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Introduction: Prostate cancer has increased in recent years, increasing the costs associated with its treatment. Second-generation oral antiandrogens have emerged as an attractive therapeutic option. Objective: To compare the health value provided by enzalutamide and apalutamide, by evaluating two stages of prostate cancer: non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Methods: To establish, through the American Society of Clinical Oncology (ASCO) value framework, a contrast between two technologies in two stages of prostate cancer. The monthly cost of the two technologies was calculated according to the current price regulation norm in Colombia. Results: Enzalutamide showed a higher net health benefit score compared to apalutamide for both nmCRPC (48.33 versus 33.46) and mHSPC (52.0 versus 40.75). The cost per net health benefit point for the nmCRPC stage was $214,723 Colombian Pesos (COP) ($54.84 USD) with enzalutamide compared to $291,925 COP ($74.56 USD) with apalutamide, and for the mHSPC stage was $199,692 COP ($51.00 USD) with enzalutamide and $239,701 COP ($61.22 USD) with apalutamide. Conclusion: After comparing enzalutamide versus apalutamide in the nmCRPC and mHSPC stages through the ASCO value framework, enzalutamide showed a more prominent net clinical benefit and a lower investment per point awarded.
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ABSTRACT Objective To evaluate whether the addition of statins to the new antiandrogens (enzalutamide or abiraterone) affects overall survival in patients with metastatic castration-resistant prostate cancer. Methods We searched studies in English language including the keywords statins, overall survival, and metastatic castration-resistant prostate cancer, at PubMed® (MEDLINE®), Embase and Cochrane databases. Results A total of 195 articles were initially identified, but only four met the inclusion criteria and were selected for the meta-analysis. A total of 955 patients, 632 on the new antiandrogens only group, and 323 on the new antiandrogens + statins group, were analyzed. In all four studies the combination therapy (new antiandrogens + statin) was well tolerated, regardless of which new antiandrogens were used. Neither the type of statin nor the doses and duration of use were well specified in the studies. The combination therapy in metastatic castration-resistant prostate cancer was associated with an overall survival improvement, and a 46% reduction in death (hazard ratio of 0.54; 95%CI 0.34-0.87; p<0.01) in multivariate analysis. Conclusion There seems to be a clinical benefit with the association of statins to the new antiandrogens in patients with metastatic castration-resistant prostate cancer, suggesting longer overall survival with no important collateral effect. However, due to fragility of the studies available in the literature, we are not yet capable of recommending this combination of drugs in the clinical practice. Further randomized prospective studies are warranted to confirm these beneficial outcomes.
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Humanos , Masculino , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/patologia , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Resultado do Tratamento , Antagonistas de Androgênios/uso terapêuticoRESUMO
OBJECTIVE: To evaluate the effect that external cooling of the salivary glands (ECSG) has on the uptake of gallium-68-labeled prostate-specific membrane antigen (68Ga-PSMA), as an indirect assessment of the capacity of ECSG to reduce the local dose in lutetium-177-PSMA-617 radioligand therapy. MATERIALS AND METHODS: Ten patients with prostate cancer were submitted to 68Ga-PSMA positron emission tomography/computed tomography with unilateral ECSG. The ECSG was started at 30 min before the injection of the radiotracer and maintained until the end of image acquisition (1 h after injection). Each salivary gland was assessed by determining the maximum, mean, and peak standardized uptake values (SUVmax, SUVmean, and SUVpeak, respectively). The volume of each gland was determined in a volume of interest delineated by a threshold SUVmax of 10%. Paired Student's t-tests were used in order to compare the results. RESULTS: In terms of the SUV parameters, there were no statistically significant differences between the cooled and contralateral salivary glands. However, the mean volume was 27% lower in the cooled parotid glands than in the contralateral parotid glands (p = 0.004). CONCLUSION: The use of ECSG does not appear to reduce 68Ga-PSMA uptake by the salivary glands. In addition, there is yet no evidence that ECSG is effective in preventing salivary gland toxicity.
OBJETIVO: Avaliar o impacto do resfriamento externo de glândulas salivares (REGS) na captação de 68Ga-PSMA como marcador indireto dessa intervenção para redução da dose local na terapia com 177Lu-PSMA. MATERIAIS E MÉTODOS: Dez pacientes com câncer de próstata foram submetidos a PET/CT com 68Ga-PSMA com REGS unilateral. O resfriamento se iniciou 30 minutos antes da injeção do radiofármaco até o fim da aquisição de imagem, 1 hora após a injeção. Cada glândula foi avaliada para os valores de captação padronizados máximo, médio e pico (SUVmáx, SUVmédio e SUVpico, respectivamente). O volume foi definido por um isocontorno usando 10% do SUVmáx. Os resultados foram comparados com o teste t de Student. RESULTADOS: Não houve diferença estatisticamente significante entre os valores de SUV das glândulas resfriadas e seus controles. Houve 27% de redução volumétrica (p = 0,004) nas parótidas resfriadas em comparação ao controle. CONCLUSÃO: Não houve redução da captação de 68Ga-PSMA nas glândulas salivares ao REGS. Atualmente não há evidências que suportem essa prática clínica.
