Cost-effectiveness analysis of rezvilutamide versus bicalutamide in the treatment of metastatic hormone-sensitive prostate cancer.

OBJECTIVES: The economic implications of combining rezvilutamide with androgen deprivation therapy (ADT) remain uncertain, despite the observed survival advantages compared with bicalutamide plus ADT. Therefore, this study evaluates the cost-effectiveness of rezvilutamide plus ADT as the first-line treatment of metastatic hormone-sensitive prostate cancer (mHSPC) from the perspective of the Chinese healthcare system. DESIGN: A partitioned survival model was developed to assess the cost-effectiveness of rezvilutamide combined with ADT. Clinical data were obtained from the CHART trial. Costs and utility values were obtained from local estimate and published literature. Only direct medical costs were included in the model. INTERVENTIONS: Rezvilutamide was administered at 240 mg daily or bicalutamide at 50 mg daily until progression. OUTCOME MEASURES: The main outputs of the model included costs and quality-adjusted life years (QALYs), which were used to determine the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analysis (PSA) were used to explore model uncertainties. RESULTS: The rezvilutamide group showed an expected gain of 2.28 QALYs and an incremental cost of US$60 758.82 compared with the bicalutamide group. The ICER for rezvilutamide group versus bicalutamide group was US$26 656.94 per QALY. The variables with the greatest impact on the model results were the utility for progression-free survival state and the price of rezvilutamide. PSA revealed that rezvilutamide group had 100% probability of being cost-effective at a willingness-to-pay threshold of US$35707.5 per QALY. CONCLUSION: Rezvilutamide in combination with ADT is more cost-effective compared with bicalutamide plus ADT as the first-line treatment of mHSPC from the perspective of the Chinese healthcare system.

Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Mixed Methods Approach to Identify Effective Interventions.

INTRODUCTION: Financial toxicity associated with treatments for metastatic prostate cancer remains poorly defined. We sought to understand aspects of financial toxicity not captured in a commonly employed financial toxicity questionnaire and identify potential interventions to help alleviate financial toxicity through a convergent mixed methods approach. METHODS: Patients seen at our institution's advanced prostate cancer clinic were approached for completion of the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire (quantitative analysis). A maximal variation purposive sample was chosen to participate in focus group discussions (qualitative analysis). Conventional content analysis was performed using an inductive approach. COST-FACIT scores were compared between patients experiencing high and low financial toxicity using Wilcoxon rank sum test. RESULTS: Three themes were identified through qualitative analysis: (1) workload, (2) coping strategies, and (3) communication. We found alignment with the existing theory of financial capacity across our findings. Two unique aspects of financial toxicity emerged that were not assessed quantitatively and deemed to be significant. Specifically, cost transparency (including health care teams knowledgeable about and willing to discuss costs) and inclusion of informal caregivers in financial toxicity screening and decision-making may guide future interventions aimed at limiting financial toxicity in this population. CONCLUSIONS: Prolonged treatment courses involving multiple lines of treatment with varying costs result in distinct financial toxicity components for patients with metastatic prostate cancer that are not assessed with COST-FACIT. Improving cost transparency, health care team knowledge and engagement, and providing resources to support informal caregivers may have a significant impact on the financial toxicity experienced by these patients.

Lifetime Health and Economic Outcomes of Biparametric Magnetic Resonance Imaging as First-Line Screening for Prostate Cancer : A Decision Model Analysis.

