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Currently, surveillance guidelines following surgical resection of clinically localized renal cell carcinoma (RCC) are clear within the first 5 yr; however, these lack the same degree of objectivity following this cutoff. We sought to investigate the long-term risk of recurrence in surgically treated RCC in order to determine the utility of long-term surveillance. A post hoc analysis of patients within the Eastern Cooperative Oncology Group—American College of Radiology Imaging Network (ECOG-ACRIN) E2805 trial cohort was performed. The 36-mo cumulative incidence of recurrence was assessed at set intervals following surgery, in order to dynamically assess recurrence through the use of a conditional survival model. Of the 1943 patients included in the original cohort, 730 developed recurrence. The 36-mo cumulative incidences of recurrence were found to be 31%, 26%, 19%, 16%, 19%, and 20% for patients at 0, 12, 24, 36, 48, and 60 mo from surgery, respectively. At 0 mo from surgery, age, pathological T3/4 stage (hazard ratio [HR] = 1.56), pathological N1/2 stage (HR = 2.38), and Fuhrman grades 3 and 4 (HR = 1.36 and HR = 2.41, respectively) were independent predictors of recurrence; however, this was not seen at 60 mo following surgery. These findings support that surveillance imaging should be performed beyond 5 yr following surgical resection of intermediate- to high-risk RCC. Patient summary : Follow-up for surgically resected localized renal cell carcinoma should be performed beyond 5 yr, for the rates of recurrence remain significant beyond this 5 yr endpoint.

INTRODUCTION AND OBJECTIVE:Men with family history of prostate cancer (PCa) constitute a high-risk cohort for PCa. Unfortunately, in absence of level 1 data, specific guidelines regarding prostate-...

INTRODUCTION AND OBJECTIVE:The prognostic significance of a ‘second’ biochemical recurrence (sBCR) after salvage radiation therapy (sRT) with/without hormonal therapy following primary radical pros...

INTRODUCTION AND OBJECTIVE:Age adjusted Prostate-Specific Antigen (aaPSA) reference ranges are used to improve the specificity and sensitivity of PSA testing due to the inherent variability and pro...

INTRODUCTION AND OBJECTIVE:A significant proportion of men that experience biochemical recurrence after radical prostatectomy do not receive timely salvage radiation therapy (sRT). It is unknown wh...

Studies have noted contrasting findings with regard to the contemporary incidence of metastatic prostate cancer (PCa) in the USA, especially in light of the United States Preventive Services Task Force (USPSTF) recommendations against prostate-specific antigen (PSA) screening in recent years. We used data from the 18 population- based tumor registries of the Surveillance, Epidemiology and End Results (SEER) 2004-2013 database to study trends in the incidence of metastatic PCa among men stratified by age and race. Joinpoint regression analyses were performed to identify time points associated with any statistically significant change in incidence. Overall, there was a significant increase in incidence between 2009 and 2013 (annual percentage change [APC] 3.10%; p

Ductal adenocarcinoma is considered a rare histological variant of prostate adenocarcinoma (PCa). Given the rarity of this subtype, optimal treatment strategies for men with nonmetastatic ductal PCa is largely unknown. We aimed to describe the impact of surgery, radiotherapy, systemic therapy, and observation on overall survival (OS) in men with nonmetastatic ductal PCa.We selected 1,656 cases of nonmetastatic ductal PCa, diagnosed between 2004 and 2015, within the National Cancer Database. Covariates included age, race, Charlson comorbidity score, clinical T stage, clinical lymph node stage, serum prostate specific antigen (PSA), income, hospital type, insurance status, year of diagnosis, and location of residence. Cox regression analysis tested the impact of treatment (surgery, radiotherapy, systemic therapy, and observation) on OS.In men with nonmetastatic ductal PCa, median (interquartile range [IQR]) age and PSA were 67 (60-73) years and 6.2 (4.2-10.7) ng/ml, respectively. Advanced local stage (≥cT3a) was most frequently observed in patients initially treated with systemic therapy (34.8%), followed by those treated with radiotherapy (18.1%), surgery (7.1%) and observation (6.4%, P0.001). Serum PSA at presentation was highest in the systemic therapy cohort (median 16.0 ng/ml, IQR: 4.9-37.7), followed by the radiotherapy cohort (median 7.2 ng/ml, IQR: 4.1-12.2), observation cohort (median 7.0 ng/ml, IQR: 4.3-13.3) and surgery cohort (median 5.9 ng/ml, IQR: 4.3-9.2, P0.001). Multivariable analysis showed that in comparison to men treated surgically, OS was significantly lower for patients receiving radiotherapy (HR 2.2; 95% CI: 1.5-3.2), under observation (HR 4.6; 95% CI: 2.8-7.6) and receiving systemic therapy (HR 5.2; 95% CI: 3.0-9.1) as an initial course of treatment.While limited by its retrospective nature, our study shows that starting treatment with surgery is associated with more favorable long-term OS outcomes than radiotherapy, systemic therapy or observation.