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Abstract Objective: To evaluate the effect that external cooling of the salivary glands (ECSG) has on the uptake of gallium-68-labeled prostate-specific membrane antigen (68Ga-PSMA), as an indirect assessment of the capacity of ECSG to reduce the local dose in lutetium-177-PSMA-617 radioligand therapy. Materials and Methods: Ten patients with prostate cancer were submitted to 68Ga-PSMA positron emission tomography/computed tomography with unilateral ECSG. The ECSG was started at 30 min before the injection of the radiotracer and maintained until the end of image acquisition (1 h after injection). Each salivary gland was assessed by determining the maximum, mean, and peak standardized uptake values (SUVmax, SUVmean, and SUVpeak, respectively). The volume of each gland was determined in a volume of interest delineated by a threshold SUVmax of 10%. Paired Student's t-tests were used in order to compare the results. Results: In terms of the SUV parameters, there were no statistically significant differences between the cooled and contralateral salivary glands. However, the mean volume was 27% lower in the cooled parotid glands than in the contralateral parotid glands (p = 0.004). Conclusion: The use of ECSG does not appear to reduce 68Ga-PSMA uptake by the salivary glands. In addition, there is yet no evidence that ECSG is effective in preventing salivary gland toxicity.
Resumo Objetivo: Avaliar o impacto do resfriamento externo de glândulas salivares (REGS) na captação de 68Ga-PSMA como marcador indireto dessa intervenção para redução da dose local na terapia com 177Lu-PSMA. Materiais e Métodos: Dez pacientes com câncer de próstata foram submetidos a PET/CT com 68Ga-PSMA com REGS unilateral. O resfriamento se iniciou 30 minutos antes da injeção do radiofármaco até o fim da aquisição de imagem, 1 hora após a injeção. Cada glândula foi avaliada para os valores de captação padronizados máximo, médio e pico (SUVmáx, SUVmédio e SUVpico, respectivamente). O volume foi definido por um isocontorno usando 10% do SUVmáx. Os resultados foram comparados com o teste t de Student. Resultados: Não houve diferença estatisticamente significante entre os valores de SUV das glândulas resfriadas e seus controles. Houve 27% de redução volumétrica (p = 0,004) nas parótidas resfriadas em comparação ao controle. Conclusão: Não houve redução da captação de 68Ga-PSMA nas glândulas salivares ao REGS. Atualmente não há evidências que suportem essa prática clínica.
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ABSTRACT 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.
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Humanos , Masculino , Médicos , Neoplasias de Próstata Resistentes à Castração/diagnóstico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Percepção , Brasil , Resultado do Tratamento , Seleção de Pacientes , ConsensoRESUMO
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.
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Consenso , Médicos , Neoplasias de Próstata Resistentes à Castração , Brasil , Humanos , Masculino , Seleção de Pacientes , Percepção , Neoplasias de Próstata Resistentes à Castração/diagnóstico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Resultado do TratamentoRESUMO
El presente trabajo es una revisión bibliográfica y actualización de los diferentes esquemas terapéuticos aprobados y en estudio, de la enfermedad con metástasis en hueso producto del cáncer de próstata avanzado con la condición de resistente a la castración. Aborda generalidades del cáncer de próstata, los mecanismos por los cuales se vuelve resistente a la castración, la aparición de metástasis óseas, la terapéutica enfocada en terapia antiresortiva, (bifosfonatos e inhibidor del Ligando RANK), radiofármacos, radioterapia y nuevas drogas (Cabozantinib)(au)
This is a literature review and update of the different therapeutic options approved and under study, of bone metastases due to castration resistant prostate cancer. It addresses general information of prostate cancer, the mechanisms by which it becomes resistant to castration, the appearance of bone metastases, treatment focused on antiresorptive therapy (bisphosphonates and RANK Ligand inhibitor), radiopharmaceuticals, radiotherapy and new drugs (Cabozantinib).(au)
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Humanos , Masculino , Próstata/patologia , Radioterapia , Castração , Compostos Radiofarmacêuticos , Difosfonatos/farmacologia , Neoplasias de Próstata Resistentes à Castração/terapia , Metástase Neoplásica/terapia , Terapêutica , Antígeno Prostático Específico , Medicamentos de Referência , Ligante RANKRESUMO
Prostate cancer represents the second cancer-related cause of death in North American and Chilean men. The main treatment for incurable stages of disease is surgical or pharmacological castration. However, with time and despite the addition of anti-androgens, the disease progresses to a clinical state that has been commonly referred to as hormone refractory. In recent years, the concept of hormone refractoriness has been challenged and replaced by castration resistance, acknowledging that further and optimal hormonal manipulation can be attained, beyond achieving testosterone levels at castration range. The purpose of this review is to summarize the recent therapeutic breakthroughs in the management of metastatic castrate resistant prostate cancer (mCRPC), with greater emphasis in the newer hormonal therapy agents such as Abiraterone and Enzalutamide. Future combination and sequential treatment strategies are contextualized in the current era of personalized cancer medicine and genomic characterization of prostate cancer.