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4576 Background: RECORD-2 (NCT00719264) primary analysis demonstrated similar median progression-free survival (PFS) for pts with mRCC treated with E+B and I+B (Dec 2011 cut-off). The primary objective was not met; median PFS in E+B/I+B was 9.3/10.0 mo (HRIFN/EVE, 0.91; 95% CI, 0.69-1.19; P=0.485) and probability of success (PoS) of a subsequent phase III trial was 5.1%. Here we present final OS and safety/exposure results (Aug 2012 cut-off). Methods: Untreated pts with clear cell mRCC and previous nephrectomy were randomized 1:1 to B 10 mg/kg every 2 weeks and either E 10 mg/day or I (9 MIU 3 times/week). The primary objective was treatment effect on PFS per central review based on an estimation of PoS (≥50%) of a subsequent phase III study. Secondary objectives included OS and safety. Results: In E+B (n=182) and I+B (n=183) arms, median age was 60/60 years and 76/72% of pts were men, respectively. In both arms, most pts (93%) were of favorable/intermediate MSKCC risk. Median follow-up was 33 mo. In E+B and I+B arms, 51/52% of pts died, respectively. Median OS (95% CI) was 27.1 mo (19.9-35.3) in the E+B arm and 27.1 mo (20.4-30.8) in the I+B arm. After discontinuing study treatment, 64/60% of pts in E+B and I+B arms, respectively, received antineoplastic therapy. Median exposure duration in E+B and I+B arms was 8.5/8.3 mo, respectively; AEs resulted in treatment discontinuation for 23/25% of pts, respectively. The most frequent AEs (%) were stomatitis (63), proteinuria (50), diarrhea (40), hypertension (38), and epistaxis (35) in the E+B arm and decreased appetite (45), fatigue (42), proteinuria (38), asthenia (35), and pyrexia (35) in the I+B arm. The most frequent grade 3/4 AEs (%) were proteinuria (24), stomatitis (11), and anemia (11) for E+B and fatigue (17), asthenia (14), and proteinuria (10) for I+B. Conclusions: OS of E+B and I+B was similar. OS results are consistent with PFS primary analysis. First-line treatment with mTOR inhibitor-based therapy did not impair chance of survival relative to standard therapy. No new safety issues were identified and E+B remained generally well tolerated. Clinical trial information: NCT00719264.

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Abstract. In Russia, prostate cancer is one of the most common cancers in men. Radical prostatectomy is an established option to treat localized prostate cancer. Almost 35% of patients will face prostate cancer progression within 10 years following radical prostatectomy. Purpose. To assess the ability of PSA density to predict biochemical relapse and detect unfavorable pathological features among patients suffering from localized prostate cancer treated with radical prostatectomy. Material and methods. The study evaluated 147 patients with localized prostate cancer who underwent an open or laparoscopic retropubic radical prostatectomy between February 2001 and August 2015. The assessment of prognostic and clinical significance of PSA density took place. Results. Biochemical recurrence was observed in 53 (36.01%) patients. PSA density (p = 0.006), Gleason score (p = 0.0006), pathological stage T (p = 0.002), extraprostatic extension (p = 0.019), seminal vesicle invasion (p = 0.001) and prostate cancer upstaging (p=0.0007) were found to significantly correlate with biochemical relapse risk. We established a relationship between PSA density and unfavorable pathological features detection following radical prostatectomy. Using ROC – curve analysis (AUC=0,635, р=0,005) we determined PSA density threshold of (>0,309 ng/mL/cc) – when exceeded, was associated with statistically significant decrease in disease – free survival. According to the results of multivariate analysis – PSA density, abnormal Gleason score and seminal vesicle invasion has proven to influence disease – free survival (p < 0.05).                                                                                                                     Conclusion. We have clearly demonstrated a PSA density as an important prognostic tool of high clinical relevance, which may aid in biochemical relapse risk estimation. A PSA density parameter incorporation into preoperative nomograms may increase the predictive potential of latter.

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BACKGROUND:The most important task in the field of improving the results of treatment of patients with prostate cancer (PCa) is their correct stratification by risk groups. Modern stratification systems do not fully provide an adequate risk assessment for all patients with prostate cancer. Further development of algorithms for predicting the clinical course of prostate cancer for a particular patient can positively affect the course and outcome of the disease. AIM:Determination of the clinical and prognostic value of the density of prostate-specific antigen (PSAD) in patients with localized prostate cancer who underwent combined external beam radiation with androgen deprivation therapy. MATERIALS AND METHODS:The effect of the PSAD parameter on the tumor-specific survival rates, as well as the clinical and morphological parameters of the tumor process, was assessed in 272 patients with localized prostate cancer who underwent combined external beam radiation with androgen deprivation therapy from January 1996 to July 2007. RESULTS:The high clinical significance of the PSAD indicator has been demonstrated. An increase in PSAD correlated with an increase in serum PSA concentration, a decrease in PSA doubling time, and a decrease in tumor differentiation. The prognostic value of PSAD was confirmed in patients with localized prostate cancer who received combined hormone-radiation therapy. Using ROC-analysis, the threshold value of the PSAD index was determined 0.36 ng / ml / cm3, the excess of which was associated with a statistically significant decrease in the level of tumor-specific survival. The area under the curve was 0.703 (95% CI 0.2360.434;p 0.001). The risk of tumor-specific mortality and recurrence increased as the PSAD value increased. CONCLUSION:The PSAD parameter is a reliable biomarker of prostate cancer with high rates of clinical and prognostic significance, the use of which is not associated with the introduction of costly and cumbersome methods of laboratory and instrumental diagnostics.

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