Randomized trial comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: Oncologic outcomes Journal Article


Authors: Bochner, B. H.; Dalbagni, G.; Marzouk, K. H.; Sjoberg, D. D.; Lee, J.; Donat, S. M.; Coleman, J. A.; Vickers, A.; Herr, H. W.; Laudone, V. P.
Article Title: 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. In this secondary analysis of cancer outcomes from our randomized controlled trial, we did not find a difference in overall recurrence rates and cancer-specific survival between open radical cystectomy and robot-assisted radical cystectomy for high-risk bladder cancer. Variations in patterns of recurrence require further study. © 2018 European Association of Urology
Keywords: adult; controlled study; aged; cancer surgery; major clinical study; overall survival; cancer recurrence; squamous cell carcinoma; cancer patient; follow up; antineoplastic agent; pelvis lymph node; pelvis; laparoscopy; prospective study; metastasis; randomized controlled trial; pelvis lymphadenectomy; bladder cancer; cancer survivor; postoperative complication; soft tissue; liver; cancer specific survival; lymph node; radical cystectomy; cystectomy; bone; lung; robotics; neoadjuvant chemotherapy; carcinomatous peritonitis; bladder carcinoma; transitional cell carcinoma; intestine; treatment refusal; urethra; urinary tract; abdominal wall; small cell carcinoma; rectum; recurrence free survival; surgical patient; adrenal gland; secondary analysis; peritoneum; clinical outcome; open surgery; intention to treat analysis; human; male; female; priority journal; article; robot assisted laparoscopic radical cystectomy; robot assisted surgery; open radical cystectomy
Journal Title: European Urology
Volume: 74
Issue: 4
ISSN: 0302-2838
Publisher: Elsevier Science, Inc.  
Date Published: 2018-10-01
Start Page: 465
End Page: 471
Language: English
DOI: 10.1016/j.eururo.2018.04.030
PROVIDER: scopus
PUBMED: 29784190
DOI/URL:
Notes: Article -- Export Date: 1 October 2018 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Jonathan Coleman
    184 Coleman
  2. Vincent Laudone
    59 Laudone
  3. Guido Dalbagni
    250 Dalbagni
  4. Sherri M Donat
    135 Donat
  5. Andrew J Vickers
    556 Vickers
  6. Daniel D. Sjoberg
    138 Sjoberg
  7. Bernard Bochner
    323 Bochner
  8. Harry W Herr
    401 Herr
  9. Justin Ka-Pun Lee
    10 Lee