Effects of primary care physician density, urologist presence, and insurance status on stage of diagnosis for urologic malignancies.

OBJECTIVE: To evaluate effects of PCP density, insurance status, and urologist presence on stage of diagnosis for urologic malignancies. Cancer stage at diagnosis is an important outcome predictor. Studies have shown an inverse relationship to primary care physician (PCP) density and insurance coverage with stage of cancer diagnosis. METHODS: Data was obtained from OK2Share, an Oklahoma Central Cancer Registry, for bladder, kidney, and prostate cancer from 2000 to 2010. Physician data was obtained through the State Licensing Board. The 2010 national census was used for population data. High PCP density was defined as greater than or equal to the median value: 3.17 PCP/10,000 persons. Chi-square and multivariate logistic regressions were used to analyze effects of PCP density, insurance status, and urologist presence on advanced stage diagnosis. RESULTS: 27,086 patients were identified across 77 counties. As PCP density increased by 1 PCP/10,000 persons, the odds ratios (OR) of an advanced stage at diagnosis were 0.383, 0.468, 0.543 for bladder, kidney, and prostate cancer respectively. Compared to private insurance, being uninsured had OR of 1.61 and 2.45 respectively for kidney and prostate cancers. The OR of an advanced stage diagnosis for bladder and prostate cancer were 3.77 and 1.73, respectively, in counties with a urologist. CONCLUSIONS: Increased PCP density and insurance coverage reduced the odds of an advanced diagnosis. Implementation of policies to improve access to healthcare including through increasing PCP density and reducing the number of uninsured patients should result in diagnosis at an earlier stage, which will likely improved cancer-related outcomes.

Minimally Invasive Versus Open Approach for Cystectomy: Trends in the Utilization and Demographic or Clinical Predictors Using the National Cancer Database.

OBJECTIVE: To examine temporal national trends of operative approach for cystectomy and identify demographic or clinical predictive factors that influence choice of approach. METHODS: We performed a retrospective cohort study of patients who underwent cystectomy for bladder cancer between 2010 and 2013 using the National Cancer Database. Approach was stratified by open vs minimally invasive (robotic or laparoscopic). Univariate Pearson chi-square and multivariate logistic regression analysis were used to assess the relationships between demographic and hospital factors and the receipt of minimally invasive or open surgical approach. RESULTS: A total of 9439 patients met our inclusion criteria, of which 34.1% received a minimally invasive approach (MIA). Frequency of MIA increased from 26.3% in 2010 to 39.4% in 2013 (P < .0001). Univariate analysis identified statistically significant associations between year of diagnosis, sex, age, race, clinical T stage, insurance status, income, education, distance from hospital, facility type, geographic location, and facility cystectomy volume, and the choice of approach (all P < .01). On multivariate analysis, independent predictors of MIA included increasing year of diagnosis, male gender, lower clinical T stage, private insurance vs Medicaid, nonacademic vs academic program, northeastern geographic region, receipt of neoadjuvant chemotherapy, and lower cystectomy volume. CONCLUSION: Utilization of MIA for cystectomy has increased nationally over the last several years likely due to increased surgeon familiarity with robotic laparoscopic pelvic surgery. Factors associated with MIA included male sex, locally confined disease, receipt of neoadjuvant chemotherapy, lower cystectomy volume centers, and nonacademic centers.

Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer.

