PREVALENCE OF FATIGUE AND IMPACT ON QUALITY OF LIFE IN CASTRATION-RESISTANT PROSTATE CANCER PATIENTS: the VITAL study.

BACKGROUND: Fatigue is one of the most prevalent symptoms among cancer patients. Specifically, in metastatic castration-resistant prostate cancer (mCRPC) patients, fatigue is the most common adverse event associated with current treatments. The purpose of this study is to describe the prevalence of fatigue and its impact on quality of life (QoL) in patients with CRPC in routine clinical practice. METHODS: This was a cross-sectional, multicentre study. Male chemo-naïve adults with high-risk non-metastatic (M0) CRPC and metastatic (M1) CRPC (mCRPC) were eligible. Fatigue was measured using the Brief Fatigue Inventory (BFI) and QoL was assessed using the Functional Assessment of Cancer Therapy questionnaire for patients with prostate cancer (FACT-P) and the FACT-General (FACT-G) questionnaire. Data were analysed using Mann-Whitney or Kruskal-Wallis tests (non-parametric distribution), a T-test or an ANOVA (parametric distribution) and the Fisher or chi-squared tests (categorical variables). RESULTS: A total of 235 eligible patients were included in the study (74 [31.5%] with M0; and 161 [68.5%] with M1). Fatigue was present in 74%, with 38.5% of patients reporting moderate-to-severe fatigue. Mean FACT-G and FACT-P overall scores were 77.6 ± 16.3 and 108.7 ± 21.4, respectively, with no differences between the CRPC M0 and CRPC M1 subgroups. Fatigue intensity was associated with decreased FACT-G/P scores, with no differences between groups. Among 151 mCRPC patients with available treatment data, those treated with abiraterone-prednisone ≥3 months showed a significant reduction in fatigue intensity (p = 0.043) and interference (p = 0.04) compared to those on traditional hormone therapy (HT). Patients on abiraterone-prednisone ≥3 months showed significantly better FACT-G/P scores than patients on HT (p = 0.046 and 0.018, respectively). CONCLUSION: Our data show a high prevalence and intensity of fatigue and its impact on QoL in chemo-naïve CRPC patients. There is an association between greater fatigue and less QoL, irrespective of the presence or absence of metastasis. Chemo-naïve mCRPC patients receiving more than 3 months of abiraterone acetate plus prednisone showed an improvement of fatigue and QoL when compared to those on traditional HT. TRIAL REGISTRATION: Not applicable since it is not an interventional study.

Recommendations on the treatment of metastatic hormone-sensitive prostate cancer: Patient selection.

The standard treatment for metastatic hormone-sensitive prostate cancer (mHSPC) is now a combination of androgen deprivation therapy plus an androgen receptor-targeted therapy (abiraterone, apalutamide, enzalutamide or darolutamide), with or without chemotherapy (docetaxel). The selection of suitable patients for each therapeutic approach has become a determining factor to ensure efficacy and minimize side effects. This article combines recent clinical evidence with the accumulated experience of experts in medical oncology, radiation oncology and urology, to provide a comprehensive view and therapeutic recommendations for mHSPC.

Initial experience with thulium fiber laser for prostate enucleation: Analysis of the intraoperative and short-term outcomes in a prospective, multicenter cohort.

INTRODUCTION: Holmium laser enucleation of the prostate has rapidly become the gold standard for the surgical treatment of benign prostate hyperplasia, although thulium fiber laser (TFL) has also been postulated as an effective and safe alternative for prostate enucleation. The aim of this study is to describe our initial experience with the TFL for endoscopic enucleation of the prostate. MATERIAL AND METHODS: All patients proposed to TFL prostate enucleation were included in the analysis, regardless their prostate volume, catheter status and severity of symptoms, in 3 centers. Preoperative characteristics, intraoperative times and functional 3-months follow-up variables were collected, along with complications. RESULTS: Fifty-six patients were available, with a mean age of 68.7 years. Enucleation and morcellation efficiencies were 2.04 and 7.47 g/min, respectively. Median hospital stay was one day. Comparable functional data, pre and 3-month post-surgery was: mean prostate volume 88.9 vs 21.3 g, maximum urinary flow 13.2 vs 27.3 ml/s, post-void residual volume 149 vs 7.8 ml, prostatic specific antigen level 11.2 vs 1 ng/ml, and International Prostate Symptom Score 20.75 vs 3.96. Fourteen out of 56 (25%) patients presented with complications grade ≤2, according to the Clavien-Dindo classification. DISCUSSION: With wider evidence for other urological indications, very recent evidence about the suitability of TFL for prostate enucleation has arisen, since the first case described in 2021. Our results seem to back up these previous successful experiences as long as we obtained good intraoperative and short term follow-up functional results. However, there is still a need of longer follow-up data. CONCLUSIONS: TFL represents a novel technology for prostate enucleation, with a good intraoperative and short follow-up functional results, and a safety profile similar to the observed for those techniques that have been wider used for this indication. Further studies with longer follow-up periods and comparative with these other techniques are necessary.