BACKGROUND: Contemporary prostate cancer (PCa) screening uses first-line prostate-specific antigen (PSA) testing, possibly followed by multiparametric magnetic resonance imaging (mpMRI) for men with elevated PSA levels. First-line biparametric MRI (bpMRI) screening has been proposed as an alternative. OBJECTIVE: To evaluate the comparative effectiveness and cost-effectiveness of first-line bpMRI versus PSA-based screening. DESIGN: Decision analysis using a microsimulation model. DATA SOURCES: Surveillance, Epidemiology, and End Results database; randomized trials. TARGET POPULATION: U.S. men aged 55 years with no prior screening or PCa diagnosis. TIME HORIZON: Lifetime. PERSPECTIVE: U.S. health care system. INTERVENTION: Biennial screening to age 69 years using first-line PSA testing (test-positive threshold, 4 µg/L) with or without second-line mpMRI or first-line bpMRI (test-positive threshold, PI-RADS [Prostate Imaging Reporting and Data System] 3 to 5 or 4 to 5), followed by biopsy guided by MRI or MRI plus transrectal ultrasonography. OUTCOME MEASURES: Screening tests, biopsies, diagnoses, overdiagnoses, treatments, PCa deaths, quality-adjusted and unadjusted life-years saved, and costs. RESULTS OF BASE-CASE ANALYSIS: For 1000 men, first-line bpMRI versus first-line PSA testing prevented 2 to 3 PCa deaths and added 10 to 30 life-years (4 to 11 days per person) but increased the number of biopsies by 1506 to 4174 and the number of overdiagnoses by 38 to 124 depending on the biopsy imaging scheme. At conventional cost-effectiveness thresholds, first-line PSA testing with mpMRI followed by either biopsy approach for PI-RADS 4 to 5 produced the greatest net monetary benefits. RESULTS OF SENSITIVITY ANALYSIS: First-line PSA testing remained more cost-effective even if bpMRI was free, all men with low-risk PCa underwent surveillance, or screening was quadrennial. LIMITATION: Performance of first-line bpMRI was based on second-line mpMRI data. CONCLUSION: Decision analysis suggests that comparative effectiveness and cost-effectiveness of PCa screening are driven by false-positive results and overdiagnoses, favoring first-line PSA testing with mpMRI over first-line bpMRI. PRIMARY FUNDING SOURCE: National Cancer Institute.

Cost analysis of new robotic competitors: a comparison of direct costs for initial hospital stay between Da Vinci and Hugo RAS for radical prostatectomy.

Robotic surgery with Da Vinci has revolutionized the treatment of several diseases, including prostate cancer; nevertheless, costs remain the major drawback. Recently, new robotic platforms entered the market aiming to reduce costs and improve the access to robotic surgery. The aim of the study is to compare direct cost for initial hospital stay of radical prostatectomy performed with two different robotic systems, the Da Vinci and the new Hugo RAS system. This is a projection study that applies cost of robotic surgery, derived from a local tender, to the clinical course of robotic radical prostatectomy (RALP) performed with Da Vinci and Hugo RAS. The study was performed in a public referral center for robotic surgery equipped with both systems. The cost of robotic surgery from a local tender were considered and included rent, annual maintenance, and a per-procedure fee covering the setup of four robotic instruments. Those costs were applied to patients who underwent RALP with both systems since November 2022. The primary endpoint is to evaluate direct costs of initial hospital stay for Da Vinci and Hugo RAS, by considering equipment costs (as derived from the tender), and costs of theater and of hospitalization. The direct per-procedure cost is €2,246.31 for a Da Vinci procedure and €1995 for a Hugo RALP. In the local setting, Hugo RAS provides 11% of cost saving for RALP. By applying this per-procedure cost to our clinical data, the expenditure for the entire index hospitalization is € 6.7755,1 for Da Vinci and € 6.637,15 for Hugo RALP. The new Hugo RAS system is willing to reduce direct expenditures of robotic surgery for RALP; furthermore, it provides similar peri-operative outcomes compared to the Da Vinci. However, other drivers of costs should be taken into account, such as the duration of OR use-that is more than just console time and may depend on the facility's background and organization. Further variations in direct costs of robotic systems are related to caseload, local agreements and negotiations. Thus, cost comparison of new robotic platform still remains an ongoing issue.

Real-world treatment patterns and medical costs of prostate cancer patients in Switzerland - A claims data analysis.