INTRODUCTION AND OBJECTIVE:The detrimental impact of lymphovascular invasion (LVI) in prostate cancer (PCa) on the risk of biochemical recurrence has been previously described. However, the impact ...

The American Joint Committee on Cancer recognizes 6 rare histological variants of prostate adenocarcinoma. We describe the contemporary presentation and overall survival of these rare variants.We examined 1,345,618 patients who were diagnosed with prostate adenocarcinoma between 2004 and 2015 within the National Cancer Database. We focused on the variants mucinous, ductal, signet ring cell, adenosquamous, sarcomatoid and neuroendocrine. Characteristics at presentation for each variant were compared with nonvariant prostate adenocarcinoma. Cox regression was used to study the impact of histological variant on overall mortality.Few (0.38%) patients presented with rare variant prostate adenocarcinoma. All variants had higher clinical tumor stage at presentation than nonvariant (all p0.001). Metastatic disease was most common with neuroendocrine (62.9%), followed by sarcomatoid (33.3%), adenosquamous (31.1%), signet ring cell (10.3%) and ductal (9.8%), compared to 4.2% in nonvariant (all p0.001). Metastatic disease in mucinous (3.3%) was similar to nonvariant (p=0.2). Estimated 10-year overall survival was highest in mucinous (78.0%), followed by nonvariant (71.1%), signet ring cell (56.8%), ductal (56.3%), adenosquamous (20.5%), sarcomatoid (14.6%) and neuroendocrine (9.1%). At multivariable analysis, mortality was higher in ductal (HR 1.38, p0.001), signet ring cell (HR 1.53, p0.01), neuroendocrine (HR 5.72, p0.001), sarcomatoid (HR 5.81, p0.001) and adenosquamous (HR 9.34, p0.001) as compared to nonvariant.Neuroendocrine, adenosquamous, sarcomatoid, signet ring cell and ductal variants more commonly present with metastases. All variants present with higher local stage than nonvariant. Neuroendocrine is associated with the worst and mucinous with the best overall survival.

Objective To examine the utilization of adjuvant radiotherapy (aRT) in contemporary prostate cancer patients with adverse pathological features at radical prostatectomy (RP). Methods We identified 189,240 patients with adverse features at RP (positive margin, stage ≥pT3a, and/or pN1 disease), from 2004 to 2015, within the National Cancer Database, and validated our findings within Surveillance, Epidemiology, and End Results (SEER) program. We examined the utilization of patients with aRT with adverse features at RP and patients with very aggressive disease (at least 2 of the following: ≥pT3b, pathological Gleason 8-10, and pN1). Regression analysis examined the relationship of various predictors of utilization adjusting to confounders. Pseudo R2 analysis examined the magnitude of influence that each variable had on the decision to use aRT. Results Within the National Cancer Database cohort, only 11.7% of our patients received aRT. In patients with very aggressive disease, aRT utilization rate was 28.9%. Within the SEER cohort, 16.3% of patients with any adverse features at time of RP received aRT. In patients with very aggressive disease, only 30% of patients received aRT. Further, year of diagnosis, Gleason grade, pathologic stage, and positive surgical margin were the variables that had the greatest influence on the decision to use aRT, and that positive surgical margin, type of institution at which care was received, and lymph node involvement were the most influential variables in patients with very aggressive disease. Conclusions The current standard of care in the United States represents a significant underutilization of aRT in eligible patients with prostate cancer. Urgent efforts are necessary to address this quality-of-care concern.

