Comparative effectiveness of treatments for high-risk prostate cancer patients.

BACKGROUND: To determine the comparative effectiveness of primary radical prostatectomy (RP) compared to external bean radiation therapy (EBRT) with androgen deprivation therapy (ADT), or EBRT plus brachytherapy (BT) with or without ADT among Medicare fee-for-service beneficiaries with high-risk prostate cancer, for 10-year, mortality (overall and prostate cancer-specific), complications, health service use, and cost. METHODS: This population-based cohort study used Surveillance, Epidemiology, and End Results - Medicare data. Eligible patients were men aged 66 or older and diagnosed with high-risk prostate cancer between 1996 and 2003. Outcomes evaluated were 10-year overall mortality and prostate cancer-specific mortality, complications, health service use, and cost. We used Cox regression, Poisson regression, and Generalized Linear Model (GLM) log-link models to assess the outcomes. MAIN FINDINGS: The 10-year overall mortality of EBRT + ADT was comparable to that of the RP group (hazard ratio [HR] = 1.09, confidence interval [CI] = 0.72-1.66). The EBRT + BT ± ADT group had overall survival advantage compared to RP (HR = 0.47, CI = 0.31-0.73). Compared to the RP group, EBRT + ADT group had higher 10-year prostate cancer-specific mortality (HR = 2.19, CI = 1.92-5.21). Both EBRT + ADT and EBRT + BT ± ADT were associated with higher 10-year cost (odds ratio = 1.72, CI = 1.35-2.20; and odds ratio = 1.63, CI = 1.29-2.04), compared to RP group. Complications and health service use varied across 3 treatment groups and across phases of care. PRINCIPAL CONCLUSIONS: Our results also demonstrate long-term overall survival benefits for EBRT + BT ± ADT, and greater bowel and bladder side effects over a decade, compared to RP. The RP group had advantage for long-term prostate-cancer specific mortality, compared to EBRT + ADT group. Thus, RP can provide superior cancer control with clear cost advantage for older men with high-risk disease. In terms of value proposition, our results support RP as preferred treatment option, compared to EBRT + ADT and EBRT + BT ± ADT for high-risk prostate cancer patients.

Comparative effectiveness of prostate cancer treatments for patient-centered outcomes: A systematic review and meta-analysis (PRISMA Compliant).

BACKGROUND: In the context of prostate cancer (PCa) characterized by the multiple alternative treatment strategies, comparative effectiveness analysis is essential for informed decision-making. We analyzed the comparative effectiveness of PCa treatments through systematic review and meta-analysis with a focus on outcomes that matter most to newly diagnosed localized PCa patients. METHODS: We performed a systematic review of literature published in English from 1995 to October 2016. A search strategy was employed using terms "prostate cancer," "localized," "outcomes," "mortality," "health related quality of life," and "complications" to identify relevant randomized controlled trials (RCTs), prospective, and retrospective studies. For observational studies, only those adjusting for selection bias using propensity-score or instrumental-variables approaches were included. Multivariable adjusted hazard ratio was used to assess all-cause and disease-specific mortality. Funnel plots were used to assess the level of bias. RESULTS: Our search strategy yielded 58 articles, of which 29 were RCTs, 6 were prospective studies, and 23 were retrospective studies. The studies provided moderate data for the patient-centered outcome of mortality. Radical prostatectomy demonstrated mortality benefit compared to watchful waiting (all-cause HR = 0.63 CI = 0.45, 0.87; disease-specific HR = 0.48 CI = 0.40, 0.58), and radiation therapy (all-cause HR = 0.65 CI = 0.57, 0.74; disease-specific HR = 0.51 CI = 0.40, 0.65). However, we had minimal comparative information about tradeoffs between and within treatment for other patient-centered outcomes in the short and long-term. CONCLUSION: Lack of patient-centered outcomes in comparative effectiveness research in localized PCa is a major hurdle to informed and shared decision-making. More rigorous studies that can integrate patient-centered and intermediate outcomes in addition to mortality are needed.

Percutaneous Renal Cryoablation: Short-Axis Ice-Ball Margin as a Predictor of Outcome.

