S. Machele Donat

Defining Early Morbidity of Radical Cystectomy for Patients with Bladder Cancer Using a Standardized Reporting Methodology

BACKGROUND Reporting methodology is highly variable and nonstandardized, yet surgical outcomes are utilized in clinical trial design and evaluation of healthcare provider performance. OBJECTIVE We sought to define the type, incidence, and severity of early postoperative morbidities following radical cystectomy (RC) using a standardized reporting methodology. DESIGN, SETTING, AND PARTICIPANTS Between 1995 and 2005, 1142 consecutive RCs were entered into a prospective complication database and retrospectively reviewed for accuracy. All patients underwent RC/urinary diversion by high-volume fellowship-trained urologic oncologists. MEASUREMENTS All complications within 90 d of surgery were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center complication grading system. Complications were defined and stratified into 11 specific categories. Univariate and multivariate regression models were used to define predictors of complications. RESULTS AND LIMITATIONS Sixty-four percent (735/1142) of patients experienced a complication within 90 d of surgery. Among patients experiencing a complication, 67% experienced a complication during the operative hospital admission and 58% following discharge. Overall, the highest grade of complication was grade 0 in 36% (n=407), grade 1-2 in 51% (n=582), and grade 3-5 in 13% (n=153). Gastrointestinal complications were most common (29%), followed by infectious complications (25%) and wound-related complications (15%). The 30-d mortality rate was 1.5%. CONCLUSIONS Surgical morbidity following RC is significant and, when strict reporting guidelines are incorporated, higher than previously published. Accurate reporting of postoperative complications after RC is essential for counseling patients, combined modality treatment planning, clinical trial design, and assessment of surgical success.

Impact of the number of lymph nodes retrieved on outcome in patients with muscle invasive bladder cancer.

Purpose: We postulate that the number of lymph nodes examined in cystectomy specimens can have an impact on the outcome of patients with bladder cancer.Materials and Methods: We analyzed data on 322 patients with muscle invasive bladder cancer who underwent radical cystectomy and bilateral pelvic lymphadenectomy. We evaluated the associations of the number of lymph nodes identified by the pathologist in the surgical specimen with the local recurrence rate and survival outcome.Results: Patients were divided into groups by lymph node status and the distribution of the number of lymph nodes examined. In stages pN0 and pN+ cases improved survival was associated with a greater number of lymph nodes examined. We determined that at least 9 lymph nodes should be studied to define lymph node status accurately.Conclusions: These results indicate that surgical resection and pathological assessment of an adequate number of lymph nodes in cystectomy specimens increases the likelihood of proper staging and impacts pati...

OUTCOME OF PATIENTS WITH GROSSLY NODE POSITIVE BLADDER CANCER AFTER PELVIC LYMPH NODE DISSECTION AND RADICAL CYSTECTOMY

PURPOSE Should the surgeon proceed with surgery when grossly positive nodes are found at cystectomy? To answer this question, we determine the outcome of patients after radical surgery alone for grossly node positive bladder cancer. MATERIALS AND METHODS A total of 84 patients with grossly node positive (N2-3) bladder cancer found at cystectomy underwent extended pelvic lymph node dissection and have been followed for up to 10 years. The end point of study was disease specific survival. RESULTS Of the 84 patients 20 (24%) survived and 64 (76%) died of disease. Median survival time was 19 months for all patients and 10 years for surviving patients. Of 53 patients with clinical stage T2 (organ confined) tumors 17 (32%) survived versus 3 of 31 (9.7%) with stage T3 (extravesical) tumors. CONCLUSIONS A proportion of patients with grossly node positive bladder cancer can be cured with radical cystectomy and thorough pelvic lymph node dissection.

Age‐adjusted Charlson comorbidity score is associated with treatment decisions and clinical outcomes for patients undergoing radical cystectomy for bladder cancer

By using the age‐adjusted Charlson comorbidity index (ACCI), the authors characterized the impact of age and comorbidity on disease progression and overall survival after radical cystectomy (RC) for transitional cell carcinoma of the bladder. Also evaluated was whether ACCI was associated with clinicopathologic and treatment characteristics.

Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial

BACKGROUND Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk. OBJECTIVE To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques. DESIGN, SETTING, AND PARTICIPANTS A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively. INTERVENTION Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score. RESULTS AND LIMITATIONS The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings. CONCLUSIONS This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique. PATIENT SUMMARY Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.

Potential Impact of Postoperative Early Complications on the Timing of Adjuvant Chemotherapy in Patients Undergoing Radical Cystectomy: A High-Volume Tertiary Cancer Center Experience

