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Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes.

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 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.

journal_name

Eur Urol

journal_title

European urology

authors

Bochner BH,Dalbagni G,Marzouk KH,Sjoberg DD,Lee J,Donat SM,Coleman JA,Vickers A,Herr HW,Laudone VP

doi

10.1016/j.eururo.2018.04.030

subject

Has Abstract

pub_date

2018-10-01 00:00:00

pages

465-471

issue

eissn

0302-2838

issn

1873-7560

pii

S0302-2838(18)30336-1

journal_volume

pub_type

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Randomized Trial Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: Oncologic Outcomes.