Study Type - Therapy (cohort) Level of Evidence 2b OBJECTIVE To evaluate the clinicopathological efficacy of neoadjuvant erlotinib (an epidermal growth factor receptor, EGFR, inhibitor) for invasive bladder cancer in patients undergoing radical cystectomy (RC) as despite definitive surgical therapy, only half of patients undergoing RC will have long-term disease-free survival, and effective adjunctive therapies, especially using agents with lower toxicity, would be a significant advance in the treatment of invasive bladder cancer. PATIENTS AND METHODS The primary endpoint of this phase II trial is to determine the effect of neoadjuvant erlotinib (150 mg once daily for 4 weeks) before RC on the pathological complete response rate (pT0 rate) in RC specimens. In addition, the safety of therapy with erlotinib was also evaluated. Patients selected for study included those with histologically confirmed muscle-invasive bladder cancer who had undergone initial transurethral resection. RESULTS In all, 20 patients with clinical stage T2 disease had neoadjuvant erlotinib therapy followed by RC. On surgical pathology, five patients (25%) were pT0; in addition, seven (35%) were clinically down-staged (</=pT1) and 15 (75%) had organ-confined disease at surgical pathology. At a mean follow-up of 24.8 months, 10 patients remain alive and with no evidence of disease, four with organ-confined disease had progression and nine died, including six from disease and three from other causes. Erlotinib was tolerated in all patients, with drug rash being the most common side-effect, in 15 patients (75%). Interestingly, all pT0 and pTis/T1 patients had a rash. CONCLUSIONS The EGFR inhibitor erlotinib, when administered in the neoadjuvant setting, can have beneficial effects in terms of surgical pathology and short-term clinical outcomes in patients undergoing RC for invasive bladder cancer. Analyses are underway to examine the molecular correlates of the apparent clinical effect of neoadjuvant therapy in these patients.

BACKGROUND: Recent small case series have now been reported for robotic-assisted laparoscopic radical cystectomy (RALRC). In most of these series, the urinary diversion has been performed in an extracorporeal fashion. There have been few case reports of an intracorporeal diversion and little description of the technique of such a procedure. OBJECTIVE: In this paper, we report our initial experience with robotic-assisted laparoscopic intracorporeal urinary diversion, describing stepwise the surgical procedure itself and evaluating perioperative and pathologic outcomes of this novel procedure. DESIGN, SETTING, AND PARTICIPANTS: We studied a single-institution case series of patients undergoing robotic-assisted cystectomy and intracorporeal urinary diversion for clinically localized urothelial carcinoma of the bladder (n=10) or for a noncompliant dysfunctional bladder refractory to more conservative management (n=2). Historical comparisons are also made to a consecutive case series of 20 patients undergoing robotic radical cystectomy and extracorporeal urinary diversion. SURGICAL PROCEDURE: RALRC and intracorporeal urinary diversion, including ileal conduit (n=9) and orthotopic ileal neobladder (n=3). MEASUREMENTS: The stepwise operative procedure is described in detail. Outcome measures evaluated in this series included operative variables, hospital recovery, and complication rate. Comparisons were made to a contemporaneous series of 20 patients who underwent a robotic cystectomy with extracorporeal diversion during this time period (from an experience of >100 robotic cystectomy patients since 2005). RESULTS AND LIMITATIONS: Twelve patients (mean age: 60.9 yr) underwent an intracorporeal diversion. Mean operating-room time of all patients was 5.3h, and mean surgical blood loss was 221ml. Mean time to flatus, bowel movement, and hospital discharge was 2.2 d, 3.2 d, and 4.5 d, respectively. Eleven of the 12 patients were discharged on or before postoperative day 5. There were six postoperative complications in five patients (42%), with one complication being Clavien grade 3 or higher. The major limitations of the study are the small sample size and the nonrandomized nature of the compared treatment groups (intracorporeal vs extracorporeal), which limits the ability to directly compare the techniques at a high level of scientific confidence. CONCLUSIONS: Our initial experience with robotic-assisted laparoscopic intracorporeal diversion appears to be favorable with acceptable operative and short-term clinical outcomes.