Using institutional data, we have previously developed an algorithm to identify the optimal candidates for adjuvant radiotherapy (aRT) among men with pN1 prostate cancer (PCa) at radical prostatectomy (RP). This study aimed to test the external validity of our previous findings using a nationwide database while focusing on overall mortality as an endpoint. To this end, we identified 5498 pN1 PCa patients who were treated with RP, pelvic lymph node dissection, and androgen deprivation therapy with or without aRT, within the National Cancer Database, between 2004 and 2015. Patients were divided into five groups based on our previously published algorithm. Similar to our previous report, multivariable Cox regression analysis showed that only two of these groups benefit from aRT: (1) those with one to two positive nodes, pathological Gleason score 7-10, and pT3b/4 disease or positive surgical margins (hazard ratio [HR]=0.75); and (2) those with three to four positive nodes, regardless of local tumor characteristics (HR=0.57, both p=0.01). In the remaining patients (25% of the cohort), aRT had no significant survival benefit. Results were confirmed on sensitivity analyses using 1:1 propensity score-matched cohorts, excluding men who died within 3 yr of surgery and using cut-off of 6 mo post-surgery to identify receipt of aRT. Our findings corroborate the validity of our previously published criteria and highlight the importance of patient selection in pN1 PCa patients who are considered for aRT.

A recent study reported an overall survival benefit for patients with metastatic urothelial carcinoma of the bladder (mUCB) managed with high-intensity local treatment (LT) of the primary tumor (chemotherapy plus radical cystectomy and/or radiation therapy ≥50Gy). Given the non-negligible morbidity of these procedures, adequate patient selection is crucial. Our objective was to identify patients who might benefit the most from high-intensity LT. Data for 3044 patients with mUCB at diagnosis were extracted from the National Cancer Data Base 2004-2013, and patients were categorized on the basis of treatment: high-intensity LT versus conservative LT (chemotherapy plus transurethral resection of bladder tumor and/or radiation therapy50Gy). Multivariate Cox regression analysis predicted baseline 2-yr overall mortality (OM) risk among patients who received conservative LT. We then assessed the interaction between predicted OM risk and LT type. Compared to conservative LT, high-intensity LT yielded a higher observed OM-free survival rate among all patients with pure mUCB, irrespective of their predicted OM risk (nonsignificant interaction, p=0.7). These findings underline the need for further retrospective and prospective evaluation. PATIENT SUMMARY: Among patients with metastatic histologically pure urothelial carcinoma of the bladder, we found an overall survival benefit of high-intensity local treatment directed at the primary tumor, regardless of predicted baseline 2-yr overall mortality risk.

Contemporary treatment trends for prostate cancer show increased rates of active surveillance. However, nationwide applicability of these reports is limited. Additionally, the effect of Commission on Cancer facility type on prostate cancer treatment patterns is unknown.We used the National Cancer Data Base to identify men diagnosed with prostate cancer, between 2004 and 2013. Our cohort was stratified on the basis of the National Comprehensive Cancer Network prostate cancer risk classes. Cochran-Armitage tests were used to evaluate temporal trends. Random effects hierarchical logit models were used to assess treatment variation at Commission on Cancer facility and institution level.In 825,707 men, utilization of radiation therapy declined and utilization of radical prostatectomy increased for all prostate cancer risk groups between 2004 and 2013 (P .0001). Observation for low-risk prostate cancer increased from 16.3% in 2004 to 2005 to 32.0% in 2012 to 2013 (P .0001). Significant treatment variation was observed on the basis of Commission on Cancer facility type. Across all risk groups, the lowest rates of radical prostatectomy and highest rates of external beam radiation therapy were observed in community cancer programs. The highest rates of observation for low-risk disease were observed in academic centers. Treatment variation according to institution ranged from 14% (95% confidence interval, 0.12-0.15) for androgen deprivation therapy up to 59% (95% confidence interval, 0.45-0.73) for cryotherapy.The increased utilization of observation in low-risk prostate cancer is an encouraging finding, which appears to be mainly derived by a decrease in radiotherapy utilization in this risk group. Regardless of tumor characteristics, significant variations in treatment modality exist among different facility types and institutions.

