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 ...
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 patient outcome. Such information is important not only for the therapy and prognosis of individuals, but also for identifying those who may benefit from adjuvant chemotherapy.
Evaluation for patients on active surveillance and following definitive therapy for renal neoplasms should include physical examination, renal function, serum studies and imaging and should be tailored according to recurrence risk, comorbidities and monitoring for treatment sequelae. Expert opinion determined a judicious course of monitoring/surveillance that may change in intensity as surgical/ablative therapies evolve, renal biopsy accuracy improves and more long-term follow-up data are collected. The beneficial impact of careful follow-up will also need critical evaluation as further study is completed.
BACKGROUND. 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. METHODS. The authors evaluated 1121 patients treated by RC for transitional cell carcinoma of the bladder at a single institution (1990–2004). Logistic regression was used to determine the relation between ACCI and clinical features. They evaluated the association between ACCI and overall and progression‐free survival by using multivariate survival‐time models with pathologic stage and nodal status as covariates. RESULTS. ACCI scores increased during the study period (P = .009). Extravesical disease was present in 43% of patients with ACCI ≤2, 49% with ACCI 3–5, and 56% with ACCI >5 (P = .051). Despite their higher prevalence of extravesical disease, patients with higher ACCI were less likely to have lymph‐node dissection (odds ratio, 0.55 and 0.35, respectively, for ACCI 3–5 and >5 vs ≤2; P = .005), and when it was performed, fewer lymph nodes were evaluated (P < .0005). Patients with higher ACCI were also less likely to have postoperative chemotherapy (odds ratio, 0.70 and 0.66, respectively, for ACCI 3–5 and >5 vs ≤2; P = .04). Higher ACCI was significantly associated with lower overall (P < .005) but not recurrence‐free (P = .17) survival after RC. CONCLUSIONS. Age and comorbidity among patients who underwent RC at a cancer referral hospital increased with time. Both age and comorbidity were associated with treatment selection and survival and should, therefore, be considered when comparing outcomes after RC. Cancer 2008. © 2008 American Cancer Society.
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