BACKGROUND: Prostate cancer (PC) is the most prevalent cancer in men in Switzerland. However, evidence on the real-world health care use of PC patients is scarce. The aim of this study is to describe health care utilization, treatment patterns, and medical costs in PC patients over a period of five years (2014-2018). METHOD: We used routinely collected longitudinal individual-level claims data from a major provider of mandatory health insurance in Switzerland. Due to the lack of diagnostic coding in the claims data, we identified treated PC patients based on the treatments received. We described health care utilization and treatment pathways for patients with localized and metastatic PC. Costs were calculated from a health care system perspective. RESULTS: A total of 5591 PC patients met the inclusion criteria. Between 2014 and 2018, 1741 patients had outpatient radiotherapy for localized or metastatic PC and 1579 patients underwent radical prostatectomy. 3502 patients had an androgen deprivation therapy (ADT). 9.5% of these patients had a combination therapy with docetaxel, and 11.0% had a combination with abiraterone acetate. Docetaxel was the most commonly used chemotherapy (first-line; n = 413, 78.4% of all patients in chemotherapy). Total medical costs of PC in Switzerland were estimated at CHF 347 m (95% CI 323-372) in 2018. CONCLUSION: Most PC patients in this study were identified based on the use of ADT. Medical costs of PC in Switzerland amounted to 0.45% of total health care spending in 2018. Treatment of metastatic PC accounted for about two thirds of spending.

Cost-Effectiveness Analysis of Triptorelin, Goserelin, and Leuprolide in the Treatment of Patients With Metastatic Prostate Cancer: A Societal Perspective.

OBJECTIVES: Metastatic prostate cancer is the most common malignant cancer and the second leading cause of death due to various types of cancer among men after lung cancer. This study aimed to analyze the cost-effectiveness of triptorelin, goserelin, and leuprolide in the treatment of the patients with metastatic prostate cancer from the societal perspective in Iran in 2020. METHODS: This is a cost-effectiveness study in which a 20-year Markov transition modeling was applied. In this study, local cost and quality-of-life data of each health state were gathered from cohort of patients. The TreeAge pro 2020 and Microsoft Excel 2016 software were used to simulate cost-effectiveness of each treatment in the long term. The one-way and probabilistic sensitivity analyses were also performed to measure robustness of the model outputs. RESULTS: The findings indicated that the mean costs and utility gained over a 20-year horizon for goserelin, triptorelin, and leuprolide treatments were $ 13 539.13 and 6.365 quality-adjusted life-years (QALY), $ 18 124.75 and 6.658 QALY, and $ 26 006.92 and 6.856 QALY, respectively. Goserelin was considered as a superior treatment option, given the estimated incremental cost-effectiveness ratio. The one-way and probabilistic sensitivity analyses confirmed the robustness of the study outcomes. CONCLUSIONS: According to the results of the present study, goserelin was the most effective and cost-effective strategy versus 2 other options. It could be recommended to policy makers of the Iran healthcare system to prioritize it in clinical guidelines and reimbursement policies.

Cost-effectiveness of Accepting Kidneys From Deceased Donors With Common Cancers-A Modeling Study.

BACKGROUND: The disparity between the demand for and supply of kidney transplants has resulted in prolonged waiting times for patients with kidney failure. A potential approach to address this shortage is to consider kidneys from donors with a history of common cancers, such as breast, prostate, and colorectal cancers. METHODS: We used a patient-level Markov model to evaluate the outcomes of accepting kidneys from deceased donors with a perceived history of breast, prostate, or colorectal cancer characterized by minimal to intermediate transmission risk. Data from the Australian transplant registry were used in this analysis. The study compared the costs and quality-adjusted life years (QALYs) from the perspective of the Australian healthcare system between the proposed practice of accepting these donors and the conservative practice of declining them. The model simulated outcomes for 1500 individuals waitlisted for a deceased donor kidney transplant for a 25-y horizon. RESULTS: Under the proposed practice, when an additional 15 donors with minimal to intermediate cancer transmission risk were accepted, QALY gains ranged from 7.32 to 20.12. This translates to an approximate increase of 7 to 20 additional years of perfect health. The shift in practice also led to substantial cost savings, ranging between $1.06 and $2.3 million. CONCLUSIONS: The proposed practice of accepting kidneys from deceased donors with a history of common cancers with minimal to intermediate transmission risk offers a promising solution to bridge the gap between demand and supply. This approach likely results in QALY gains for recipients and significant cost savings for the health system.