BACKGROUND Perioperative cisplatin combination chemotherapy is associated with a survival benefit in patients with invasive bladder cancer (BCa). However, in a recent report from the National Cancer Database (NCDB), only 11.6% of stage III BCa patients received perioperative chemotherapy, the majority in the adjuvant setting. OBJECTIVE We explore the impact of postoperative complications on the timing of adjuvant chemotherapy. DESIGN, SETTING, AND PARTICIPANTS An independent review board approved the review of 1142 consecutive radical cystectomies (RC), and data from these cases were entered into a prospective complication database (1995-2005) which was utilized and retrospectively reviewed for accuracy at a single, academic, tertiary cancer center. INTERVENTIONS All patients underwent RC/urinary diversion by high-volume, fellowship-trained, urologic oncologists. MEASUREMENTS All complications within 90 d of surgery were defined and graded using a five-grade modification of the original Clavien system utilized at Memorial Sloan-Kettering Cancer Center and stratified into 11 categories. Grade 2-5 complications typically prohibit starting adjuvant chemotherapy. Univariate and multivariable logistic regression were used to evaluate variables associated with complications. RESULTS AND LIMITATIONS Overall, 64% (735 of 1142 patients) experienced one or more complications, of which 83% (611 of 735) were grade 2-5. Furthermore, 57% of grade 2-5 complications (347 of 611) occurred between discharge and 90 d, 38% (233 of 611) within 6 wk, and 19% (114 of 611) between 6 wk and 12 wk, the general time frame for adjuvant chemotherapy. Overall, 26% (298 of 1142 patients) required readmission. Surgical morbidity at a high-volume tertiary cancer center may not reflect the case mix or surgical experience seen in the community setting. CONCLUSION This series demonstrates that 30% of patients (347 of 1142) undergoing RC may not have been able to receive adjuvant chemotherapy due to postoperative complications. This information should be taken into consideration when planning multimodal therapy and further supports the use of perioperative chemotherapy in the neoadjuvant setting.

A comparison of white-light cystoscopy and narrow-band imaging cystoscopy to detect bladder tumour recurrences

To determine whether narrow‐band imaging (NBI) cystoscopy enhances the detection of non‐muscle‐invasive bladder tumours over standard white‐light imaging (WLI) cystoscopy, as surveillance WLI is the standard method used to diagnose patients with recurrent bladder tumours, but they can be missed by WLI cystoscopy, possibly accounting for early recurrences.

POST-CHEMOTHERAPY SURGERY IN PATIENTS WITH UNRESECTABLE OR REGIONALLY METASTATIC BLADDER CANCER

PURPOSE We update our experience with post-chemotherapy surgery in patients with unresectable or lymph node positive bladder cancer. METHODS Of 207 patients with unresectable or regionally metastatic bladder cancer 80 (39%) underwent post-chemotherapy surgery after treatment with a cisplatin based chemotherapy regimen. We assessed the impact of surgery on achieving a complete response to chemotherapy and on relapse-free survival. RESULTS No viable cancer was present at post-chemotherapy surgery in 24 of the 80 cases (30%), pathologically confirming a complete response to chemotherapy. Of the 24 patients 14 (58%) survived 9 months to 5 years. Residual viable cancer was completely resected in 49 patients (61%), resulting in a complete response to chemotherapy plus surgery, and 20 (41%) survived. Post-chemotherapy surgery did not benefit those who failed to achieve a major complete or partial response to chemotherapy. Only 1 of the 12 patients (8%) who refused surgery remains alive. CONCLUSIONS Post-chemotherapy surgical resection of residual cancer may result in disease-free survival in some patients who would otherwise die of disease. Optimal candidates include those in whom the pre-chemotherapy sites of disease are restricted to the bladder and pelvis or regional lymph nodes, and who have a major response to chemotherapy.

Quality control in transurethral resection of bladder tumours

Transurethral resection (TUR) is the essential surgical procedure used to diagnose, stage and treat primary and recurrent non-muscleinvasive bladder tumours. TUR of bladder tumours (TURBT) is both a diagnostic and a therapeutic operation. The initial TURBT has three main goals: to provide pathological material to determine the histological type and grade of bladder tumours, to determine the presence, depth, and type of tumour invasion (broad front or tentacular), and to remove all visible and microscopic superficial and invasive tumours. The findings are used to direct additional therapy, dictate follow-up schedules, and indicate prognosis.

Radical Cystectomy in Octogenarians—Does Morbidity Outweigh the Potential Survival Benefits?

PURPOSE Surveillance, Epidemiology, and End Results data indicate only 19.7% of patients 80 years old or older with muscle invasive bladder cancer undergo radical cystectomy vs 49.4% of those with similar stage disease age 65 to 79 years, reflecting concern for perioperative morbidity. We evaluated the morbidity and survival outcomes of octogenarians treated with radical cystectomy at a tertiary cancer center. MATERIALS AND METHODS We conducted a retrospective review of 1,142 patients entered prospectively into a hospital based complication database between 1995 and 2005 using a modified Clavien system. Complications were classified as minor or major based on the complexity of intervention required. Disease specific and competing risk survival curves for patients younger than 80 years vs 80 years old or older were created. RESULTS Octogenarians had a nonsignificantly higher rate of minor (55% vs 50%) and major complications (17% vs 13%) than younger patients, respectively (global p = 0.15). After adjusting for baseline characteristics the risk of any complication was roughly flat across all ages (p = 0.9). For major complications risk appeared to increase slightly up to age 65 years and then plateau (p = 0.16). After adjusting for deaths from other causes the cumulative incidence of death from bladder cancer in octogenarians was comparable to that in younger patients (5-year cumulative incidence of death from bladder cancer 26% vs 25%). CONCLUSIONS In our experience radical cystectomy in older patients with bladder cancer provides similar disease control and survival outcomes with risks of high grade perioperative morbidity comparable to those in younger patients, and remains an important treatment option.