Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer.

BACKGROUND: Most available prognostic nomograms in metastatic castration-resistant prostate cancer (mCRPC) are derived from datasets not representative of the current treatment landscape. A prognostic nomogram for first-line mCRPC treatment was developed from patients treated in the PREVAIL study. OBJECTIVE: To validate the Armstrong model in the COU-AA-302 trial. DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis of mCRPC patients treated in the COU-AA-302 trial was carried out (NCT00887198). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The Armstrong prognostic model was applied to patients treated in COU-AA-302. A continuous risk score was derived from coefficients from the original model. Time-dependent area under the curve (tAUC) was used to evaluate the overall predictive ability of the model. Patients were categorized according to the number of risk factors present into those at a low (three or fewer risk factors), intermediate (four to six risk factors), and high (seven to ten risk factors) risk. The association with survival was assessed with Cox regression models. Interaction tests were used to assess the impact of treatment arm in each of the prognostic groups. RESULTS AND LIMITATIONS: A total of 1088 patients were analyzed. The risk score was associated with overall survival (OS; tAUC 0.733). Most patients were at a low (49%) or intermediate (41%) risk. Risk category was significantly associated with OS (hazard ratio [HR]: 2.3; 95% confidence interval [CI]: 1.9-2.4; p < 0.001), radiographic progression-free survival (rPFS; HR: 1.7; 95% CI: 1.5-1.8; p < 0.001), and prostate-specific antigen progression-free survival (HR: 1.7; 95% CI: 1.5-1.9; p < 0.001). A significant interaction between risk group and OS (p = 0.007) and rPFS (p = 0.009) was observed. Survival was superior in low-risk patients (HR: 0.73; 95% CI: 0.59-0.89; p = 0.009), but similar in intermediate-risk (HR: 0.97; 95% CI: 0.79-1.21; p = 0.9) and high-risk (HR: 1.35; 95% CI: 0.80-2.28; p = 0.5) patients. Two-year OS rates in abiraterone versus placebo were 82% versus 74% in low-risk, 55% versus 52% in intermediate-risk, and 28% versus 31% in high-risk patients. CONCLUSIONS: We validate the prognostic value of the Armstrong risk model in patients treated with first-line androgen receptor signaling inhibitors. Abiraterone provided a greater benefit in low-risk patients with less aggressive disease. Further research is needed to establish the role of Armstrong risk groups for treatment selection in mCRPC patients. PATIENT SUMMARY: In this report, we validated the Armstrong nomogram in the COU-AA-302 trial population. We found a similar prognostic performance to that of the original model. Good-risk patients received the greatest benefit from abiraterone.

Evaluation of a severity score to predict the prognosis of Fournier's gangrene.

OBJECTIVE: To determine the validity of a Fournier's gangrene severity index (FGSI), developed to assign a numerical score describing the severity of FG, and evaluate factors in the survival of patients with FG. PATIENTS AND METHODS: We retrospectively reviewed 51 patients diagnosed with FG between 1994 and 2006. Data were collected on their medical history, which included vital signs (temperature, heart and respiratory rates) and metabolic variables (sodium, potassium, creatinine, bicarbonate levels, haematocrit, and white blood cell count). We computed a score relating to the severity of the disease at the time, and compared it to other features according to whether the patient survived or died. The different prognostic factors were assessed by univariate analysis with the Mann-Whitney U and Kendall A-B tests. RESULTS: Of the evaluated 51 inpatients, eight died (16%) and 43 survived (84%). The median (range) age was 63 (17-85) years and the median time from the onset of the symptoms until the admission to the emergency room was 7.8 (1-60) days. The mean hospital stay was 33 (2-90) days and 17 patients were admitted to the intensive-care unit for a mean of 4.5 days. There was no statistically significant difference between the groups. Body surfaces involved were the scrotum in five patients (10%), the penis and scrotum in 11 (22%), the scrotum and perineum in 30 (59%) and the abdominal wall in five (10%). There was no statistically significant difference in the distribution in those who survived or died (P = 0.131). The median age of 60 (17-81) years in the survivors was significantly lower than that of 73.5 (50-85) years in those who died (P = 0.02). There was no significant difference (P = 0.06) between the number of repeated debridements in the survivors (3.23) and those who died (5.25). The mean (range) FGSI score for survivors was 6.7 (0-14), vs 8.7 (6-13) for those who died (P = 0.12). The only laboratory variables associated with death were serum bicarbonate (P = 0.04) and serum sodium (P = 0.02) levels. CONCLUSIONS: FG is an unpredictable disease process with wide variability in its presentation. In our experience, the FGSI gives no indication of the likelihood of survival, but the risk factors for predicting the severity of FG seem to be greater in older patients and those with high sodium and low bicarbonate levels.

Normograma de flujometría en pacientes sin sintomatología urinaria / Normograma of flujometría in patients without urinary sintomatología

Se realizó un estudio descriptivo sobre los hallazgos de la flujometría en pacientes sin sintomatología urinaria que acuden a consulta urológica preventiva. Se recolectó una base de datos de 1680 pacientes, de los cuales 586 se sometieron a flujometría. Selecccionando apenas 200 que cumplieron los criterios de inclusión, éstos fueron sometidos a valoración clínica, estudio ecográfico y flujometría, con lo cual se trazó el normograma del Instituto Médico de Urología. Los pacientes fueron de sexo masculino con un rango de edad de 40 a 80 años. El promedio de edad encontrado en el estudio es de 55 años, con una media de 59 años. El promedio de flujo máximo de la serie fue de 16.02 ml/seg, lo que se ecuentra dentro de los valores aceptados internacionalmente...