The 340B Program and oral specialty drugs for advanced prostate cancer.

INTRODUCTION: Expensive oral specialty drugs for advanced prostate cancer can be associated with treatment disparities. The 340B program allows hospitals to purchase medications at discounts, generating savings that can improve care of the socioeconomically disadvantaged. This study assessed the effect of hospital 340B participation on advanced prostate cancer. METHODS: The authors performed a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer from 2012 to 2019. The primary outcome was use of an oral specialty drug. Secondary outcomes included monthly out-of-pocket costs and treatment adherence. We evaluated the effects of 1) hospital 340B participation, 2) a regional measure vulnerability, the social vulnerability index (SVI), and 3) the interaction between hospital 340B participation and SVI on outcomes. RESULTS: There were 2237 and 1100 men who received care at 340B and non-340B hospitals. There was no difference in specialty drug use between 340B and non-340B hospitals, whereas specialty drug use decreased with increased SVI (odds ratio, 0.95, p = .038). However, the interaction between hospital 340B participation and SVI on specialty drug use was not significant. Neither 340B participation, SVI, or their interaction were associated with out-of-pocket costs. Although hospital 340B participation and SVI were not associated with treatment adherence, their interaction was significant (p = .020). This demonstrated that 340B was associated with better adherence among socially vulnerable men. CONCLUSIONS: The 340B program was not associated with specialty drug use in men with advanced prostate cancer. However, among those who were started on therapy, 340B was associated with increased treatment adherence in more socially vulnerable men.

Value-based payment models and management of newly diagnosed prostate cancer.

OBJECTIVE: To examine the effect of urologist participation in value-based payment models on the initial management of men with newly diagnosed prostate cancer. METHODS: Medicare beneficiaries with prostate cancer diagnosed between 2017 and 2019, with 1 year of follow-up, were assigned to their primary urologist, each of whom was then aligned to a value-based payment model (the merit-based incentive payment system [MIPS], accountable care organization [ACO] without financial risk, and ACO with risk). Multivariable mixed-effects logistic regression was used to measure the association between payment model participation and treatment of prostate cancer. Additional models estimated the effects of payment model participation on use of treatment in men with very high risk (i.e., >75%) of non-cancer mortality within 10 years of diagnosis (i.e., a group of men for whom treatment is generally not recommended) and price-standardized prostate cancer spending in the 12 months after diagnosis. RESULTS: Treatment did not vary by payment model, both overall (MIPS-67% [95% CI 66%-68%], ACOs without risk-66% [95% CI 66%-68%], ACOs with risk-66% [95% CI 64%-68%]). Similarly, treatment did not vary among men with very high risk of non-cancer mortality by payment model (MIPS-52% [95% CI 50%-55%], ACOs without risk-52% [95% CI 50%-55%], ACOs with risk-51% [95% CI 45%-56%]). Adjusted spending was similar across payment models (MIPS-$16,501 [95% CI $16,222-$16,780], ACOs without risk-$16,140 [95% CI $15,852-$16,429], ACOs with risk-$16,117 [95% CI $15,585-$16,649]). CONCLUSIONS: How urologists participate in value-based payment models is not associated with treatment, potential overtreatment, and prostate cancer spending in men with newly diagnosed disease.

Cost-effectiveness analysis of abiraterone, docetaxel or placebo plus androgen deprivation therapy for hormone-sensitive advanced prostate cancer / Análise de custo-efetividade da adição de abiraterona ou quimioterapia ao tratamento do câncer de próstata metastático hormônio-sensível

ABSTRACT Objective To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. Methods We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. Results Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. Conclusion The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.