Transplant renal artery stenosis: Study of incidence using doppler ultrasound, risk factors and analysis is effect in graft outcomes.

INTRODUCTION AND OBJECTIVES: Transplant renal artery stenosis (TRAS) is a vascular complication after kidney transplantation which estimated incidence is 13%. It could cause refractory arterial hypertension, kidney dysfunction and premature death in transplant recipients. METHODS: We carried out a retrospective study including every patient who underwent renal transplantation between 2014 and 2020. They were evaluated with a systematic post-transplant renal Doppler ultrasound. To identify independent risk factors for transplant renal artery stenosis we performed a multivariate analysis. RESULTS: Seven hundred twenty-four kidney transplants were included, 12% ​​were living donors and 88% were deceased donors. The mean age was 54.8 in recipients and 53 in donors. Transplant renal artery stenosis was diagnosed in 70 (10%) recipients, the majority in the first 6 months after surgery. 51% of patients with transplant renal artery stenosis were managed conservatively. The multivariate analysis showed diabetes mellitus, graft rejection, arterial resuture and donor body mass index as independent risk factors for transplant renal artery stenosis. Survival of the grafts with transplant renal artery stenosis was 98% at 6 months and 95% at two years. CONCLUSIONS: The systematic performance of Doppler ultrasound in the immediate post-transplant period diagnosed 10% of transplant renal artery stenosis in our cohort. Despite the above risk factors, an adequate monitoring and treatment could avoid the increased risk of graft loss in patients with transplant renal artery stenosis.

Hormone sensitive protocol for metastatic prostate cancer, an update.

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology.

European Association of Urology biochemical recurrence risk groups after radical prostatectomy: External validation and identification of independent risk factors for progression and death.

BACKGROUND: The EAU proposed a progression and death risk classification in patients with biochemical recurrence after radical prostatectomy (PR). OBJECTIVE: To validate the EAU BCR-risk classification in our setting and to find factors related to progression and death. MATERIAL AND METHODS: Multicenter, retrospective, observational study including 2140 patients underwent RP between 2011 and 2015. Patients with BCR were identified and stratified in low risk (PSA-DT >1yr and pGS <8) or high-risk (PSA-DT ≤1yr or pGS ≥8) grouping. PSA and metastatic free survival (PSA-PFS, MFS), cancer specific survival (CSS) and overall survival (OS) were calculated (Kaplan Meier curves and log-rank test). Independent risk factors were identified (Cox regression). RESULTS: 427 patients experienced BCR (32.3% low-risk and 67.7% high-risk). Median PSA-PFS was 135,0 mo (95% CI 129,63-140,94) and 115,0 mo (95% CI 104,02-125,98) (p<0,001), for low and high-risk groups, respectively. There were also significant differences in MFS and OS. The EAU BCR risk grouping was independent factor for PSA-progression (HR 2.55, p 0.009). Time from PR to BCR, was an independent factor for metastasis onset (HR 0.43, 95% CI 0.18-0.99; p 0.044) and death (HR 0.17, 95% CI 0.26.0.96; 23 p 0.048). Differences in MFS (p 0.001) and CSS (p 0.004) were found for <12, ≥12-<36 and ≥36 months from PR to BCR. Others independent factors were early salvage radiotherapy and PSA at BCR. CONCLUSIONS: High-risk group is a prognostic factor for biochemical progression, but it has a limited accuracy on MP and death in our setting. The inclusion of other factors could increase its predictive power.

Analysis of patient outcomes after urological surgery during the second and third waves of SARS-CoV-2 pandemic in a high incidence area.

