortality in older men in the United States (USA) and Western Europe. Androgen-deprivation therapy alone (ADT) remains the first line of treatment in most cases, for metastatic disease. We performed a systematic review and meta-analysis of all randomized controlled trials (RCT) that compared the efficacy and adverse events profile of a chemohormonal therapy (ADT ± docetaxel) for metastatic hormone-naive prostate cancer (mHNPC). METHODS: Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoint was overall survival. Data extracted from the studies were combined by using the hazard ratio (HR) or risk ratio (RR) with their corresponding 95% confidence intervals (95% CI). RESULTS: The final analysis included 3 trials comprising 2,264 patients (mHNPC). Patients who received the chemohormonal therapy had a longer clinical progression-free survival interval (HR = 0.64; 95% CI: 0.55 to 0.75; p<0.00001), and no heterogeneity (Chi2 = 0.64; df = 1 [p = 0.42]; I2 = 0%). The biochemical progression-free survival (bPFS) also was higher in patients treated with ADT plus docetaxel (HR = 0.63; 95% CI: 0.57 to 0.69; p<0.00001), also with no heterogeneity noted (Chi2 = 0.48; df = 2 [p = 0.79]; I2 = 0%). Finally, the combination of ADT with docetaxel showed a superior overall survival (OS) compared with ADT alone (HR = 0.73; 95% CI: 0.64 to 0.84; p<0.0001), with moderate heterogeneity (Chi2 = 3.84; df = 2 [p = 0.15]; I2 = 48%). A random-effects model analysis was performed, and the results remained favorable to the use of ADT plus docetaxel (HR = 0.73; 95% CI: 0.60 to 0.89; p = 0.002). In the final combined analysis of the high-volume disease patients, the use of the combination therapy also favored an increased overall survival (HR = 0.67; 95% CI: 0.54 to 0.83; p = 0.0003). Regarding adverse events and severe toxicity (grade ≥3), the group receiving the combined therapy had higher rates of neutropenia, febrile neutropenia and fatigue. CONCLUSION: The combination of ADT with docetaxel improved the clinical progression-free survival, bPFS and OS of patients with mHNPC. A superior OS was seen especially for patients with metastatic and high-volume disease. This contemporary combination therapy may now be offered as a first-line treatment for selected patients.
Subject(s)
Androgen Antagonists/therapeutic use , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Prostatic Neoplasms/drug therapy , Taxoids/therapeutic use , Tubulin Modulators/therapeutic use , Aged , Docetaxel , Humans , Lymphatic Metastasis , Male , Middle Aged , Patient Safety , Prostatic Neoplasms/mortality , Prostatic Neoplasms/pathology , Randomized Controlled Trials as Topic , Survival Analysis , Treatment OutcomeABSTRACT
BACKGROUND: Prostate cancer is the most common cancer in older men in the United States (USA) and Western Europe. Androgen deprivation (AD) constitutes, in most cases, the first-line of treatment for these cases. The negative impact of CAD in quality of life, secondary to the adverse events of sustained hormone deprivation, plus the costs of this therapy, motivated the intermittent treatment approach. The objective of this study is to to perform a systematic review and meta-analysis of all randomized controlled trials that compared the efficacy and adverse events profile of intermittent versus continuous androgen deprivation for locally advanced, recurrent or metastatic hormone-sensitive prostate cancer. METHODS: Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The endpoints were overall survival (OS), cancer-specific survival (CSS), time to progression (TTP) and adverse events. We performed a meta-analysis (MA) of the published data. The results were expressed as Hazard Ratio (HR) or Risk Ratio (RR), with their corresponding 95% Confidence Intervals (CI 95%). RESULTS: The final analysis included 13 trials comprising 6,419 patients with hormone-sensitive prostate cancer. TTP was similar in patients who received intermittent androgen deprivation (IAD) or continuous androgen deprivation (CAD) (fixed effect: HR = 1.04; CI 95% = 0.96 to 1.14; p = 0.3). OS and CSS were also similar in patients treated with IAD or CAD (OS: fixed effect: HR = 1.02; CI 95% = 0.95 to 1.09; p = 0.56 and CSS: fixed effect: HR = 1.06; CI 95% = 0.96 to 1.18; p = 0.26). CONCLUSION: Overall survival was similar between IAD and CAD in patients with locally advanced, recurrent or metastatic hormone-sensitive prostate cancer. Data on CSS are weak and the benefits of IAD on this outcome remain uncertain. Impact in QoL was similar for both groups, however, sexual activity scores were higher and the incidence of hot flushes was lower in patients treated with IAD.