BACKGROUND: The efficacy of neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (BCa) was established primarily with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), with complete response rates (pT0) as high as 38%. However, because of the comparable efficacy with better tolerability of gemcitabine and cisplatin (GC) in patients with metastatic disease, GC has become the most commonly used regimen in the neoadjuvant setting. OBJECTIVE: We aimed to assess real-world pathologic response rates to NAC with different regimens in a large, multicenter cohort. DESIGN, SETTING, AND PARTICIPANTS: Data were collected retrospectively at 19 centers on patients with clinical cT2-4aN0M0 urothelial carcinoma of the bladder who received at least three cycles of NAC, followed by radical cystectomy (RC), between 2000 and 2013. INTERVENTION: NAC and RC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was pathologic stage at cystectomy. Univariable and multivariable analyses were used to determine factors predictive of pT0N0 and ≤pT1N0 stages. RESULTS AND LIMITATIONS: Data were collected on 935 patients who met inclusion criteria. GC was used in the majority of the patients (n=602; 64.4%), followed by MVAC (n=183; 19.6%) and other regimens (n=144; 15.4%). The rates of pT0N0 and ≤pT1N0 pathologic response were 22.7% and 40.8%, respectively. The rate of pT0N0 disease for patients receiving GC was 23.9%, compared with 24.5% for MVAC (p=0.2). There was no difference between MVAC and GC in pT0N0 on multivariable analysis (odds ratio: 0.89 [95% confidence interval, 0.61-1.34]; p=0.6). CONCLUSIONS: Response rates to NAC were lower than those reported in prospective randomized trials, and we did not discern a difference between MVAC and GC. Without any evidence from randomized prospective trials, the best NAC regimen for invasive BCa remains to be determined. PATIENT SUMMARY: There was no apparent difference in the response rates to the two most common presurgical chemotherapy regimens for patients with bladder cancer.

Trends in the use of perioperative chemotherapy for localized and locally advanced muscle-invasive bladder cancer: a sign of changing tides.

BACKGROUND: Despite the documented survival benefit conferred by neoadjuvant (NAC) and adjuvant chemotherapy (AC), there has been a slow adoption of guideline recommendations for the use of perioperative chemotherapy (POC) in patients with muscle-invasive bladder cancer (MIBC). OBJECTIVE: To evaluate temporal trends in POC utilization and identify factors influencing POC delivery in a representative cohort of patients with MIBC. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study identifying factors associated with receipt of POC and evaluating temporal changes in NAC and AC utilization. We included patients from the National Cancer Data Base (NCDB) with no prior malignancy who ultimately underwent radical cystectomy for ≥ cT2/cN0/cM0 MIBC between 2006 and 2010. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Relationships between demographic and hospital factors and the likelihood of receiving POC were evaluated using Pearson chi-square and Wilcoxon rank-sum tests, and multivariable logistic regression. Temporal changes in NAC and AC use were detected using a linear test of trend. RESULTS AND LIMITATIONS: A total of 5692 patients met our inclusion criteria. POC use increased from 29.5% in 2006 to 39.8% in 2010 (p < 0.001). NAC use increased from 10.1% in 2006 to 20.8% in 2010 (p = 0.005); AC remained stable between 18.1% and 21.3% (p = 0.68). Multivariable modeling revealed advanced age, increasing comorbidity, lack of insurance, increased travel distance, geographic location outside the northeastern United States, and lower income as negatively associated with POC receipt (all p < 0.05). Limitations include retrospective design and potential sampling bias, excluding patients treated at non-NCDB facilities. CONCLUSIONS: POC use for MIBC increased from 2006 to 2010, with this increase disproportionately due to rising NAC utilization. Nonetheless, there is persistent variation in the likelihood of receiving POC secondary to nonclinical factors. PATIENT SUMMARY: When retrospectively analyzing a representative cohort of patients undergoing radical cystectomy for muscle-invasive bladder cancer between 2006 and 2010, we noted that preoperative chemotherapy rates increased steadily while use of chemotherapy after surgery remained stable. Factors related to access to care significantly influenced receipt of chemotherapy.

Korean version of the functional assessment of cancer therapy (FACT)-vanderbilt cystectomy index (VCI): translation and linguistic.

PURPOSE: To develop a Korean version of the Functional Assessment of Cancer Therapy (FACT)-Vanderbilt Cystectomy Index (VCI) from the original English version, with subsequent linguistic validation in Korean patients who underwent radical cystectomy with urinary diversion. MATERIALS AND METHODS: Translation and linguistic validation were carried out between January and May of 2013, which consisted of the following stages:(1) permission for translation;(2) forward translation;(3) reconciliation;(4) backward translation;(5) cognitive debriefing and(6) final proof-reading. RESULTS: During the forward translation phases,word as such as "bother","spend time", "support", "coping" and "concern" were adjusted to be more comprehensible to the target population. There conciled Korean version was accepted without certain objections because the original version and the backward translation were almost congruent except for minor differences in a subset of questions. The translation was tested using 5 Korean-speaking subjects. The subjects took an average of 8.2 minutes to complete the questionnaire, without difficulty and found the questionnaire clear and easy to understand. The panel discussed each of the issues raised by subjects and most terms were judged by the panel as to not require further changes because the overall comprehension levels were relatively high and because the translated terms were accurately rendered in the target languages. CONCLUSION: This report has demonstrated that despite translation difficulties, the linguistic validation of the FACT-VCI in the Korean language was successful. The next step is to assess the psychometric properties of the Korean version of FACT-VCI.