INTRODUCTION AND OBJECTIVES:The last decade witnessed an increasing adoption of active surveillance (AS) as a treatment option in low-risk prostate cancer (PCa) patients. However, low-risk patients...

INTRODUCTION AND OBJECTIVES:American Joint Committee on Cancer (AJCC) recognizes five rare histological variants of PCa. Our aim was to describe the contemporary presentation and overall survival (...

INTRODUCTION AND OBJECTIVES:To evaluate rates and patterns of local and metastatic disease occurrence in patients with node-negative non-metastatic prostate cancer at radical prostatectomy (RP) tha...

EORTC 30904 reported that for solitary renal mass

Background: To evaluate the potential impact of lead-time bias on the reported beneficial role of early salvage radiotherapy (sRT), defined as delivering radiation at a relatively low pre-sRT prostate-specific antigen (PSA) value, in treating prostate cancer patients with biochemical recurrence after radical prostatectomy (RP). Methods: All available demographic, tumor-specific, and overall survival data from 760 men who participated in the RTOG 9601 trial were extracted using the Project Data Sphere platform. Patients were stratified based on pre-sRT PSA ( 1.5-4.0 ng/mL [n=118]) as reported in the original trial. Cox regression analysis assessed the impact of pre-sRT PSA on overall mortality, after controlling for covariates. To ascertain the role of lead-time bias, survival time zero was set to the time of (1) initiation of sRT, and (2) RP. Findings: There were no statistically significant differences amongst men within the three groups, except for a greater proportions of African-American patients and men with post-RP PSA nadirs ≥0.5 ng/mL within the higher pre-sRT PSA groups. For men with pre-sRT PSA 1.5-4 ng/mL, estimated 15-year overall mortality was 39%, 45%, and 50%, respectively (p=0.005) when calculated from time since sRT, and 23%, 29%, and 36% respectively (p=0.08) when assessed from time since RP. On multivariable regression analyses, pre-sRT PSA >1.5-4.0 ng/mL was significantly associated with overall mortality only when measured from time of initiation of sRT (HR 1.61, 95% confidence interval [CI] 1.13-2.28; p=0.008), but not from time since RP (HR 1.24, 95% CI 0.87-1.76; p=0.2). Interpretation: Our findings suggest that the putative survival benefit with early sRT instituted at lower PSA thresholds is mitigated when measured from time since surgery, highlighting the role of lead-time bias. These findings need further validation given their significant clinical implications. Funding Statement: There was no funding for this study. The corresponding author had full access to all data in the study and had final responsibility for the decision to submit for publication. Declaration of Interests: Firas Abdollah is a consultant for GenomeDx Biosciences. Ethics Approval Statement: An institutional review board waiver was obtained before the study was conducted, in accordance with institutional regulation when dealing with de-identified previously collected data.

Background: Active surveillance (AS) is increasingly recognized as a recommended treatment option for prostate cancer (PCa) patients with clinically localized, low-risk disease; however, previous studies suggested that its utilization is uncommon in the United States. Objective: We evaluated the nationwide utilization rate of AS in the contemporary era. Design, setting, and participants: We relied on the 2010-2011 Surveillance Epidemiology and End Results (SEER) database using all 18 SEER-based registries. We identified 9049 patients that fulfilled the University of California, San Francisco AS criteria (prostate-specific antigen level