RESUMO Objetivo Avaliar a relação custo-efetividade da adição de quimioterapia ou abiraterona à terapia de privação hormonal. Métodos Um modelo analítico foi desenvolvido para determinar a relação custo-efetividade da adição de docetaxel ou abiraterona comparada à terapia de privação hormonal isolada. Custos diretos e indiretos foram incluídos no modelo. Os efeitos foram expressos em Anos de Vida Ajustados para Qualidade corrigidos pelos efeitos colaterais de cada terapia. Resultados A adição de quimioterapia e de abiraterona à terapia de privação hormonal aumentou os Anos de Vida Ajustados para Qualidade em 0,492 e 0,999, respectivamente, em comparação à terapia de privação hormonal isolada. A abiraterona promoveu ganho de Anos de Vida Ajustados para Qualidade de 0,506 em relação ao docetaxel. O custo incremental por Anos de Vida Ajustados para Qualidade foi R$ 133.649,22 para o docetaxel, R$ 330.828,70 para a abiraterona e R$ 571.379,42 para a abiraterona comparada ao docetaxel. Conclusão A adição de quimioterapia à terapia de privação hormonal é mais custo-efetiva que a adição de abiraterona à terapia de privação hormonal. Contudo, descontos no custo da abiraterona poderiam tornar esse tratamento mais custo-efetivo.

Cost effectiveness of chemohormonal therapy in patients with metastatic hormone-sensitive and non-metastatic high-risk prostate cancer / Custo-efetividade da adição de quimioterapia ao tratamento hormonal do câncer de próstata metastático sensível a hormônio ou localizado de alto risco

ABSTRACT Objective To assess the cost-effectiveness of chemohormonal therapy in patients with metastatic hormone-sensitive and non-metastatic high-risk prostate cancer. Methods An analytical decision model was developed to determine the cost-effectiveness of chemohormonal therapy versus androgen deprivation therapy alone in patients with metastatic hormone-sensitive prostate cancer and patients with non-metastatic high-risk prostate cancer. The cost-effectiveness in metastatic patients with a high-volume disease was assessed separately. The model used data from randomized clinical trials and drug acquisition costs in Brazil. In addition, the costs of post-progression therapies have been included in this model. The benefits to health are expressed as the quality-adjusted life-years, and the incremental cost-effectiveness ratios were calculated. Results Chemohormonal therapy may be associated with improved quality-adjusted life-years for all patient. The improvement was more than six times greater for patients with high-volume metastatic disease. In these patients, the incremental cost-effectiveness ratios were up to 74% lower than the incremental cost-effectiveness ratios of patients with non-metastatic disease. Conclusion Chemohormonal therapy has been more cost-effective in patients with high-volume metastatic disease.

RESUMO Objetivo Avaliar a relação custo-efetividade da adição de quimioterapia hormonal em pacientes com câncer de próstata metastático sensível a hormônio ou localizado de alto risco. Métodos Um modelo de decisão analítico foi desenvolvido para determinar o custo-efetividade da adição de quimioterapia versus a monoterapia de privação de andrógeno para pacientes com câncer de próstata metastático hormônio-sensível e pacientes de alto risco com câncer de próstata não metastático. O custo-efetividade em pacientes metastáticos com um alto volume da doença foi verificado isoladamente. Os dados do modelo foram obtidos de ensaios clínicos randomizados utilizando custos de aquisição de medicamentos no Brasil. Os custos de terapias pós-progressão também foram incluídos no modelo. Os efeitos foram expressos em anos de vida ajustados por qualidade, e foram calculadas as razões de custo-efetividade incremental. Resultados A adição de quimioterapia levou a um ganho de anos de vida ajustados por qualidade para todos os doentes. Este incremento foi seis vezes maior para os pacientes com doença metastática de alto volume. Nestes pacientes, as taxas do custo incremental por anos de vida ajustados por qualidade foram até 74% mais baixos do que o aumento das taxas dos pacientes com doença não metastática. Conclusão A adição de quimioterapia foi mais custo-efetiva para pacientes com doença metastática de alto volume.

