Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. / Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real.

INTRODUCTION AND OBJECTIVES: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. MATERIAL AND METHODS: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. RESULTS: The mean age of the 26 patients included was 63.7±11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). CONCLUSION: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies.

Low-dose-rate brachytherapy for prostate cancer in renal transplant recipients.

PURPOSE: Prostate cancer (PCa) is the most common malignancy among men and one of the most common neoplasms affecting renal transplant recipients (RTRs). The available treatments for localized PCa among the general population (GP), surgery and external beam radiotherapy, carry a risk of damage to the transplanted kidney, the ureters, and the bladder and therefore tend to be avoided by most groups. The objective of this study was to assess the efficacy and feasibility of low-dose-rate brachytherapy (LDR-BT) for PCa in RTRs. METHODS AND MATERIALS: We carried out a retrospective review on all RTRs diagnosed of PCa who had undergone LDR-BT at our institution between 2000 and 2015. Nine patients met these criteria, but 1 did not fulfill the followup. Hence, we analyzed 8 patients. We reviewed all clinical data for PCa and graft function in these patients and compared the results with the GP. RESULTS: Mean baseline prostate-specific antigen was 6.8 ± 1.9 ng/mL. All PCa had a Gleason score of 6 and were classified as low risk according the Europe Association of Urology guidelines. Mean followup after seed implantation was 48 ± 12.8 months. All 8 patients remain free of prostate-specific antigen failure. Five-year progression-free survival, cancer-specific survival, and overall survival rates were 100%, 100%, and 62.5%. There was no specific toxicity associated with LDR-BT, and there were no acute adverse events affecting the graft. CONCLUSIONS: LDR-BT is a feasible and acceptable treatment for localized PCa in RTRs. Oncological outcomes are similar to the GP, and there is minimal toxicity to the renal graft.

Learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. / Curva de aprendizaje en el manejo de los inhibidores de tirosina quinasa como primera línea de tratamiento en pacientes con cáncer renal metastásico.

OBJECTIVES: To analyse the learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. MATERIAL AND METHODS: We evaluated 32 consecutive patients treated in our department for metastatic renal cancer with tyrosine kinase inhibitors (pazopanib or sunitinib) as first-line treatment between September 2012 and November 2015. We retrospectively analysed this sample. We measured the time to the withdrawal of the first-line treatment, the time to progression and overall survival using Kaplan-Meier curves. The learning curve was analysed with the cumulative sum (CUSUM) methodology. RESULTS: In our series, the median time to the withdrawal of the first-line treatment was 11 months (95% CI 4.9-17.1). The mean time to progression was 30.4 months (95% CI 22.7-38.1), and the mean overall survival was 34.9 months (95% CI 27.8-42). By applying the CUSUM methodology, we obtained a graph for the CUSUM value of the time to withdrawal of the first-line treatment (CUSUM TW), observing 3 well-differentiated phases: phase 1 or initial learning phase (1-15), phase 2 (16-26) in which the management of the drug progressively improved and phase 3 (27-32) of maximum experience or mastery of the management of these drugs. The number of treated patients needed to achieve the proper management of these patients was estimated at 15. CONCLUSIONS: Despite the limitations of the sample size and follow-up time, we estimated (in 15 patients) the number needed to reach the necessary experience in the management of these patients with tyrosine kinase inhibitors. We observed no relationship between the time to the withdrawal of the first-line treatment for any cause and progression.

PSA levels in patients on hemodialysis treatment.

OBJECTIVES: Standardized prostate-specific antigen (PSA) levels are based upon the general population levels and, although a higher incidence of prostate cancer in patients on hemodialysis (HD)has not been demonstrated, some studies point at the possibility of observing higher PSA levels in this type of patients than in males with preserved renal function. The objective of the present study is to compare PSA levels in males on hemodialysis with those of the population with normal renal function. METHODS: Comparative, transversal study of the variables age, total PSA, free PSA and PSA index in 190 patients with chronic renal disease on hemodialysis treatment (group 1) and 237 subjects without renal disease ( group 2). We carried out a descriptive analysis and a comparative study of the above mentioned variables using the SPSS software. RESULTS: Median age of patients on HD was 55 in cases (47-61)and 59 in controls (54-63.5). Mean total PSA was 1.49 ng/mL [1.24-1.73] in cases and 1.62 ng/mL [1.29-1.95] in controls; mean free PSA was 1.40 ng/mL [0.89-1.91] in group 1 and 2.31 ng/mL [-0.83-5.45] in group 2; mean PSA index was 27.67% [19.91-35.63] in cases and 14.82%[12.79-16.85]] in controls. The comparative study showed differences between the two groups in free PSA (p ≤ 0.007), PSA index (p ≤ 0.000) and total PSA (p ≤ 0.000) in patients under 50 after an age-specific analysis. CONCLUSIONS: Total PSA is higher in patients on HD within the subgroup of patients under 50 with statistically significant but not clinically relevant difference. PSA index is remarkably higher in the group of patients on HD. These data could have clinical implications as far as indications for biopsy is concerned.