Subject(s)
Androgen Antagonists/administration & dosage , Androgen Antagonists/adverse effects , Neoplasm Recurrence, Local/prevention & control , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/secondary , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/mortality , Causality , Comorbidity , Disease-Free Survival , Humans , Male , Neoplasm Recurrence, Local/mortality , Prevalence , Prostatic Neoplasms/mortality , Quality of Life , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: The purpose of this work was to conduct a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy and side effect profile of hypofractionated versus conventional external-beam radiation therapy for prostate cancer. METHODS: Several databases were searched, including Medline, EmBase, LiLACS, and Central. The endpoints were freedom from biochemical failure and side effects. We performed a meta-analysis of the published data. The results are expressed as the hazard ratio (HR) or risk ratio (RR), with the corresponding 95% confidence interval (CI). RESULTS: The final analysis included nine trials comprising 2702 patients. Freedom from biochemical failure was reported in only three studies and was similar in patients who received hypofractionated or conventional radiotherapy (fixed effect, HR 1.03, 95% CI 0.88-1.20; P = 0.75), with heterogeneity [χ(2) = 15.32, df = 2 (P = 0.0005); I2 = 87%]. The incidence of acute adverse gastrointestinal events was higher in the hypofractionated group (fixed effect, RR 2.02, 95% CI 1.45-2.81; P < 0.0001). We also found moderate heterogeneity on this analysis [χ(2) = 7.47, df = 5 (P = 0.19); I2 = 33%]. Acute genitourinary toxicity was similar among the groups (fixed effect, RR 1.19, 95% CI 0.95-1.49; P = 0.13), with moderate heterogeneity [χ(2) = 5.83, df = 4 (P = 0.21); I2 = 31%]. The incidence of all late adverse events was the same in both groups (fixed effect, gastrointestinal toxicity, RR 1.17, 95% CI 0.79-1.72, P = 0.44; and acute genitourinary toxicity, RR 1.16, 95% CI 0.80-1.68, P = 0.44). CONCLUSION: Hypofractionated radiotherapy in localized prostate cancer was not superior to conventional radiotherapy and showed higher acute gastrointestinal toxicity in this meta-analysis. Because the number of published studies is still small, future assessments should be conducted to clarify better the true role of hypofractionated radiotherapy in patients with prostate cancer.
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OBJECTIVE: To perform a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy of Sipuleucel-T versus placebo for asymptomatic or minimally symptomatic metastatic castration-refractory prostate cancer (mCRPC). MATERIALS AND METHODS: Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The endpoints were overall survival (OS), time to progression (TTP) and side effects. We performed a meta-analysis (MA) of the published data. The results are expressed as Hazard Ratio (HR) or Risk Ratio (RR), with their corresponding 95% confidence intervals (CI 95%). RESULTS: The final analysis included 3 trials comprising 737 patients. The TTP was similar in patients who received Sipuleucel-T or placebo (fixed effect: HR = 0.89; CI 95% = 0.75 to 1.05; p = 0.16), with no heterogeneity detected on this analysis (Chi2 = 2.14, df = 2 (P = 0.34); I2 = 6%). The results showed a higher overall survival in patients treated with Sipuleucel-T (fixed effect: HR = 0.74; CI 95% = 0.61 to 0.89; p = 0.001; NNT = 3). We found no heterogeneity on this analysis either (Chi2 = 1.46, df = 2 (P = 0.48); I2 = 0%). The incidence of adverse events (grade > 3) was the same in both groups. CONCLUSION: Sipuleucel-T prolongs overall survival in patients with asymptomatic or minimally symptomatic mCRPC.