OBJECTIVE: To analyze surgical safety through postoperative COVID-19 incidence and mortality at the urology department of a tertiary hospital located in Madrid (Spain). METHODS: Observational, prospective study including all patients undergoing urological surgery from 1st March 2020 to 28th February 2021. According to the hospital organization and local epidemiological situation we delimitate three epidemic waves. A set of screening and protective measures was applied from 4th May onwards. Demographic, baseline, surgical and perioperative variables, as well as postoperative outcomes, were collected. Telephone follow-up was performed at least 3 weeks after hospital discharge. RESULTS: 940 urological surgeries were performed, 12 of them had to be rescheduled due to active or recent SARS-CoV-2 infection identified by the screening protocol. Thirty-one patients developed COVID-19 (3.3% incidence) and 7 died (22.6% mortality). The average time to onset of symptoms was 62.6 days after discharge, being 25 cases attributable to community transmission. The remaining 6 cases, due to in-hospital transmission, had worse outcomes. Five of them were identified during the first wave, especially when no preoperative PCR was obtained. In contrast, during the second and third waves, fewer and milder cases were diagnosed, with just 1 in-hospital transmission among 857 urological patients. CONCLUSIONS: After implementing complete protective measures, postoperative in-hospital COVID-19 cases almost disappeared, even during the second and third waves. Most of the cases were due to community transmission and thus driven by the general epidemiological situation. While hospitals follow recommendations to avoid COVID-19 infection, urological surgery remains safe and can be maintained.

Impact of COVID-19 outbreak on urology surgical waiting lists and waiting lists prioritization strategies in the Post-COVID-19 era. / Impacto del brote de COVID-19 en las listas de espera de cirugía urológica y estrategias de priorización en la era post-COVID-19.

INTRODUCTION: The suspension of most elective surgeries during COVID-19 pandemic caused the lengthening of urology surgical waiting lists. The objective of this study is to evaluate the impact of COVID-19 pandemic on urology surgical waiting list in a high-volume hospital. METHODS: An observational descriptive study was designed. All patients included in the urology surgical waiting list of our high-volume center on May 1st 2020 (46 days after the suspension of elective surgery) were analyzed. Baseline variables, priority on the waiting list, main urological disease, type of scheduled surgery, and waiting time were recorded. Other variables recorded were the presence of a urinary catheter, number of accesses to the emergency department, evidence of COVID-19 infection, number of deaths and their cause. The waiting time for each disease was compared with the time to surgery in 2019. RESULTS: A total of 350 patients were included. The mean (SD) time on the waiting list was 97.33 (55.47) days. Priority 1 patients, who normally should undergo surgery within 30 days, were on the waiting list for a mean (SD) time of 60.51 (20.14) days. They were mainly patients with ureteral lithiasis (25.6%), high-risk or muscle-invasive bladder cancer (20.9%) and high-risk prostate cancer (13.9%). The mean waiting time had already significantly exceeded the mean time to surgery in 2019 for radical cystectomy (p = 0.04) and URS (p = 0.003). CONCLUSIONS: The suspension of most elective surgeries due to COVID-19 had a significant impact on urology surgical waiting list of our high-volume center, especially in priority 1 group.

Evaluation of health care-associated infections following radical cystectomy. / Estudio de las infecciones relacionadas con la asistencia sanitaria tras la realización de cistectomía radical.

INTRODUCTION AND OBJECTIVE: Radical cystectomy is a complex surgery with a high rate of complications including infections, which lead to increased morbidity and mortality, longer hospital stay and higher costs. The aim of this work is to evaluate health care-associated infections (HAIs) in these patients, as well as associated microorganisms, antibiotic resistance profiles and risk factors. MATERIAL AND METHODS: Prospective study from 2012 to 2017. Epidemiologic variables, comorbidities and surgical variables are collected. The microorganisms involved and antibiotic susceptibility patterns are analyzed. RESULTS: 122 patients. Mean age 67 (SD:18,42). Mean hospital stay 23.5 days (18.42). HAIs rate of 45%, with predominant urinary tract infections (43%) and surgical wound infections (31%). Positive cultures in 78.6% of cases. Increased isolation of Enterococcus (18%) and Escherichia coli (13%). Forty-three percent of microorganisms were resistant to amoxicillin/ampicillin, 23% to beta-lactamases and 36% to quinolones. Empirical treatment was adequate in 87.5%. Hospital stay is increased (17 days, p< 0.05) due to HAIs. Lower rate of infectious complications in the laparoscopic vs. open approach (p< 0.001) and in orthotopic vs. ileal conduit diversion (p = 0.04) CONCLUSIONS: We found a high rate of HAIs in our radical cystectomy series, with predominant urinary tract and surgical wound infections. E.coli and Enterococcus spp. are the most frequently isolated microorganisms, with high rates of resistance to some commonly used antibiotics.