BACKGROUND: Patients with locally advanced or organ confined, high risk, prostate cancer are at significant risk of having disease recurrence despite definitive local therapy. We evaluated the 2-year progression-free survival of subjects treated with chemotherapy administered prior to definitive therapy with surgery or radiation. PATIENTS AND METHODS: Patients (n = 24) with locally advanced and high risk localized prostate cancer were treated with neoadjuvant docetaxel 36 mg/m2 i.v. weekly for 3 weeks and estramustine 140 mg orally 3 times daily for 3 consecutive days every 28 days prior to definitive treatment with prostatectomy or radiation. RESULTS: All evaluable patients, except 1, completed the proposed cycles of neoadjuvant chemotherapy with minimal dose reductions or delays. Of the 22 evaluable patients, 12 underwent radical prostatectomy and 10 underwent external beam radiation therapy. Twenty-one of 22 patients achieved a prostate-specific antigen (PSA) reduction > 25%. There were no pathologic complete responses. With a median follow-up of 24 months, the 2-year progression-free survival was 45%. CONCLUSIONS: Our findings support the safety, tolerability, and efficacy of neoadjuvant chemotherapy in patients with men with high risk, locally advanced prostate adenocarcinoma, although the relative contributions of androgen deprivation therapy and docetaxel cannot be determined. The effectiveness of neoadjuvant chemotherapy in preventing prostate cancer relapses should be studied in a randomized trial.

PURPOSE: Radical cystectomy remains the most effective treatment for patients with localized, invasive bladder cancer and recurrent noninvasive disease. Recently some surgeons have begun to describe outcomes associated with less invasive surgical approaches to this disease such as laparoscopic or robotic assisted techniques. We report our maturing experience with 100 consecutive cases of robotic assisted laparoscopic radical cystectomy with regard to perioperative results, pathological outcomes and surgical complications. MATERIALS AND METHODS: A total of 100 consecutive patients (73 male and 27 female) underwent robotic radical cystectomy and urinary diversion at our institution from January 2006 to January 2009 for clinically localized bladder cancer. Outcome measures evaluated included operative variables, hospital recovery, pathological outcomes and complication rate. RESULTS: Mean age of this cohort was 65.5 years (range 33 to 86). Of the patients 61 patients underwent ileal conduit diversion, 38 received a neobladder and 1 had no urinary diversion (renal failure). Mean operating room time for all patients was 4.6 hours (median 4.3) and mean surgical blood loss was 271 ml (median 250). On surgical pathology 40% of the cases were pT1 or less disease, 27% were pT2, 13% were pT3/T4 disease and 20% were node positive. Mean number of lymph nodes removed was 19 (range 8 to 40). In no case was there a positive surgical margin. Mean days to flatus were 2.1, bowel movement 2.8 and discharge home 4.9. There were 41 postoperative complications in 36 patients with 8% having a major complication (Clavien grade 3 or higher) and 11% being readmitted within 30 days of surgery. At a mean followup of 21 months 15 patients had disease recurrence and 6 died of disease. CONCLUSIONS: We report a relatively large and maturing experience with robotic radical cystectomy for the treatment of bladder cancer providing acceptable surgical and pathological outcomes. These results support continued efforts to refine the surgical management of high risk bladder cancer.

PURPOSE: Recently robotic approaches to cystectomy have been reported, and while clinical and oncological efficacy continues to be evaluated, potential financial costs have not been clearly evaluated. In this study we present a financial analysis using current cost structures and clinical outcomes for robotic and open cystectomy for bladder cancer. MATERIALS AND METHODS: The financial costs of robotic and open radical cystectomy were categorized into operating room and hospital components, and further divided into fixed and variable costs for each. Fixed operating room costs for open cases involved base cost as well as disposable equipment costs while robotic fixed costs included the amortized machine cost as well as equipment and maintenance. Variable operating room costs were directly related to length of surgery. Variable hospital costs were directly related to transfusion requirement and length of stay. The means of the prior 20 cases of robotic and open cystectomy were used to perform a comparative cost analysis. RESULTS: Mean fixed operating room costs for robotic cases were $1,634 higher than for open cases. Operating room variable costs were also higher by a difference of $570, directly related to increased operating room time. Hospital costs were nearly identical for the fixed component while variable costs were $564 higher for the open approach secondary to higher transfusion costs and longer mean length of stay. Based on these findings robotic cystectomy is associated with an overall higher financial cost of $1,640 (robotic $16,248 vs open $14,608). Cost calculators were constructed based on these fixed and variable costs for each surgical approach to demonstrate the expected total costs based on varying operating room time and length of stay. CONCLUSIONS: Robotic assisted laparoscopic radical cystectomy is associated with a higher financial cost (+$1,640) than the open approach in the perioperative setting. However, this analysis is limited by its single institution design and a multicenter followup study is required to provide a more comprehensive analysis.