PURPOSE: To determine if CT characteristics of intraprocedural ice balls correlate with outcomes after cryoablation. MATERIALS AND METHODS: A retrospective review was performed on 63 consecutive patients treated with renal cryoablation. Preprocedural and intraprocedural images were used to identify the size and location of renal tumors and ice balls as well as the tumor coverage and ice-ball margins. Review of follow-up imaging (1 mo and then 3-6-mo intervals) distinguished successful ablations from cases of residual tumor. RESULTS: Patients who underwent successful ablation (n = 50; 79%) had a mean tumor diameter of 2.5 cm (range, 0.9-4.3 cm) and mean ice-ball margin of 0.4 cm (range, 0.2-1.2 cm). Patients with residual tumor (n = 13; 21%) had a mean tumor diameter of 3.8 cm (range, 1.8-4.5 cm) and mean ice-ball margin of -0.4 cm (range, -0.9 to 0.4 cm). Residual and undertreated tumors were larger and had smaller ice-ball margins than successfully treated tumors (P < .01). Ice-ball diameters were significantly smaller after image reformatting (P < .01). Ice-ball margins of 0.15 cm had 90% sensitivity, 92% specificity, and 98% positive predictive value for successful ablation. Success was independent of tumor location or number of cryoprobes. CONCLUSIONS: Ice-ball margin and real-time intraprocedural reformatting could be helpful in predicting renal cryoablation outcomes. Although a 0.5-cm margin is preferred, a well-centered ice ball with a short-axis margin greater than 0.15 cm strongly correlated with successful ablation.

Impact on renal function of percutaneous thermal ablation of renal masses in patients with preexisting chronic kidney disease.

PURPOSE: To examine the effect of percutaneous thermal ablation of renal masses on renal function among patients with baseline chronic kidney disease (CKD). MATERIALS AND METHODS: Patients with baseline CKD (initial glomerular filtration rate [GFR] < 60 mL/min/1.73 m(2)) who underwent percutaneous cryoablation or radiofrequency (RF) ablation of renal masses were reviewed. RESULTS: A total of 48 patients with a GRF of 60 mL/min/1.73 m(2) or lower were treated with renal cryoablation or RF ablation and had follow-up GFR measurement 1 month afterward. Mean patient age was 73 years (range, 47-89 y). Cryoablation was performed in 22 patients and RF ablation was performed in 26. Mean tumor diameter was 3.4 cm (range, 0.9-10.2 cm). Mean overall GFRs were 39.8 mL/min/1.73 m(2) at baseline and 39.7 mL/min/1.73 m(2) at 1 month after ablation (P = .85). A total of 38 patients had 1-year follow-up GFR measurement (cryoablation, n = 18; RF ablation, n = 20), and their mean GFR was 40.9 mL/min/1.73 m(2) ± 11.4 (SD), compared with a preablation GFR of 41.2 mL/min/1.73 m(2)(P = .79). In the cryoablation group, mean GFRs at 1 month and 1 year were 41.4 mL/min/1.73 m(2) and 44.4 mL/min/1.73 m(2), compared with respective baseline GFRs of 41.1 mL/min/1.73 m(2) and 42.1 mL/min/1.73 m(2) (P = .75 and P = .19, respectively). In the RF ablation group, mean GFRs at 1 month and 1 year were 38.2 mL/min/1.73 m(2) and 37.8 mL/min/1.73 m(2), compared with respective baseline GFRs of 38.7 mL/min/1.73 m(2) and 40.4 mL/min/1.73 m(2) (P = .58 and P = .09, respectively). CONCLUSIONS: Independent of ablation modality, percutaneous renal mass ablation does not appear to affect renal function among patients with CKD.

Embolization of giant renal angiomyolipomas: technique and results.

PURPOSE: To evaluate the efficacy and safety of prophylactic embolization of angiomyolipomas (AMLs) larger than 10 cm. MATERIALS AND METHODS: Sixteen patients (mean age, 41.2 years; 14 women and two men) underwent embolization for 23 AMLs larger than 10 cm. All lesions were embolized by using microcatheters with ethanol and ethiodized oil mixed to a ratio of 7(ethanol) to 3(ethiodized oil). Data collected included pre- and posttreatment AML size, creatinine level, technical success, volume of embolic material used, clinical success, and complications. RESULTS: The mean AML size before treatment was 15 cm (range, 10-25 cm). Ten of the 16 patients (62%) had all their AMLs treated in one session, whereas six (38%) required multiple sessions. A mean volume of 8.6 mL of the ethanol-ethiodized oil mixture (range, 2-20 mL) was administered per lesion. Patients were followed up for a mean of 29 months (range, 1-80 months). No patient had an increase of 0.2 mg/dL (17.7 mumol/L) or greater in mean serum creatinine level during the follow-up period. Two of the 16 patients (12%) required repeat embolization due to AML regrowth (n = 1) or reperfusion (n = 1) seen at surveillance imaging. One of the 16 patients (6.2%) had an AML hemorrhage 59 months after AML embolization. CONCLUSIONS: Embolization of giant renal AMLs to decrease the risk of bleeding can be done safely without loss of renal function. Although recurrence was infrequent, additional treatment may be necessary and giant renal AMLs should be followed up with serial imaging studies.