Blood loss associated with radical cystectomy: a prospective, randomized study comparing Impact LigaSure vs. stapling device.

OBJECTIVES: Radical cystectomy (RC) is associated with significant blood loss and transfusion requirement. We performed a prospective, randomized trial to compare blood loss, operative time, and cost using 2 different and commonly employed approaches to tissue ligation and division during RC: mechanical (stapler device) and electrosurgical (heat-sealing device). METHODS AND MATERIALS: Eighty patients undergoing RC for urothelial bladder carcinoma were randomized to use of either an Endo GIA Stapler or Impact LigaSure device for tissue ligation and division. Primary outcomes were blood loss, operative time, and device costs. Data were analyzed with Wilcoxon rank sum test and Welch 2-sample t test. RESULTS: There were no significant demographic or preoperative differences between the cohorts. Mean estimated blood loss was similar between the electrosurgical (687 ml) and stapler (708 ml) arms (P = 0.850). There were no significant differences between cohorts when comparing operative times or transfusion requirement. There was a significant increase in the mean number of adjunctive suture ligatures used in the stapling device arm (3.0 vs. 1.5, P = 0.047). Total device costs were significantly lower with the LigaSure compared with the GIA Stapler ($625.00 vs. $1490.10, P<0.001). There were no complications attributable to either device. CONCLUSIONS: This prospective, randomized study demonstrates no significant difference in blood loss, transfusion requirement, or safety between mechanical vs. electrosurgical control of the vascular pedicles. The LigaSure device, however, is significantly less costly than the GIA Stapler and required fewer additional measures for hemostasis.

Volume outcomes of cystectomy--is it the surgeon or the setting?

PURPOSE: Hospital volume and surgeon volume are each associated with outcomes after complex oncological surgery. However, the interplay between hospital and surgeon volume, and their impact on these outcomes has not been well characterized. We studied the relationship between surgeon and hospital volume, and overall mortality after radical cystectomy. MATERIALS AND METHODS: The SEER (Surveillance, Epidemiology and End Results)-Medicare linked database was used to identify 7,127 patients with urothelial carcinoma of the bladder who underwent radical cystectomy from 1992 to 2006. Hospital volume and surgeon volume were expressed by tertile. The primary outcome measure was overall survival. Covariates included age, Charlson comorbidity index, stage, grade, node count, node density, number of positive nodes, urinary diversion and year of surgery. Multivariate analyses using generalized linear multilevel models were used to determine the independent association between hospital and surgeon volume and survival. RESULTS: When hospital volume or surgeon volume was included in the multivariate model, a significant volume-survival relationship was observed for each. However, when both were in the model, hospital volume attenuated the impact of surgeon volume on mortality while the significant hospital volume-mortality relationship persisted (HR 1.18, 95% CI 1.08-1.30, p <0.01). In addition, the adjusted 3-year probability of survival was significantly correlated with hospital volume in each distinct surgeon volume stratum while survival was not correlated with surgeon volume in each hospital volume stratum. CONCLUSIONS: After adjustment for patient and disease characteristics, the relationship between surgeon volume and survival after radical cystectomy is accounted for by hospital volume. In contrast, hospital volume remained an independent predictor of survival, suggesting that structure and process characteristics of high volume hospitals drive long-term outcomes after radical cystectomy.

Sperm banking: use and outcomes in patients treated for testicular cancer.