To determine if American men with prostate cancer are at increased risk of suicide/accidental death compared with other cancers and if the receipt of definitive treatment alters this association, as patients with cancer are at increased risk of suicide and evidence suggests a relationship between suicides and deaths due to accidents and externally caused injuries.Demographic, socio-economic and tumour characteristics of men with prostate cancer and men with other solid malignancies were extracted from the Surveillance, Epidemiology and End Results (SEER) database (1988-2010). Poisson regression models were fitted to compare the incidence of suicidal and accidental deaths in prostate cancer vs other solid cancers. Multivariate Cox regression was used to determine if receipt of definitive primary treatment impacted the risk of suicide or accidental death in men with localised/regional prostate cancer.Risk of suicidal and accidental death was significantly lower in men with prostate cancer (1 165 [0.2%] and 3 199 [0.6%]) than men with other cancers (2 232 [0.2%] and 4 501 [0.5%], respectively), except within the first year of diagnosis (adjusted relative risk [ARR] 3.98, 95% confidence interval [CI] 3.02-5.23 and ARR 4.22, 95% CI 3.24-5.51, respectively, 0-3 months after diagnosis). Men with non-metastatic prostate cancer who were White, uninsured, or recommended but did not receive treatment (hazard ratio vs treated 1.44, 95% CI 1.20-1.72, and 1.44, 95% CI 1.30-1.59, both P0.001) were at increased risk of suicidal and accidental mortality, respectively. Absence of data about previous co-morbidities and drug addictions in the SEER dataset was an important limitation.Relative to other cancers, men with prostate cancer were at increased risk of suicide and accidental deaths within the first year of diagnosis and when definitive treatment was recommended but not received, suggesting the need for close monitoring and coordination with mental health professionals in at-risk men with potentially curable disease.

Purpose Despite documented oncologic benefit, use of postoperative adjuvant radiotherapy (aRT) in patients with prostate cancer is still limited in the United States. We aimed to develop and internally validate a risk-stratification tool incorporating the Decipher score, along with routinely available clinicopathologic features, to identify patients who would benefit the most from aRT. Patient and Methods Our cohort included 512 patients with prostate cancer treated with radical prostatectomy at one of four US academic centers between 1990 and 2010. All patients had ≥ pT3a disease, positive surgical margins, and/or pathologic lymph node invasion. Multivariable Cox regression analysis tested the relationship between available predictors (including Decipher score) and clinical recurrence (CR), which were then used to develop a novel risk-stratification tool. Our study adhered to the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis guidelines for development of prognostic models. Results Overall, 21.9% of patients received aRT. Median follow-up in censored patients was 8.3 years. The 10-year CR rate was 4.9% vs. 17.4% in patients treated with aRT versus initial observation ( P < .001). Pathologic T3b/T4 stage, Gleason score 8-10, lymph node invasion, and Decipher score > 0.6 were independent predictors of CR (all P < .01). The cumulative number of risk factors was 0, 1, 2, and 3 to 4 in 46.5%, 28.9%, 17.2%, and 7.4% of patients, respectively. aRT was associated with decreased CR rate in patients with two or more risk factors (10-year CR rate 10.1% in aRT v 42.1% in initial observation; P = .012), but not in those with fewer than two risk factors ( P = .18). Conclusion Using the new model to indicate aRT might reduce overtreatment, decrease unnecessary adverse effects, and reduce risk of CR in the subset of patients (approximately 25% of all patients with aggressive pathologic disease in our cohort) who benefit from this therapy.

Poor nutritional status is thought to influence peri- and postoperative outcomes. We assessed the association of hypoalbuminemia, a surrogate for poor nutritional status, with perioperative outcomes in patients undergoing one of 16 major surgical procedures.Patients undergoing one of 16 major surgeries were identified using the ACS-NSQIP (2005-2011). Risk-adjusted logistic regression models examined the association of hypoalbuminemia on perioperative outcomes.Overall, 204,819 complete cases were identified, of whom 25.4% underwent major cardiovascular, 19.0% orthopedic and 55.6% oncologic surgery. Patients with hypoalbuminemia had significantly higher rates of complications, reoperations, readmissions, prolonged length-of-stay and mortality (all p 0.001). After adjustment, hypoalbuminemia was an independent predictor of overall complications in 12 of the procedures examined and 30-day mortality in 11 of the procedures. Individual perioperative complication profile varied widely among procedures.Hypoalbuminemia exerts significant impact on perioperative outcomes. Its effect is procedure-specific and thus warrants targeted management strategies to improve surgical outcomes. In the absence of clear recommendations, our findings invite surgeons to assess preoperative albumin levels and to manage nutritional status accordingly.