Prostate cancer mortality according to marginalization status in Mexican states from 1980 to 2013 / Comportamiento de la mortalidad por cáncer de próstata en México de acuerdo al índice de marginación estatal, de 1980 a 2013

Abstract Objective: To assess prostate cancer (PC) mortality in Mexico from 1980 to 2013, according to the state marginalization level. Materials and methods: Using age-adjusted rates in men ≥ 40 years old, we estimated trends and age-cohort-period effects of PC mortality from 1980-2013 according to state marginalization status by using a joinpoint regression model and a Poisson regression model proposed by Holford. Results: The PC mortality risk has increased nationwide at a constant rate (2% annually) during the past 13 years. The highest annual increase was observed among states with very high (4.4%) and high (7.7%) marginalization rates. In contrast, states with very low levels of marginalization showed a significant reduction of 1.5% per year. The main changes were observed in the 1945-1950 birth year cohorts. Conclusions: Differences in PC mortality across regions of Mexico may reflect differences in the timing of the diagnosis and treatment of PC.

Resumen Objetivo: Evaluar la mortalidad por cáncer de próstata (CP) en México de acuerdo con la marginación estatal de 1980 a 2013. Material y métodos: Mediante el método directo se estimaron las tasas de mortalidad por CP ajustadas por edad en hombres ≥ 40 años; se analizaron las tendencias y el efecto de edad-cohorte-periodo de la mortalidad por esta causa a nivel nacional y por nivel de marginación estatal, utilizando modelos joinpoint y de regresión de Poisson propuesto por Holford. Resultados: En los últimos 13 años, la mortalidad por CP a nivel nacional mostró un incremento constante (2% anual), principalmente en los estados de muy alta (4.4%) y alta marginación (7.7%), mientras que en los de muy baja hubo una reducción de 5% anual. Los principales cambios se observaron en las cohortes de nacimiento de 1945-1950. Conclusiones: Los resultados posiblemente reflejan las diferencias regionales, en la oportunidad del diagnóstico y tratamiento del CP.

Manejo de las terapias hormonales para el tratamiento del cáncer de próstata avanzado hormonodependiente: evaluación fármaco: económica del tratamiento con Degarelix û Firmagon frente a Triptorelina genérica / Management of hormonal therapy for the treatment of advanced hormone-dependent prostate cancer: A pharmacoeconomics assessment of the use of Degarelix û Firmagon compared to generic triptorelin

Objetivo: Evaluación farmacoeconómica de dos tratamientos con drogas de distinto mecanismo de acción: Degarelix y triptorelina en el manejo de pacientes con cáncer de próstata avanzado hormonodependiente. Material y método: Se realizó una revisión de la literatura sobre el tratamiento estándar de estos pacientes, efectos tempranos y tardíos de las terapias existentes y además una valoración de Costo Integral del Tratamiento usando el tarifario de Essalud. Resultados: El Costo Integral del Tratamiento, es S/ 10 793 para un paciente que usa Degarelix y S/ 12 251 para un paciente que usa triptorelina genérica; es decir, la terapia con el antagonista de la GnRH genera un ahorro de S/ 1 458 por paciente. Conclusiones: Este ahorro representa S/ 1 008 017 para el total de pacientes con cáncer de próstata avanzado hormonodependiente que se atienden en Essalud, a nivel nacional, con la ventaja adicional que Degarelix no genera costos adicionales por complicaciones producto del efecto Flare.

Objective: This is a pharmacoeconomic evaluation of two therapy schedules using drugs with different modes of action: Degarelix and triptorelin in the treatment of patients with advanced hormone-dependent prostate cancer. Methods: We reviewed the literature on the standard treatment for these patients, early and late effects of existing therapies, and we also performed a valuation using the Comprehensive Cost Treatment EsSalud (Peruvian Social Security) rates. Results:The Comprehensive Cost Treatment is S/. 10 793 for a patient using Degarelix and S/. 12 251 for a patient using generic triptorelin, so the therapy with the GnRH antagonist generates S/. 1 458 savings per patient. Conclusions: This represents S/. 1,008,017 savings for all patients with advanced hormone-dependent prostate who attend to EsSalud, with the added advantage that there are no extra costs with the use of Degarelix because of the absence of complications due to any flare effect.