OBJECTIVE: To identify the frequency that sperm banking was used by men being treated for testicular cancer at our institution, and to characterize the differences between men choosing to bank sperm or not, and outcomes in terms of after-treatment pregnancies. PATIENTS AND METHODS: A questionnaire addressing sperm banking and fertility was administered to men treated for testicular cancer at our institution between 1994 and 2004; the results were evaluated statistically. RESULTS: Overall, 31 of 129 (24%) respondents had banked sperm. Of these, two had used their banked sperm to father a child, and 12 had had children naturally. Men who banked sperm were a mean of 10.3 years younger (P < 0.001) and less likely to have children at the time of diagnosis (P < 0.025) than men choosing not to bank sperm. The cost of banking sperm was reported to include a mean fee of US dollars 358 (median 300, range 0-1000), and a mean annual maintenance fee of US dollars 243.86 (median 300, range 0-1200). CONCLUSIONS: Only a minority of men in this study chose to bank sperm (24%). Among those who did, the use of banked sperm was low (<10%), and many men could have children without using banked sperm. Given the relatively high costs of sperm banking and the low rate of sample use, patients should be counselled on the costs and benefits of sperm banking before treatment for testicular cancer.

Robotic assisted laparoscopic radical prostatectomy versus retropubic radical prostatectomy: a prospective assessment of postoperative pain.

PURPOSE: Laparoscopic prostatectomy, whether or not coupled with robotic assistance, is often considered less invasive than open radical retropubic prostatectomy (RRP). Minimal postoperative pain has been reported following robot assisted laparoscopic prostatectomy (RALP) but there have been few comparative studies with RRP. We compared perioperative narcotic use and patient reported pain in a prospective patient series. MATERIALS AND METHODS: Between June 2003 and May 2004, 314 patients underwent radical prostatectomy at our institution, including RALP in 159, RRP in 154 and conversion in 1. All patients were treated on a postoperative clinical pathway that included 30 mg ketorolac intravenously immediately postoperatively, followed by 15 mg intravenously every 6 hours. No regional anesthesia (epidural/spinal) narcotics or patient controlled analgesic pumps were used. All narcotic use was converted to morphine sulfate equivalents for purpose of analysis. A Likert scale of 0 to 10 was used to assess pain on the day of surgery, and on postoperative days 1 and 14. RESULTS: The total mean morphine sulfate equivalent +/- SD in patients in the RALP and RRP groups was low and, when corrected for length of stay, it was not statistically different (22.41 +/- 1.13 vs 23.01 +/- 1.16 mg, p = 0.72). Mean Likert pain perception scores were low at all time points in the RALP and RRP groups but statistically lower on the day of surgery in the RALP cohort (2.05 +/- 1.99 vs 2.60 +/- 2.25, p = 0.027). Patient reported mean pain scores were almost identical for RALP vs RRP on postoperative days 1 (1.76 +/- 1.87 vs 1.73 +/- 1.77, p = 0.880) and 14 (2.51 +/- 1.91 vs 2.42 +/- 1.84, p = 0.722). CONCLUSIONS: Perioperative narcotic use and patient reported pain are low regardless of the surgical approach used for radical prostatectomy. RALP did not provide a clinically meaningful decrease in pain compared with RRP, primarily because of the low pain scores reported in each group. Outcomes other than pain will ultimately determine the role of laparoscopic radical prostatectomy and RALP.

Single-center comparison of purely laparoscopic, hand-assisted laparoscopic, and open radical nephrectomy in patients at high anesthetic risk.