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) concluded that radical prostatectomy (RP) offered no survival benefit compared with observation in men with clinically localized prostate cancer (PCa). We identified patients within the National Cancer Database (NCDB) for the period 2004-2012 who met the inclusion criteria of PIVOT (ie, histologically confirmed PCa, clinical stage T1-2NxM0, prostate-specific antigen50 ng/ml, age75 yr, estimated life expectancy10 yr, and undergoing RP or observation as initial treatment within 12 mo of diagnosis) to confirm the generalizability of the PIVOT results to the US population. Life expectancy was calculated using the US Social Security Administration life tables and was adjusted for comorbidities at diagnosis. Compared with PIVOT, men in the NCDB were younger (mean age 60.3 vs 67.0 yr) and healthier (Charlson-Deyo comorbidity index of 0: 93% vs 56%; both p0.001). Furthermore, 42% of men randomized to receive RP in PIVOT harbored D'Amico low-risk PCa, whereas 32% of men undergoing RP in the NCDB had low-risk disease. Our findings were confirmed in a sensitivity analysis including men regardless of life expectancy but satisfying all other inclusion criteria of PIVOT. Given that the NCDB represents nearly 70% of all incident cancers diagnosed in the United States, our data provide further evidence that PIVOT results may not be generalizable to contemporary clinical practice.We observed that men diagnosed with clinically localized prostate cancer within the National Cancer Database (2004-2012) were younger, healthier, and more likely to have radical prostatectomy for higher risk disease than men in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), raising questions about the applicability of PIVOT conclusions to the contemporary US population.

INTRODUCTION AND OBJECTIVES: The role of local treatment (LT) in prostate cancer (PCa) patients with M1 disease at diagnosis is controversial. We set to test the hypothesis that the potential efficacy of such treatment on overall mortality (OM) is influenced by tumor characteristics, as well as patient general health status. We based our analyses on the National cancer database (NCDB), which captures 70% of newly diagnosed tumors in US. METHODS: We focused on 16,274 PCa patients diagnosed with M1 disease, between 2004 and 2011, within the NCDB database. Men receiving radical prostatectomy, and/or radiotherapy targeted to prostate were categorized as LT, everybody else was categorized as non-local treatment (NLT). Multivariable regression analysis (MVA) including tumor and patient characteristics was used to predict OM in patients that received NLT. To assess whether the benefit of LT was different by baseline risk, we tested the interaction between predicted OM risk and LT status. RESULTS: Overall, 719 (4.4%) of patients received LT. Patients with NLT tended to be older, had higher comorbidity, and harbored more aggressive tumors. (all p 1 vs 0, respectively), PSA (HR 1.003), biopsy Gleason (HR 1.4 for 8-10 vs. 7), clinical stage (HR 1.09 for cT3/4 vs cT1/2), and clinical M stage (HR 1.5, and 1.9 for M1b vs M1a and M1c vs M1a, respectively) were independent predictors of OM (all p

Renal cell carcinoma (RCC) is well known for its ability to metastasize to different organs, but the involvement of gynecological organs is rare. Our case represents the first case of bilateral RCC with metastasis to the myometrium. The patient was a 60-year-old woman who underwent bilateral robotic partial nephrectomy surgeries for clear cell RCC, low-grade, low-stage with negative margins. Her 1-year postoperative computed tomography scan showed an enlarging necrotic uterine mass. She underwent a debulking excision, including hysterectomy, with pathology showing metastatic RCC to the uterus. The patient developed widespread metastatic disease, and died months later of metastatic RCC.

5035Background: Using institutional data, we have previously identified sub-groups of patients with pN1 prostate cancer, who can benefit from aRT plus adjuvant hormonal therapy (aHT) after RP. Our ...