[Impact of COVID-19 outbreak on urology surgical waiting lists and waiting lists prioritization strategies in the Post-COVID-19 era]. / Impacto del brote de COVID-19 en las listas de espera de cirugía urológica y estrategias de priorización en la era post-COVID-19.

Introduction: The suspension of most elective surgeries during COVID-19 pandemic caused the lengthening of urology surgical waiting lists. The objective of this study is to evaluate the impact of COVID-19 pandemic on urology surgical waiting list in a high-volume hospital. Methods: An observational descriptive study was designed. All patients included in the urology surgical waiting list of our high-volume center on May 1st 2020 (46 days after the suspension of elective surgery) were analyzed. Baseline variables, priority on the waiting list, main urological disease, type of scheduled surgery, and waiting time were recorded. Other variables recorded were the presence of a urinary catheter, number of accesses to the emergency department, evidence of COVID-19 infection, number of deaths and their cause. The waiting time for each disease was compared with the time to surgery in 2019. Results: A total of 350 patients were included. The mean (SD) time on the waiting list was 97.33 (55.47) days. Priority 1 patients, who normally should undergo surgery within 30 days, were on the waiting list for a mean (SD) time of 60.51 (20.14) days. They were mainly patients with ureteral lithiasis (25.6%), high-risk or muscle-invasive bladder cancer (20.9%) and high-risk prostate cancer (13.9%). The mean waiting time had already significantly exceeded the mean time to surgery in 2019 for radical cystectomy (p = 0.04) and URS (p = 0.003). Conclusions: The suspension of most elective surgeries due to COVID-19 had a significant impact on urology surgical waiting list of our high-volume center, especially in priority 1 group.

Androgen deprivation therapy in patients with localized disease: Comparison with curative intent treatments and time to castration resistance. Results of the Spanish Prostate Cancer Registry. / Terapia de privación de andrógenos en pacientes con enfermedad localizada: comparación de las opciones de tratamiento y tiempo hasta la resistencia a la castración. Resultados del Registro Español de Cáncer de Próstata.

BACKGROUND: The effect of primary androgen deprivation therapy (ADT) in patients with localized prostate cancer (PCa) has not been well documented. The objective of the present study was to analyze the outcome of tumors treated with ADT as primary therapy in the Spanish Prostate Cancer Registry (19.4% of the series). PATIENTS AND METHODS: Patients were classified in three groups: 1) with low/intermediate risk clinically localized tumors; 2) with high risk and locally advanced (T3-4) tumors; 3) with metastatic tumors. Time to castration resistance and overall cancer-specific survival were analyzed. In non-metastatic tumors, survivals in patients treated with ADT were compared with data from patients who underwent local treatments from the Spanish Prostate Cancer Registry. RESULTS: 703 cases were analyzed. There were significant differences in the time to castration resistance, which was lower in the group of metastatic tumors. During follow-up, there were 179 deaths (25.5%) of which 89 (12.6%) were due to PCa. After 3 years of ADT, only 14.6% of patients in group 1 had died (1% due to PCa), 20.5% in group 2 and 46.8% in group 3 (9.2% and 31.3% due to PCa, respectively). Cancer-specific survival was significantly worse in group 1 using ADT than radical prostatectomy or radiotherapy. In high-risk and locally advanced tumors, ADT also had a lower cancer-specific survival than local treatments. CONCLUSION: A longer time until the castration resistance was observed in patients with well- and intermediate-risk localized tumors treated with ADT. Patients with metastatic tumors showed the shortest time to castration resistance.

Design of an assistance protocol for the restart of scheduled urologic surgery in a COVID-19 epidemic period. / Diseño de un protocolo asistencial para el reinicio de la cirugía urológica programada en periodo de epidemia COVID-19.