BACKGROUND AND PURPOSE: The laparoscopic approach for management of high-risk patients with renal-cell carcinoma (RCC) may reduce perioperative and postoperative morbidity. The aim of this study was to compare the outcome of purely laparoscopic radical nephrectomy (LRN), hand-assisted laparoscopic radical nephrectomy (HALRN), and open radical nephrectomy (ORN) for renal tumors in a population of patients at high risk for perioperative complications. PATIENTS AND METHODS: All patients undergoing radical nephrectomy for presumed RCC between August 1999 and August 2001 at Vanderbilt University Medical Center and having an American Society of Anesthesiologists (ASA) score of >/=3 were reviewed. Patients with known metastasis, local invasion, caval thrombi, or additional simultaneous surgical procedures were excluded from analysis. Thirteen patients underwent LRN, eight patients underwent HALRN, and 26 underwent ORN. The patient demographics were similar in the three groups. The groups were compared with regard to intraoperative and postoperative parameters. Statistical analysis was done using chi-square testing for categorical variables and analysis of variance (ANOVA) for continuous variables. Differences in outcomes were examined using ANOVA and Dunnett's T for pairwise comparisons. RESULTS: The ASA 4 patients had significantly longer hospital stays and total hospital costs than the ASA 3 patients. The mean operative time in the ASA 3 patients was similar in the three groups: 2.8 hours, 2.8 hours, and 2.5 hours for the LRN, HALRN, and ORN patients, respectively. Both the LRN patients (22.9 mg of morphine sulfate equivalent) and the HALRN patients (42.1 mg) required less pain medication than the open surgery patients (97.7 mg). When the total hospital costs were compared, LRN was less costly than HALRN ($6089 v $7678; P = 0.57) and open surgery ($6089 v $7694; P = 0.04). The complication rate in the LRN, HALRN, and ORN group was 0%, 25%, and 27%, respectively, although the differences were not statistically different (P = 0.12). CONCLUSIONS: Both LRN and HALRN can be performed safely in patients with significant comorbid conditions. Careful preoperative preparation, intraoperative monitoring, and awareness of laparoscopy-induced oliguria can preclude inadvertent overhydration, hemodilution, and congestive heart failure. Both LRN and HALRN result in less pain medication requirement and faster return to oral intake than ORN, and LRN results in fewer perioperative complications than HALRN or ORN in patients at high perioperative risk. The LRN technique has a 21% lower total cost than both HALRN and ORN.

Health related quality of life assessment after radical cystectomy: comparison of ileal conduit with continent orthotopic neobladder.

PURPOSE: Health related quality of life after urinary diversion has been increasingly recognized as an important outcome measure. However, few studies have directly compared patients with an ileal conduit with those with a continent orthotopic neobladder and even fewer have used validated quality of life instruments. Therefore, we compared health related quality of life in patients who underwent neobladder versus ileal conduit creation using validated questionnaires. MATERIALS AND METHODS: We mailed 2 validated questionnaires that are measures of health related quality of life, namely the RAND 36-Item Health Survey (SF-36) and Functional Assessment of Cancer Therapy-General (FACT-G), to patients who underwent radical cystectomy for urothelial carcinoma between January 1995 and December 1999. Statistical analysis was performed, including univariate and multivariate analysis. RESULTS: A total of 112 patients were available for assessment. A total of 72 (64%) questionnaires were returned, including 23 (32%) and 49 (68%) from patients with an ileal conduit and neobladder, respectively. On the SF-36 questionnaire there were significant univariable relationships between treatment and age (p <0.001 and 0.01, respectively). Younger patients and those with a neobladder had higher health related quality of life scores, including significant differences in 5 of the 9 SF-36 domains (general health, physical functioning, physical health, social functioning and energy/fatigue). There was no relationship between health related quality of life and the final pathological stage (p = 0.25). On multivariate analysis adjusting for age led to a suggestive but nonsignificant difference in health related quality of life scores favoring neobladders (p = 0.09). On the FACT-G there were no significant differences in health related quality of life due to treatment (p = 0.28), pathological stage (p = 0.5), age (p = 0.72) or current disease status (p = 0.27). On the FACT-G 2 of the 4 domains (emotional and functional well-being) were significantly in favor of neobladders. Overall satisfaction was high in the 2 groups with 96% and 85% of patients with a neobladder and ileal conduit, respectively, reporting that they would make the same choice of diversion. CONCLUSIONS: Based on validated health related quality of life instruments these findings suggest that patients with an orthotopic neobladder have marginal quality of life advantages over those with an ileal conduit. However, differences in health related quality of life in the 2 types of urinary diversion are confounded by age since patients who underwent orthotopic diversion were younger and as a result of age would be expected to have a higher health related quality of life score. A prospective longitudinal study of health related quality of life after adjusting for differences in age among patients undergoing urinary diversion is currently underway to extend further these observations.