BACKGROUND: In recent years, surgeons have begun to report case series of minimally invasive approaches to radical cystectomy, including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge. Despite these experiences and observations, at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent, and the current experiences represent case series with limited comparisons to historical controls at best. OBJECTIVE: We report our results on a prospective randomized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes, complications, and short-term narcotic usage. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are candidates for radical cystectomy for urothelial carcinoma of the bladder. Of the 41 patients who underwent surgery, 21 were randomized to the robotic approach and 20 to the open technique. INTERVENTION: Radical cystectomy, bilateral pelvic lymphadenectomy, and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique. MEASUREMENTS: The primary end point was lymph node (LN) yield with a noninferiority margin of four LNs. Secondary end points included demographic characteristics, perioperative outcomes, pathologic results, and short-term narcotic use. RESULTS AND LIMITATIONS: On univariate analysis, no significant differences were found between the two groups with regard to age, sex, body mass index, American Society of Anesthesiologists classification, anticoagulation regimen of aspirin, clinical stage, or diversion type. Significant differences were noted in operating room time, estimated blood loss, time to flatus, time to bowel movement, and use of inpatient morphine sulfate equivalents. There was no significant difference in regard to overall complication rate or hospital stay. On surgical pathology, in the robotic group 14 patients had pT2 disease or higher; 3 patients had pT3/T4 disease; and 4 patients had node-positive disease. In the open group, eight patients had pT2 disease or higher; five patients had pT3/T4 disease; and seven patients had node-positive disease. The mean number of LNs removed was 19 in the robotic group versus18 in the open group. Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study. CONCLUSIONS: We present the results of a prospective randomized controlled noninferiority study with a primary end point of LN yield, demonstrating the robotic approach to be noninferior to the open approach. The robotic approach also compares favorably with the open approach in several perioperative parameters.

OBJECTIVE: The purpose of this study was to examine the effects of a theory-based decision-making uncertainty management intervention (DMUMI) providing newly diagnosed prostate cancer patients with information, communication skills and personally designed prompts. METHODS: A randomized clinical trial was conducted using a 3x2 design with intervention and control groups including both Caucasian and African-American men. General linear mixed models were used to compare intervention groups over time. RESULTS: Significant main effects for the treatment groups were found for uncertainty management (cancer knowledge, problem-solving, and patient-provider communication), medical communication competence, number and helpfulness of resources for information, and decisional regret. CONCLUSION: The intervention was effective in uncertainty management for Caucasian and African-American men, specifically in preparing competent patients with improved knowledge, problem-solving skills, information resources, and communication skills. Using the Uncertainty in Illness Theory, specific skills were selected with a focus on the antecedents of uncertainty. PRACTICE IMPLICATIONS: In the treatment decision-making context, patients and supportive others need information about disease, treatment options and side effects but they also need communication skills training prior to the treatment decision consultation.

INTRODUCTION: Patients commonly use the Internet to acquire health information. While a large amount of health-related information is available, the accuracy is highly variable. We sought to evaluate the current web-based information that exists with regard to robotic cystectomy. METHODS: Two common search engines (Google and Yahoo) were used to search the term "robotic cystectomy" and obtain the top 50 websites for each. These 100 sites were analyzed with regard to type of site, presence and accuracy of information on bladder cancer, and of information related to robotic cystectomy outcomes (surgical/oncologic, functional, and recovery). In addition, information taken from Intuitive Corp website was identified, as was the presence (or absence) and literature-based references. RESULTS: Of the 100 sites, 61 were surgeon/provider sites, 23 links to articles, 8 news stories, 3 patient support sites, 3 meeting program, and 2 were the Intuitive site. Analysis of all 61 provider sites showed that 13% provided factually accurate information, 7% had both factual and erroneous information, and 80% had no information on bladder cancer. With regard to the purported benefits and outcomes of the robotic approach, a significant number of the sites had nonevidence-based claims with regard surgical/oncologic aspects (54%), functional recovery (26%), and surgical recovery (47%). Information taken directly from the Intuitive site was found on 33% sites, with 16% sites having a direct link. Only 4 provider sites (7%) had listed any references. CONCLUSIONS: These findings suggest that surgeons provide the majority of Internet information but do not often present evidence-based information and often over-state claims and outcomes of the robotic approach. This highlights the need for providers to deliver factual and evidence-based information to the public, and not suggest untrue/unproven claims that seem to presently occur.