Phase 2 Multicenter Single-Arm Study of Second-Line Axitinib in Favorable Risk Patients with Metastatic Renal Cell Carcinoma: FavorAx.

BACKGROUND: Targeted therapy with axitinib resulted in a greater objective response rate and prolonged progression-free survival (PFS) compared to sorafenib in patients with previously treated metastatic renal cell carcinoma (mRCC) in the phase 3 AXIS study, where 75% of patients had intermediate and poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk. OBJECTIVE: In this phase 2 study (FavorAx), we assessed the activity of axitinib in mRCC patients with a favorable risk and history of prior vascular endothelial growth factor receptor (VEGFR)-directed therapy. PATIENTS AND METHODS: Patients were required to have clear-cell mRCC, favorable risk according to IMDC criteria, and to have received first-line treatment with sunitinib or pazopanib. Prior treatment with other agents was not permitted. The primary endpoint of the study was 5 months PFS. Additional endpoints included response rate, safety, PFS, and overall survival (OS). RESULTS: A total of 21 patients were enrolled, 62% of whom were male. The mean age was 60 years. Eleven (52%) patients had two or more metastatic sites. 67% and 33% of patients received first-line sunitinib or pazopanib, respectively, with a median PFS of 17 months [95% confidence interval (CI), 14-20]. After a median follow-up of 25 months, the median PFS was 19 months (95% CI, 15-23). The current study did achieve its primary endpoint based on the 5-month PFS of 100%. The median OS was not yet reached. The 18 months OS rate was 85.7%. The objective response rate was 33% and one patient achieved a complete response. Seven patients had dose escalation of axitinib and four patients had dose reduction. Grade 3 adverse events were observed in 19% of cases. There was no discontinuation of therapy due to toxicity. CONCLUSIONS: The encouraging PFS and favorable safety profile observed in the FavorAx study support the administration of axitinib in mRCC patients with favorable IMDC risk and a history of prior sunitinib or pazopanib.

Lower Urinary Tract Symptoms in Metabolic Syndrome in Young Adults.

BACKGROUND AND OBJECTIVE: Metabolic syndrome (MS) is widespread among middle age people and presents an acute issue in preventive cardiology. A list of conditions associated with MS is quite long and it is constantly growing. Despite the data, described in scientific literature, on general pathogenetic mechanisms, the conditions associated with androgynous status, are not included into the register of MS associated nosologies. Such association is identified in men older than 60 years old and is explained by age related hypoandrogenaemia. However, the issue of occurrence rate of lower urinary tract syndromes (LUTS) in young men with MS and their association of androgen levels remains open. METHODS: 62 European men aged from 25 to 40 (30 patients with MS and 32 conditionally healthy persons) were examined. Apart from generally accepted methods of physical and instrumental examination, evaluation of hormonal status (insulin, testosterone, dehydrotestosteron), IPSS-QOI testing and transrectal USI of prostate and bladder were performed. RESULTS: Revealed a high frequency of increasing the size and volume of the prostate gland, the number of points on the IPSS questionnaire, corresponding to the initial manifestation of hyperplastic prostate diseases on the background of insulin resistance and normal androgen levels raises questions about the search for new pathogenetic links of the metabolic syndrome with the processes of induction of prostate growth. CONCLUSION: Modern standards of examination of patients with MS do not include routine methods for the detection of prostate diseases. The above data raise questions about the need for further study in young patients with verified MS, including IPSS-QOI questionnaire surveying and TRUS.