Análisis coste-efectividad de samario-153 (Quadramet®) en el tratamiento del dolor en pacientes con cáncer de próstata y metástasis óseas / Cost-effectiveness analysis of samario-153 (Quadramet®) for the treatment of patients with prostate cancer and bone metastases

Objetivo. Realizar un análisis coste-efectividad de samario [153Sm-EDTMP] (Quadramet®) respecto a la terapia convencional, para el tratamiento del dolor causado por metástasis óseas en pacientes con cáncer de próstata. Metodología. Se ha adaptado un modelo de árbol de decisión, que representa el tratamiento del dolor óseo metastásico, al contexto español. El modelo muestra las opciones terapéuticas habituales en el contexto sanitario español para la población del estudio. El horizonte temporal del modelo es de 4 meses y calcula el cociente coste-efectividad por paciente controlado. Los datos de eficacia del modelo provienen de un ensayo clínico aleatorizado. Las pautas de tratamiento habituales en España han sido indicadas por varios especialistas médicos. Resultados. El coste por paciente controlado para la terapia convencional es de 12.515,39 € y para la terapia con samario-153 (Quadramet®) es de 5.595,52 €. El análisis coste-efectividad incremental muestra que samario-153 (Quadramet®) es una terapia dominante, es decir, que presenta una mayor eficacia y un menor coste que la terapia convencional. Los resultados obtenidos han demostrado ser robustos en un extenso análisis de sensibilidad. Conclusiones. La terapia con samario-153 (Quadramet®) es eficiente en el tratamiento del dolor de pacientes con cáncer de próstata y metástasis óseas

Objective. To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet®) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases. Method. A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts. Results. The cost of pain control per patient is €12,515.39 for conventional therapy and € 5,595.52 for samarium-153 (Quadramet®) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet®) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust. Conclusion. Samarium-153 (Quadramet®) is cost-effective in treating pain in patients with prostate cancer and bone metastases

Evidencia Científica actual sobre la utilidad del Ultrasonido de Alta Intensidad (HIFU) en el tratamiento del Adenocarcinoma Prostático / Scientific evidence on the use of high-intensity focal ultrasound (HIFU) in the treatment of prostatic carcinoma

Objetivo: Evaluar en la literatura específica existente la evidencia científica sobre la utilización del Ultrasonido de Alta Intensidad (HIFU) en el tratamiento del adenocarcinoma prostático (Cap).Método: Se revisa la literatura a través de tres bases de datos: PubMed, Cochrane Library, HTA data base. Se seleccionaron varios artículos teniendo en cuenta el número de casos, los criterios de inclusión de los pacientes, el tiempo de seguimiento. Intentamos evaluar la mejor evidencia disponible llevando a cabo una revisión sistemática de la eficacia clínica y del coste-efectividad del HIFU en el tratamiento del Cap. Analizamos supervivencia global, supervivencia libre de enfermedad y calidad de vida, incluyendo complicaciones, efectos adversos y aceptación de la técnica. Resultados: Los trabajos disponibles se centran en dos indicaciones principales: la aplicación del HIFU como primer escalón terapéutico y como terapia de rescate en recidivas post-radioterapia. Encontramos una gran dificultad para extraer conclusiones sobre los beneficios relativos del HIFU: ausencia de media o alta evidencia y falta de comparaciones de esta terapia emergente con los tratamientos estándar. En cuanto a resultados sobre coste-efectividad tampoco objetivamos datos que nos permitieran extraer evidencia científica de calidad media/alta sobre la técnica. La mayoría de trabajos ofrecían disparidad en la definición de supervivencia libre de enfermedad (SLE), lo que dificulta la interpretación de resultados y la extracción de conclusiones. Los criterios de inclusión fueron también heterogéneos entre los diversos autores. Conclusiones: Actualmente la evidencia científica sobre la utilidad del HIFU en el tratamiento del adenocarcinoma prostático es de calidad baja. Entre los aspectos a destacar tenemos en cuenta su capacidad de destrucción tumoral local tanto en los casos sin terapia previa como en las recidivas post-radioterapia. No se pueden extraer, sin embargo, conclusiones a medio y largo plazo por la falta de ensayos clínicos randomizados y controlados con seguimiento suficiente para medir beneficios en términos de supervivencia global y calidad de vida (balance efectos adversos/beneficios), la ausencia de comparaciones con las terapias estándar así como la heterogeneidad de criterios de definición de la SLE (AU)

