Bernard H Bochner1, Guido Dalbagni2, Karim H Marzouk3, Daniel D Sjoberg4, Justin Lee3, Sheri M Donat2, Jonathan A Coleman2, Andrew Vickers4, Harry W Herr2, Vincent P Laudone2. 1. Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA. Electronic address: bochnerb@mskcc.org. 2. Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Weill Cornell Medical College, New York, NY, USA. 3. Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 4. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Abstract
BACKGROUND:Open radical cystectomy (ORC) has proven to be an important component in the treatment of high-risk bladder cancer (BCa). ORC surgical morbidity remains high; therefore, minimally invasive surgical techniques have been introduced in an attempt to improve patient outcomes. OBJECTIVE: To compare cancer outcomes in BCa patients managed withORC or robotic-assisted radical cystectomy (RARC). DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized trial was completed between 2010 and 2013. Patients were randomized to ORC/pelvic lymphadenectomy (PLND) or RARC/PLND, with all undergoing open/extracorporeal urinary diversion. Median follow-up was 4.9 (IQR: 3.9-5.9) yr after surgery among surviving patients. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Secondary outcomes to the trial included recurrence-free, cancer-specific, and overall survival. RESULTS AND LIMITATIONS: The trial randomized 118 patients who underwent RC/PLND and urinary diversion. Sixty were randomized to RARC and 58 to ORC. Four RARC-assigned patients refused randomization and received ORC; however, an intention to treat analysis was performed. No differences were observed in recurrence (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.69-2.36; p=0.4) or cancer-specific survival (p=0.4). No difference in overall survival was observed (p=0.8). However, the pattern of first recurrence demonstrated a nonstatistically significant increase in metastatic sites for those undergoing ORC (sub-HR [sHR]: 2.21; 95% CI: 0.96-5.12; p=0.064) and a greater number of local/abdominal sites in the RARC-treated patients (sHR: 0.34; 95% CI: 0.12-0.93; p=0.035). The major limitation to this study is that the trial was not powered to determine differences in cancer recurrences, survival outcomes, or patterns of recurrence. CONCLUSIONS: The secondary outcomes from our randomized trial did not definitively demonstrate differences in cancer outcomes in patients treated with ORC or RARC. However, differences in observed patterns of first recurrence highlight the need for future studies. PATIENT SUMMARY: Of 118 patients randomly assigned to undergoradical cystectomy/pelvic lymphadenectomy and urinary diversion, half were assigned to open surgery and half to robot-assisted techniques. We found no difference in risk of recurring or dying of bladder cancer between the two groups.
RCT Entities:
BACKGROUND: Open radical cystectomy (ORC) has proven to be an important component in the treatment of high-risk bladder cancer (BCa). ORC surgical morbidity remains high; therefore, minimally invasive surgical techniques have been introduced in an attempt to improve patient outcomes. OBJECTIVE: To compare cancer outcomes in BCapatients managed with ORC or robotic-assisted radical cystectomy (RARC). DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized trial was completed between 2010 and 2013. Patients were randomized to ORC/pelvic lymphadenectomy (PLND) or RARC/PLND, with all undergoing open/extracorporeal urinary diversion. Median follow-up was 4.9 (IQR: 3.9-5.9) yr after surgery among surviving patients. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Secondary outcomes to the trial included recurrence-free, cancer-specific, and overall survival. RESULTS AND LIMITATIONS: The trial randomized 118 patients who underwent RC/PLND and urinary diversion. Sixty were randomized to RARC and 58 to ORC. Four RARC-assigned patients refused randomization and received ORC; however, an intention to treat analysis was performed. No differences were observed in recurrence (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.69-2.36; p=0.4) or cancer-specific survival (p=0.4). No difference in overall survival was observed (p=0.8). However, the pattern of first recurrence demonstrated a nonstatistically significant increase in metastatic sites for those undergoing ORC (sub-HR [sHR]: 2.21; 95% CI: 0.96-5.12; p=0.064) and a greater number of local/abdominal sites in the RARC-treated patients (sHR: 0.34; 95% CI: 0.12-0.93; p=0.035). The major limitation to this study is that the trial was not powered to determine differences in cancer recurrences, survival outcomes, or patterns of recurrence. CONCLUSIONS: The secondary outcomes from our randomized trial did not definitively demonstrate differences in cancer outcomes in patients treated with ORC or RARC. However, differences in observed patterns of first recurrence highlight the need for future studies. PATIENT SUMMARY: Of 118 patients randomly assigned to undergo radical cystectomy/pelvic lymphadenectomy and urinary diversion, half were assigned to open surgery and half to robot-assisted techniques. We found no difference in risk of recurring or dying of bladder cancer between the two groups.
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