OBJECTIVE: Design a care protocol to restart scheduled surgical activity in a Urology service of a third level hospital in the Community of Madrid, in a safe way for our patients and professionals in the context of the SARS-CoV-2 coronavirus epidemic. MATERIAL AND METHODS: A multidisciplinary group reviewed the different recommendations of the literature, national and international health organizations and scientific societies, as well as their application to our environment. Once scheduled surgery has restarted, the patients undergoing surgery for complications related to COVID-19 are being followed up. RESULTS: Since the resumption of surgical activity, 19 patients have been scheduled, of which 2 have been suspended for presenting COVID-19, one diagnosed by positive PCR for SARS-CoV-2, and another by laboratory and imaging findings compatible with this infection. With a median follow-up of 10 days (4-14 days), no complications related to COVID-19 were detected. CONCLUSIONS: Preliminary results indicate that the protocol designed to ensure the correct application of preventive measures against the transmission of coronavirus infection is being safe and effective.

Urological surgery during SARS-CoV-2 pandemic. Descriptive analysis of the experience in a Urology Department across the pandemic phases. / Cirugía urológica durante la pandemia por SARS-CoV-2. Análisis descriptivo de la experiencia en un Servicio de Urología durante distintas fases epidemiológicas.

INTRODUCTION: The SARS-CoV-2 pandemic has changed the urological practice around the world. Our objective is to describe the outcomes presented by patients undergoing surgery in the urology department of a tertiary hospital, across the pandemic phases. METHODS: Observational, cohort study including all patients undergoing surgery from March 1 to May 14. According to the hospital organization, we identified three periods: there were no changes during the first two weeks (1st. period), the following seven weeks, when only urgent interventions were carried out after performance of nasopharyngeal swab test (2nd. period), and finally, elective surgery was resumed on May 4, after the implementation of a multidisciplinary screening protocol (3rd. period). Demographic, baseline, surgical and perioperative variables, as well as postoperative outcomes, were obtained in a retrospective (periods 1 and 2) and prospective (period 3) manner. Telephone follow-up was initiated at least 3 weeks after hospital discharge. RESULTS: 103 urological surgeries were performed, and 11 patients were diagnosed with COVID-19, 8 of them within the 1st. PERIOD: The diagnosis was already known in 1 patient, while the other 10 developed the disease in an average of 25 days after the intervention and 16,6 days after discharge. Of seven transplant patients, four got the infection. Three deaths were recorded due to the disease: a 69-year-old woman transplanted and two men over 80 with comorbidities and high anesthetic risk who underwent drainage of retroperitoneal abscess and retrograde intrarenal surgery, respectively. CONCLUSIONS: SARS-CoV-2 infection mainly affected renal transplant recipients or elderly patients with high anesthetic risk, during the first 2 weeks of the pandemic. After implementing preoperative PCR tests and a comprehensive screening protocol, cases were substantially reduced, and safe surgical procedures were achieved.

New immunotherapies for high-risk non-muscle invasive bladder cancer: Current state and future perspectives. / Nuevas inmunoterapias en el cáncer de vejiga no músculo-invasivo de alto riesgo: estado actual y perspectivas de futuro.

BACKGROUND: The standard treatment for high-risk non-muscle invasive bladder tumors (NMIBT) is transurethral resection of the bladder and BCG instillations. However, responses are limited, and new therapeutic alternatives for these patients are required. The results of checkpoint inhibitors in advanced tumors have led to interest in the use of these molecules in NMIBT. METHODS: We conducted a search on PubMed using the terms «bladder cancer¼ and «check point inhibitors¼. We have used the search engines clinicaltrials.gov and clinicaltrialsregister.eu for the search of clinical trials. RESULTS: There are currently 5 trials in progress on BCG untreated patients. There are no results available. As for BCG non-responders, there are 15 ongoing trials, two of them with preliminary results: Keynote 057, with promising results with pembrolizumab, which has led the FDA to approve its use in January 2020, and SWOG S1605, which has shown similar results with atezolizumab. Other trials are using intravesical administration of these drugs, which is an attractive option if it is effective for cancer control. CONCLUSIONS: Checkpoint inhibitors offer a new possibility for patients who do not respond to BCG. These will probably be used in the future for previously BCG untreated patients. Preliminary data from clinical trials show promising results. A good understanding of these molecules by urologists and the creation of multidisciplinary teams are crucial in order to offer the best therapeutic alternatives to these patients.

Three-year interim results of overall and progression-free survival in a cohort of patients with prostate cancer (GESCAP group). / Resultados preliminares de supervivencia global y libre de progresión a tresaños en una cohorte de pacientes diagnosticados de cáncer de próstata (grupo GESCAP).

