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Randomized Controlled Trial
. 2018 Oct;74(4):465-471.
doi: 10.1016/j.eururo.2018.04.030. Epub 2018 May 18.

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

Bernard H Bochner  1 , Guido Dalbagni  2 , Karim H Marzouk  3 , Daniel D Sjoberg  4 , Justin Lee  3 , Sheri M Donat  2 , Jonathan A Coleman  2 , Andrew Vickers  4 , Harry W Herr  2 , Vincent P Laudone  2
Affiliations
Randomized Controlled Trial

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

Bernard H Bochner et al. Eur Urol. 2018 Oct.

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.

Keywords: Bladder cancer; Radical cystectomy; Robotics.

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Figures

Fig. 1 –
Fig. 1 –
Kaplan–Meier risk estimates for recurrence after radical cystectomy for the robotic and open surgery arms. Log-rank p = 0.4.
Fig. 2 –
Fig. 2 –
Kaplan–Meier risk estimates for death from bladder cancer after radical cystectomy for the robotic and open surgery arms. Log-rank p = 0.4.
Fig. 3 –
Fig. 3 –
Kaplan–Meier risk estimates for death after radical cystectomy for the robotic and open surgery arms. Log-rank p = 0.8.
See this image and copyright information in PMC

Comment in

References

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