Objectives: To evaluate in the literature scientific evidence on the use of High-Intensity Focal Ultrasound (HIFU) in the treatment of prostatic carcinoma (PC).Method: Three database are searched: PubMed, Cochrane Library, HTA database. Several articles were selected taking into account number of cases, inclusion criteria, duration of follow-up period. We have evaluated the best evidence available thorugh a systematic review of clinical efficacy and cost-effectiveness of HIFU in the treatment of PC. We analized global survival, disease free survival, and quality of life, including complications, adversal effects and acceptance of the technique. Results: Publications available are focused on two main indications of the therapy: first step of management of PC and salvage therapy for locally recurrent PC after external beam radiotherapy. It was very difficult to draw conclusions on the relative benefits of the HIFU: lack of high or medium quality evidence and no comparisons between this technique an standard treatments. In relation to results on cost-effectiveness, no relevant studies were identified in order to get conclusions on the quality of the treatment. Most of reports offered disparity in the definition of free survival disease concept. This fact produce some misunderstanding of results and conclusions cannot be drawn correctly. Inclusion criteria were also heterogeneous between authors. Conclusions: No high-quality clinical evidence can be established currently on the utility of HIFU as treatment of prostatic cancer. An important fact to stress is the capacity of therapy to produce tumour necrosis both as first-step treatment and as salvage therapy. No conclusions can be drawn in the long-term due to the paucity of controlled and randomized trials with adequate follow-up to establish benefits in terms of global survival and quality of life (balance adversal effects/benefits), lack of comparisons with standard options as long as different definitions of free-survival disease (AU)

La punción biopsia prostática transrectal guiada por ecografía, el PSA y el tacto rectal en la detección del cáncer de próstata / Prostate cancer: transrectal US guided biopsy, digital rectal examination and prostatic specific antigen

El cáncer de próstata tiene una incidencia creciente en varones sexagenarios, cuyo diagnóstico se basa en el tacto rectal, el PSA y la punción biopsia. Para contrastar nuestro grupo de pacientes biopsiados en 1999, con aquellos de otros servicios privados, examinados retrospectivamente nuestro archivo de historias clínicas, los datos de servicios de patología, de laboratorios y del Registro Regional de Tumores. De 1089 estudios ecográficos prostáticos separamos 49 con historia clínica completa, tabulando edad, tacto, histología, tomas, volúmen y ecogenicidad de la próstata, inflamación y niveles de PSA. Obtuvimos diagnósticos de 227 punciones del medio privado, edades, y cantidades de PSA efectuadas en laboratorios, y los datos del Registro Regional de Tumores. Tratamos nuestros datos con test de "t", ANOVA de una vía y regresiones con técnica "forward stepwise". Vimos relación entre PSA y número de muestras (p=0,2231) y entre tacto rectal y cáncer (p=0,1678). Las restantes variables mostraron entre ellas p<0,05. No obtuvimos pendiente de regresión en ninguno de los modelos planteados. Nuestra serie mostró nueve pacientes con cáncer de próstata, cuatro de ellos con PSA por debajo de 4 ng/ml. Diagnosticamos cáncer en el 18 por ciento de nuestros biopsiados. La incidencia de cáncer prostático aumentó, al menos, 81 por ciento en la década, cuyo diagnóstico temprano se ha incrementado por el PSA y por la ecografía. No deberían excluirse a candidatos a biopsia sólo por un PSA normal. No encontramos regresión entre PSA y cáncer en nuestras series, ni entre volúmen y cáncer y vimos relación entre tacto y cáncer. Presumimos que cada uno de los 62 cánceres de próstata diagnosticados durante 1999 puede haber insumido $3.744 al sistema (AU)