AIMS: To describe the 3-year progression-free survival (PFS), overall survival (OS) and disease-specific mortality in the prospective prostate cancer GESCAP cohort, as well as the progression to castration resistance in patients on hormone therapy. MATERIAL AND METHODS: Prospective, observational, epidemiological, multicentre study. Of the 4087 patients recruited, 3843 were evaluable. The variables analysed were the risk group (localized, locally advanced, lymph involvement, metastatic), age, prostate-specific antigen (PSA) levels, Gleason score and initial treatment. Kaplan Meier survival analysis, the log-rank test and the Cox model were used to evaluate the survival data. RESULTS: Three-year PFS was 81.4% and OS was 92.4%. During the 3 years of follow-up, 303 patients died (7.9%), 110 of them (36.3%) due to disease-related causes. The probability of castration resistance for all patients on hormone therapy (n=715) was 14.2%: 5%, 9.9%, 26.1% and 44.4% in localized, locally advanced, lymph involvement and metastatic cancer, respectively (log-rank P<.0001). Patients with metastases had poorer outcomes with respect to PFS, OS, disease-specific mortality and castration resistance. In the multivariate analysis, the Gleason score, PSA and presence of metastases were associated with shorter OS and PFS. CONCLUSIONS: Our study showed stratification of risk, with a more unfavourable prognosis for patients with metastases. Patients with locally advanced disease differed with respect to those with localized disease due to their higher risk as regards disease-specific mortality. (Controlled-trials.com ISRCTN19893319).

Factors related to early castration resistance in metastatic prostate cancer. Results from the National Prostate Cancer Registry in Spain. / Factores relacionados con la resistencia a la castración precoz en el cáncer de próstata metastásico. Resultados del Registro nacional de cáncer de próstata en España.

INTRODUCTION: The objective of the study was to determine the factors independently related with the development of castration resistance (CR) in prostate cancer (PC) in the medium term. MATERIAL AND METHODS: 155 patients diagnosed with metastatic PC with a follow-up of up to 39 months. Data taken from the National PC Registry. The evaluated variables were age, PSA, nadir PSA, Gleason, perineural invasion, TNM stages, and ADT type (intermittent/continuous). RESULTS: Mean follow-up 26,2±13,4 months. 47.1% developed early CR, with mean time until onset of 12,2±8,7 months. Univariate analysis the mean PSA was correlated with CR (290±905,1 ng/mL in non CR, 519,1±1437,2 ng/mL in CR, P<.001), mean age (73,3±8,3 years in non CR, 69,1±9,3 in CR P=.01), mean PSA nadir (15,5±57,3ng/mL in non CR, 15,9±23,7 ng/mL in CR, p<0,001), Gleason (in ≥8, HR:2,11. 95% CI: 1.22-3.65, p=0.006), and T stage (in T3-T4, HR: 2.85. 95% CI: 1.57-5.19, P<.001). Multivariate analysis the independent variables associated to CR are age (HR: 0.96. 95% CI: 0.94-0.99, P=.01), PSA nadir (HR: 1.65. 95% CI: 1,43-1,91, P<.001), and T3-T4 stage (HR: 2.11. 95% CI: 1.10-4.04, P=.02). CONCLUSIONS: PSA nadir and T3-T4 tumor stage at diagnosis are associated to an increased risk of developing CR. In addition, age at diagnosis is shown as a variable that decreases risk. Therefore, an older age would be associated with lower risk probability of CR in the medium term.

[Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer]. / Efectividad y tolerabilidad del acido zoledrónico en el tratamiento del cancer de próstata metastásico.

OBJECTIVES: To assess the effectiveness and tolerability of zoledronic acid in prostate cancer patients with bone metastases at the hormone-sensitive (HS) and hormone-independent (HI) stages. MATERIALS AND METHODS: A nationwide, observational, prospective, open and multi-centre trial was devised, with a total of 218 male patients diagnosed with prostate cancer at the HS stage (36%) or HI stage (64%) who were administered zoledronic acid (4 mg/IV/month for 6 months) in addition to their specific oncological treatment. Effectiveness was assessed by the following means: 1) Assessment of the improvement in pain and mobility; 2) Incidence and time to onset of skeletal-related events (SREs) and 3) Analysis of bone markers. Tolerability was assessed by means of registering the number and type of adverse effects. A satisfaction survey was carried out amongst the patients after the end of the trial. RESULTS: Out of the 218 patients, 170 (78%) were evaluable for effectiveness. A decrease in pain ratings at rest and during movement was observed in all patients, whether in the HS or HI groups (p < 0.0001). Improved mobility was observed likewise (p = 0.005), as was quality of life. The global incidence of skeletal events was 11.2%, with a time to onset of SREs of 10.7 months. There were no significant differences observed between HS vs. HI patients. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. For safety reasons. 212 patients were evaluable (97.2%). The incidence of adverse drug reactions was 16% (34/212) and was found to be significantly higher in HS patients (22.4%) compared with HI patients (11.9%). Overall, the tolerability of zoledronic acid was good, with no significant morbidity in either group (HS and HI). 66% of the patients reported feeling satisfied or very satisfied. CONCLUSIONS: Zoledronic acid proved effective in the relief of pain, improving mobility and quality of life as well as reducing or delaying the occurrence of skeletal-related events in prostate cancer patients presenting metastatic bone disease, regardless of the phase, whether HS or HI, they found themselves in. Tolerability and patient satisfaction were rates as good.

Radium-223 for the treatment of metastatic castration-resistant prostate cancer: A window of opportunity. / Radio-223 en el tratamiento del cáncer de próstata resistente a la castración metastásico: una ventana de oportunidad.

CONTEXT: The elimination of bone metastases, restoration and/or preservation of bone morphology and prevention and/or delay of skeletal events are a fundamental objective in the management of metastatic castration-resistant prostate cancer (mCRPC). Radium-223 is the first targeted alpha therapy with effects on bone that has been shown to increase survival in these patients, besides providing other bone-related benefits. OBJECTIVE: To analyze the impact of bone metastasis on mCRPC, and the benefits and the window of opportunity provided by radium-223 in the treatment of patients with mCRPC in the current treatment era. EVIDENCE ACQUISITION: A bibliographic search of PubMed and Spanish and international congresses on radium-223 and other first-line treatments for mCRPC was performed. Recent guidelines and recommendations by experts were also consulted. SUMMARY OF THE EVIDENCE: Evidence for the mechanism of action of radium-223 widen its effects to the tumor bone environment. Survival of patients treated with radium-223 is higher in those with mild symptoms as opposed to those with moderate-severe symptoms. The presence of visceral metastases even in the early stages of mCRPC supports starting radium-223 therapy before the symptoms become clinically relevant. A 3-year study has confirmed its good safety profile. Changes in tALP and LDH may be useful markers for monitoring the treatment with radium-223, but they are not predictors of overall survival. CONCLUSION: Radium-223 is a valuable therapeutic alternative in the treatment of patients with mCRPC in early stages of the disease, with a good safety profile. Its benefits extend to the bone environment.

Radium-223 in the therapeutic sequence of metastatic castration-resistant prostate cancer. / Radio-223 en la secuencia terapéutica del cáncer de próstata resistente a la castración metastásico.

CONTEXT: Radium-223 is an □ -particle transmitter with specific action on bone metastases. The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) study showed that radium-223 extended overall survival and delayed the onset of bone events in patients with symptomatic castration-resistant prostate cancer with bone metastases (mCRPC) and without visceral metastases, with a good safety profile. OBJECTIVE: To review the new scientific evidence on radium-223 based on prespecified and post-hoc analyses of the ALSYMPCA study and on early-access programs after the publication of the ALSYMPCA study, thereby providing new data on the management of patients with mCRPC. ACQUISITION OF EVIDENCE: We searched for evidence on PubMed and in the abstracts of international urology and oncology congresses, as well as ongoing clinical trials (ClinicalTrials.gov). SYNTHESIS OF THE EVIDENCE: The results of the reviewed studies offer promising results that will broaden the therapeutic benefits of radium-223 to patients with mild symptoms and those with no symptoms. The results also provide preliminary evidence on the benefit of radium-223 treatment after the failure of docetaxel, enzalutamide or abiraterone or the combination of radium-223 with these agents or other therapeutic agents such as bone-targeted agents and immunotherapy. CONCLUSION: Radium-223 can be a treatment option for patients with mild symptoms and can provide a therapeutic benefit after failure of currently available treatments or in combination with these treatments. This evidence should be corroborated in clinical trials before being added to clinical practice.